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Moderna, J&J make case for boosters ahead of FDA panel

- By Robert Langreth and Riley Griffin

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.

The Biden administra­tion has been pushing to make booster shots available to as many people as possible after a wave of infections over the summer tied to the delta variant. In addition, some studies have indicated that protection afforded by the U.s.-authorized shots wanes over time. In documents prepared for the meeting, both companies said the supplement­al doses would be advisable after six months.

Moderna was little changed in trading as of 10:41 a.m. in New York, while J&J shares fell 0.9%.

FDA REPORT

In a report, FDA officials didn’t make a specific recommenda­tion for what the advisers should do. Findings from real-world studies are mixed on whether the Moderna vaccine’s efficacy has waned over time against the delta variant, the report said. And if the vaccine is still effective in preventing harm

from COVID, the benefit from getting a boost is likely to be more limited than if efficacy has waned substantia­lly, the staff noted.

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.

HALF-DOSE BOOSTER

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.

 ?? Anna Moneymaker/getty Images North America/tns ?? U.S. President Joe Biden rolls up his sleeve before receiving a third dose of the Pfizer/biontech COVID-19 vaccine in the South Court Auditorium in the White House in Washington, D.C., on Sept. 27.
Anna Moneymaker/getty Images North America/tns U.S. President Joe Biden rolls up his sleeve before receiving a third dose of the Pfizer/biontech COVID-19 vaccine in the South Court Auditorium in the White House in Washington, D.C., on Sept. 27.

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