The latest on the Covid-19 pandemic in the US

Dr. Paul Offit, a member of the US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee, told CNN he thinks the decision on whether to offer Covid-19 vaccine boosters to the general public is being rushed because of a target date set by the Biden administration.

“Why did we see the New England Journal of Medicine study essentially the day before (the) meeting? I think the rush is that the date was set by the Biden administration – the Biden administration gave a date and now we’re scrambling to meet that date. I think it should have taken more time.” 

On Wednesday evening, the New England Journal of Medicine published three reports that support the argument that people may need a booster dose of Pfizer/BioNTech’s Covid-19 vaccine over time, and suggest such boosters would be safe.

Biden administration officials last month announced a plan to provide booster shots for people vaccinated against Covid-19 starting the week of Sept. 20, pending sign-off from the FDA and the US Centers for Disease Control and Prevention.

The FDA’s advisory committee meets today, and the CDC’s Advisory Committee on Immunization Practices is scheduled to meet next week. 

Three reports published Wednesday support the argument that people may need a booster dose of Pfizer's Covid-19 vaccine over time, and suggest such boosters would be safe.

The reports are part of a batch of data that will be discussed Friday by vaccine advisers to the US Food and Drug Administration. The FDA is considering a request by Pfizer to approve a third, booster dose of its vaccine for most people six months after they get their first two doses of vaccine.

But while the FDA clearly signaled it would grant emergency use authorization to Pfizer's and Moderna's vaccines last December, that it would grant EUA to Johnson & Johnson's vaccine in February and that it would fully approve Pfizer's vaccine last month, it was notably neutral about the question of booster doses for the general public.

There are "many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," it said in a briefing document released Wednesday ahead of the meeting of its Vaccines and Related Biological Products Advisory Committee.

One of the reports is the formal presentation of data from Israel released earlier this month that showed booster doses of vaccine not only raised immunity as measured in the blood, but also showed a real-world reduction in infection.

Two others, sponsored by Pfizer, support the argument that immunity, as measured in the blood, does begin to wane over time after people get both initial doses. One shows a booster restores that immunity.

The reports, all published in the New England Journal of Medicine, are being used by Pfizer and by some federal officials to support the argument that most people will need booster doses starting around six months after they are initially vaccinated.

Read more here.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on Friday will hear presentations from FDA vaccine experts, officials from the US Centers for Disease Control and Prevention and Pfizer, as well as Israeli researchers, ahead of a vote on whether to recommend boosters doses of Pfizer/BioNTech’s Covid-19 vaccine, according to an agenda and documents posted on Wednesday.

The committee is expected to vote after 2:25 p.m. ET Friday, according to the agenda posted Wednesday.

In a Pfizer briefing document posted on Wednesday, the company says it pursued licensure of a booster dose based on its own studies and data from Israel that suggest immunity is waning over time.

A US Food and Drug Administration briefing document posted ahead of Friday’s FDA vaccine advisers' meeting does not include a recommendation on whether Pfizer/BioNTech Covid-19 vaccine boosters are warranted for the general population, and says the benefit of such boosters may be “more limited” if the primary two-dose series is still effective at preventing serious outcomes from Covid-19.

The Vaccines and Related Biological Products Advisory Committee is meeting today to discuss “whether the data Pfizer has submitted are sufficient to support licensure of a booster dose of COMIRNATY administered approximately 6 months after the primary series to individuals 16 years of age and older,” the document says.

There are “many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” the FDA document says. Some of the studies will be summarized during Friday’s meeting, when Pfizer officials and researchers from Israel make presentations. The document includes descriptions of research previously shared by Pfizer and Israeli researchers.

“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability. Due to these biases some studies may be more reliable than others,” the FDA document says. “Furthermore, US-based studies of post- 9 authorization effectiveness of BNT162b2 may most accurately represent vaccine effectiveness in the US population.”

The document says the expected benefits of boosters depend on the impact they could have in reducing disease relative to the current two-dose series.