The FDA Panel supports Moderna COVID boosters for seniors and adults at risk.


The Federal Advisory Board voted Thursday to support booster shots of the Moderna COVID-19 vaccine for people over the age of 65 and young adults working to increase the risk of certain medical problems or infections. ..

Booster shots are half the dose of the same vaccine already given. Company data suggested that low doses were just as effective, but potentially less side effects.

The Food and Drug Administration committee needs to validate the decision by another advisory board and the chief federal government, with data and booster effects on the safety and efficacy of the third dose of the Moderna vaccine on Thursday. I considered about. About the outbreak of COVID-19 in Israel.

The booster shot discussion does not change the definition of “complete vaccination”. This remains 2 shots for the Pfizer-BioNTech and Moderna vaccines and 1 shot for the J & J. Those who need to be fully vaccinated for work or activity do not need extra shots.

The Vaccines and Related Biological Products Advisory Board voted 19-0 to support boosters in a limited population. Some members said they didn’t feel they could deny the booster to Moderna’s recipients after granting boosters to people who had been vaccinated with the Pfizer-BioNTech vaccine.

Dr. Stephen Pergum, an infectious disease specialist at the Fred Hutchinson Cancer Research Center in Washington, said: “I think it’s a practical problem.”

Last month, the Commission assisted boosters for people over the age of 65 who received the Pfizer-BioNTech vaccine, under the age of 65 in certain health conditions, or at high risk of becoming infected with COVID-19 for work. Did.

People with weakened immunity due to organ transplants, cancer treatments, medications, or similar situations can already receive a third dose of either the Moderna or Pfizer-BioNTech vaccine.

On Friday, the Commission will consider whether people who have received the COVID-19 vaccine made by Johnson & Johnson should be granted a second vaccination.

The information about the Moderna booster is not as big or supportive as the committee considered at Pfizer-BioNTech Shot.

“The data aren’t strong, but they’re certainly moving in favor of this vote,” said Dr. Patrick Moore, a committee member and immunologist at the University of Pittsburgh Cancer Institute.

“The data aren’t complete, but these are extreme times and we need to handle incomplete data,” said Brigam and Boston Women’s Hospital, chairman of the New England Journal of Medicine.

Obviously, Rubin said that vaccination of more people on the first shot would do more to stop the COVID-19 pandemic than boosters.

“Boosters are far less effective than vaccination of unvaccinated individuals at home and abroad,” he said. “We want to include a message that if you want to get out of things, you have to vaccinate unvaccinated people.”

As FDA scientists explained, Moderna’s study of about 170 people who received booster shots failed to meet the goal of quadrupling the immune activity against COVID-19. Among people with low antibody levels, generally those over the age of 65, protection was dramatically increased compared to those with high antibody levels.

A study comparing people who were vaccinated with Moderna more than a year ago and people who were vaccinated with Moderna about eight months ago found that protection against infection and serious illness was the time after Moderna vaccination. It seems to fade with.

The booster dose of modana appeared to be safe and most side effects were the same as or less than those seen in the first two doses, but many people who received the booster booster received the previous two doses. He complained of swelling and tenderness at the injection site after the third dose.

Although the data are still preliminary, there were no signs of increased incidence of myocarditis, especially heart swelling in young men after the second dose, on the third dose.

According to Dr. Sharon Alroy Price, Head of Public Health Services at the Department of Health, Israel, which is still deploying booster doses to the youngest adults, has a higher incidence of myocarditis than the second and subsequent doses. It seemed that there were fewer people after the first time.

In Israel, about 80% of the total population fires twice, about half fires three times, first deployed among the country’s oldest citizens, and then gradually this summer and early fall. Deployed among young citizens.

Alroy-Preis said the infection surged earlier this summer due to the delta variant. She said it made no difference to return to the vaccine passport requirements to enter the indoor space.

Providing boosters to people over the age of 60 reduced COVID-19 infections in that age group, but the national infection rate continued to rise. The rate didn’t start to fall until the boosters were offered to young adults, she said.

Currently, national cases are declining rapidly, even among unvaccinated people such as infants, Alroy-Preis said.

“There is no doubt that the curve break was the implementation of booster doses,” she said.

In May, associate nurses draw the Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic at Gillette Stadium in Foxborough, Massachusetts.

Committee members said Israeli data convinced them that booster immunization of both Pfizer-BioNTech and Moderna vaccines should be recommended, even with limited Moderna data. ..

More than 235 million Americans have been vaccinated with Pfizer-BioNTech vaccine at least once, and 153 million have been vaccinated with Moderna at least once. Both vaccines require a double dose regimen for complete vaccination.

According to data from the Centers for Disease Control and Prevention, over 15 million people have been J & J shots and are considered fully vaccinated.

Committee members said they were keen to make boosters accessible to healthcare professionals, grocery store clerks, etc. who may be exposed to COVID-19. According to committee members, they are at risk to help others, and society cannot let them miss their jobs without serious illness. They are also likely to be of color facing the issue of medical equity.

The panel also discussed whether booster shots should be offered to all Americans... Some members said they disagreed with the universal booster idea, as the data suggest that the first shot still protects against serious illness and hospitalization.

Dr. Paul Offit, a member of the Philadelphia Children’s Hospital’s Vaccine Education Center, said vaccines should not be expected to prevent all illnesses.

Vaccines still do a good job of preventing serious illnesses under the age of 70, he said, saying that everyone needs a booster, except those under the age of 30, who are at high risk of myocarditis. He added that he didn’t think.

Data show that protection against COVID-19 infection declines over time since vaccination.

According to Alroy-Preis, whether a third dose is sufficient to provide long-term protection, as it occurs in some diseases, or whether people get regular booster shots and vaccines, The virus that causes COVID-19.

The FDA’s Deputy Commissioner will approve the Commission’s decisions in the coming days. On October 20th and 21st, another independent expert committee will review the same data and make recommendations to the head of the CDC. They will only be generally available if she decides to support boosters.

The Biden administration has stated that it has pre-purchased enough COVID-19 vaccine to continue to provide it to Americans free of charge.

Please contact Karen Weintraub ([email protected]) and Elizabeth Weise ([email protected]).

Health and patient safety coverage at USA TODAY was partially made possible by grants from the Masimo Foundation for Ethics, Innovation and Competition for Healthcare. The Masimo Foundation does not provide editorial input.

The FDA Panel supports Moderna COVID boosters for seniors and adults at risk

Source link The FDA Panel supports Moderna COVID boosters for seniors and adults at risk


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