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FDA panel unanimously recommends Moderna booster shot for vulnerable adults

Even though they were worried about the dearth of data surrounding Moderna’s Covid-19 booster shot, the advisory committee members unanimously recommended a similar booster regimen to the one approved for the Pfizer vaccine last month.

(CN) — Even while noting the scant amount of data provided to them to make their decision, members of an advisory committee for the Food and Drug Administration recommended Thursday that people at higher risk from Covid-19 who received the Moderna vaccine get booster shots.

“The data are not perfect, but this is an extraordinary time and we have to work with imperfect data,” said committee member Eric Rubin, a professor of immunology and infectious diseases at Harvard University, before the 19-member panel voted unanimously in favor of the move.

Another committee member, Dr. Patrick Moore, professor at University of Pittsburg School of Medicine, explained after the vote – which was conducted over video teleconferencing software and streamed to YouTube – that his vote was made was on “gut feeling” and the FDA explained Moderna’s data better than the company.

Moderna argued Thursday before the FDA’s Vaccines and Related Biological Products Advisory Committee that a third shot was needed to prevent and head off breakthrough infections in vaccinated individuals. As part of its justification, the company showed the FDA results of a clinical study where 171 participants were given a booster dose six months after they received Moderna’s two-dose regimen.

On Sept. 3, the company suggested to the FDA that the emergency use authorization be amended to give a half dose to those that already received the two-dose Moderna vaccine to three groups of individuals: those over 65, those 18 and older who risk getting a severe case of Covid-19 if they contract it, and those who are frequently exposed to the virus and risk serious complications or severe illness.

The committee met Thursday to hash through the data to determine whether it supported a booster shot for those individuals six months after they got their second dose.

According to the emergency use authorization already in place, immunocompromised individuals can receive a third dose of the Moderna shot, a dose of 100 micrograms.  

But Moderna was seeking a lower dose of 50 micrograms across the population in order to prevent those vulnerable individuals from contracting the virus.

The company's request comes after the rise of the delta variant and data shows that as time goes on, the efficacy of the vaccine wanes and there is evidence of breakthrough infections among vaccinated individuals.

A screenshot from the Oct. 14, 2021, meeting of the FDA Vaccines and Related Biological Products Advisory Committee, in which Moderna sought to amend the emergency use authorization for its Covid-19 vaccine to include a booster shot for some at-risk individuals. (Image via Courthouse News)

“Taken together, these data support the public health benefit of a booster dose of [the Moderna vaccine] approximately six months after the second dose of [the Moderna vaccine] to restore antibody titer levels and reduce the number of breakthrough cases, particularly against [variants of concern],” the company’s briefing document states.

Dr. Jacqueline Miller of Moderna Therapeutics told the committee that the data shows the rate of adverse reactions among individuals who got the booster were similar to the rates of those who had an adverse reaction to the second dose. However, recipients of the booster told researchers they experienced more swelling and tenderness in their upper arm afterwards.

“We chose the 50-microgram dose for the booster because we believe we should vaccinate with the lowest amount of antigen needed to induce an immune response,” Miller said.

Moderna's Covid-19 shot is similar to that of Pfizer’s vaccine in that they are both mRNA vaccines, although Moderna differed from Pfizer’s in that its vaccine did not need to be stored at the cold temperatures. Both received emergency use authorization late last year.

The lion’s share of Americans – 103.6 million – have been fully vaccinated using Pfizer’s two-dose regimen. About 69.2 million Americans arrived at fully vaxxed status using Moderna’s shot, according to data from the Centers for Disease Control and Prevention.

Moderna’s emergency use authorization was updated on Aug. 13 to allow for a third shot of 100 micrograms for immunocompromised individuals, such as those who received an organ transplant. CDC data shows that 1.5 million individuals have received those third rounds of Moderna vaccines.

Thursday's meeting of the FDA panel is the first step in a four-step process towards approving a booster shot policy. Next, the agency will make its call based on the panel's recommendation. Then, the issue of boosters heads over to the CDC where its own independent panel weighs the question before the CDC director makes a final determination.

A few weeks ago, the CDC director, Dr. Rochelle Walensky, went beyond the recommendation of s CDC panel that called for boosters for the elderly and those with underlying health conditions, also mandating booster shots for individuals whose jobs may bring them in close contact with Covid-19, such as health care workers.

The meeting comes as Moderna faces questions about its distribution of the vaccine to low and low-to-middle income countries around the world. While sitting on a panel Wednesday, Dr. David Kessler, the White House’s chief science officer spearheading its response to Covid-19, said there was a shortfall of about a billion doses – not booster shots -- going to the vaccine program backed by the United Nations, Covax.

Pointing out that Pfizer has already pledged to send a billion doses to Covax, Kessler said Moderna, which pledged 500 million doses to Covax, needed “to step up as a company.”  

Noting that the U.S. government has had some “very, very intense discussions” with Moderna, Kessler said the company should provide doses to Covax at not-for-profit prices.

“Do not underestimate the resolve of the United States government in addressing this issue,” Kessler said. “I think these companies understand our authorities and understand that we would not be afraid to use them.”

Earlier this week, Moderna’s chairman Noubar Afeyan said while the company has no plans to protect its patents for the Covid-19 vaccine during the pandemic, it would not be sharing the vaccine’s formula.

The FDA’s advisory committee will meet again Friday to discuss whether to recommend booster shots to those who received Johnson and Johnson’s vaccine and consider whether users can mix and match Covid-19 vaccines manufactured by different companies.

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