A key federal advisory committee is expected to start two days of meetings that are expected to strongly influence decisions about 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 external panel advising the FDA is expected to vote on Thursday on whether to recommend emergency clearance a third blow for the recipients of the vaccine from Moderna.
The panel will vote on the request for emergency authorization of a second dose of Johnson & Johnson on Friday. While regulators are not obligated to follow the panel’s recommendations, they generally do.
The panel may be more skeptical of a booster injection for Moderna beneficiaries than for Johnson & Johnson. Some vaccine experts have long argued that Johnson & Johnson should be a two-dose vaccine because it is less effective than injections produced by both Moderna and Pfizer-BioNTech.
Pfizer-BioNTech got clearance for a booster for many recipients last month after arguing that its vaccine, although very protective in the first few months, had lost some potency against severe Covid-19 and l hospitalization over time.
But Moderna’s potency against hospitalization has held up better over time than that of Pfizer, according to a recent study from the Centers for Disease Control and Prevention.
In documents released Tuesday, Moderna did not argue that her vaccine required a booster to prevent serious illness or hospitalization. Instead, he focused his arguments on preventing infections and mild to moderate illness.
Moderna said the average antibody level of participants in her study was 1.8 times higher after the booster than after the second stroke. In another measure, the booster increased neutralizing antibodies at least four times in 87.9% of people compared to after the second dose, failing to meet the agency’s 88.4% requirement.
Since Moderna’s vaccine still appears to protect strongly against serious illness, at least some committee members should be reluctant to recommend a third dose. “Maybe it won’t be a slam dunk,” said Dr. Peter J. Hotez, vaccine expert at Baylor College of Medicine, of the panel’s vote. “Maybe we should wait a little longer on Moderna, drop it more before boosting.”
One of the first presentations on Thursday will come from Israeli health officials, who will discuss the results of their recall campaign using Pfizer-BioNTech’s vaccine.
What to know about Covid-19 booster injections
The FDA has cleared booster shots for a select group of people who received their second dose of the Pfizer-BioNTech vaccine at least six months ago. This group includes: Pfizer beneficiaries who are 65 years of age or older or who live in long-term care facilities; adults who are at high risk for severe Covid-19 due to an underlying medical problem; healthcare workers and others whose jobs put them at risk. People with weakened immune systems are eligible for a third dose of Pfizer or Moderna four weeks after the second injection.
Regulators have yet to clear the booster shots for Moderna and Johnson & Johnson vaccine recipients, but an FDA panel is due to meet to weigh the booster shots for adult recipients of Moderna and Johnson & Johnson vaccines.
The CDC said the conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood disorders; 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 has cleared the boosters for workers whose work puts them at high risk of exposure to potentially infectious people. The CDC says this group includes: emergency medical workers; education workers; food and agricultural workers; manufacturing workers; correctional workers; workers in the US postal service; public transport workers; employees of grocery stores.
It is not recommended. For now, recipients of the Pfizer vaccine are advised to be vaccinated by Pfizer, and recipients of Moderna and Johnson & Johnson must wait until booster doses from these manufacturers are approved.
Yes. The CDC says the Covid vaccine can be given regardless of the timing of other vaccines, and many pharmacy websites allow people to schedule a flu shot along with a booster dose.
The Biden administration has followed Israel’s experience closely as the country has a nationalized health system that allows it to closely monitor beneficiaries. Israeli officials are expected to say that the rates of infection and serious illness are significantly lower among those who received a booster than among those who did not. The Israeli definition of critical illness is significantly broader than that used in the United States.
Since Israel’s data is only for Pfizer’s vaccine, it’s not clear what weight committee members will give it. But it will provide them with more information than last month before voting to recommend a recall for a wide range of Pfizer beneficiaries.
Israeli scientists analyzed the rates of infection and serious illness in 4.6 million people from July 30, when the country started offering booster shots, until October 6. They found that infection rates at least 12 days after a third injection were 5 to 11 times lower among the boosted population than among those who did not receive an additional injection.
Critical illness rates were 6.5 times lower for people aged 60 or older and three times lower for people aged 40 to 60, the researchers said. Death rates were almost five times lower for people 60 and older.
The Israeli results were published by a prepublication service but were not peer reviewed.