Advisors to the Food and Drug Administration questioned an important statement made by researchers in Israel and the pharmaceutical company Pfizer on Friday: that its coronavirus vaccine declines not only against infection, but also against serious illness and hospitalization.
The counselors met to review Pfizer’s application to allow booster doses for all Americans 16 and older. Some of the details that have emerged during the lively debate include: Israel and the United States define major illnesses differently.
In Israel, anyone with an accelerated breathing rate and oxygen levels below 94 percent is seriously ill. In contrast, the Centers for Disease Control and Prevention consider people sick enough to be hospitalized as a serious illness, said Dr. Sara Oliver, a CDC scientist, at the advisory committee meeting.
The discrepancy could help explain why the two countries reported very different results in fully vaccinated people.
Israeli researchers said they saw large numbers of patients in the hospital who had received two doses two months earlier. But in the United States, the CDC has reported that vaccinated patients make up only 2 percent of the people hospitalized for Covid-19.
This is just one of many scientific discrepancies that came to light this week.
On Monday, an international team of scientists analyzed dozens of studies in The Lancet magazine and concluded that boosters are not yet needed by the general population and that the world would be better served if the billions of people protected by vaccine doses remained unvaccinated.
On Wednesday, FDA scientists published an online assessment suggesting they, too, are not convinced that there is enough evidence that boosters are needed.
“Overall, the data indicate that Covid-19 vaccines currently licensed or approved in the United States still offer protection against severe Covid-19 disease and death,” it says in its summary.
But some FDA executives have publicly endorsed booster vaccinations. “The need for an additional dose after six months to provide longer-term protection should come as no surprise as it is likely to be required for the formation of a mature immune response,” Dr. Peter Marks, one of the agency’s top officials, said at the meeting on Friday.
Concerned by the increase in cases, Israeli officials have offered a third dose of the vaccine to anyone over the age of 12. Researchers from Israel published the first results of this introduction in the New England Journal of Medicine on Wednesday – but few outside scientists found the study convincing.
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, a reversal of 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 against mandatory vaccines for students but are more likely to support masking requirements for students, teachers, and staff who are not vaccinated.
- 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, with no weekly testing option. Municipal 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.
The team collected data on the effects of the booster from the health records of more than 1.1 million people over 60. At least 12 days after the booster, infection rates were eleven times lower – and severe illness rates nearly twenty times lower – in those cases requiring a booster compared to those who received only two doses, the researchers found.
The results aren’t surprising, experts said, and don’t suggest any long-term benefit.
“We have known for some time that the vaccines produce less robust immune responses in the elderly,” said Dr. Celine Gounder, Infectious Disease Specialist at Bellevue Hospital Center and former advisor to the Biden Administration. “The recommendation of additional vaccination doses for older people is not controversial.”
In all studies published so far, the vaccine effectively protects against serious illness and hospitalization in the vast majority of people, experts said. But the vaccines appear to be less effective against infections in people of all ages, especially those exposed to the highly contagious Delta variant.
The cumulative data so far suggests that only older adults need boosters, a view underscored by the FDA’s advisory committee, which voted on Friday to advocate boosters only for Americans 65 and older and those at risk for serious illness .