A key federal advisory committee is set to begin two days of meetings that will strongly influence decisions on whether Moderna and at least some recipients of the Johnson & Johnson coronavirus vaccine will soon be eligible for booster shots. expected to do.
After hearing from Moderna officials, Food and Drug Administration scientists, members of the public and others, the panel of outside experts advising the FDA is scheduled to vote Thursday whether a third shot is available to recipients of Moderna’s vaccine. emergency authorization to be recommended.
The panel will vote on Friday on Johnson & Johnson’s request for emergency authorization of a second dose. While regulators are not obligated to follow the panel’s recommendations, they usually do so.
Panel may be more skeptical about booster shots for Moderna recipients than Johnson & Johnson. Some vaccine experts have long argued that Johnson & Johnson should have a two-dose vaccine because its effectiveness is lower than that of shots produced by both Moderna and Pfizer-BioNtech.
pfizer-biontech Won authorization for booster shot That’s after several recipients last month argued that its vaccine, while highly protective in the early months, lost some power against severe Covid-19 and hospitalization over time.
But Moderna’s ability against hospitalization has been better than Pfizer’s over time, According to a recent study by the Centers for Disease Control and Prevention.
In documents released Tuesday, Moderna did not argue that its vaccine needed a booster to prevent serious illness or hospitalization. Instead, it focused its arguments on preventing infection and mild to moderate disease.
Moderna said the average antibody level of participants in its study was 1.8 times higher after the booster than after the second shot. In another measurement, the booster increased antibodies by at least four times 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 still appears to strongly protect against serious disease, at least some committee members are expected to recommend a third dose. “It probably won’t be a slam dunk,” said Dr., a vaccine expert at Baylor College of Medicine, of the panel’s vote. Peter J. Hotez said. “Maybe we should wait a bit longer on Moderna, leave it more first before promoting it.”
One of the first presentations on Thursday will come from Israeli health officials, who will discuss the results of their booster campaign using Pfizer-BioNtech’s vaccine.
What to know about Covid-19 booster shots
FDA Authorized booster shots For a select group of people who received a second dose of the Pfizer-BioNTech vaccine at least six months ago. That group includes: Pfizer recipients who are 65 years of age or older or who live in long-term care facilities; Adults who are at high risk of severe Covid-19 because of an underlying medical condition; Health care workers and others whose jobs put them at risk. people with weak immune system Four weeks after the second shot are eligible for a third dose of Pfizer or Moderna.
The CDC states that conditions that qualify a person for a booster shot include: high blood pressure and heart disease; diabetes or obesity; cancer or blood disorder; weakened immune system; chronic lung, kidney or liver disease; Dementia and some disabilities. Pregnant women and current and former smokers are also eligible.
The FDA authorizes boosters for workers whose jobs put them at high risk of coming into contact with potentially infectious people. The CDC says the group includes: emergency medical workers; education worker; food and agricultural workers; construction workers; reform worker; US Postal Service employees; public transport workers; Grocery store workers.
It is not recommended. For now, Pfizer vaccine recipients are advised to get the Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until a booster dose is approved from those manufacturers.
Yes. The CDC says the Covid vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites are allowing people to schedule the flu shot at the same time as a booster dose.
The Biden administration is watching 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 the rate of infection and serious illness is much lower than in people who have not received a booster shot. Israel’s definition of critical illness is much broader than that used in the United States.
Since Israel’s data deals with Pfizer’s vaccine itself, it is not clear how much weight committee members will give to it. But it will give them more information than they did last month before they voted to recommend the booster to a wider swath of Pfizer recipients.
Israeli scientists analyzed rates of infection and serious illness among 4.6 million people since July 30, when the country first began offering booster shots, October 6. They found that the infection rate was five to 11- at least 12 days after the third injection. Less in the increased population than in those who did not receive additional injections.
The rate of serious illness was 6.5 times lower for people 60 years of age or older and three times lower for people 40 to 60 years of age, the researchers said. The death rate was almost five times lower for those aged 60 and older.
Israel’s results has been published By a preprint service but not peer-reviewed.