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Pfizer and BioNTech said Wednesday they have filed with the Food and Drug Administration for additional approval of a coronavirus vaccine booster vaccine for those 16 and older, and will submit all their supporting data by the end of this week. The move came as companies said the third vaccine shot had sharply increased antibody levels against the virus.
The companies did a study of 306 volunteers who received a booster shot about five to eight months after their second shot. The researchers found that the level of coronavirus-blocking antibodies jumped three times more than after the second dose.
The companies said the side effects of a third injection were pretty much the same as after the first two doses. Baseline data were not included in the newsletter, and the dates or location of the study were not specified. The companies said they are preparing a scientific publication describing the research.
News of Pfizer and BioNTech’s booster application comes two days after the FDA fully approved Two doses of the vaccine for those aged 16 and over, making it the first to go beyond the emergency use case.
Over the past few weeks, federal regulators have been racing to collect and evaluate data on booster shots. If the FDA decides that additional vaccines are safe and effective, Biden’s administration said it would require adults to receive a third injection eight months after their second Pfizer or Moderna vaccine, beginning the week of September 20.
Federal health officials said last week that they believe the efficacy of the Pfizer-BioNTech and Moderna vaccines diminishes over time, increasing the risk of infection from the highly contagious Delta variant. While data shows vaccines continue to offer strong protection against hospitalizations and severe illness, officials said they feared the situation could change without booster vaccines.
Some public health experts defied the plan early, saying that current data show that the vaccines hold up well against serious illness and hospitalizations, including the Delta variant. Extra vaccines could only be warranted if vaccines failed to meet this standard. said.
Pfizer executives offered an early look at support data for July 23 during their second-quarter earnings call. In a smaller study, they found that antibody levels dropped significantly in the months following the second dose. However, these levels rose again after the third dose. When the researchers expanded their focus to a larger group of subjects, they continued to find a strong effect from the boosters.
Antibodies that can neutralize the coronavirus are just one of the types of defense our immune systems use to fight it. The new study did not include details on other defenses provoked by the vaccine, such as immune cells trained to kill infected cells.
Participants in the new support study were between the ages of 18 and 55. It was not immediately clear why the study did not include the elderly. The volunteers were followed for an average of 2.6 months.
Understand the Vaccine and Mask Instructions in the US
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- vaccination rules. On August 23, the Food and Drug Administration Pfizer-BioNTech’s coronavirus vaccine granted full approval It paves the way for people aged 16 and over to increase their tenure in both the public and private sectors. became private companies increasingly mandatory vaccines for employees. Such powers legally allowed and upheld in court appeals.
- Mask rules. Centers for Disease Control and Prevention in July suggested The fact that all Americans, regardless of vaccination status, wear masks in public in areas with outbreaks was a reversal of the guidance it presented in May. See where the CDC guidance applies, and where states created their own mask policies. The battle over masks has become contentious in some states. local leaders defying state bans.
- Colleges and universities. More than 400 colleges and universities require their students to be vaccinated against Covid-19. Nearly all in states that voted for President Biden.
- Schools. Both of them California and New York City imposes vaccination requirements for education personnel. A survey published in August found that many American parents with school-age children are against compulsory vaccinations for students, but More support for mask missions for unvaccinated students, teachers and staff.
- Hospitals and medical centers. Many hospitals and major healthcare systems require their employees to be vaccinated against Covid-19. He speaks of increased caseloads fueled by the delta variant and stubbornly low vaccination rates in their communities, even within the workforce.
- New York City. Proof of vaccination is required for workers and customers. indoor dining, gyms, performances and other indoor situations, but the app doesn’t start until September 13. Teachers and other education workers The city’s large school system will need at least one dose of the vaccine by September 27, with no weekly testing option. City hospital staff they should also be vaccinated or undergo weekly tests. Similar rules apply to New York State employees.
- at the federal level. The Pentagon has announced that it will try to make coronavirus vaccines mandatory for the country. 1.3 million active-duty soldiers No later than mid-September. President Biden announced all civilian federal employees would have to get vaccinated against coronavirus or subject to regular testing, social distancing, mask requirements and restrictions on most trips.
Pfizer and BioNTech said they plan to submit their data to regulatory authorities in Europe and other countries, in addition to the FDA.
Administration’s support plan does not yet include recipients of Johnson & Johnson’s one-time vaccine. Johnson and Johnson announced Earlier on Wednesday, a study of 17 volunteers showed little change in antibody levels over six months, unlike Moderna’s and Pfizer’s vaccines.
But the study also showed that when volunteers were given a second vaccine six months after the first, their antibodies to the coronavirus jumped nine times more than after the first dose. Company officials said they look forward to discussing a potential support strategy for their vaccines with federal health officials.
While the Pfizer-BioNTech vaccine has been fully approved as a two-step regimen for those aged 16 and over, adolescents aged 12 to 15 years can continue to be vaccinated under emergency use authorization for the vaccine. The regulators only allowed a third shot for some people with compromised immune systems.
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