A key federal advisory committee began two days of meetings that are expected to strongly influence decisions on whether at least some recipients of the Moderna and Johnson & Johnson coronavirus vaccines will soon be eligible for booster shots.
After hearing from Moderna officials, Food and Drug Administration scientists, members of the public and others, the panel of outside experts advising the F.D.A. is scheduled to vote Thursday on whether to recommend emergency authorization of a third shot for recipients of Moderna’s vaccine. (You can watch the meeting here.)
The panel will vote Friday on Johnson & Johnson’s request for emergency authorization of a second dose. They will also discuss, but not vote on, whether a booster dose of both the Pfizer-BioNTech or Moderna vaccines should be offered to people who are not elderly or in high-risk categories. That would broaden the eligibility categories that the government set for a Pfizer booster last month.
While regulators are not obligated to follow the panel’s recommendations, they typically do.
The panel may be more skeptical of a booster shot for Moderna recipients than for Johnson & Johnson. Some vaccine experts have long argued that Johnson & Johnson should be a two-dose vaccine since its effectiveness is lower than those of the shots produced by both Moderna and Pfizer-BioNTech.
Pfizer-BioNTech won authorization for a booster shot for many recipients last month after arguing that its vaccine, while highly protective in the early months, lost some potency against severe Covid-19 and hospitalization over time.
But Moderna’s potency against hospitalization has held up better over time than Pfizer’s, according to a recent study by the Centers for Disease Control and Prevention.
In documents released Tuesday, Moderna did not argue that its vaccine requires a booster to prevent severe disease or hospitalization. Instead, it concentrated its arguments on preventing infection and mild to moderate disease.
Moderna said the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In another measurement, the booster raised neutralizing antibodies at least fourfold in 87.9 percent of people compared to after the second dose, narrowly failing to meet the agency’s requirement of 88.4 percent.
Given that Moderna’s vaccine appears to still strongly protect against severe disease, at least some committee members are expected to balk at recommending a third dose. “Maybe it won’t be a slam dunk,” said Dr. Peter J. Hotez, a vaccine expert at the Baylor College of Medicine, of the panel’s vote. “Maybe we should wait a little bit longer on Moderna, let it drop off more first before we boost.”
One of the first presentations Thursday came from Israeli health officials, who said their booster campaign offering a third shot to recipients of Pfizer-BioNTech’s vaccine significantly lowered rates of infection and severe disease.
The Biden administration has been closely watching Israel’s experience because the country has a nationalized health care system that allows it to closely track recipients.
Since Israel’s data deal only with Pfizer’s vaccine, it was not clear how much weight committee members will give it. But it did provide them with more information than they had last month before voting to recommend a booster for a broad swath of Pfizer recipients. Several panel members described the data as compelling.
Israeli scientists analyzed rates of infection and of severe illness among 4.6 million people from July 30, when the country first began offering booster shots, to Oct. 6. They compared rates of both among people who got a third dose to those among people who did not, and said they used the same definition of severe disease as the one used by the National Institutes of Health.
Israeli officials said they found a booster dose improved protection against infection across all age groups about tenfold.
Rates of severe illness were six to 20 fold lower for those 60 years or older and three to 20-fold lower for those aged 40 to 60, the researchers said, although the number of severely ill people in the latter group was very small even before boosters were given. Death rates were three to 10-fold lower among the elderly, they said.
A crucial question that was not clearly answered during the Israelis’ presentation, though, was whether the recent drop in cases there could be at least partly due to the retreat of the highly contagious Delta variant.
The Israeli results have been published by a preprint service but have not been peer-reviewed.
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