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FDA permits third dose for the immune-deficient

FDA permits third dose for the immune-deficient

The Food and Drug Administration authorized Covid-19 vaccine booster shots for people with weakened immune systems, a highly anticipated move intended to shield some of the most vulnerable Americans from the highly contagious delta variant.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The agency said organ transplant recipients and people who are similarly immunocompromised can receive a third dose of the Pfizer-BioNTech or Moderna vaccines. The FDA also emphasized that other fully vaccinated people are “adequately protected” and currently do not need an extra dose.

The FDA OK is not the final go-ahead. The Centers for Disease Control and Prevention’s vaccine advisory committee has scheduled a meeting Friday to consider shots for immunocompromised Americans. If they issue a recommendation and it is approved by the CDC, third shots could begin immediately.

White House chief medical advisor Dr. Anthony Fauci said last week that federal health officials were speeding regulatory efforts to clear third doses for such people, including cancer and HIV patients or those who have had organ transplants. He said new data suggested they don’t produce an adequate immune response after receiving two doses of a Covid vaccine.

“Immunocompromised individuals are vulnerable,” Fauci said Thursday. “It is extremely important for us to move to get those individuals their boosters, and we are now working on that, and we will make that be implemented as quickly as possible. … It is a very high priority.”

Such people represent only about 2.7% of the U.S. adult population but make up about 44% of hospitalized Covid breakthrough cases, which is when a fully vaccinated individual becomes infected, according to recent data from a Centers for Disease Control and Prevention advisory group.

Studies suggest that a third vaccine shot might help patients whose immune systems don’t respond as well to a first or second dose.

Four small studies cited by the CDC last month showed that 16% to 80% of people with weakened immune systems didn’t have detectable antibodies to fight Covid after two shots. Among vaccinated patients who had no detectable antibody response, 33% to 50% developed an antibody response after receiving an additional dose, according to the CDC.

With delta surging in the U.S., doctors fear leaving such groups unprotected against the virus could lead to even more dangerous variants.

Fauci, speaking with “CBS This Morning” earlier Thursday, said it is “likely” everybody will eventually need to receive a booster dose. But the priority right now, he said, is to give boosters to people who have compromised immune systems.

Some doctors had long been pushing for the U.S. to allow immunosuppressed populations to get an extra dose, and many of them are already finding additional doses of the vaccines on their own, medical experts say.

A CDC advisory group met last month to consider whether fully vaccinated Americans with weakened immune systems need a booster dose after data showed they are less likely to have antibodies to fight the disease and more likely to suffer from a breakthrough infection.

“The hardest to vaccinate people are those who are immunosuppressed,” Dr. Dan Barouch, an immunologist at Harvard Medical School, said in late June. Data suggests at least a third of them respond well if they get a third dose, he added.

The FDA’s move comes after the World Health Organization urged wealthy nations last week to temporarily stop the distribution of booster shots, citing vaccine inequity across the globe. However, world health officials made sure to emphasize they were not referring to the extra doses that may be needed now for certain groups, like those with weakened immune systems.

Other countries, such as France, are already giving out third shots to people living with cancer or other immune impairments. Israel announced plans last month to offer booster shots to people over age 60, another high-risk population, as the shot’s effectiveness appears to wane in those individuals.

In the U.S., Mississippi, a state with some of the lowest vaccination rates, is advising that doctors consider a booster dose for people with weakened immune systems. Health officials there recommend waiting at least four weeks after full vaccination before receiving a booster.

This is a developing story. Please check back for updates.

— CNBC’s Christine Wang contributed to this report.

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Politics

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

C.D.C. Panel Recommends Third Vaccine Dose for Immunocompromised

Dr. Jose U. Scher, a rheumatologist at NYU Langone Health who has studied the effect of vaccines on the immunocompromised, said that the C.D.C. vote — and the guidance from its experts — would help patients who had been agonizing over whether to seek out a third shot. Previously, he said, when people tested themselves for antibodies after vaccination and came up empty, “there were no tools for us to respond to that.”

Updated 

Aug. 13, 2021, 5:00 a.m. ET

“We now know that this population was being left behind,” he said.

Immunocompromised people will not need a doctor’s permission or a prescription to get a third shot, C.D.C. officials said. They will need only to attest that they meet the eligibility requirements for an additional dose. Anyone else, including people with chronic medical conditions, like diabetes or asthma, should not be getting third shots at this point, they said.

Dr. Scher predicted that this honor-system approach could be messy. “I don’t know if there’s any way of corroborating someone’s claim” of being immunocompromised, he said. Requiring some kind of proof, such as a doctor’s note, would be a better process, he said.

The updated F.D.A. authorizations do not apply to immunocompromised people who received the single-dose Johnson & Johnson vaccine. The C.D.C. panel did not offer recommendations on additional shots for that group, which is believed to be small. But the lack of guidance from either the F.D.A. or C.D.C. has left that group in limbo.

Understand the State of Vaccine and Mask Mandates in the U.S.

    • Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in indoor public places within areas experiencing outbreaks, a reversal of the guidance it offered in May. See where the C.D.C. guidance would apply, and where states have instituted their own mask policies. The battle over masks has become contentious in some states, with some local leaders defying state bans.
    • Vaccine rules . . . and businesses. Private companies are increasingly mandating coronavirus vaccines for employees, with varying approaches. Such mandates are legally allowed and have been upheld in court challenges.
    • College and universities. More than 400 colleges and universities are requiring students to be vaccinated against Covid-19. Almost all are in states that voted for President Biden.
    • Schools. On Aug. 11, California announced that it would require teachers and staff of both public and private schools to be vaccinated or face regular testing, the first state in the nation to do so. A survey released in August found that many American parents of school-age children are opposed to mandated vaccines for students, but were more supportive of mask mandates for students, teachers and staff members who do not have their shots.  
    • Hospitals and medical centers. Many hospitals and major health systems are requiring employees to get a Covid-19 vaccine, citing rising caseloads fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their work force.
    • New York. On Aug. 3, Mayor Bill de Blasio of New York announced that proof of vaccination would be required of workers and customers for indoor dining, gyms, performances and other indoor situations, becoming the first U.S. city to require vaccines for a broad range of activities. City hospital workers must also get a vaccine or be subjected to weekly testing. Similar rules are in place for New York State employees.
    • At the federal level. The Pentagon announced that it would seek to make coronavirus vaccinations mandatory for the country’s 1.3 million active-duty troops “no later” than the middle of September. President Biden announced that all civilian federal employees would have to be vaccinated against the coronavirus or submit to regular testing, social distancing, mask requirements and restrictions on most travel.

“We do understand the challenges here, and because of that we will continue to work very diligently to try to have a solution,” Dr. Peter Marks, the F.D.A.’s top vaccine regulator, said at the panel’s meeting. The F.D.A. is waiting on more data that it expects to receive this month, including Johnson & Johnson’s clinical trial data on the safety and efficacy of two doses.

Dr. Kathleen Dooling, a C.D.C. official, said that patients who qualify for a third dose should ideally seek out the vaccine they already received, but that they could take the other two-dose vaccine if necessary.

Presenting studies that supported giving third doses, Dr. Dooling emphasized that immunocompromised people who receive a third dose should still wear a mask, maintain social distancing with people they do not live with, and avoid crowds and poorly ventilated indoor spaces. She said that people with weakened immune systems had also been shown to be at greater risk of breakthrough infection.

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Health

One Dose of J.&J. Vaccine Is Ineffective Towards Delta, Examine Suggests

One Dose of J.&J. Vaccine Is Ineffective Against Delta, Study Suggests

The coronavirus vaccine manufactured by Johnson & Johnson is much less effective against the Delta and Lambda variants than against the original virus, according to a new study published online on Tuesday.

The results show that the 13 million people who used the J. & J. The vaccine may need to be given a second dose – ideally one of the Pfizer-BioNTech or Moderna mRNA vaccines, the authors said.

However, the conclusions contradict those from smaller studies published earlier this month by Johnson & Johnson, which suggest that a single dose of the vaccine is effective against the variant even eight months after being vaccinated.

The new study had not yet been peer-reviewed or published in a scientific journal and was based on laboratory experiments. However, it is consistent with observations that a single dose of the AstraZeneca vaccine – which has a similar architecture to the J. & J. Vaccine – only shows about 33 percent effectiveness against symptomatic diseases caused by the Delta variant.

“The message we wanted to get across wasn’t that people were making the J. & J. Vaccine, but we hope it will be reinforced with in the future either another dose of J. & J. or a boost with Pfizer or Moderna, ”said Nathaniel Landau, a virologist at NYU’s Grossman School of Medicine who led the study.

Other experts said the results are what they expected as all vaccines seem to work better when given in two doses. “I have always thought and often said that J. & J. Vaccine is a two-dose vaccine, ”said John Moore, a virologist at Weill Cornell Medicine in New York.

Dr. Moore pointed to several studies in monkeys and humans that showed greater effectiveness with two doses of the J. & J. Vaccine compared to a dose. He said the new study was particularly credible because it was published by a team with no ties to any of the vaccine manufacturers.

But the data from the new study “doesn’t speak about the whole nature of immune protection,” said Seema Kumar, a spokeswoman for J. & J. Company-sponsored studies suggest that the vaccine “produces strong, sustained activity against the rapidly spreading Delta variant,” she said.

The delta variant is the most contagious version of the coronavirus to date. It accounts for 83 percent of infections in the United States, said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, at a Senate hearing on Tuesday.

The variant could also be responsible for a recent surge in infections: although they’re still low compared to last winter, cases are increasing in all 50 states and hospital admissions are increasing in almost all. In the two weeks ended Tuesday, there were an average of 268 deaths per day in the nation.

Delta can cause more breakthrough infections than previous forms of the virus, but more than 99 percent of hospitalizations and deaths occur in unvaccinated people. The vaccination rates in the country have stalled, almost 60 percent of adults are fully protected against the virus.

Several studies have shown that Pfizer-BioNTech and Moderna’s mRNA vaccines retain their effectiveness against the coronavirus, including all variants identified so far. For example, a recent study showed that the vaccines trigger a sustained immune response in the body that can protect against the coronavirus for years.

Updated

July 20, 2021, 4:10 p.m. ET

But evidence for the J. & J. The vaccine was limited as it was introduced later than the mRNA vaccines. Most of the studies on the effectiveness of the coronavirus vaccines were conducted in medical centers and hospitals, based on samples from staff who had received the mRNA vaccines.

The J. & J. The vaccine has also been followed by reports of blood clots and a rare neurological syndrome, as well as contamination problems at a Baltimore manufacturing facility.

Small studies published by researchers associated with J. & J. suggested that the vaccine against the Delta variant was only slightly less effective than against the original virus and that the antibodies stimulated by the vaccine grew in strength within eight months.

Dr. Landau would likely have seen a similar increase in the vaccine’s effectiveness if they looked at the data over time, said Dr. Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston. The data for the J. & J. The strength of the vaccine against the Delta variant on day 29 is not much different from what was reported in his own study, said Dr. Barouch.

“Basically, I don’t see any discrepancies,” he said. “The question is that of kinetics, it’s not just size, because immune responses are not static over time.” The new study does not consider other components of the immune system either, he added.

Dr. Landau and colleagues examined blood samples from 17 people who received two doses of an mRNA vaccine and 10 people who received one dose of the J. & J. Vaccination.

The J. & J. Vaccine started with less potency than the mRNA vaccines and showed a greater potency drop against the Delta and Lambda variants. “The lower baseline means that what is left against Delta is very weak,” said Dr. Moors. “That is a major concern.”

Very few vaccines are given as a single dose because the second dose is needed to raise antibody levels, noted Akiko Iwasaki, an immunologist at Yale University. Persons familiar with the J. & J. Vaccines “rely on this primary response to maintain high levels of antibody, which is particularly difficult against the variants,” she said.

Boosting immunity with a second dose should raise antibody levels high enough to counter the variants, she said.

For the second shot, let’s turn to an mRNA vaccine rather than another J. & J. Shot, Possibly Better: Several studies have shown that combining a dose of the AstraZeneca vaccine with a dose of the Pfizer BioNTech or Moderna vaccine is more effective than two doses of AstraZeneca.

The Food and Drug Administration has said, “Americans who have been fully vaccinated don’t need a booster right now,” and the agency is unlikely to change its recommendations based on laboratory studies. But the new data should cause the FDA to reconsider its recommendations, said Dr. Landau: “I hope you read our paper and think about it.”

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Health

Does It Matter if I Skip My Second Dose of Covid Vaccine?

Does It Matter if I Skip My Second Dose of Covid Vaccine?

It’s also not clear how long the protection of the first dose lasts without the surge of a second dose, said Dr. Fauci during a press conference at the White House in April.

Updated

April 29, 2021, 6:12 p.m. ET

“We were and still are concerned that if you look at the level of protection after a dose, you can say it’s 80 percent, but it’s a little weak 80 percent,” said Dr. Fauci. He said there was concern that more contagious variants that continue to spread around the globe might partially dodge after just one dose of vaccine-induced antibodies. “You’re in a weak zone if you don’t get the full effect of two doses,” he said.

Breakthrough infections after vaccination, while rare, do occur. A recent study of 250 people in Israel who were infected with the Pfizer vaccine after partial vaccination – between two weeks after the first dose and one week after the second dose – showed that they infected disproportionately with B.1.1.7 variant were first identified in Great Britain. The same study found that a group of 149 people infected after the second dose of vaccine developed eight infections with B.1.351 (the variant first identified in South Africa) between the seventh and 13th day after the second dose. No breakthrough infections with the South African variant were observed 14 days after the second dose. Although it was a small sample, the result suggested that full vaccination would provide more protection against the variants, said Adi Stern, the study’s lead author, a professor at Tel Aviv University’s Shmunis School of Biomedicine and Cancer Research .

Another study showing the benefits of full vaccination looked at a group of 91,134 patients previously seen by doctors at the Houston Methodist Hospital system and followed them between December and April. Most were not vaccinated, but 4.5 percent were partially immunized and 25.4 percent were fully immunized. There were 225 deaths from Covid-19 in the group and 219 (97 percent) were among the unvaccinated. However, five deaths (2.2 percent) occurred in the partially immunized. Only one person (0.004 percent) died in the fully immunized group. In this study, full vaccination was protected 96 times from hospitalization and 98.7 percent from death from Covid-19. However, the partially vaccinated were only 77 percent protected from hospitalization and 64 percent from fatal Covid-19.

The study’s lead author, Saad B. Omer, director of the Yale Institute for Global Health, said he started the research with a “neutral” view of the benefits of two doses over a single dose. But he is now convinced that the benefits of a second dose matter.

“Given the data from our study and other evidence, it doesn’t make sense for people to skip their second dose,” said Dr. Omer. “When it comes to preventing death from vaccines, the jar is 64 percent full, but wouldn’t you rather have it almost 100 percent full for a result as drastic and irreversible as death?”

Aside from the obvious health risks, skipping the second dose can also make your life more complicated if you’re traveling or visiting facilities that require proof of vaccination. “You are not considered fully vaccinated,” said Dr. Brownstein. “It can have an impact on getting back to normal. If your vaccination record or card does not show full status, there may be certain things you cannot do. You may not be able to get on a plane. “

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Single dose of vaccine can virtually halve transmission

Pfizer says shot is 100% effective in kids ages 12 to 15

A nurse, Cindy Mendez, wearing a protective mask, holds a syringe containing a dose of Pfizer-BioNTech COVID-19 vaccine during the coronavirus disease (COVID-19) pandemic at NYC Health + Hospitals Harlem Hospital in the Manhattan neighborhood of New York City. New York, February 25, 2021.

Jeenah Moon | Reuters

LONDON – A single dose of coronavirus vaccine can cut transmission within a household by up to half, a study by Public Health England found.

People who became infected with the coronavirus three weeks after receiving a single dose of the Pfizer-BioNTech or AstraZeneca-University of Oxford vaccine were between 38% and 49% less likely to pass the virus on to their household contacts than those who weren’t vaccinated, the PHE found -Study.

Protection was observed approximately 14 days after vaccination with similar levels of protection regardless of the age of the cases or contacts.

That protection comes on top of the reduced risk that a vaccinated person will develop symptomatic infection in the first place, which is around 60% to 65% – four weeks after a dose of either vaccine, according to PHE. Both doses of a coronavirus vaccine (the delay between doses is up to 12 weeks in the UK) offer even greater protection against Covid infections.

UK Health Secretary Matt Hancock hailed the study’s results as “great news”. “We already know that vaccines save lives, and this study is the most comprehensive real-world data to show that they also reduce the transmission of this deadly virus.”

“It further underscores that vaccines are the best way out of this pandemic as they protect you and potentially prevent you from unwittingly infecting anyone in your household.”

“I urge everyone to get their vaccines as soon as they are eligible and make sure you get your second dose to ensure the best possible protection,” he added.

Both Pfizer BioNTech and AstraZeneca vaccines are used extensively in the UK, and the Moderna vaccine is now also included in the immunization program.

The introduction of vaccines was a tremendous success in the UK and a silver lining after the devastation of the pandemic that has caused over 127,000 deaths in the country to date.

In the UK, cases, hospitalizations and deaths have fallen dramatically since it was launched in December, along with strict lockdown measures. To date, nearly 34 million adults in the UK have had a first dose of vaccine and over 13 million two doses, government data shows.

The PHE study found that households are at high risk for transmission and provide early evidence of the effects of vaccines on preventing transmission. Similar results might be expected in other settings with similar transmission risks, for example in shared apartments and prisons.

The study, which is a pre-print that has not yet been peer-reviewed, included over 57,000 contacts from 24,000 households who had a laboratory-confirmed coronavirus case vaccinated, compared to nearly 1 million contacts from unvaccinated cases.

By linking case and household contact data with vaccination status, the study compared the probability of transmission for a vaccinated case with a non-vaccinated one.

PHE is also conducting separate studies on the effects of vaccination on transmission in the broader population.

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Health

Single dose cuts an infection charge by 65%, examine finds

Single dose cuts infection rate by 65%, study finds

James Shaw, 82, receives Oxford University / AstraZeneca COVID-19 vaccine from advanced nurse Justine Williams on January 4, 2021 at Lochee Health Center in Dundee, Scotland, UK.

Andy Buchanan | Reuters

LONDON – A single dose of the Covid-19 vaccine from Oxford-AstraZeneca or Pfizer-BioNTech drastically reduces the risk of infection in adults of all ages, British researchers have found.

Two studies published on Friday analyzed more than 1.6 million nasal and throat swabs from 373,402 people between December and April. The data was collected as part of the ongoing Covid-19 infection survey carried out by Oxford University, the UK Office for National Statistics and the UK Department of Health and Welfare.

The researchers found that 21 days after a single dose of the Oxford-AstraZeneca or Pfizer-BioNTech vaccine, new Covid infections – both symptomatic and asymptomatic – had decreased by 65%.

Symptomatic infections decreased by 74% three weeks after a single dose of either vaccine, while asymptomatic cases decreased by 57%, the data showed.

A second dose of vaccine reduced the overall infection rate by 70%, reducing symptomatic Covid infections by 90% and asymptomatic cases of the virus by 49%.

The researchers compared these effects to the natural immunity obtained from infection with the virus.

However, they warned that the fact that vaccinated people could still be infected – even if those infections were mostly asymptomatic – meant “transmission possible”.

The study found that vaccines had a similar effect in reducing infection rates in adults of all ages. Their ability to reduce infection was also similar, regardless of whether the participants had long-term health conditions or not.

What about antibody resistance?

The scientists also looked at the effects of Covid vaccinations on participants’ antibody levels.

They found that older adults – especially those over 60 – who had never been infected with Covid had a lower immune response to a single dose of vaccine than those who had previously been infected with the virus.

Antibody responses to two doses of the Pfizer BioNTech vaccine were high in all age groups. The data showed that older adults were able to achieve antibody levels similar to those who received a vaccine dose after a previous Covid infection.

Too few people in the UK had received two doses of the Oxford AstraZeneca vaccine for researchers to assess the effects on antibody response. However, it was found that immune responses to a first dose differed between the Oxford AstraZeneca vaccine and the Pfizer BioNTech vaccine.

Antibody levels rose more slowly after a single dose of the Oxford-AstraZeneca vaccine than after the Pfizer-BioNTech alternative. However, after a dose of the latter, antibody levels fell more rapidly, especially in older adults, so patients achieved antibody levels similar to those seen after an initial dose of the Oxford-AstraZeneca vaccine.

Although immune responses differed between age groups, the scientists emphasized that there was no group that did not respond to either vaccine. However, a small number of people – less than 5% – had poor immune responses to both vaccines.

Important to get the second dose

The Oxford-AstraZeneca vaccine has been approved for use in the UK, India and several other countries, but has been temporarily suspended in some markets amid concerns that it could be linked to rare blood clots. Global health officials have stated that the benefits of giving the vaccine continue to outweigh the risks.

The WHO recommends an interval of eight to 12 weeks between the first and second dose of the Oxford AstraZeneca vaccine.

The Pfizer BioNTech vaccine is also given in several countries, including the United States. The U.S. Centers for Disease Control and Prevention recommends receiving a second dose of the vaccine three weeks after the first.

In February, the UK started a study to see if mixing doses of the Oxford-AstraZeneca and Pfizer-BioNTech vaccines could be effective.

Sarah Walker, professor of medical statistics and epidemiology at Oxford University and chief investigator and academic director of the Covid-19 infection survey, said Friday that scientists are still not sure how strong and how long an antibody response is. was needed for long-term protection against Covid.

David Eyre, associate professor at Oxford University’s Big Data Institute, added that the results released on Friday highlighted the importance of a second dose of vaccine for increased protection.

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Individuals who get Covid between vaccine pictures can get second dose after restoration

People who get Covid between vaccine shots can get second dose after recovery

The director of the National Institute for Allergies and Infectious Diseases, Dr. Anthony Fauci, speaks to reporters in the Brady Press Briefing Room at the White House in Washington, DC on April 13, 2021.

Chip Somodevilla | Getty Images

People who contract the coronavirus between Covid-19 vaccinations can get their second dose after recovering from the disease and are no longer considered contagious, White House chief medical officer Dr. Anthony Fauci, on Thursday.

Pfizer and Moderna’s Covid vaccines require two doses three to four weeks apart. Both vaccines are about 95% effective against the virus, but that strong protection doesn’t kick in until two weeks after the second dose, officials say.

Some people have reported that Covid was diagnosed after the first vaccine shot and before the second vaccine. In that case, Fauci said, they can get their second dose after they recover from the disease and meet the isolation criteria.

According to the Centers for Disease Control and Prevention, people who have had Covid-19 may be around others after at least 10 days, 24 hours without a fever, and when other symptoms, if any, improve.

Fauci also noted that a small percentage of fully vaccinated people will continue to develop Covid-19 – so-called “breakthrough cases”. CDC director Dr. Rochelle Walensky said Monday that U.S. health officials had confirmed fewer than 6,000 cases of Covid-19 from 84 million Americans with full protection against the virus.

Fauci said officials do not yet understand the risk of developing persistent symptoms, also known as “long covid,” after a breakthrough post-vaccination.

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Pfizer CEO says third Covid vaccine dose doubtless wanted inside 12 months

Pfizer CEO says third Covid vaccine dose likely needed within 12 months

President Joe Biden listens as Pfizer CEO Albert Bourla speaks at the Pfizer Kalamazoo manufacturing facility in Portage, Michigan on February 19, 2021.

Brendan Smialowski | AFP | Getty Images

Albert Bourla, CEO of Pfizer, said people “likely” will need a booster dose of a Covid-19 vaccine within 12 months of being fully vaccinated. His comments were posted on Thursday but recorded on April 1st.

Bourla said it was possible that people would need to be vaccinated against the coronavirus annually.

“A likely scenario is that a third dose is likely to be needed, somewhere between six and twelve months, and there will be an annual revaccination from there, but all of this needs to be confirmed. And again the variants will play a key role,” said he Bertha Coombs of CNBC during an event with CVS Health.

“It is extremely important to suppress the pool of people who may be susceptible to the virus,” Bourla said.

The comment comes after Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to be vaccinated against Covid-19 annually, just like seasonal flu shots.

Researchers still don’t know how long protection against the virus will last once someone has been fully vaccinated.

Pfizer said earlier this month that up to six months after the second dose, its Covid-19 vaccine was more than 91% effective against the coronavirus and more than 95% effective against serious illnesses. Moderna’s vaccine, which uses technology similar to Pfizer, was also shown to be highly effective after six months.

Pfizer’s data was based on more than 12,000 vaccinated participants. However, researchers say more data is needed to determine if protection continues after six months.

David Kessler, the Biden government’s chief science officer for Covid Response, said earlier Thursday that Americans should expect booster vaccinations to protect against coronavirus variants.

Kessler told US lawmakers that currently approved vaccines offer high levels of protection, but that new variants may “question” the effectiveness of the shots.

“We don’t know everything right now,” he told the House Select subcommittee on the coronavirus crisis.

“We are investigating the durability of the antibody response,” he said. “It seems strong, but it’s wearing off a bit and no doubt the variants are challenging … they make these vaccines work harder. So I think we should, for planning purposes, for planning purposes only, expect us to possibly need to increase. “”

In February, Pfizer and BioNTech announced that they were testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

At the end of last month, the National Institutes of Health began testing a new Covid vaccine from Moderna, in addition to the existing one, which is intended to protect against a problematic variant first found in South Africa.

Moderna CEO Stephane Bancel told CNBC on Wednesday that the company is hoping to have a booster shot for its two-dose vaccine in the fall.

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Moderna says its shot is 90% efficient 6 months after second dose

Moderna asks FDA to authorize 5 additional doses per Covid vaccine vial to speed distribution, source tells CNBC

A healthcare worker holds a vial of the Moderna COVID-19 vaccine at a pop-up vaccination facility operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in New York on January 29, 2021.

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Moderna’s Covid-19 vaccine was more than 90% effective against Covid and more than 95% effective against serious diseases up to six months after the second dose, the company said Tuesday, referring to updated data from its clinical Phase 3 study.

The update brings Moderna one step closer to filing its application for full US approval for its vaccine. Full approval requires a more rigorous review process to show that the shot is safe and effective for its intended use. With full approval, Moderna can begin marketing the recordings directly to consumers and selling them to individuals and private companies in the United States

The new data included Covid-19 cases through April 9 and assessed over 900 cases, including more than 100 serious cases. The vaccine is currently approved for emergency use by the Food and Drug Administration for those aged 18 and over. The authority can revoke the emergency permit (EUA) at any time. Moderna only submitted safety data to the EEA for two months. The FDA typically takes six months for full approval.

The company said its results are preliminary. Moderna announced that updated data on effectiveness against asymptomatic infections and antibody persistence will be released later this year.

The new data comes from a study published in the New England Journal of Medicine that showed that antibodies induced by the Moderna vaccine were still present six months after the second dose. It also comes after Pfizer said earlier this month that its vaccine, which uses technology similar to Moderna’s, was also shown to be highly effective six months after the second dose.

Dr. Isaac Bogoch, an infectious disease specialist who served on various drug data and safety monitoring boards, described Moderna’s update as “amazing news” and is pleased to hear that both mRNA vaccines are highly effective after six months.

“I think it’s fair to estimate that both will have decent effectiveness over many months,” he said.

Moderna is still evaluating its vaccine in people aged 17 and younger.

The company announced Tuesday that its study testing the vaccine in adolescents ages 12 to 17 is now fully enrolled and has approximately 3,000 participants in the United States

Participants are currently enrolling in his study, which is testing the vaccine in children aged 6 months to 11 years. It is expected that 6,750 healthy pediatric participants will be enrolled in the US and Canada. As in Pfizer’s study, children first receive a low dose of the vaccine before gradually moving on to higher doses.

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CDC examine reveals single dose of Pfizer or Moderna Covid vaccines was 80% efficient

CDC changes Covid vaccine guidance to OK mixing Pfizer and Moderna shots

According to a new study by the Centers for Disease Control and Prevention of vaccinated health care workers, a single dose of the Covid-19 vaccine from Pfizer or Moderna was 80% effective in preventing coronavirus infections.

The effectiveness of the partial immunization was noted two weeks after the first dose, according to the CDC, which studied nearly 4,000 health care workers, first responders and frontline workers between December 14 and March 13, according to other key study staff, which began on Monday had no prior laboratory documentation of the Covid-19 infection.

Two doses are better than one, federal health officials said, adding that the vaccines’ effectiveness rose to 90% two weeks after the second dose.

“These results show that approved mRNA-COVID-19 vaccines in adults of working age effectively prevent SARS-CoV-2 infection under real conditions, regardless of symptom status,” wrote the US agency in the study. “The COVID-19 vaccination is recommended to all entitled persons.”

The new CDC results should back up arguments by some health experts and health officials that the US should give Americans only one dose of vaccines as a priority before moving on to a second dose, accelerating the pace of vaccination across the country.

The CDC results were released just minutes before the press conference by the agency’s director, Dr. Rochelle Walensky, the hospital also released as vaccinations nationwide expedite.

Unlike the Johnson & Johnson vaccine, which requires one dose, the Pfizer and Moderna vaccines require two vaccinations three to four weeks apart. The Chief Medical Officer of the White House, Dr. Anthony Fauci, has said repeatedly over the past few months that the US should stick to the two-dose regime.

Dr. Paul Offit, a voting member of the FDA’s Advisory Committee on Vaccines and Related Biological Products who reviewed both Pfizer’s and Moderna’s vaccines for emergency approval, said the CDC study was overall “good news” .

However, he said he feared people would now think a dose of the vaccines was “good enough” and would not return for a second shot. He said studies have shown that immunity actually appears to be “more permanent” after the second dose, meaning protection may last longer.

“The reason these are two-dose vaccines is because the second dose provides a titer of neutralizing antibodies, virus-specific neutralizing antibodies, that is nearly ten times greater than the first dose,” he told CNBC. Neutralizing antibodies play an important role in the defense of cells against the virus.

Second, and more importantly, scientists have also discovered what are known as T cells, another important part of the immune response that usually lasts longer Immunity, he said.

There are also still questions about the highly contagious variants and whether the vaccines protect mild to moderate forms of the disease, he said.

Of the 3,950 participants in the study, 2,479, or 62.8%, received both recommended doses, and 477, or 12.1%, received only one dose, according to the CDC. The infection rate among the vaccinated participants was 0.04 compared to 1.38 among the non-vaccinated participants.

The study was conducted in eight locations in the United States: Phoenix, Tucson, and other areas in Arizona; Miami, Florida; Duluth, Minnesota; Portland, Oregon; Temple, Texas; and Salt Lake City, Utah. The majority of the participants were female, white, and had no chronic illnesses, according to the CDC.

The study had limitations, the CDC said, adding that delays in deliveries could reduce virus detection sensitivity of Covid-19 tests.

Preliminary real-world vaccine efficacy results for both vaccines complement and expand on estimates of vaccine efficacy from other recent studies, the CDC said. A large study published in the New England Journal of Medicine in February found that Pfizer’s vaccine was 94% effective against symptomatic Covid.