Pfizer and BioNTech announced on Wednesday that they will now apply to the Food and Drug Administration for additional approval of a coronavirus vaccine booster for people aged 16 and older and will submit all of their supporting data by the end of this week. The move came when companies said a third shot of the vaccine greatly increased antibody levels to the virus.
The companies conducted a study of 306 volunteers who received a booster dose approximately five to eight months after their second vaccination. The researchers found that the level of the antibodies that block the coronavirus was more than three times what it was after the second dose.
The side effects of a third injection were roughly the same as after the first two doses, the companies said. The underlying data was not included in the press release, nor was the dates or location of the study stated. The companies said they are preparing a scientific paper describing the research.
The news of Pfizer and BioNTech’s booster application came two days after the FDA fully approved their two-dose vaccine for people aged 16 and over.
In the past few weeks, the federal supervisory authorities have fought to collect and evaluate data on booster vaccinations. If the FDA decides that additional vaccinations are safe and effective, the Biden government would like adults to have a third injection eight months after their second vaccination with Pfizer or Moderna vaccines from the week of September 20th.
Federal health officials said last week that they believe the Pfizer-BioNTech and Moderna vaccines may become less effective over time, increasing the risk of infection from the highly contagious Delta variant. While the data suggests vaccines continue to offer robust protection against hospitalization and serious illness, officials fear the situation could change without a booster.
Some public health experts have challenged the plan as premature, saying the available data shows the vaccines against serious illness and hospitalizations, including the Delta variant, are doing well. Additional vaccinations would only be warranted if the vaccines did not meet this standard, some said.
Pfizer executives presented an early look at their booster data during their second quarter results conference call on July 23. In a smaller study, they found that antibody levels decreased significantly in the months after a second dose. But these values started again after a third dose. As the researchers broadened their focus to include a larger group of subjects, they continued to see a strong effect from the boosters.
Antibodies that can neutralize the coronavirus are just one type of defense our immune system uses to fight it. The new study did not provide details on other defense mechanisms created by the vaccine, such as immune cells that are trained to kill infected cells.
The participants in the new booster study were between 18 and 55 years old. It wasn’t immediately clear why the study didn’t include the elderly. The volunteers were followed for a median of 2.6 months.
Understand US vaccination and mask requirements
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
- College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for educational staff. A survey published in August found that many American parents of school-age children are opposed to mandatory vaccines for students but are more supportive of masking requirements for students, teachers, and staff who do not have a vaccination.
- Hospitals and medical centers. Many hospitals and large health systems require their employees to receive a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
- New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13th. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, without the option of weekly testing. City hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.
Pfizer and BioNTech said they plan to submit their data to regulators in Europe and other countries in addition to the FDA.
The government booster plan does not yet include recipients of Johnson & Johnson’s one-time vaccine. Johnson & Johnson announced on Wednesday that, unlike the Moderna and Pfizer vaccine studies, a study of 17 volunteers showed little change in their antibody levels over the course of six months.
However, the study also showed that antibodies to the coronavirus were nine times higher than after the first dose when the volunteers were given a second injection six months after the first. Company officials said they look forward to discussing a possible booster strategy for their vaccine with federal health officials.
While the Pfizer BioNTech vaccine has been fully approved as a two-shot scheme for people aged 16 and older, adolescents ages 12-15 can still be vaccinated as part of the vaccine’s emergency approval. Regulators have only allowed a third injection for some people with compromised immune systems.