FDA Scientists Decline to Take Stance on Moderna COVID-19 Booster Shots

By Zachary Stieber
Zachary Stieber
Zachary Stieber
Reporter
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.
October 12, 2021 Updated: October 12, 2021

Scientists at the Food and Drug Administration (FDA) on Tuesday said they were not taking a stance on a proposal to authorize booster shots of Moderna’s COVID-19 vaccine.

Moderna has asked the FDA to expand the emergency use authorization for its jab to allow a third dose for millions of Americans, pointing to waning effectiveness against infection of the CCP (Chinese Communist Party) virus, which causes COVID-19.

But FDA staff said the vaccine and the two others cleared for use in the United States are still holding up well against severe disease.

“Some real world effectiveness studies have suggested declining efficacy of Moderna COVID-19 Vaccine over time against symptomatic infection or against the Delta variant, while others have not. However, overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” staffers wrote in a 45-page document (pdf).

The Vaccines and Related Biological Products Advisory Committee, which advises the FDA on vaccines, is set to meet later this week to consider booster clearance requests by Moderna and Johnson & Johnson.

Pfizer previously applied for and received clearance for booster shots.

In discussions by the committee and its equivalent for the Centers for Disease Control and Prevention (CDC) before the clearance was granted, members said the scant data on boosters wasn’t sufficient to recommend it for the general population. Some expressed concern over allowing boosters for youth in light of the elevated risk young people have for myocarditis or pericarditis, two types of heart inflammation, following the second shot of messenger RNA vaccines, according to surveillance data.

“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of the Moderna COVID-19 Vaccine,” FDA staff wrote in the new document.

Data from trial participants who received a booster showed they enjoyed higher protection against both infection and hospitalization, scientists noted.

Both the Pfizer and Moderna vaccine utilize mRNA technology but studies indicate that Moderna’s vaccine, which contains a higher dosage, offers better protection, especially against hospitalization.

A booster of Moderna’s jab would be half the amount of the doses people receive in the primary series. Pfizer’s booster is the full amount.

In a briefing document submitted to the FDA’s panel ahead of its meetings, Moderna said data show more COVID-19 cases cropping up among people who are vaccinated, also known as breakthrough cases.

The data show a booster given approximately 6 months after the second shot in the initial regimen would “restore antibody titer levels and reduce the number of breakthrough cases,” said the company, which has seen its vaccine paused in multiple European countries over side effect concerns.

Signage is seen outside of FDA headquarters in White Oak, Maryland
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

Johnson & Johnson put forth a similar case, asserting that more protection is needed against infection and severe COVID-19 even as vaccines continue holding up well against severe disease.

FDA scientists have not weighed in on Johnson & Johnson’s booster bid.

Dr. Monica Gandhi, professor of medicine at University of California, San Francisco/San Francisco General Hospital, said she thinks FDA scientists not taking a stance on Moderna’s request is a signal of how they will treat the filing.

“It seems like by not taking a stance they are not going to authorize this,” she told The Epoch Times.

Boosters are a contentious issue. Worldwide, top officials like the World Health Organization’s executive director have argued that countries authorizing boosters could detract from efforts to get unvaccinated people initial doses. In the United States, top Biden administration officials in August, including the acting head of the FDA, announced that everybody should get a booster. The announcement took many off guard, since it came ahead of any decisions by the regulatory agency or its advisory panel.

The resulting fallout saw two senior FDA vaccine regulators announce their retirements. The officials later joined other scientists in penning a medical journal article that argued there’s no need for most populations to get a booster.

The FDA ultimately took up recommendations from its advisory panel, which rejected a proposal to authorize a Pfizer booster for everybody. Members did recommend boosters for those 65 and older and people at elevated risk of CCP virus exposure in their jobs.

The CDC’s advisory panel offered stricter recommendations but the agency’s director overrode them.

Zachary Stieber
Zachary Stieber covers U.S. news and stories relating to the COVID-19 pandemic. He is based in Maryland.