F.D.A. Advisory Panel Meets to Discuss Moderna Boosters
A recommendation is expected to follow Thursday’s meeting on whether to authorize a third dose for recipients of the Moderna vaccine. On Friday, the panel will consider boosters for the Johnson & Johnson shot.,
A key federal advisory committee is beginning 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. 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 will come from Israeli health officials, who will discuss results of their booster campaign using Pfizer-BioNTech’s vaccine.
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. The Israeli officials are expected to say that rates of infection and serious disease are significantly lower among those who got a booster shot than among those who did not. Israel’s definition of severe disease is significantly broader than the one used in the United States.
Since Israel’s data deal only with Pfizer’s vaccine, it is not clear how much weight committee members will give it. But it will provide them with more information than they had last month before voting to recommend a booster for a broad swath of Pfizer recipients.
Israeli scientists analyzed rates of infection and severe illness among 4.6 million people from July 30, when the country first began offering booster shots, to Oct. 6. They found that infection rates at least 12 days after a third injection were five- to 11-fold lower among the boosted population than among those who did not receive an extra injection.
Rates of severe illness were 6.5-fold lower for those 60 years or older and threefold lower for those aged 40 to 60, the researchers said. Death rates were nearly fivefold lower for those aged 60 and up.
The Israeli results have been published by a preprint service but have not been peer-reviewed.
An independent panel of experts advising the Food and Drug Administration is meeting regarding Moderna’s coronavirus vaccine booster shot on Thursday, and on Johnson & Johnson’s on Friday. Each day will culminate in a vote by the panel on whether to recommend emergency authorization for that booster for recipients of that vaccine.
So what happens after the panel votes? There are further steps at the F.D.A., then steps at the Centers for Disease Control and Prevention, and the process ends with the states. Here’s how it breaks down:
The F.D.A., a federal agency of the Department of Health and Human Services that controls and supervises medications and other elements related to public health, takes up the advisory panel’s recommendation, which includes the question of who should be eligible. The advisory panel’s votes are not binding, but the F.D.A. typically follows them.
The F.D.A.’s top official — its acting commissioner, Dr. Janet Woodcock — issues the agency’s final determination on whether to authorize the boosters and for whom. Such decisions are typically issued within a few days of advisory committee meetings.
An advisory panel to the Centers for Disease Control and Prevention, the United States’ public health agency, reviews the F.D.A.’s decision. On Thursday and Friday of next week, that panel is scheduled to meet and vote on its recommendations regarding boosters.
The C.D.C. takes up that panel’s recommendations, and the agency’s director, Dr. Rochelle P. Walensky, issues the agency’s guidance on whether boosters should be used and who should be eligible. That guidance is deeply influential for states, doctors, pharmacies and other health care institutions and the general public. As with the process at the F.D.A., the panel’s recommendations are not binding, but the C.D.C. usually follows them.
However, there was a rare exception last month: When a C.D.C. advisory panel rejected the F.D.A.’s recommendation that frontline workers be included among those eligible for the Pfizer-BioNTech booster, Dr. Walensky overrode her own agency’s advisers and sided with the F.D.A.
State health departments generally follow the recommendations of the C.D.C. In the case of the Pfizer-BioNTech booster, the shots began being administered widely immediately after Dr. Walensky announced the C.D.C.’s guidance to allow them for people over 65, patients in nursing homes and other institutional settings, those with underlying medical conditions, and frontline workers.
Kyrie Irving, the N.B.A. star who has been indefinitely barred from practicing or playing with the Brooklyn Nets because of his refusal to get the Covid-19 vaccine, spoke out publicly on Wednesday night for the first time since the team decided to keep him off the court, saying his refusal was a matter of personal freedom.
“You think I really want to lose money?” Irving, who is set to earn about $40 million in salary this season, said on his Instagram feed in a meandering monologue that included incorrect medical information. More than 90 percent of players in the league are vaccinated, a proportion much higher than in the general population of the United States.
“You think I really want to give up on my dream to go after a championship?” Irving, 29, said. “You think I really just want to give up my job? You think I really want to sit at home?”
On Tuesday, the Nets said they had barred Irving from playing until he becomes “eligible to be a full participant.” New York City requires most teenagers and adults to have at least one vaccination shot to enter facilities such as sports arenas, and Irving has not practiced with the Nets in Brooklyn. Irving joined the Nets in 2019 as they built a team of superstars that includes Kevin Durant and James Harden.
Irving asked that his decision to remain unvaccinated be respected and said that he has no plans to retire. He couched his refusal to get vaccinated in his opposition to mandates, saying nobody should be “forced” to do it.
Irving falsely claimed his decision to remain unvaccinated does not harm other people. The highly contagious Delta variant has quickly spread in areas with low vaccination rates. And hospitals in those areas have been overrun with unvaccinated patients, leaving few beds and staff members to treat other patients.
By the time vaccines for the coronavirus were introduced late last year, the pandemic had taken two of Lucenia Williams Dunn’s close friends. Still, Ms. Dunn, the former mayor of Tuskegee, contemplated for months whether to be inoculated.
It was a complicated consideration, framed by the government’s botched response to the pandemic, its disproportionate toll on Black communities and an infamous 40-year government experiment for which her hometown is often associated.
“I thought about the vaccine most every day,” said Ms. Dunn, 78, who finally walked into a pharmacy this summer and rolled up her sleeve for a shot, convinced after weighing with her family and doctor the possible consequences of remaining unvaccinated.
“What people need to understand is some of the hesitancy is rooted in a horrible history, and for some, it’s truly a process of asking the right questions to get to a place of getting the vaccine.”
In the first months after the vaccine rollout, Black Americans were far less likely than white Americans to be vaccinated. In addition to the difficulty of obtaining shots in their communities, their hesitancy was fueled by a powerful combination of general mistrust of the government and medical institutions, and misinformation over the safety and efficacy of the vaccines.
But a wave of pro-vaccine campaigns and a surge of virus hospitalizations and deaths this summer, mostly among the unvaccinated and caused by the highly contagious Delta variant, have narrowed the gap, experts say. So, too, have the Food and Drug Administration’s full approval of a vaccine and new employer mandates. A steadfast resistance to vaccines in some white communities may also have contributed to the lessening disparity.
South Korea plans to ship almost 1.6 million doses of AstraZeneca’s coronavirus vaccine to Vietnam and Thailand this week, the foreign ministry announced Tuesday, as the Southeast Asian nations struggle to contain the spread of the virus.
The donation comes as South Korea’s vaccination program has accelerated rapidly, with 70 percent of the population expected to be inoculated by the end of the month.
About 62 percent of South Korea’s total population has been fully vaccinated, according to the Ministry of Health and Welfare, and the nation is expected to ease the most severe restrictions by next month. Thailand has fully vaccinated 33 percent of its population and Vietnam about 17 percent.
About 1.1 million doses will go Vietnam and 470,000 to Thailand, South Korea’s government said.
South Korea was among the last of the world’s wealthiest nations to start a vaccination program, leading to frustration among citizens who had already spent a year living under restrictions to control the spread of the virus. Eight months later, the country has inoculated more people per capita than the United States, which has secured the largest supply of vaccines in the world.
The U.S. government invested about $1.2 billion in the development of AstraZeneca’s vaccine, hoping that it would be one of many in an arsenal. Instead, federal officials have yet to approve the use of the shot and million of doses are sitting unused, likely destined to be exported. President Biden promised to donate up to 60 million doses of the AstraZeneca vaccine to countries in Latin America, Southeast Asia and Africa.
AstraZeneca’s vaccine is cheaper and easier to store than the mRNA vaccines produced by Pfizer-BioNTech and Moderna, but it has been dogged by production mishaps, questions about its efficacy and reports of very rare blood clots. Amid the concerns, South Korea temporarily suspended use of the vaccine in April, but cleared it for use again several days later.