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 Johnson & Johnson’s request for emergency authorization of a second dose 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 recipients 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 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.
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 shot 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 give them more information than they had 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, through 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.
An independent panel of experts advising the Food and Drug Administration will review data on Moderna’s coronavirus vaccine booster on Thursday and Johnson & Johnson’s on Friday. Each day will end with a panel vote on whether to recommend emergency clearance for this recall for recipients of this vaccine.
So what happens after the panel votes? There are other steps at the FDA, then steps at the Centers for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down:
The FDA, a federal agency of the Department of Health and Human Services that controls and oversees drugs and other public health-related items, echoes the advisory committee’s recommendation, which includes the question of who should be eligible. Advisory committee votes are not binding, but the FDA generally follows them.
The top FDA official – its acting commissioner, Dr. Janet Woodcock – makes the agency’s final decision on whether to authorize boosters and for whom. These decisions are usually made a few days after the advisory committee meetings.
An advisory committee from the Centers for Disease Control and Prevention, the United States’ public health agency, is reviewing the FDA decision. Thursday and Friday of next week, this panel is due to meet and vote on its recommendations for boosters.
The CDC takes up the recommendations of this panel, and the director of the agency, Dr Rochelle P. Walensky, issues the agency’s guidelines on the use of boosters and who is eligible. This direction is deeply influential for states, physicians, pharmacies and other health care facilities, and the general public. As with the FDA process, the panel’s recommendations are not binding, but the CDC generally follows them.
However, there was a rare exception last month: When a CDC advisory committee rejected the FDA’s recommendation to include frontline workers among those eligible for the Pfizer-BioNTech recall, Dr. Walensky took stepped over advisers from his own agency and sided with the FDA.
State health departments generally follow CDC recommendations. In the case of the Pfizer-BioNTech recall, injections began to be widely administered immediately after Dr. Walensky announced CDC guidelines to allow them to people over 65, patients in nursing homes and others. institutions, settings, those with underlying health issues, and frontline workers.
Kyrie Irving, the NBA star who has been banned indefinitely from training or playing with the Brooklyn Nets due to his refusal to be vaccinated against Covid-19, spoke publicly Wednesday night for the first time since the team decided to kick him out of court, saying his refusal was a matter of personal freedom.
“Do you think I really want to lose money?” Irving, who is expected to earn around $ 40 million in salary this season, said on his Instagram feed in a curvy monologue that included incorrect medical information. More than 90 percent of the league’s players are vaccinated, a much higher proportion than the general population of the United States.
“Do you think I really want to give up my dream of chasing a championship?” Irving, 29, said. “Do you think I really want to quit my job?” Do you think I really want to stay home?
On Tuesday, the Nets said they had banned Irving from playing until he became “eligible to be a full participant.” New York City requires most teens and adults to have at least one vaccine to enter facilities such as sports arenas, and Irving did not train with the Nets in Brooklyn. Irving joined the Nets in 2019 as they formed a team of superstars including Kevin Durant and James Harden.
Irving demanded that his decision not to be vaccinated be honored and said he had no plans to retire. He expressed his refusal to be vaccinated in his opposition to the warrants, saying no one should be “forced” to do so.
Irving falsely claimed that his decision to remain unvaccinated did not harm others. The highly contagious Delta variant quickly spread to areas with low vaccination rates. And hospitals in those areas have been overrun with unvaccinated patients, leaving few beds and staff to treat other patients.