HomeAmericaCovid live updates: FDA panel to vote on Moderna Booster

Covid live updates: FDA panel to vote on Moderna Booster

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Credit…Sharon Chisilli for The New York Times

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.

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.

Credit…Stephanie Reynolds for The New York Times

An independent panel of experts advising the Food and Drug Administration will examine Moderna’s coronavirus vaccine booster shot on Thursday and data from Johnson & Johnson on Friday. Each day will end as a vote by the panel on recommending emergency authorization for that booster to recipients of that vaccine.

So what happens after the panel vote? The FDA steps in, then the Centers for Disease Control and Prevention steps in, and the process ends with the states. Here’s how it breaks down:

FDA

  • The FDA, a federal agency of the Department of Health and Human Services that regulates and oversees drugs and other elements related to public health, seeks advisory panels’ recommendations, which include questions about who should be eligible. The advisory panel’s votes are not binding, but the FDA generally follows them.

  • The top FDA officials — its acting commissioner, Dr. Janet Woodcock — issue the agency’s final determination on whether to authorize boosters and for what. Such decisions are usually issued within a few days of the meetings of the advisory committee.

CDC

  • An advisory panel from the United States Public Health Agency, the Centers for Disease Control and Prevention, reviews the FDA’s decision. On Thursday and Friday of next week, that panel is to meet and vote on its recommendations regarding the booster.

  • The CDC takes the recommendations of that panel, and the agency’s director, Dr. Rochelle P. Valensky, issues agency guidance on whether boosters should be used and who should be eligible. This guidance is very effective for states, doctors, pharmacies and other health care institutions and the general public. Like the FDA’s 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 panel rejected the FDA’s recommendation that frontline workers be included among those eligible for the Pfizer-BioNTech booster, Dr. Valensky overrides Advised by his own agency and favored by the FDA

Credit…Stephanie Reynolds for The New York Times

State

State health departments generally follow the CDC’s recommendations. In the case of the Pfizer-BioNTech booster, Dr. Valensky began widely administering the shots soon after the CDC’s guidance was announced that they should be given to those over 65. people, nursing homes and other institutional patients to be allowed. settings, those with underlying medical conditions, and frontline workers.

Credit…Adam Hunger / The Associated Press

Kyrie Irving, the NBA star who has been barred indefinitely From practicing or playing with the Brooklyn Nets because he refused to receive a Covid-19 vaccine, Wednesday night spoke publicly for the first time since the team decided to keep him off the court, it says. that their denial was a matter of personal liberty. .

“You think I really want to lose money?” Irving, who is set to earn a salary of about $40 million this season, said in a confusing monologue on his Instagram feed that included false medical information. more than 90 percent Players in the league are vaccinated, which is much higher than the general population of the United States.

“You think I really want to give up on my dream of going after the championship?” Irving, 29, said. “You think I really want to quit my job? You think I really want to sit at home?”

On Tuesday, the Nets said they barred Irving from playing until he “qualifies to be a full participant”. Most teens and adults in New York City need at least one vaccination shot to enter facilities such as a playground, and Irving hasn’t practiced with the Nets in Brooklyn. Irving joined the Nets in 2019 as he built a team of superstars that includes Kevin Durant and James Harden.

Irving asked that his decision to go without vaccination be respected and said he had no plans to retire. He denied vaccination in protest of the mandate, saying no one should be “forced” to do so.

Irving liar Claimed that his decision to go without vaccination does not harm other people. highly contagious delta version has spread rapidly in areas with low vaccination rate. And Hospital done in those areas rose up with unvaccinated For the treatment of patients other than patients, some beds and staff members.

Credit…Yonhap/EPA, via Shutterstock

South Korea plans to send about 1.6 million doses of AstraZeneca’s coronavirus vaccine to Vietnam and Thailand this week, the foreign ministry announced on Tuesday, as Southeast Asian nations struggle to contain the spread of the virus.

The donation comes as South Korea’s vaccination program ramps up, with 70 percent of the population expected to be vaccinated by the end of the month.

About this 62 percent South Korea’s total population has been fully vaccinated, according to the Ministry of Health and Welfare, and the country’s most severe restrictions are expected to be eased by next month. Thailand has fully vaccinated 33 percent of its population and Vietnam about 17 percent of the population.

South Korea’s government said about 1.1 million doses would go to Vietnam and 470,000 to Thailand.

South Korea was the last of them world’s richest nations will start a vaccination program, which will lead to Disappointment Among citizens who had already spent a year under restrictions to control the spread of the virus. Eight months later, the country has vaccinated more people per capita United States, which has secured the largest supply of vaccines in the world.

The US government invested about $1.2 billion into AstraZeneca’s vaccine development, hoping it would be one of many in the arsenal. Instead, federal officials have yet to approve the shot’s use and millions of doses are sitting unused, likely to be exported. President Biden promised to donate up to 60 million doses AstraZeneca Vaccine in 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 stabbed From production accidents, questions about its efficacy and reports of very rare blood clots. Amid concerns, South Korea temporarily suspended use of the vaccine in April, but approved it for use again several days later.

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