Pfizer and BioNTech said on Wednesday they are now asking the Food and Drug Administration for further approval of a coronavirus vaccine booster for people aged 16 and older, and will submit all of their data in support of here the end of this week. The move came as the companies said a third shot of the vaccine sharply increased levels of antibodies to the virus.
The companies conducted a study of 306 volunteers who received a booster injection approximately five to eight months after their second injection. The researchers found that the level of antibodies that block the coronavirus jumped more than three times higher than the level after the second dose.
Side effects from a third injection were about the same as after the first two doses, the companies said. The underlying data was not included in the press release, nor the dates or location of the study specified. The companies said they were preparing a scientific publication describing the research.
News of Pfizer and BioNTech’s recall request came two days after the FDA fully approved their two-dose vaccine for those 16 and over, making it the first to go beyond emergency use status. .
In recent weeks, federal regulators have been rushing to collect and assess data on booster injections. If the FDA decides additional injections are safe and effective, the Biden administration has said it wants adults to receive a third injection eight months after their second injection of Pfizer or Moderna vaccines, starting the week of September 20. .
Federal health officials said last week that they believe the potency of the Pfizer-BioNTech and Moderna vaccines wanes over time, increasing the risk of infection with the highly contagious Delta variant. While the data indicates that vaccines continue to offer strong protection against hospitalization and serious illness, officials said they fear the situation will change without booster shots.
Some public health experts have challenged the plan as premature, saying available data shows the vaccines are resistant to serious illness and hospitalization, including against the Delta variant. Additional injections would only be warranted if the vaccines did not meet that standard, some said.
Pfizer executives presented a snapshot of their recall data on July 23 during their second quarter earnings call. In a smaller study, they found that antibody levels dropped significantly in the months following a second dose. But these levels rose again after a third dose. When the researchers focused on a larger group of subjects, they continued to find a powerful effect from the boosters.
Antibodies capable of neutralizing the coronavirus are just one type of defense our immune system uses to fight it. The new study did not include details about other defenses caused by the vaccine, such as immune cells formed to kill infected cells.
Participants in the new booster study were between 18 and 55 years old. It was not immediately clear why the study did not include the elderly. The volunteers were followed for a median period of 2.6 months.
Understanding the mandates of vaccines and masks in the United States
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people 16 years of age and older, paving the way for increased tenure in the public and private sectors. Private companies increasingly require vaccines for their employees. Such mandates are legally authorized and have been confirmed in legal challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of their immunization status, wear masks in indoor public places in areas affected by epidemics, a reversal of guidelines it offered in May. . See where the CDC guidelines would apply and where states have instituted their own mask policies. The battle for masks has become controversial in some states, with some local leaders defying state bans.
- College and universities. More than 400 colleges and universities require students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California and New York City have both introduced vaccination mandates for education staff. A survey released in August found that many American parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who don’t. don’t have their vaccines.
- Hospitals and medical centers. Many hospitals and large healthcare systems are requiring their employees to be vaccinated against Covid-19, citing an increase in the number of cases fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their hand -work.
- New York City. Proof of vaccination is required from workers and customers for indoor meals, gyms, shows and other indoor situations, although enforcement does not begin until September 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by September 27, with no possibility of weekly testing. Employees of the city’s hospitals must also get vaccinated or undergo weekly tests. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon has said it will seek to make coronavirus vaccination mandatory for the nation’s 1.3 million active-duty soldiers “no later than” mid-September. President Biden announced that all federal civilian employees should be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
Pfizer and BioNTech said that in addition to the FDA, they plan to submit their data to regulatory authorities in Europe and other countries.
The administration booster plan does not yet include recipients of the single injection vaccine from Johnson & Johnson. Johnson & Johnson announced earlier on Wednesday that unlike studies of Moderna and Pfizer’s vaccines, a study of 17 volunteers showed little change in their antibody levels over the six months.
But the study also showed that when volunteers received a second injection six months after the first, their antibodies to the coronavirus jumped nine times higher than the level after the first dose. Company officials said they were eager to discuss a potential recall strategy for their vaccine with federal health officials.
While the Pfizer-BioNTech vaccine has been fully approved as a two-shot regimen for those 16 years of age and older, adolescents aged 12 to 15 may continue to be vaccinated under the authorization for use of vaccine emergency. Regulators have only authorized a third injection for some people with weakened immune systems.