A key federal advisory committee is set to begin two-day meetings that are expected to strongly influence decisions about whether at least some recipients of Moderna and Johnson & Johnson coronavirus vaccines will be eligible for revaccination anytime soon.
After listening to Moderna officials, FDA scientists, members of the public and others, a panel of external experts advising the FDA on Thursday should vote on whether to recommend an emergency authorization for a third injection for Moderna vaccine recipients. …
On Friday, the commission will vote on Johnson & Johnson’s request to authorize a second dose in an emergency. While regulators are not required to follow the commission’s recommendations, they generally do.
The group may be more skeptical about strengthening the vaccine for Moderna recipients than Johnson & Johnson. Some vaccine experts have long argued that Johnson & Johnson should be a two-dose vaccine because it is less effective than both Moderna and Pfizer-BioNTech’s vaccines.
Last month, Pfizer-BioNTech received approval to revaccinate many recipients after it claimed that its vaccine, although highly protective in the early months, had lost some efficacy against severe Covid-19 and over time with hospitalization.
But according to a recent study by the Centers for Disease Control and Prevention, Moderna’s hospital admission performance has proven better than Pfizer’s over time.
In Tuesday’s documents, Moderna did not claim that the vaccine requires booster vaccinations to prevent serious illness or hospitalization. Instead, he focused his case on preventing mild to moderate infections and diseases.
Moderna reported that the average antibody levels in study participants were 1.8 times higher after booster vaccination than after the second vaccine. In another measure, the booster vaccine increased the number of neutralizing antibodies at least fourfold in 87.9 percent of people, compared with the figure after the second dose, which fell short of the agency’s 88.4 percent requirement.
Given that the Moderna vaccine still appears to provide strong protection against severe illness, it is expected that at least some committee members will be reluctant to recommend a third dose. “It might not be a good dunk,” said Dr. Peter J. Hotez, a vaccine expert at Baylor College of Medicine, of the commission’s vote. “Maybe we should wait a bit with Moderna, let her fall first before we start.”
One of the first presentations on Thursday will be made by Israeli health officials, who will discuss the results of their revaccination campaign using the Pfizer-BioNTech vaccine.
What you need to know about COVID-19 vaccinations
The FDA has approved the vaccination of a select group of people who received a second dose of Pfizer-BioNTech vaccine at least six months ago. This group includes: Pfizer beneficiaries 65 years of age or older or living in long-term care facilities; adults who are at high risk for severe Covid-19 due to an underlying medical condition; health workers and others whose work puts them at risk. People with weakened immune systems are eligible for a third dose of Pfizer or Moderna four weeks after the second shot.
Regulators have yet to authorize boosters for Moderna and Johnson & Johnson vaccine recipients, but the FDA team plans to hold a meeting to weigh up boosters for adults who received Moderna and Johnson & Johnson vaccines.
The CDC stated that conditions under which a person can be given a booster vaccination include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; a weakened immune system; chronic diseases of the lungs, kidneys, or liver; dementia and certain disorders. Pregnant women and current and former smokers are also eligible for assistance.
The FDA has approved boosters for workers whose work puts them at high risk of contact with potentially infectious people. The CDC reports that this group includes: emergency medical workers; educators; workers in the food industry and agriculture; workers in production; correctional workers; United States Postal Service workers; public transport workers; Grocery store workers.
Not recommended. At this time, Pfizer recipients are advised to receive a Pfizer booster vaccine, while Moderna and Johnson & Johnson recipients should await approval of booster doses from those manufacturers.
Yes. The CDC says the Covid vaccine can be administered without considering the timing of other vaccines, and many pharmacies allow people to schedule a flu shot at the same time as the booster dose.
The Biden administration is following Israel’s experience closely because the country has a nationalized health care system that allows it to closely track recipients. Israeli officials are expected to say that rates of infection and serious illness are significantly lower among those who received the booster than among those who did not. The definition of severe illness in Israel is much broader than in the United States.
Since the Israel data only concern the Pfizer vaccine, it is unclear how much weight the committee members will give it. But he will provide them with more information than they had last month before the vote to recommend the booster to a wide range of Pfizer recipients.
Israeli scientists analyzed the level of infection and serious illness among 4.6 million people from July 30, when the country first began offering booster vaccinations, to October 6. They found that infection rates at least 12 days after the third injection ranged from 5 to 11. Several times lower among the population who received the additional injection than among those who did not receive the additional injection.
According to the researchers, the incidence of serious illness was 6.5 times lower among people aged 60 and over and three times lower among people aged 40 to 60 years. The death rate among people aged 60 and over was almost five times lower.
The results were published in Israel by the Preprint Service but were not peer reviewed.