A key U.S. advisory panel has green-lit booster shots of COVID-19 vaccines for older adults and people at high risk of disease, but regulators say they don’t yet have enough evidence for the broader population. New data on the vaccines is continuously coming in and further determinations are expected soon, Dr. Anthony Fauci said Sunday.
The debate over booster shots has divided scientists as countries adopt different approaches to giving additional vaccines to people who were once considered fully vaccinated. Recent data has indicated that the effectiveness of the mRNA vaccines like Pfizer and Moderna declines over time, although they still provide very significant protection against both infection and more serious symptoms of the disease.
U.S. regulators had already approved booster shots for immunocompromised individuals who need extra protection from COVID-19.
“Boosters are not unusual. You look at the other common vaccines: Hepatitis vaccine requires three doses. Polio vaccine requires four doses,” Dr. Leana Wen, an emergency physician and author of “Lifelines: A Doctor’s Journey in the Fight for Public Health,” told Yahoo News. “We’re used to getting a flu shot every year. The fact that you may need to get a booster at some point, it does not mean that the vaccine doesn’t work.”
A widespread plan to distribute booster shots in the United States is pending approval of the FDA and the CDC’s Advisory Committee on Immunization Practices. These agencies are responsible for looking at the safety and effectiveness of a third dose of the vaccines and ultimately making a final determination.
On Friday, the FDA began that process. A key advisory committee to the agency met virtually to decide whether to endorse extra doses of Pfizer's COVID-19 vaccine.
After reviewing the data available, mostly from Israel and the U.S., the FDA experts were set to vote on one basic question: Does the evidence show that a Pfizer booster would be safe and effective for people 16 and older?
The vote was a resounding no, with 16 of the committee’s 18 outside advisers voting against a new round of vaccinations for this age group, citing insufficient data to make that recommendation.
“I’d like to see more data before I would recommend it for a younger age group,” said Dr. Archana Chatterjee, one of the FDA panelists who voted against boosters for individuals 16 and older.
But Fauci, the White House chief medical adviser, told CNN on Sunday that these recommendations could change at any moment as more data becomes available.
“One thing I think people need to realize is that data is coming in literally on a weekly and daily basis,” Fauci said. “They’re going to continue to look at this in real time. More data will be coming in on both safety for younger individuals and efficacy, both from Israel, other countries, as well as our substantial cohorts that the CDC is following.”
Shortly after the Friday vote, the FDA advisory panel moved to recommend booster shots for people 65 and older, and for people who are at high risk of disease due to underlying health conditions or occupational exposure. The recommendation was for people who had received their second Pfizer dose at least six months ago.
The panel of experts agreed that for these individuals, there was enough data to show that the Pfizer booster shot was safe and effective and that it could increase immunity by tenfold.
The FDA has the final word on vaccine approvals, and it is expected to issue a decision this week. The agency is not bound by the outside panel’s recommendation, but it will take the vote into consideration and is expected to follow the guidance.
It is not clear yet who will qualify under these “high-risk” categories for booster shots, but more information is expected this week after a CDC advisory committee meets to discuss booster shots before that agency.
Depending on how “at high risk” is defined, tens of millions of Americans could be eligible for additional shots of the Pfizer vaccine, including health care professionals and teachers.
The recommendations have just been for Pfizer recipients, leaving the millions of people who received the Moderna and Johnson & Johnson vaccines looking for clarity.
According to Fauci, the data needed to determine booster shots for the two other U.S. vaccines is just weeks away from being released.
“We’re working on that right now to get the data to the FDA, so they can examine it and make a determination about the boosters for those people,” he told NBC’s “Meet the Press” on Sunday.
On Tuesday, Johnson & Johnson released some details of three studies looking at various aspects of its Janssen vaccine, and said they showed that the vaccine provided long-lasting protection that could be boosted with an extra shot.
This booster, the company said, could raise immunity even more, and should also protect people strongly against infection.
It’s important to note that various studies, conducted both in the U.S. and abroad, have shown that COVID breakthrough infections remain low despite the Delta variant, and that the vaccines continue to offer strong protection against the most severe forms of the disease.
“We may have been giving a message that sounds like the vaccines aren’t working very well, which to me can scare the vaccinated and actually doesn’t make the unvaccinated think they should get a vaccine,” Dr. Monica Gandhi, an infectious disease specialist and professor of medicine at the University of California, San Francisco, told Yahoo News.
“[Vaccinated] people are really very protected from severe disease. … I think we need to be way more positive,” she added.
Read more from Yahoo News: