December 6, 2021

Johnson & Johnson released results from a study showing the benefits of getting a J&J booster six months after being vaccinated with the Pfizer-BioNTech Covid vaccine. The new results are more evidence that mixing vaccine types can be beneficial.

The study found that both antibody and T-cell levels increased more following the J&J booster than from a Pfizer booster. Antibodies and T-cells are two different ways that the immune system fights against the coronavirus that causes Covid-19.

The U.S. FDA and CDC have both allowed individuals to "mix-and-match" boosters, where the booster shot is a different vaccine than the original Covid vaccine shots.

Gradually, more and more evidence is accumulating that a mix-and-match approach can provide robust protection against Covid, perhaps even more robust than taking a third shot from the same manufacturer.

October 30, 2021

Children under 12 years will finally be able to get vaccinated against Covid-19, now that the U.S. FDA has approved the Pfizer-BioNTech vaccine for those aged 5 to 11. After an expected recommendation by the CDC, wide availability is expected across the U.S.

The new approval could signal a giant step towards bringing schools into the post-pandemic era, since now all students in grades 1 through 12 can be vaccinated, as well as teachers and staff.

Like adults receiving the vaccine, the under-12's will get two shots, given three weeks apart. However, due to the smaller size of these children, each shot will have a smaller amount of vaccine than is given to adults.

The FDA's approval was in the form of an Emergency Use Authorization (EUA), which the FDA has been using for the initial approval stage for the various Covid vaccines. In August, the FDA granted full approval for the Pfizer-BioNTech vaccine to be given to those ages 16 and up.

October 20, 2021

The U.S. FDA approved booster shots for people who originally received either the J&J or Moderna vaccine. Until now, boosters have only been approved in the U.S. for those who had the Pfizer vaccine.

In another first, the booster shot can be from a different vaccine producer than the original shot. Previously, the FDA only allowed a third Pfizer shot for those who had received the two-shot treatment of Pfizer vaccine.

There are some indications that a booster of a different vaccine can enhance the extra immunity produced. For example, people who received the J&J vaccine may get higher protection by taking a Pfizer or Moderna booster than from a J&J booster. These results are preliminary and need further confirmation.

The FDA did not express a preference about whether the booster should match the original vaccine, but will leave that decision to individuals and their doctors.

Moderna proposed using a half-dose of vaccine as a booster shot, and the FDA's approval was for a half-dose booster, although using a full doses could provide even higher protection.

October 10, 2021

New data from Johnson & Johnson show that a booster shot of their Covid vaccine increases its protection to 94% effectiveness against getting sick with Covid-19. It was also 100% effective in preventing death from Covid in the test group. A J&J booster is a second shot, since the vaccine is given as a single shot.

Such high effectiveness means that booster shots can keep the population safe against renewed outbreaks of Covid-19, even against the recently seen variants of the SARS-CoV-2, the virus that causes Covid.

The company submitted the new data to the U.S. FDA, which will consider approving booster shots for people who received the vaccine originally. J&J is recommending booster shots six months after the first shot.

The data was based on giving boosters two months after the first shot, but J&J feels that six months after is enough to maintain high protection against Covid illness or death.

September 23, 2021

Pfizer and BioNTech announced that their vaccine is highly effective - and safe - for children aged from 5 to 11 years old, based on a recently completed study. The companies are submitting the data to the U.S. FDA, which could approve the use of the vaccine by children by the end of October.

Approval of a vaccine for the 5-to-11 age range would be a huge step forward for keeping schools safe from Covid outbreaks, since elementary school children would become eligible for vaccination. This means that an entire school district population, including all students, staff, and teachers, could be vaccinated.

The children in the study received two shots of the Pfizer-BioNTech vaccine, three weeks apart. Each shot contained 10 micrograms of the vaccine, which is one-third the dose given to people aged 12 and up. Over 2,000 children participated in the study.

Pfizer said that the antibody response seen in the participating children was similar to that seen in teenagers and young adults who receive the vaccine.

Pfizer is also conducting vaccine trials for children less than 5 years old, although those results are probably still a few months away.

August 23, 2021

The U.S. FDA today gave full approval to the Pfizer-BioNTech vaccine for Covid-19. It is the first Covid vaccine to be granted full approval, the other vaccines being approved under an Emergency Use Authorization (EUA). The Pfizer-BioNTech had EUA status until this current FDA action.

The full approval includes vaccine use for all people age 16 and over. Youth aged 12 to 15 can still receive the vaccine under the existing EUA. Pfizer is expected to request full authorization for the younger age group after it collects more data about the vaccine's use by the under-16s.

Many health and civic leaders are hopeful that full authorization will convince more people that getting the vaccine is safe. The FDA Commissioner Janet Woodcock commented, "Today's milestone puts us one step closer to altering the course of this pandemic."

Pfizer and BioNTech are also testing the vaccine on children age 11 and under, and such use could be granted emergency authorization by the FDA in the coming months.

Some U.S. government officials have started to recommend a third, "booster" shot of the Pfizer-BioNTech vaccine eight months after receiving the second shot. Not all health officials are convinced that this step is necessary, however.

August 17, 2021

New data show that a third shot of the Pfizer-BioNTech vaccine is 86% effective for people over age 60. The data come from Israel, which has been giving third doses to many older members of the population, in response to an increase in Covid cases from the Delta variant.

An Israeli health care provider looked at almost 150,000 people over 60 who received a third dose, and compared the prevelance of Covid among them to those who only got two shots.

Israel originally gave the Pfizer vaccine to large parts of its population in January and February 2021; it was one of the first countries to vaccinate a large proportion of its people. If the effectiveness of the original shots has started to fade, a third shot may be appropriate for some people.

Israeli health care providers have started giving third shots to older citizens, to protect them from Covid and to stamp out the new wave of infections.

The new data provides reassurance the the existing vaccines can be effective in stopping outbreaks of the Delta variant of Covid.

August 7, 2021

A large real-world study has released data showing that people who received the single-shot J&J vaccine were 98% protected against severe Covid, even in the case of breakthrough infections by the Delta variant.

The study was conducted among over 450,000 health care workers in South Africa, where the Delta variant has become the dominant strain of the virus that causes Covid-19. The "vast majority" of breakthrough cases were mild, the study investigators said.

The results confirm that the J&J vaccine remains highly effective in protecting people from getting seriously ill or dying from Covid, even in places where the disease is primarily caused by the Delta variant of SARS-CoV-2, the virus that causes Covid-19.

Combined with other results showing that protection by the J&J vaccine lasts at least eight months, the data also imply that booster shots are not needed at this time.

Unlike some other Covid vaccines, the J&J vaccine only requires one shot, and can be stored for months in an ordinary refrigerator. These qualities make the vaccine a key tool in helping South Africa and other African countries fight Covid.

July 29, 2021

Moderna released data showing that a single booster shot of its vaccine provides increased protection against Covid. In addition to using its original vaccine, the company also tested a modified version designed to fight the virus variant first seen in South Africa.

In an ongoing Phase 2 Trial, a booster from either the original vaccine or the modified version increased antibody levels, indicating hightened protection against infection. However, the modified booster gave better protection against B.1.351, the so-called South African variant, than a booster of the original vaccine.

In the trial, the booster shots were seen to be equally as safe as the original two shots of the vaccine.

Because the Moderna vaccine is created using messenger RNA, known as mRNA, new vaccine variants can quickly be created to target new or concerning variants of SARS-CoV-2, the virus that causes Covid-19.

It is not clear if a vaccine variant will be needed against the Delta variant, since data show that the existing Moderna vaccine is effective in protecting against Delta. It is possible that a booster shot of the vaccine could be recommended to help stop the spread of the Delta variant.

July 21, 2021

A new study shows that the Pfizer-BioNTech vaccine is strongly effective against the Delta variant of SARS-CoV-2, the virus that causes Covid-19. The vaccine is 88% effective in preventing symptomatic illness against Delta, close to its 94% effectiveness against the orignal virus variant, now known as the Alpha variant.

The same study also reports that the AstraZeneca vaccine is 67% effective against Delta, again close to its 74% effectiveness against Alpha.

These results add to evidence that the current vaccines remain highly effective against the Delta variant, almost as effective as against the original virus. There has been concern about the Delta variant because it has been spreading more quickly than other variants, and has become the most common strain of the virus in the world.

The study, published in the New England Journal of Medicine, was based on Covid cases in the U.K., where virus identification is commonly done, and where the Delta variant is now causing the majority of Covid cases.

July 6, 2021

Two new studies point to the high effectiveness of J&J's vaccine against the Delta variant of the virus that causes Covid. The Delta variant, first seen in India, has caused concern due to its rapid spread in several countries. The studies also showed the vaccine to be effective against other variants, including Beta and Gamma.

In one of the studies, the J&J vaccine had a higher measured effectiveness against the Delta than against the Beta variant, which was first seen in South Africa. This study compared antibody activity levels against the different variants of SARS-CoV-2, the virus that causes Covid-19.

The other study looked at the length of protection of the vaccine, and found that a single shot of the J&J vaccine was still effective eight months after being given. The study found that the level of protective antibodies stimulated by the vaccine remained high at the eight month mark.

This second study also showed that protective T-cells also last at least eight months after the vaccine is given. The actual length of protection could be much longer, but data confirming that is not yet available.

Both studies were small and need to be followed up by larger studies to confirm the results.

June 15, 2021

A late-stage trial of the Covid-19 vaccine from Novavax has shown it to be 90% effective in preventing illness, and 100% effective in preventing severe cases of Covid. The trial had about 30,000 participants. Only mild side effects appeared among the participants.

Since three other Covid vaccines have already been approved for use in the U.S., the new vaccine is more urgently needed elsewhere, leading Novavax to apply for regulatory approval in other countries before seeking FDA approval in the U.S.

The vaccine could be approved in the E.U., the U.K., and in India, with U.S. approval following in the fall of 2021.

Another possibility is that the new vaccine could be used for booster shots in the U.S., if Covid immuninity is found to be fading among people who received another vaccine in early 2021. Some scientists believe that a booster from a different vaccine than the original shot would be best for extending robust protection.

Novavax has partnered with various vaccine manufacturing companies, and said it will quickly ramp up high-volume production. It plans to be producing 150 million doses per month by the end of 2021.

May 27, 2021

Moderna released results from its vaccine trial in teens ages 12 through 17, showing an effectiveness of 93% in preventing symptomatic Covid two weeks after participants received the second dose of the vaccine. The trial included over 3,700 participants in the U.S.

The company said it plans to submit its vaccine to regulators early in June to seek approval for use by all people ages 12 and older. Moderna will continue collecting data on the vaccine recipients in the meantime.

In addition to the effectiveness, the results showed the vaccine to be safe, with no serious side effects appearing.

Pfizer's Covid vaccine has already been approved by the FDA for use by people 12 and older. The additional approval of MOderna's vaccine will help speed the vaccination of the overall population. A higher percentage of vaccinated children will also help more schools to reopen in the fall for face-to-face learning.

May 10, 2021

The U.S. FDA today approved the Covid-19 vaccine from Pfizer and BioNTech for adolescents and teens ages 12 to 15 years old. It is the first Covid vaccine approved in the U.S. for those younger than 16.

The approval adds a large segment of the population to those eligible for vaccination, and will increase the proportion of the population vaccinated over the next few months.

The two companies conducted a trial with over 2,000 participants, with half given the vaccine and half given a placebo. Each participant was given two shots, three weeks apart. There were 18 cases of symptomatic Covid among those who got the placebo, and zero cases among those who got the real vaccine.

The trial also shows the vaccine to be safe for adolescents, with side effects similar to those seen in young adults. The effectiveness if anything seems to be higher in adolescents than in adults, although the new trial was too small to be sure.

Pfizer and BioNTech are currently conducting a trial of the vaccine in children ages 2 to 11 years old. They could ask the FDA to approve the vaccine for that age group as soon as September, if the data show it to be safe and effective, as they expect.

May 2, 2021

The CDC released results from a study showing that the Pfizer-BioNTech and Moderna vaccines are, combined, 94% effective in preventing hospitalizations due to Covid-19 among the over-65 population. The data, measured among the general population, confirms the powerful benefits of these vaccines that were estimated in clinical trials.

The study was relatively small, looking at just over 400 Covid patients, aged 65 or over, admitted to hospitals during the first three months of 2021. About half of the patients were 75 or older.

A single shot of one of the vaccines reduced the chance of Covid hospitalization by 64% among over-65s. The second shot therefore provided a full 30% additional reduction in the chances of hospitalization, emphasizing the benefit of getting the second shot.

The study examined Covid hospitalizations at 24 hospitals across 14 states in the U.S.

Although Covid hospitalization does sometimes occur in older adults who have been vaccinated, their risk goes down by a factor of 20, according to this new data. Such a dramatic reduction can secure the hospital system against being overwhelmed by Covid patients.

April 19, 2021

In one of the first studies of Covid vaccine effectiveness in real-world conditions - not in clinical trials - the two mRNA vaccines, by Moderna and Pfizer-BioNTech, were measured to be approximately 90% effective in preventing Covid-19. The first shot of an mRNA vaccine was measured at 80% effectiveness.

In the study, almost 4,000 essential workers were monitored as they received first one, and later a second, shot of either of the two mRNA vaccines, starting in mid-December 2020. About 75% of the participants received at least one vaccine dose. All participants were tested weekly for infection with SARS-CoV-2, the virus that causes Covid-19.

These two vaccines previously had shown about 95% effectiveness in Phase 3 clinical trials. It is important to also study the effectiveness of medical treatments after rollout to the public, where there may be diffences from the clinical trials in population or conditions.

There were only 3 Covid cases among study participants who had received both vaccine doses, and merely 16 cases among those who received a single dose. But there were 161 cases among participants who had not received any vaccine.

The two mRNA vaccines were studied as a group, and separate measurements were not made.

April 9, 2021

Johnson & Johnson announced that it is expanding the ongoing Covid vaccine trial to include teenagers and adolescents aged 12 to 17. The Phase 2a trial is testing both single-shot and double-shot vaccinations, and testing various time intervals between two shots.

The trial started in September, 2020, with participants aged 18 to 55. The new expansion is starting with teenagers ages 16 and 17, then will expand to younger adolescents after confirming there are no safety issues with the teenagers.

The FDA has authorized use of the J&J vaccine for those 18 and older. Expanding to teens and adolescents would extend vaccination to a huge portion of the population that is not currently eligible for it. Vaccinating teens and kids would be a major milestone on the way to opening schools on time in the fall of 2021.

The first new teen participants are joining the trial from Spain and the U.K. Later on, teens and adolescents in the U.S., Canada, and the Netherlands will be able to join.

March 31, 2021

In another extremely positive set of vaccine results, new data from a Phase 3 trial of the Pfizer-BioNTech vaccine in children aged from 12 to 15 showed that it was 100% effective in blocking symptomatic cases of Covid-19. Half of the 2,260 adolescents in the trial received the vaccine, and none of those developed Covid. In the half that received a placebo instead, 18 developed Covid.

Covid antibody levels were also meaasured, and were found to be even higher in the adolescents who received the vaccine than in young adult recipients. Side effects were minor, and occurred at the same frequency among the adolescents as among teenagers and young adults.

The Pfizer-BioNTech vaccine is currently authorized in the U.S. for people aged 16 and over. The companies will now file a request with the FDA to authorize use on those ages 12 and up. The vaccine could be approved in time to vaccinate adolescents before they return to school in the fall.

The companies also recently started testing the vaccine on children younger than 12. Those results are expected in a few months. Moderna also has an ongoing trial of its Covid vaccine for teenagers aged 12 to 18.

March 27, 2021

The two companies behind one of the most successful of the current Covid-19 vaccines are launching tests to find safe and effective doses that can be given to children as young as six months. If successful, the vaccine could be given to children before the end of 2021, and later become another routine childhood vaccination.

The tests are a follow-on to an ongoing trial of the vaccine for children ages 12 to 15. Results from that trial could be reported in June, resulting in approval during the summer for the vaccine to be given to everyone 12 and older. Currently the Pfizer-BioNTech vaccine is approved for those 16 and older.

To avoid side effects in younger children, small doses of the vaccine in various sizes will be given to small groups during the first phase of the upcoming tests. When the correct dosage level is found - both effective and with minimal side effects - larger trials will begin. Researchers will measure the amount of antibodies produced to estimate effectiveness.

If the trials go according to plan, results could be reported during the fall of 2021, with an FDA emergency approval following shortly thereafter.

March 23, 2021

Data from a 32,000-person trial of AstraZeneca's Covid vaccine being conducted in the U.S. and other countries has found it to be 79% effective in preventing sympomatic cases of Covid-19, and 100% effective in preventing hospitalizations and deaths from Covid. The study also found the vaccine to be safe, with no evidence of blood clots or other serious health complications.

In the Phase 3 trial, two-thirds of the participants received two shots of the vaccine, while the other third received a placebo. None of those receiving the vaccine developed a severe case of Covid-19.

The trial is still continuing, and further analysis will be done after more data is gathered.

Although 79% is somewhat lower than the effectiveness measured in earlier trials of vaccines from Moderna and Pfizer, the current AstraZeneca trial is being done in the presence of several new variants of SARS-CoV-2, the virus that causes Covid-19. Considering these different circumstances, many experts say the AstraZeneca vaccine is roughly as effective as those other vaccines.

AstraZeneca designed its vaccine to be inexpensive to manufacture and easy to store. It can be kept at normal refrigeration for up to six months.

March 13, 2021

New results from Novavax's late-stage trial in the U.K. show that its vaccine is 96% effective against the orginal version of SARS-CoV-2, the virus that causes Covid-19, and is 86% effective against the newer variant that has spread widely in the U.K. There were no instances of severe Covid cases, or deaths, among the vaccine recipients.

The vaccine was 55% effective in South Africa, where a different variant of the virus has been spreading widely. Despite the lower effectiveness rate, there were no severe cases or deaths among vaccine recipients in South Africa.

The results are from a trial in the U.K. with more than 15,000 participants.

Novavax has also been conducting a trial in the U.S. and Mexico with about 30,000 participants, with results expected in early April. Timing for U.S. approval depends on whether the U.S. regulators agree to include the U.K. results in the approval submission data. If they do, U.S. approval could occur as soon as May, 2021.

The Novavax vaccine is administered in two shots.

March 3, 2021

In a rare case of cooperation among rivals in face of the Covid pandemic, pharma giant Merck will manufacture tens of millions of doses of J&J's new vaccine. The deal, pushed along by the White House, paves the way for an acceleration in the rate of vaccinations in the U.S.

Although J&J had planned for quick production of vast numbers of doses, its manufacturing efforts ran into unspecified roadblocks, leaving vaccine delivery plans behind schedule. By adding Merck to the the effort, the joint effort should quickly ramp up to compensate for the earlier delays.

Merck is one of the largest vaccine manufacturers in the world. Earlier, it had attempted to create its own Covid vaccine, but that project was dropped after disappointing early results.

The U.S. government is taking other steps to enable J&J to ramp up its own vaccine production. The new logistical support, using a wartime law called the Defense Production Act, will allow J&J to produce vaccine doses around the clock.

President Biden compared the cooperation among industrial rivals to similar efforts that occurred during World War II.

February 27, 2021

The FDA today granted Emergency Use Authorization (EUA) for the Covid-19 vaccine developed by Johnson & Johnson. It becomes the third Covid vaccine approved in the U.S., and the first that requires only a single shot.

The new vaccine can also be stored for three months at normal refrigeration temperatures, making it much easier to transport and administer than the two previously approved vaccines. This could make the J&J vaccine the preferred choice in areas where maintaining subzero temperatures across a delivery chain would be difficult.

The FDA examined all the data from J&J's large Phase 3 trial, which included over 44,000 participants around the world. It measured the vaccine to be 100% effective at preventing hospitalizations and deaths from Covid, and 72% effective at preventing moderate cases.

The new vaccine also had a lower rate of side effects than other vaccines.

J&J has said it can ship around four million doses within the U.S. right away, 16 million by the end of March, and 100 million by the end of June. Because it only takes one shot, this new vaccine can significantly accelerate the task of vaccinating the entire population against Covid-19.

February 22, 2021

The FDA announced that it will not require lengthy trials before approving updated vaccines that target new variants of SARS-CoV-2, the virus that causes Covid-19. The announcement clears the way for rapid vaccine updates if mutations make the virus more infectious or more harmful.

Due to the long trials that led up to the FDA approval of the original vaccines, a great deal is already known about the effectiveness and safety of the vaccines, and these should not be greatly changed due to the updates.

The companies producing the vaccines will still need to conduct studies that measure the immune response of the new versions of the vaccines against the new variants of the virus. The FDA will examine the results of those studies. Even including these new studies, the process should be much faster than the large-scale Phase 3 trials that were done before the original FDA approval.

All viruses mutate, and recent mutations of the Covid-causing virus seem to make the virus spred more easily. Updating the vaccines might be necessary to keep blocking Covid effectively.

February 5, 2021

Data from a U.K. trial of a Covid-19 vaccine from biotech company Novavax show it to be 90% against SARS-CoV-2, the virus that causes Covid. The high effectiveness raises hope that the vaccine will be added to the arsenal of highly effective vaccines fighting the virus.

The results are still preliminary, as the trial is continuing and more data is needed to fully confirm these early numbers.

Another question is whether the vaccine remains as effective against a variant of the virus that has been found in South Africa. A small trial in that country has given early indication that the level of effectiveness may drop to approximately 50%. Further study of this point is needed, and the vaccine could be modified to increase its power against the virus variant.

Novavax is conducting an even larger trial of its vaccine in North America, and more than 20,000 participants have been enrolled in the United States and Mexico. The company said it could have early data from that trial as soon as April, followed by submission to the FDA not long after that.

The Novavax vaccine is one of several that have been supported in the U.S. by Operation Warp Speed, a government initiative to spur development of Covid-19 vaccines. The vaccine is given in two shots, and can be stored at normal refrigerator temperatures.

January 29, 2021

J&J today released long-awaited data from the large-scale trial of its single-shot Covid vaccine, showing 85% effectiveness in preventing severe cases of Covid-19. Overall the vaccine was 66% effective worldwide against moderate or worse cases, and 72% in the U.S. There were over 44,000 participants in the trial.

J&J's is the only major vaccine effort that requires only one dose, making it much faster to innoculate large populations than the other vaccines which require people to come back for a second dose before being fully protected.

The trial also confirmed the safety of the new vaccine.

Even better, the new vaccine can be kept at normal refrigeration temperatures for up to three months. This is a much easier storage requirement than is needed for the mRNA vaccines already on the market, which require significantly colder, frozen storage. These factors make the new vaccine extremely promising for quick, large-scale rollout across the world.

Like the other approved vaccines, J&J's vaccine targets the spike protein on the outside of SARS-CoV-2, the virus that causes Covid-19. In the new vaccine, a piece of DNA that encodes the spike protein is carried inside a different type of virus, an adenovirus, that has been configured to enter cells but not replicate.

The company said it would apply for emergency approval from the FDA within days. J&J is also testing a two-shot version of the vaccine, which should increase its effectiveness even further.

January 25, 2021

A new experimental Covid vaccine is about to start human testing, says biotech firm Gritstone Oncology, producer of the vaccine. Although there are already effective vaccines, the new one could become a valuable weapon if mutations of the virus reduce the effectiveness of the current vaccines.

The existing Covid vaccines target the spike proteins on the surface of SARS-CoV-2, the virus that causes Covid-19. The new vaccine candidate from Gritstone targets proteins elsewhere on the virus. This approach can allow it to be effective even if the spike protein changes to elude the existing vaccines.

The company worked with the La Jolla Institute for Immunology (LJI) to identify promising antigen targets on the virus, apart from the spike protein. The antigens they selected are located in areas of the virus that seem to remain stable despite mutations in the virus.

In laboratory tests the new vaccine successfully produced strong immune responses against the virus.

The trial for the Gritstone vaccine is an early-stage, Phase 1 trial with approximately 70 participants. If successful, it will be followed by a larger-scale trial to confirm both effectiveness and safety.

January 15, 2021

Newly published results from an early stage trial of J&J's one-shot Covid-19 vaccine shows that the single shot provoked a strong and long-lasting immune response in the recipients. A single-shot vaccine would allow a much faster and simpler rollout to the broad population compared to two-shot vaccines.

The new data, published in the New England Journal of Medicine, show that over 90% of vaccine recipients generated neutralizing antibodies - cells that are key to the body's defense against the virus - within 30 days, and all 100% within 60 days. The antibodies lasted for at least 71 days, which was the length of the phase 1/2 trial.

J&J is currently conducting a large late-stage trial of the vaccine with about 45,000 participants. Results from that trial are expected around the end of January. The new results from the earlier trial, with about 800 participants, also confirmed the safety of the vaccine, with only minor side effects appearing among recipients.

These results bolster expectations that the next set of data will show show high effectiveness, perhaps 80% or more. FDA approval of the vaccine could come as soon as late February.

The J&J vaccine can be stored at normal refrigerated temperatures for three months, a fact which, combined with its single-shot nature, will greatly ease the logistics of getting large populations vaccinated.

January 12, 2021

A trial of a Chinese vaccine in Brazil has led officials there to conclude that the vaccine is 78% effective in preventing Covid-19. The results will likely lead to the vaccine's approval in Brazil. None of the vaccine recipients in the trial contracted contracted serious cases of Covid.

The vaccine, called CoronaVac, is made by Chinese company Sinovac, based in Beijing. The company is producing doses of the vaccine as quickly as possible, and will supply millions of doses to Brazil and other countries.

Chinese companies have developed multiple Covid vaccines, but concrete results from large-scale scientific trials have been rare. That situation gives extra weight to the Brazilian trial, which was conducted by the Butantan Institute in the Brazilian state of Sao Paolo.

Developing countries have had difficulty securing large quantities of the tested-and-approved vaccines that are currently being rolled out in the U.S. and Europe. Chinese vaccines could potentially help fill that need, and China has been promoting its vaccines to developing countries.

Brazil has been hard hit by the Covid-19 pandemic, and the health ministry said it will buy 100 million doses of CoronaVac to help bring the crisis under control.

January 6, 2021

J&J announced that it has completed the enrollment stage of the Phase 3 trial for its single-shot Covid-19 vaccine. The 45,000 participants in the trial is less than an earlier estimate of 60,000, because the high current case numbers of Covid mean the trial will see the needed number of infections with less participants.

The currently approved vaccines from Pfizer-BioNTech, Moderna and AstraZeneca were all tested and approved for two-shot use. A single-shot vaccine will greatly accelerate the task of vaccinating a majority of the population.

If the trial proceeds as planned, J&J said it would have enough data to ask the FDA to approve the vaccine in February 2021. The exact timing depends when a certain number of Covid cases are contracted among the trial participants.

The trial was paused once, in October, to investigate an illness in a participant; the trial subsequently resumed after scientists concluded that the vaccine was not a cause of the illness.

The company has also started a 2-shot trial of the same vaccine, to compare the effectiveness of a single shot versus two shots.

January 2, 2021

American biotech firm Novavax announced that it has started a Phase 3 trial of NVX-CoV2373, its vaccine for Covid-19, in the U.S. The trial will include 30,000 participants, and follows a Phase 1/2 trial that showed the vaccine producing high levels of antibodies capable of fighting the virus.

Novavax is already conducting a Phase 3 trial in the U.K. with 15,000 participants.

The vaccine being testing is called a protein subunit vaccine, and contains the spike protein that appears on the outside of SARS-CoV-2, the coronavirus that causes Covid-19. Novavax adds a substance, called an adjuvant, to the vaccine that can help accelerate the immune system's production of antibodies.

The new trial will be conducted at over 100 sites in the U.S., and an additional 7 sites in Mexico. Two-thirds of participants will receive the vaccine in two shots, three weeks apart. The other third will receive two shots of a placebo.

December 30, 2020

The U.K. became the first country to approve the Covid-19 vaccine developed by Oxford University in partnership with pharmaceutical giant AstraZeneca. The U.K. should see large-scale rollout of the vaccine to its population, especially since the newly approved vaccine is easier to store than previously approved vaccines.

The Oxford-designed vaccine can be stored for six months in regular refrigerators, making logistics simpler and cheaper than is needed for the vaccines from Moderna and Pfizer-BioNTech, which require ultra-cold storage.

The Oxford vaccine is also inexpensive, at an expected price of $4 per shot. The low price and easy shipment and storage will likely add up to a favored vaccine for many countries around the world.

Although the Oxford-AstraZeneca vaccine requires two shots, the British government decided to delay the second shot in order to administer the first shot to as many people as possible as quickly as possible. This strategy has not been used before in the Covid pandemic, but could stop the pandemic more quickly than the typical two-dose schedule. Britain has recently seen a surge in Covid cases and has placed severe restrictions on most activities.

The large scale trials of the prominent vaccines were designed to test effectiveness of two shots. So the delay-second-shot strategy doesn't have full experimental data behind it. Still, many experts consider it the best chance of stopping the pandemic as soon as this spring. People will still receive the second shot eventually, perhaps 12 weeks after the first.

AstraZeneca said it is rapidly scaling up manufacturing of the vaccine, and could make as many as three billion doses by the end of 2021.

December 24, 2020

New data show that the vaccine from Oxford and AstraZeneca can help prevent asymptomatic cases of Covid-19. It is the first vaccine to be shown to do so, making it a weapon that can help stop the spread of Covid and end the pandemic.

The vaccines from Moderna and from Pfizer-BioNTech have been approved based on their ability to prevent symptomatic Covid, but it is unknown whether they prevent asymptomatic cases. If there are still asymptomatic cases among the vaccinated, then Covid could still spread and the pandemic could linger.

The trial of the Oxford vaccine, being developed in partnership with AstraZeneca, included testing of participants for asymptomatic cases, producing the new results.

The vaccine was 59% effective in preventing asymptomatic Covid cases among trial participants who received a half dose followed by a full dose of the vaccine. This level of effectiveness was not apparent in participants who received two full doses. Research is ongoing to gain deeper understanding of these results.

The data also include evidence that the vaccine helps prevent severe cases of Covid-19, although data is still being collected to measure this effect more precisely.

Approval of the Oxford-AstraZeneca vaccine is pending until more data from the ongoing trial is gathered.

December 19, 2020

The U.S. FDA approved Moderna's Covid-19 vaccine for widespread use under an Emergency Use Authorization (EUA). It is the second vaccine approved by the FDA, after a similar EUA issued last week for the vaccine from Pfizer and BioNTech.

Moderna said it will start shipping almost six million doses of the vaccine around the country within days of the approval.

The newly approved vaccine does not require storage at ultracold temperatures, which is needed for the Pfizer-BioNTech vaccine. This will allow wider distribution of the Moderna vaccine, including to smaller health care offices and rural areas that do not have the capability to handle the other vaccine.

The EUA follows one day after an expert advisory panel to the FDA voted 20 to 0 to recommend approval of Moderna's vaccine. The vaccine was shown to be over 94% effective in a large-scale trial, putting it among the most effective vaccines that have been developed.

Both of the two approved vaccines are based on a new way of developing vaccines based on genetic molecules called messenger RNA, or mRNA. The companies involved have been able to develop and test the Covid vaccines in less than a year, far faster than any previous vaccine.

December 18, 2020

A key FDA advisory panel voted overwhelmingly to approve the use of Moderna's Covid-19 vaccine for adults 18 and over. The vote was 20 in favor and 0 opposed, with one abstention (based on wording of the question). The Moderna vaccine will become the second vaccine in use, once the FDA itself issues its official Emergency Use Authorization (EUA), which is likely to happen as soon as today.

The panel reviewed data from a large-scale trial of the vaccine showing an extremely high 94% effectiveness in preventing symptomatic Covid-19. Even those few in the trial who did contract Covid after receiving the vaccine almost always had only a mild form of the disease.

Last week, the same panel voted to approve the vaccine from Pfizer and BioNTech, which then became the first FDA-approved vaccine the following day. The Pfizer-BioNTech vaccine is approved for people 16 and up, although that younger age caused a few no votes in the panel.

Both the Moderna and the Pfizer-BioNTech vaccines use mRNA, a genetic molecule, to instruct cells to make the spike protein that appears on the surface of SARS-CoV-2, the virus that causes Covid-19. The presence of that spike then triggers the immune system to create antibodies and other tools that can fight off a virus infection.

The speed of vaccine development for Covid-19 has been remarkable. The virus first appeared in the U.S. in January 2020, and two vaccines have been developed, tested and approved by the end of the year. There have been no previous examples in medical history of such rapid vaccine deployment.

Both of the approved vaccines require two shots, although data seem to indicate some protection even after a single shot. The trial of the Moderna vaccine is continuing, and additional data will add more details about the type and level of protection it confers.

December 15, 2020

New data released by the FDA show that Moderna's Covid-19 vaccine show that it prevents severe cases of the disease, and also that it works equally well regardless of the gender, ethnicity or underlying health of the recipient.

No participants in Moderna's Phase 3 trial came down with severe cases of Covid if they had received the vaccine, but 30 such cases developed among patticipants who received a placebo. The ability to block hospitalization of Covid patients would be a great step towards ending the pandemic.

Analysis of the new data also pointed to the vaccine's ability to block transmission of SARS-CoV-2, the virus that causes Covid-19. Those who received the vaccine were less likely to have asymptomatic infections than those who received the placebo, implying a lower chance of infecting others.

The Moderna vaccine, like the recently approved Pfizer-BioNTech vaccine, is based on genetic molecules called messenger RNA, or mRNA. The vaccines include mRNA that causes cells to produce parts of the virus, and at that point the immune system starts to build protections against the virus.

Both mRNA vaccines require two injections, a few weeks apart, for full effectiveness. The FDA data indicates that the vaccine is safe to take, although mild or moderate side effects often occur, especially after the second dose.

The FDA could approve the Moderna vaccine as soon as this Friday, December 18. Moderna has said it is ready to ship over five million doses as soon as the approval is official.

December 12, 2020

The FDA granted Emergency Use Authorization (EUA) late last night for the Covid-19 vaccine developed by Pfizer and BioNTech. It is the first Covid vaccine granted approval in the U.S. and marks a milestone in the global fight against the Covid pandemic. The approval also kicks off a massive logistical effort to ship millions of doses of the vaccine to all 50 states.

The EUA came quickly after an expert advisory panel voted the previous day to recommend FDA approval. The FDA regulators reportedly worked feverishly to complete the EUA by Friday night.

Pfizer said that it has 2.9 million doses ready to ship across the U.S. The company has been lining up partners in preparation for this step because the vaccine's storage requirements require special equipment and handling procedures. Pfizer is using boxes packed with dry ice to keep the vaccines cold during shipment.

Up to 20 million doses are likely to be shipped to sites in the U.S. during December, and up to 100 million by the end of March 2021. The U.K. and Canada recently granted similar approval for the vaccine.

The vaccine was shown to be 95% effective in a trial with over 44,000 participants.

The approval caps the fastest vaccine development effort ever completed, since Pfizer and BioNTech started developing the vaccine less than a year ago. Vaccines typically take at least 5 years for development and testing. The rapid, unprecedented success of the vaccine effort is a great accomplishment for medical science.

Another Covid vaccine, from Moderna, is scheduled to be considered for approval next week. That vaccine, like the Pfizer-Moderna vaccine, is based on a new technology called mRNA, which uses genetic molecules to trigger an immune response that can protect against Covid-19.

December 10, 2020

An expert panel voted today to recommend approval of the Pfizer-BioNTech vaccine, based on data from a large trial that shows it to be highly effective in protecting against Covid-19. The FDA can now move ahead and issue an Emergency Use Authorization (EUA), which will allow immediate rollout of the vaccine in the U.S. The FDA approval could happen within a few days.

The vote was 17 to 4, with the dissenters mainly concerned about approving the vaccine for use with 16- and 17-year-olds, due to lower amounts of trial data for those age groups. There was also some uncertainty about its use by pregnant women.

The trial showed that the vaccine is both highly effective - around 95% - and also safe. Today's vote confirmed that interpretation of the results.

Although the vaccine trial was large, at around 44,000 participants, it included a relatively small number of 16- and 17-year olds. The trial is ongoing and has recently expanded to include younger participants, including children as young as 12.

Pfizer is expected to ship over 6 million doses of the vaccine within a day or so of the FDA approval, leading to vaccinations as early as next week. The same vaccine was recently approved in the U.K.

Another mRNA-based Covid vaccine, from Moderna, will soon come up for a similar panel vote, likely next week.

December 8, 2020

New data released today show that the Pfizer-BioNTech vaccine starts protecting people against Covid-19 soon after the first dose. The quick protection provided by the vaccine raises hopes for a faster-than-expected suppression of the pandemic as the Covid vaccines start to roll out. Case numbers could decline even before the full effects of the second dose are felt.

The second dose, given about three weeks later, adds additional protection, and may also extend the duration of the protection. Pfizer said that the vaccine's effectiveness is 52% after one dose, and 95% after two doses. Within ten days of receiving the first dose, trial participants showed reduced cases of Covid-19.

The additional data, gathered from the large, 44,000-participant late stage trial, also show that the vaccine protects people from all ethnic groups equally. It is also effective for people with underlying health conditions considered to be risk factors for Covid, such as obesity.

Even better, the vaccine is as effective for people 65-and-older as for those who are younger. There has been concern that Covid vaccines might be less effective for older adults.

The new data was provided to the US FDA as part of the review process that will likely lead to approval of the Pfizer-BioNTech vaccine in the next week or two. The trial is ongoing and will continue to gather new data.

December 2, 2020

The U.K. became the first country to officially approve a vaccine for Covid-19 today when it approved the vaccine jointly developed by Pfizer and BioNTech. The vaccine has generated suffient data from a large, Phase 3 trial to convince the U.K. regulators that it is both safe and effective.

The two companies have also submitted the vaccine to the U.S. FDA, and U.S. approval could come within a few weeks. Separately, biotech firm Moderna has also requested approval of its vaccine, in both the U.K. and the U.S., after a similar level of Phase 3 testing.

The first vaccinations in the U.K. under the new approval could occur within days. One hospital in London was reported to be scheduling vaccinations starting next Monday, December 7. The country had previously ordered 40 million doses of the Pfizer-BioNTech vaccine. Each person will be given two doses, about three weeks apart.

The U.S. has ordered 100 million doses of the vaccine, and Pfizer has said that about 20 million of them will be available within December.

The vaccine trial data shows the Pfizer-BioNTech vaccine to be 95% effective in preventing symptomatic cases of Covid-19, placing it among the highest levels of vaccine effectiveness.

November 30, 2020

On the heels of its trial results showing over 90% effectiveness, Moderna officially submitted all required data to the US FDA in a request for approval. The company also released more complete results from the late-stage trial, confirming the efficacy of the vaccine at 94%.

Moderna's request closely follows one from Pfizer in partnership with BioNTech, whose vaccine also showed effectiveness in the 90% range. Both Covid vaccines are based on mRNA technology, delivering genetic code to cells in order to provoke an immune response that can fight off SARS-CoV-2, the virus that causes Covid-19.

The FDA has said it will act quickly, and many observers expect both vaccines to be approved by Emergency Use Authorization (EUA) during December. Moderna also has "rolling" applications under way in Europe, Canada, and the U.K.

One of the most impressive results from Moderna's 30,000-person trial is that there was not a single severe case of Covid-19 among the participants who received the vaccine. Even the very few cases of Covid among the vaccinated were only mild or moderate cases.

Moderna also said that no serious safety issues have come up during the trial, and the company confirmed that the vaccine is effective regardless of the age, gender, or ethnicity of the participant.

The company plans to produce about 20 million doses of the vaccine before the end of 2020. Both the Moderna and the Pfizer vaccines require two shots, given about three weeks apart.

November 25, 2020

J&J announced it is starting a two-dose trial of its Covid-19 vaccine, even as its large one-dose trial continues apace. Both are Phase 3 trials that can lead to FDA approval for widespread use of the vaccine.

The ongoing one-dose trial, code-named ENSEMBLE, is one of the largest trials of any Covid vaccine under development, with 60,000 participants. A one-dose vaccine would be a great help in the fight against Covid-19, due to the convenience and ease of compliance compared to two-dose vaccines.

In an update on the one-dose trial, J&J said it anticipates asking for FDA approval of the vaccine by February 2021 at the latest. The trial started in September, although it was paused in October to investigate a health incident in one participant; it was later resumed.

The company said that the two-dose trial, which it calls ENSEMBLE 2, is part of its "extremely thorough" investigation of the vaccine's effectiveness under a variety of conditions and doses. J&J listed nine countries that will serve as investigation sites for the new trial.

Meanwhile, the company is producing the vaccine in large amounts, so that it can quickly be rolled out worldwide once it is approved. It is aiming to make at least one billion doses by the end of 2021, and has committed to deliver 100 million doses to the U.S., 200 million to Europe, and 30 million to the U.K.

J&J develops and tests vaccines via its Janssen Pharmaceutial division.

November 21, 2020

A major milestone in the fight against Covid-19 has been reached with the first application to the FDA for a protective vaccine. Pfizer and BioNTech, the companies behind the vaccine, made an official submission to the FDA that should lead to approval via an Emergency Use Authorization (EUA).

The Phase 3 trial, with almost 44,000 participants, has collected enough data to confirm that the vaccine is both safe and effective. In a prior announcement a few days ago, the companies said that the vaccine is 95% effective in prevention of Covid-19. 95% is much higher than most health professionals were expecting.

The FDA will convene a panel of outside experts to review the data before it makes a final decision, although most experts expect approval relatively quickly.

The vaccine is given in two doses, about three weeks apart.

Other vaccines in late-stage trials are likely to follow the same path. Next up, Moderna is widely expected to have enough data for a similar submission within weeks. Both the Moderna and the Pfizer-BioNTech vaccines are based on mRNA, a relatively new technology for vaccine development.

Pfizer said it will provide 25 million doses of the vaccine in December, and then 500 million during 2021.

Scientists have been working intensively since early 2020 on a vaccine to protect against Covid. Having a vaccine ready for use in less than a year is a unheard-of accomplishment - no vaccine has ever been been developed so quickly for any other illness.

"This is an historic day for science", said Albert Bourla, the CEO of Pfizer.

November 19, 2020

Pfizer and BioNTech said that their Covid vaccine's final measured effectiveness is 95%, they said upon completing that portion of the large-scale vaccine trial. The result is even higher than the "over 90%" rate that was reported last week after a review of preliminary data, and also edges out the 94.5% preliminary result from Moderna's vaccine.

With this key portion of the late-stage trial complete, Pfizer and BioNTech are preparing to apply to the FDA for permission to deploy the vaccine under an emergency use authorization (EUA). That application is likely to be filed "within days", they said.

Both the Pfizer-BioNTech and Moderna vaccines are based on delivering genetic material called messenger RNA (mRNA) to cells, spurring activity that leads the immune system to produce antibodies that can attack SARS-CoV-2, the virus that causes Covid-19.

Pfizer said that 162 out of 170 Covid cases among trial participants were contracted by people who received a placebo, and only 8 by those who received the vaccine. This result shows that the vaccine strongly protects against the disease.

The data also indicate that the vaccine can reduce the severity of Covid-19, in those relatively few cases where it is contracted by someone who has been vaccinated.

The vaccine trial continues to track the health of the approximately 44,000 participants, to confirm the safety as well as the effectiveness of the vaccine.

November 16, 2020

Moderna released data on its mRNA-based vaccine today and the data show an astounding 94.5% effectiveness level. This is much higher than expected, and puts the vaccine on a par with some of the most effective childhood illness vaccines, such as measles.

By comparison, the FDA was looking to approve vaccines at only 50% effectiveness, and seasonal flu vaccines are typically only in the 40%-60% range.

Moderna's numbers follow last week's release of data from Pfizer, in partnership with BioNTech, which showed its vaccine to be "over 90%" effective. Both vaccines are made from mRNA, a genetic molecule that triggers production of the spike on the surface of SARS-CoV-2, the virus that causes Covid-19. The spike in turns spurs the immune system to create antibodies that protect against Covid.

The data from Moderna comes from an early analysis of results from its Phase 3 trial, which involves 30,000 participants in the U.S. The trial is continuing, and more data will lead to more accurate measures of effectiveness. The company also said that the vaccine appears safe, as well as effective, for all age and ethnic groups. The data was analyzed by an independent committee.

Moderna is manufacturing the vaccine and said it will ship about 20 million doses in December, and then will produce over 500 million doses in 2021. The FDA still needs to approve the vaccine before it can be made widely available.

November 9, 2020

Pfizer released its first data from the late-stage trial of its Covid-19 vaccine, and the results were extremely positive, showing an effectiveness rate of "more than 90%".

Most experts had been expecting an effectiveness in the range of 50% to 60%, which these numbers easily surpassed. The 90% rate is comparable to the best vaccines for childhood illnesses, such as measles.

The company also said that no serious safety issues have appeared.

Pfizer said that it is still collecting and analyzing incoming data from the trial, to further refine the effectiveness and safety measurements. The full Phase 3 trial includes more than 43,000 participants. After more data is collected, Pfizer will move to seek approval for the vaccine from the FDA.

The company is partnering with German biotech company BioNTech, which started working on it in early 2020, after getting the genetic information about SARS-CoV-2, the virus that causes Covid-19. The vaccine delivers messenger RNA, or mRNA, to cells in order to provoke immune protection to the virus.

Pfizer is ramping up manufacturing of the vaccine, named BNT162b2, and said it could have enough to vaccinate 25 million people by the end of 2020, and over half a billion in 2021.

October 27, 2020

Two closely watched vaccine trials have resumed, after pauses to investigate safety concerns. The resumptions, after only modest delays, are a strong sign of progress toward fully tested vaccines that can be approved for public use.

The U.S. FDA gave the green light to both late-stage trials after investigating cases where participants had become ill.

AstraZeneca is conducting a late-stage trial of AZD1222, its Covid-19 vaccine candidate, which was developed in partnership with Oxford University. It was paused in September after one participant developed a neurological condition. An investigation found no evidence that the condition was caused by the vaccine.

The AstraZeneca trial had already received approval to resume in other countries. The FDA approval allows it to resume in the U.S. as well.

The J&J vaccine trial was put on hold on October 12, after one participant suffered a stroke. An independent committee investigated that incident but found no evidence linking it to the vaccine.

It's common for some participants to get sick during large vaccine trials such as these, and such cases get investigated carefully in well-run trials, to ensure that the vaccine is not causing people to become ill.

October 22, 2020

Biotech company Moderna announced major steps towards bringing its Covid vaccine into widespread use.

First, it completed the enrollment phase of the Phase 3 trial of mRNA-1273, as the vaccine is known, with a full 30,000 people signed up. More than 25,000 of them have already received two shots of the vaccine, and the company is already collecting information about the infection rates of those participants.

Second, Moderna has started the approval process for mRNA-1273 in Canada by making a "rolling submission" to Health Canada, the agency responsible for evaluating and approving vaccines. In a rolling submission, the agency can review trial data as it becomes available, thus starting its review process before the trial is complete. This method should speed up the timeline to final approval.

The vaccine is based on the company's mRNA technology, which uses genetic material that triggers the body to produce parts of the virus, which in turn triggers production of protective antibodies by the immune system.

In the trial, each of the participants receives two injections. Half of them get the vaccine, and the others get a placebo. The trial measures and compares the rates of Covid-19 infections by both groups. It also checks the side effects of the vaccine injection.

October 19, 2020

A review of the latest published data from Pfizer and Moderna show that their late-stage trials of Covid-19 vaccines are nearing their enrollment goals.

Both vaccines are so-called "mRNA vaccines", because they operate by injecting genetic material called mRNA, which the cells then use to produce proteins that are part of SARS-CoV-2, the virus that causes Covid-19. Antibodies are then produced by the immune system to fight these newly created proteins - antibodies that can later attack the actual virus.

Both trials are giving two shots of the vaccine to the participants.

Pfizer reported that 39,862 participants have enrolled, and 34,601 have received both shots. Moderna reported 29,521 and 24,496 for the enrollment and second shot numbers, respectively. The total enrollments goals are 44,000 for Pfizer and 30,000 for Moderna.

Moderna has dozens of sites across the U.S. to enroll, inject and observe participants. Pfizer is using about 150 sites in six countries, including the U.S.

The CEO of Pfizer recently said that it may submit data and request approval in the U.S. as soon as the end of November. Pfizer is partnering with BioNTech on the vaccine, and has already started the approval process in Europe and Canada.

October 11, 2020

Vaccine partners Pfizer and BioNTech announced that they have started the process of seeking approval for their Covid-19 vaccine in Europe.

The ongoing Phase 3 trial of the vaccine, known as BNT162b2, has shown "encouraging preliminary results", according to the companies, leading them to take this step towards deployment. They noted in particular results showing that in response to the vaccine, the body produces neutralizing antibodies and T cells that fight SARS-CoV-2, the virus that causes Covid-19.

The action is being called a "rolling submission", meaning that the existing trial data will be augmented by additional results as they become available. The clinical data will be reviewed by the European Medicines Agency (EMA). The rolling submission should result in a faster time-to-approval than waiting for the complete Phase 3 trial data to become available.

This regulatory review procedure is consistent with the companies' goal to maintain "the highest ethical standards while adhering to sound scientific principles", said Dr. Ugur Sahin, CEO of BioNTech.

The vaccine candidate uses mRNA technology from BioNTech and vaccine development and production from Pfizer. The mRNA encodes the spike protein on the surface of SARS-CoV-2, thereby provoking the body to create antibodies that target the spike.

September 29, 2020

Newly published data from the Phase 1 trial of Johnson & Johnson's Covid-19 vaccine shows that 98% of those who received a single shot still had neutralizing antibodies 29 days later. The antibodies were present in levels comparable to that shown by patients who have recovered from Covid-19.

The vaccine, dubbed Ad26.COV2.S, includes the spike protein on SARS-CoV-2, the virus that causes Covid-19. The results were technically an interim result, since data is still being collected and analyzed from participants.

J&J said that the vaccine produced "strong antibody responses, strong T cell responses, and a Th1 response". These are all tools used by the body's immune system to fight viral infections.

Older participants, age 65 and higher, also showed "strong" immune responses. However, immune response data was available from only 15 such older participants in this review.

The Phase 1 trial was conducted in the U.S. and Belgium, and included over 800 participants. J&J recently started a Phase 3 trial of the vaccine candidate, and plans to include 60,000 participants.

September 25, 2020

Novavax announced that it has started a Phase 3 trial for NVX-CoV2373, its vaccine candidate to fight Covid-19. The trial will include about 10,000 participants in the U.K.

The Novavax vaccine is an adjuvanted subunit vaccine, a more tested vaccine type than the newer mRNA vaccines that some companies, such as Moderna, are developing for the new coronavirus. It uses a proprietary adjuvant called Matrix-M to enhance the immune response.

Half of the trial participants will receive two shots of NVX-CoV2373, 21 days apart. The other half will receive two shots of placebo. Novavax is optimistic that the trial will produce results fairly soon, given the current rate of Covid infections in the U.K.

The company also said it is ramping up its manufacturing ability, with a goal of producing the vaccine at a rate of 2 billion doses a year.

September 21, 2020

The U.K. government will fund the world's first challenge trial for Covid-19 vaccines, it was revealed. In a vaccine challenge trial, participants first receive the vaccine and later are intentionally exposed to the pathogen.

Challenge trials are controversial for potentially fatal diseases such as Covid-19, and most other countries have decided not t o pursue them for Covid vaccines. Challenge trials have been used for other diseases, such as malaria and cholera.

A challenge trial does have some key advantages, however. For one thing, they can be completed much faster than a conventional late-stage study, where it is necessary to wait a fairly long time for enough participants to be exposed to the pathogen as they go about their ordinary lives. A challenge trial can also be much smaller, since all participants are guaranteed to become exposed.

The participants in the challenge study will be isolated at a quarantine facility during the trial, which is expected to start in early 2021. They will be closely observed by medical staff, with various medical treatments close at hand should any fall seriously ill.

A group called 1Day Sooner has signed up about 2,000 volunteers for the challenge trials in the U.K., and many more globally. Those selected will receive some payment for their participation, since they will need to be isolated.

The trial may involve several different vaccine candidates, although specific vaccines have not been announced.

September 7, 2020

More evidence of the effectiveness and safety of the Covid-19 vaccine candidate from Pfizer and BioNTech was published by the companies, as a result of analyzing data from the Phase 1 trial that was conducted in the U.S. and Germany.

Antibody levels in the trial participants were almost 4 times higher than that found in recovered Covid-19 patients. T cells, another mechanism of the body's defense against the virus, were also measured at high levels.

Participants in the Phase 1 trial received two shots of BNT162b2, as the vaccine is named. Antibody levels went up significantly after the second shot, indicating that the second shot improved the level of protection against Covid-19.

Older and younger participants showed similar levels of antibody production, adding to confidence that the vaccine can protect people of all ages.

Less than 20% of participants developed a fever after receiving the vaccine. The results of the early phase trial continue to be analyzed, and more results may be made public in the future. BNT162b2 is an RNA-based vaccine that prompts the body to produce a protein associated with SARS-CoV-2, the virus that causes Covid-19.

A later stage trial of the vaccine started in July and continues to enroll patients around the world, aiming to reach 30,000 participants. Pfizer and BioNTech plan to produce up to 100 million doses by the end of 2020, and 1.3 billion doses by the end of 2021.

September 4, 2020

Johnson & Johnson announced that in a preclinical study, the company's Covid-19 vaccine prevented "severe" disease in Syrian golden hamsters. These animals are valuable for such studies because they are more susceptible to disease than are non-human primates.

The study was a "challenge trial", in which the hamsters were first given a shot of the vaccine, and were later exposed to a "high dose" of SARS-CoV-2, the virus that causes Covid-19. A group of unvaccinated hamsters, serving as a control population, was also exposed. The vaccinated animals had less weight loss (a sign of illness severity) than the unvaccinated animals, and had no deaths.

Phase 3 trials in humans for J&J's candidate vaccine, known for now as Ad26.COV2.S, is planned to begin later in September 2020.

The study was conducted by Janssen Pharmacutical, a division of J&J, in partnership with Beth Israel Deaconess Medical Center.

August 23, 2020

Vaccine company Moderna released further information about its Covid-19 vaccine's effects on participants' immune systems. The data show that the vaccine produced similar immune responses in both older and younger adults.

The news is reassuring, since there has been concern that some vaccines may be less effective in protecting older as opposed to younger adults. The new data indicate that at least this vaccine is likely to show similar levels of protection on all adults.

The new information is based on analysis of the Phase 1 trial that was done for Moderna's vaccine candidate, code-named mRNA-1273.

Data was collected from 20 adults age 55 or older, who each received two shots of the vaccine. Two months later, these partipants had antibody levels that were on average 2 to 3 times higher than the levels typically seen in recovered Covid-19 patients.

A Phase 3 trial of mRNA-1273 started on July 23.

August 19, 2020

Johnson & Johnson is supersizing its vaccine trial. In new details of its planned Phase 3 trial, J&J said it will include up to 60,000 people, twice as much as most other Phase 3 trials, such as those by Moderna and Pfizer.

The trial of its vaccine candidate, dubbed Ad26.COV2.S, will be conducted at almost 200 locations across nine countries, including the U.S. Up to a third of participants are expected to be located in Latin America, which has been subject to widespread Covid-19 infections.

The vaccine is designed to produce immunity from a single shot, which would be much simpler and quicker to administer, compared to many of the other vaccine candidates, which require two shots.

J&J is expecting the trial to start by the end of September.

August 4, 2020

Novavax released data from the Phase 1 trial of its Covid-19 vaccine, and the strong results were praised for their efficacy without serious side effects.

The trial included 131 adults in a randomized study. All those who received two shots of the vaccine, known as NVX-CoV2373, went on to develop neutralizing antibodies. No serious side effects were seen among those receiving the vaccine, although minor side effects did occur.

The Novavax vaccine is an adjuvanted subunit vaccine, a more tested vaccine type than the newer mRNA vaccines that some companies, such as Moderna, are developing for the new coronavirus. It uses a proprietary adjuvant called Matrix-M to enhance the immune response.

Charles Duncan, an analyst at Cantor Fitzgerald, called the results "class-leading", implying they match or beat those of other Covid vaccine candidates. Other observers have predicted that protein-based vaccines such as Novavax's would produce better results than other types.

Novavax, which has received funding from the U.S. government's Operation Warp Speed, produces its vaccine using moth cells, which can be a faster production method than vaccines produced from mammal cells. It is planning a Phase 2 trial in "the near future", it said.

August 1, 2020

Biotech firm Inovio reported the results of vaccine trial where non-human primates were vaccinated and then challenged with the SARS-CoV-2 virus, which causes Covid-19.

Rhesus macaque monkeys were given two shots of INO-4800, which is Inovio's vaccine candidate for Covid-19. The monkeys were given exposed to the virus 13 weeks after the shot, and showed lower viral load, and the presence of neutralizing antibodies and T cells.

The trial is significant because it shows that the protective impact due to the vaccine lasted more than 3 months from the vaccination. Not all other primate studies have shown such long-lived protection.

INO-4800 is currently in Phase 1 human trials, with a Phase 2/3 trial being planned for later in the summer. It is a DNA-based vaccine that has the advantage of being stable at room temperatures, Inovio said.

July 30, 2020

Scientists reported that a single dose of Johnson & Johnson's top vaccine candidate prevented the coronavirus from infecting the lungs of nonhuman primates.

The vaccine candidate, known as Ad26.COV2.S, in currently in a phase 1/2 trial with 1,000 human participants in the U.S. and Belgium. J&J hopes to start a larger later-stage human trial in September, 2020. The vaccine encodes the spike protein on the surface of SARS-CoV-2, the virus that causes Covid-19.

Moderna recently reported similar results from testing their Covid-19 vaccine candidate, although in that case the monkeys were given two doses of the vaccine.

In the J&J study, seven different vaccine candidates were given in single shots to 32 rhesus macaque monkeys. All the vaccines prompted antibody production. Six of the monkeys were given Ad26,COV2.S, which J&J later deemed the best of the vaccine candidates as it produced the most anti-virus antibodies. In all six, the virus was prevented from infecting the lungs by the vaccine.

A single-shot vaccine would be easier to administer to a large segment of the general population than a double-shot vaccine. However, giving a second shot is likely to increase the effectiveness of the vaccine.

July 28, 2020

Scientists reported that monkeys who were given the Moderna candidate vaccine for Covid-19 were able to successfully fight off the virus when they were exposed to it. Although these results don't totally ensure success in humans, the positive outcome in related primates is considered a good sign.

Moderna's vaccine is now being tested in a Phase 3 trial that recently started. Additional data from early-stage and preclinical testing is welcome for assessing the vaccines potential in humans.

The study included 24 rhesus macaques; 12 were given various doses of the vaccine in two shots, while the remaining 8 were controls. Later, the macaques were exposed to SARS-CoV-2, the virus that causes coronavirus. The virus is not considered fatal to these monkeys.

The macaques given the virus were able to prevent the virus from spreading to the lungs, although it did remain in their noses. The vaccinated macaques also produced strong immune system responses to the infection.

Dr. Barney Graham, the lead author of the study, said that "the virus was cleared very rapidly in the vaccinated animals".

July 27, 2020

Moderna said it has started the a large-scale, late-stage trial of its candidate vaccine for Covid-19. This trial is the first of its kind in the U.S., bringing closer the day when a vaccine is approved for use in the general population.

The Phase 3 trial is expected to include about 30,000 participants at various locations. Half of the participants will receive the vaccine, while the other half receive a placebo. The first participant received a shot this morning in Savannah, Georgia.

The trial will monitor the particants to see if those receiving the vaccine are less likely to contract Covid-19 than those receiving the placebo. They will also be monitored for any side effects of the vaccine itself.

Even if some of those receiving the vaccine contract Covid-19, the vaccine may reduce the chances of infection. It may also tend to lessen the severity of the illness.

The vaccine candidate, known as mRNA-1273, was developed by Moderna in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). The Institute's Director, Dr. Anthony Fauci, said that the late-stage trial was warranted because earlier trials had already established that mRNA-1273 "is safe and immunogenic". Dr. Fauci also said that results from the trial will hopefully be available in November, 2020.

mRNA refers to messenger RNA, which is delivered by the vaccine and prompts the body to produce the spike protein that appears on the surface of SARS-CoV-2, the virus that causes Covid-19. The production of the spike protein, in turn, prompts the body's immune system to develop antibodies and other defense mechanisms.

July 25, 2020

Pfizer said it has started a late-stage trial of its Covid-19 vaccine. The Phase 2/3 trial is planned to include a total of 30,000 participants across the world, including in the U.S., Germany, Brazil, and Argentina.

Pfizer has developed the vaccine, dubbed BNT162b2, in partnership with German company BioNTech. The vaccine is based on messenger RNA, which prompts the body to make a protein that is part of SARS-CoV-2, the virus that causes Covid-19.

In the study, half the participants will receive the vaccine, while the other half receive a placebo.

The companies said they hope for sufficiently positive results to request regulatory review in October, 2020. If the vaccine is approved, the companies plan to produce 100 million doses by the end of 2020, and about 1.3 billion doses by the end of 2021.

Pfizer and BioNTech also have another vaccine candidate, BNT162b1, which also produced immune responses in early stage trials. The companies believe that BNT162b2, the candidate chosen for the late-stage trial, produces a more robust immune response, including production of T-cells to fight the virus.

July 21, 2020

Positive results from an early stage trial of a vaccine were announced by Pfizer and BioNTech, the companies behind the vaccince, known for now as BNT162b1. Participants developed both antibodies and T-cells at levels considered capable of fighting off the SARS-CoV-2 virus, which causes Covid-19.

The Phase 1/2 trial, conducted in Germany, gave the vaccine in various dosages to 60 participants, in two injections three weeks apart.

At the higher doses of the vaccine, participants produced more antibodies than the typical recovered Covid-19 patient. T-cells, which is another mechanism used by the body's immune system to fight disease, was also produced by all participants except a few who received the lowest dose of the vaccine.

Some participants reported side effects of the vaccine, but none that are considered serious.

The vaccine is based on mRNA, using genetic sequences to stimulate production of pieces of the virus, which in turn stimulate the immune system.

A large trial is being planned and could start around the end of July. If the larger trial is successful, the companies plan to produce up to 100 million doses by the end of 2020, and 1.3 billion by the end of 2021.

July 20, 2020

Results were released from the anticipated early stage trial of the coronavirus vaccine being developed by Oxford University in partnership with AstraZencia. The results confirm that the vaccine caused the immune system to produce both antibodies and T-cells that can protect against SARS-CoV-2, the virus that causes Covid-19.

Antibodies and T-cells are two tools that the immune system uses to protect the body against harmful pathogens. The fact that this vaccine stimulates production of both of them is highly promising for the ultimate effectiveness against the disease.

The trial included 1,077 participants. Some were part of a control group given a placebo instead of the vaccine. There were side effects of the vaccine, but none considered serious.

The team is proceeding to larger scale testing. The new trials will probably give 2 doses of the vaccine to each participant, although it is not clear if two doses are necessary to protect against infection. Dr. Sarah Gilber, the lead vaccine scientist at Oxford, said that a large trial in the U.S. should start within a few weeks.

AztraZeneca may start delivering vaccine this fall, as early as September (in the U.K.) or October (in the U.S.).

There are over one hundred vaccine candidates for Covid-19 in various stages of development, but the one developed at Oxford is considered one of the most promising, and also one of the furthest along. Other leading vaccine candidates are those from Moderna and from Pfizer.

The results were published in The Lancet.

July 15, 2020

A journal article details the Phase 1 trial of Moderna's Covid-19 vaccine, including the safety of the vaccine and its ability to provoke immune responses. The paper, published in The New England Journal of Medicine , provides follow-up data to a Moderna press release from May 18.

The Moderna vaccine, called mRNA-1273, is a new type of vaccine, based on mRNA genetic material.

The Phase 1 test included 45 people who received each received two injections of the candidate vaccine. Although some of the subjects suffered some side effects, such as headeaches, soreness, and fatigue, the vaccince is considered safe, since the side effects were not serious and only lasted a short time.

On the efficacy side, all trial partipants were seen to develop "neutralizing antibodies", which are capable of fighting SARS-CoV-2, the virus that causes Covid-19.

Moderna also said that it will begin a large-scale Phase 3 test on July 27, 2020. The Phase 3 test will involve approximately 30,000 people. Large scale trials are required of vaccines to ensure safety and effectiveness, before giving a vaccine to wide swaths of the population.

July 1, 2020

Pharmaceutical company Pfizer and its partner BioNTech have reported promising results from early stage trials of the Covid-19 vaccine they have developed.

Three dosages were tested on healthy volunteers, although the highest dosage was stopped due to pain at the site of injection. The two dosages remaining both produced "a strong immune response", said Ugur Sahin, BioNTech's CEO. The vaccine candidate is called BNT162b1.

The data was released from a Phase 1/2 trial, which is continuing. Only moderate side effects, such as a low fever, were shown by the test participants after receiving the vaccine. Participants showed antibody levels due to the vaccine matched or exceeded the levels in patients that recovered from actual Covid-19 infection.

The companies will follow up with larger scale trials to fully test if the vaccine prevents Covid-19. The next trial could involve as many as 30,000 participants.

BioNTech is a German biotech company. It has other Covid-19 vaccine candidates as well, but this test was the first of them to produce results.

Other Covid-19 vaccines have also shown positive results in early stage testing, including those from Moderna, Inovio, and Chinese firm CanSino Biologics.

June 14, 2020

A Covid-19 whole-virus vaccine has successfully caused antibody production in participants of a phase 1/2 trial, says Chinese company Sinopharm. All the people who received the vaccine in two injections 28 days apart produced antibodies that fight against the virus that causes Covid-19.

The company also reported that there were no serious problems that developed in the people receiving the vaccine, implying that a high likelihood of its safety.

The vaccine was produced by China National Biotec Group (CNBG), as subsidiary of Sinopharm. The vaccine was created by modifying SARS-CoV-2 to make it inactive, yet still capable of provoking an immune response.

An additional, phase 3, trial is still needed to confirm that the immune response produced by the vaccine is strong enough to protect against infection by the virus. The Chinese company will likely need to cooperate with foreign companies in the phase 3 trial, due to the low levels of Covid-19 in China itself.

June 10, 2020

Pharmaceutical giant Johnson & Johnson announced that it is accelerating its Covid-19 vaccine development, moving up the start of human trials by two months, from September to July 2020. The company says the acceleration is due to the optimistic results of preclinical testing.

The company also released additional details about the trial. The vaccine will be tested on 1,045 healthy adults in the U.S. and Belgium. Its vaccine candidate is dubbed Ad26.COV2-S.

Johnson & Johnson is conducting the trial through its subsidiary, Janssen Pharmaceutical. It hopes to also accelerate a phase 3 trial, pending a successful result from this first trial, which it calls a "Phase 1/2a" trial.

The company is also building out its vaccine production capabilities, to be able to ramp up the vaccine quickly upon approval. It's goal is to produce one one billion doses through the end of 2021.

May 26, 2020

Biotech firm Novavax announced that its Covid-19 vaccine candidate has entered Phase 1 testing, with plans for a quick transition to Phase 2 should the first stage show that the vaccine is both safe and produces an immune response. Results from Phase 1 are expected in July 2020.

The vaccine, known as NVX-CoV2373, is based on Nanovax' proprietary nanoparticle technology. In pre-clinical testing, it spurred production of antibodies at a high level. It will be given to 130 trial participants at two sites in Australia.

Novavax engineers 3D nanostructures that include virus-related proteins in order to produce effective vaccines.

May 22, 2020

The U.S. governemet has promised $1.2 billion to U.K. pharmaceutical giant AstraZeneca for access to 300 million doses of the Covid-19 vaccine that the company plans to produce.

The vaccine, which goes by code name AZD1222, was developed by researchers at Oxford University and then licensed to AstraZeneca for development and mass deployment.

AstraZeneca has confirmed its ability to produce at least one billion doses, starting in September 2020. It is likely that the first doses will be provided to the U.K. itself, with the U.S. doses following soon afterwards.

Of course, significant amounts of testing still need to be successfully completed before it is ready for widespread use. The agreement with the U.S. calls for Phase 3 trials of the vaccine to include at least 30,000 people in the U.S.

A trial that combines Phases 1 and 2 is already under way, and includes over one thousand participants in the U.K.

May 19, 2020

In a big step forward on the road to a vaccine, Moderna announced that its Covid-19 vaccine candidate successfully produced immune system activity that blocked the virus from replicating, in a preliminary study.

In the Phase 1 study, eight healthy volunteers were given two doses of the vaccine. Subsequent testing showed that the immune systems of the volunteers produced antibodies in response to the vaccine, and that those antibodies succeeded in preventing the replication of SARS-CoV-2, the virus that causes Covid-19.

Furthermore, the level of antibodies produced in response to the vaccine was simlar to that seen in patients who have previously had Covid-19.

Moderna's vaccine candidate uses mRNA, a form of genetic material that is a new approach to vaccine design, and is known by the code name mRNA-1273. The Phase 1 trial, which started in mid-March, was led by the National Institute of Allergy and Infectious Diseases (NIAID).

The company is proceeding with larger scale testing. Phase 3 trials are likely to start in July 2020. If the later trials are successful, Moderna expects that the vaccine could be ready for public distribution in late 2020 or early 2021.

May 6, 2020

Pharmaceutical giant Pfizer announced that it has started trials of its Covid-19 vaccine candidate, and that it is preparing to accelerate production if the trial proves successful.

The vaccine being tested is based on messenger RNA, or mRNA for short. Pfizer and its partner, German company BioNTech, have designed an mRNA segment that will instruct cells to make the spike protein on the surface of SARS-CoV-2, the virus that causes Covid-19.

The immune system should then react to the newly make spike protein by creating antibodies, which will then be present to attack any actual instances of SARS-CoV-2, if they are exposed in the future.

mRNA should be relatively straightforward to manufacture in bulk, if the tests prove effective. However, mRNA is a relatively new vaccine technology and its effectiveness has not been proven.

The vaccine candidate is known as BNT162.

April 19, 2020

Moderna announced that it wil receive $483 million in federal funding to scale up manufacturing and testing of its candidate vaccine for Covid-19.

The vaccine, dubbed mRNA-1273 by Moderna, contains RNA that produces a stable form of the spike protein on the surface of SARS-CoV-2, the virus that causes Covid-19.

The funding will come from BARDA, the U.S. Biomedical Advanced Research and Development Authority, and is intended to fund Moderna's work on the vaccine through FDA approval.

A phase 1 trial of the candidate vaccine is being conducted by the NIH. Planning is underway for later stage trials, in order to speed up the full trial process.

April 14, 2020

Johnson & Johnson is preparing to produce as many as 900 million doses of its Covid-19 vaccine within a year, if planned human trials go well. It will be able to produce at least one billion doses during all of 2021.

The comments came from J&J executives during its quarterly earnings call.

Human trials will begin by September 2020. Positive results could lead to emergency use by health care workers in early 2021. J&J CEO Alex Gorsky also repeated a previous commitment that the vaccine would be made available on a "not for profit" basis.

J&J will start manufacturing the vaccine "at risk" in the near future, meaning that the manufacturing will occur even before the trial results are known.

J&J has been developing the vaccine with its subsidiary Janssen Vaccines & Prevention.