Food and Drug Administration (FDA) panel votes on COVID vaccine booster shots
The embattled Biden administration’s plan to distribute COVID-19 booster shots to most Americans faced its first major hurdle Friday as a government advisory panel met to decide whether to approve additional doses of the Pfizer vaccine.
Scientists in and out of government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to giving rich countries a third round of vaccines when poor countries don’t have enough vaccine against them. The first of them.
The panel, made up of outside experts advising the Food and Drug Administration, weighed less than the obvious case: While research indicates that immunity levels in those vaccinated diminish over time and boosters can reverse this, Pfizer’s vaccine remains highly protective against severe disease and death, Even amid a highly contagious delta variant spread.
FDA experts were to vote on one basic question: Does the evidence show that a Pfizer booster will be safe and effective for people 16 and older? If a yes vote, the Food and Drug Administration is expected to quickly approve Pfizer shot boosters.
But this is just one step in the process. The more difficult question of who should get the injections and when will be discussed next week by advisors to the Centers for Disease Control and Prevention. The CDC generally adopts the group’s recommendations, which set policy for US vaccination campaigns.
Some members of the group explained that they would prefer to give third doses to older adults, nursing home residents, and frontline health care workers, rather than all adults.
Separate decisions by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will be needed for people who have received Moderna or J&J shots to get the boosters.
Friday’s meeting came as variable delta continues to bring cases and deaths in the United States back to levels not seen since last winter. That has given urgency to efforts by top health officials to bolster protection for Americans from the virus.
Dr. Peter Marks, the FDA’s top vaccine regulator, admitted there were severe differences in opening remarks to the advisory panel.
“We know there may be different opinions in interpreting the data,” he said. “We strongly encourage all different perspectives to be expressed and discussed regarding complex and evolving data.”
President Joe Biden’s top health advisers, including the heads of the Food and Drug Administration and the CDC, announced plans for massive booster doses a month ago, targeting the week of September 20 as a fully-certain start date. The boosters will be dispensed eight months after the second dose of the Pfizer and Modern vaccines, she said.
But that was before scientists working for the Food and Drug Administration completed their own evaluations of the data. Some experts have questioned whether Biden is breaking his pledge to “follow the science” on COVID-19 by getting out before government scientists.
Earlier this week, two of the Food and Drug Administration’s top vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said that ongoing studies show that the snapshots perform well despite the delta variable.
The editorial came two weeks after the reviewers announced plans to retire from the Food and Drug Administration. One of them, Dr. Marian Gruber, addressed the American people directly in her opening speech on Friday but did not say why she was retiring.
“All of my actions and decisions during my 32-year FDA career have been based on science with you in mind and in the best interests of your health and safety,” Gruber said.
Biden’s boosted plan has raised significant ethical concerns, given the severe shortages of a vaccine in poorer parts of the world. But the administration argued that the plan was not our choice or they, and indicated that the United States is providing large quantities of the vaccine to the rest of the world.
The United States has already approved Pfizer and Moderna boosters for some people with compromised immune systems, such as cancer patients and transplant recipients. Some Americans, healthy or not, have been able to get their boosters insidiously by going to clinics and pretending they haven’t yet had their initial vaccinations.
On Friday, Pfizer was expected to provide data indicating that immunity from its vaccine began to wane somewhere six to eight months after the second dose.
The committee was also due to hear from Israeli health officials, who began delivering reinforcements over the summer. Officials there tracked about a million people age 60 or older and found that those who got an extra shot were less likely to be infected soon afterward.