The Moderna logo is seen at the Moderna campus in Norwood, Massachusetts, on Dec. 2, 2020, where the biotechnology company is mass producing its COVID-19 vaccine. (Joseph Prezioso/AFP via Getty Images/TNS)

Moderna, J&J make case for COVID boosters

Moderna Inc. and Johnson & Johnson said that data they’ve gathered supports the need for booster shots for their COVID-19 vaccines, ahead of a key regulatory meeting later this week.

A panel of scientific experts who advise the U.S. Food and Drug Administration on vaccines is scheduled to meet Thursday and Friday to weigh the evidence for booster doses for each of the two vaccines. The regulator has already authorized a booster for the COVID shot made by Pfizer Inc. and BioNTech SE for those 65 and older and other at-risk adults.

Moderna’s vaccine uses a higher dose than the Pfizer vaccine; even the reduced booster dose Moderna is proposing contains more active ingredient than Pfizer’s shot. While data are still emerging, some real-world studies have suggested that Moderna’s shot produces more antibodies or may hold up slightly better over time compared to the Pfizer vaccine.

Pfizer’s booster shot was cleared last month, and regulators have allowed some immunocompromised people to receive an additional dose of the Moderna shot. According to the Centers for Disease Control and Prevention, some 7.8 million people have received a COVID vaccine booster so far.

While Pfizer’s booster is the same dose as the first two shots, Moderna is asking the FDA to authorize a 50-microgram booster, half the amount in each of the initial two. The company noted that breakthrough cases increased among participants in its final-stage trial during July and August, as the highly infectious delta variant took over. Such cases were higher among people who got the vaccine early in the trial compared with those who got it later, another possible indication of waning immunity.

In a trial of the booster, the half-dose raised levels of protective antibodies at least 15-fold within one month, compared to levels before the boost, Moderna said in the documents. Antibody levels were also significantly higher after the booster than after the second shot, the company said.

“Lower doses for boosters have been shown to be safe and immunogenic for other vaccines, such as diphtheria,” the company said. In addition, lowering the booster dose would help Moderna increase its vaccine supply for the rest of the world.

Use of J&J’s vaccine has lagged those from Pfizer and Moderna, and as of Oct. 12, only about 15 million people in the U.S. have received the single shot, according the the CDC. J&J said that data support a favorable benefit-risk profile for a booster in adults 18 and older. The booster will likely result in increased protection against symptomatic COVID, as well as the current variants, the company said.

The New Brunswick, N.J.-based drug giant recommended a booster at six months or more after the initial shot, but said it may also be administered as early as two months, based on the strength of the immune response. The need for a booster dose — and the timing in which it should be given — must be determined by local COVID conditions and the needs of individuals or specific populations, J&J said.

“In the early stages of a pandemic, a single dose vaccine is an efficient tool to rapidly increase vaccine uptake and reduce the burden on health care systems by preventing severe disease outcomes, especially where supply limitations were present,” J&J said. “In the current stage of the pandemic, and given emergence of different variants under certain circumstances, focus may shift to protecting individuals by maximizing and prolonging vaccine-induced protection.”

In parts of the U.S. where vaccination rates remain low, J&J said, the focus isn’t just in preventing severe disease. Providing a booster is an optimal path forward, helping stop transmission as the delta variant continues to spread at high rates in the face of such hesitancy, the company said.

The most intriguing part of the two-day meeting could come at the close, where the FDA advisers are scheduled to hear a presentation from University of Maryland scientists leading a U.S. government-sponsored study of whether its possible to mix and match COVID boosters with different vaccines than were used for the primary inoculation. The FDA has not released details of what the Maryland scientists will say.

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