HomeAmericaFDA Moderna, J&J will take up Covid-19 booster questions, including mix-and-match shots

FDA Moderna, J&J will take up Covid-19 booster questions, including mix-and-match shots

On Thursday, they will focus on the application of adding a booster dose to Moderna’s two-dose vaccine schedule. On Friday, they will consider Johnson & Johnson’s request for a booster.

Researchers are trying a variety of combinations.

“We started looking at people who had previously received Johnson & Johnson, Moderna and Pfizer and boosted them with an additional dose of the Moderna vaccine,” said Dr. Angela Brunche, assistant professor at the University of Rochester School of Medicine. told CNN to run some clinical trials combining booster doses. Researchers have also attempted to boost volunteers with vaccines from Pfizer and Johnson & Johnson.

a Preprint of that National Institutes of Health study Posted online on Wednesday says the blend booster produced a stronger immune response. The study, which involved more than 400 people, has not yet been peer-reviewed or published.

For participants who initially received the single-shot Johnson & Johnson vaccine, the boost from Pfizer or Moderna Vaccine appears to provide a stronger antibody response. Those who initially got Pfizer or Modern Shot got a comparable response with any of the boosters.

The study also found that it appeared to be safe for people to receive a separate Covid-19 booster from the vaccine they initially received.

The side effects were the same as those experienced with the initial shot. Half of the study participants experienced some side effects, including pain, fatigue, nausea, chills, headache and muscle aches at the injection site. Most symptoms were felt one to three days after the booster. None of the side effects were serious.

“Reactogenicity and adverse events were similar in the booster groups,” study said. “These data suggest that if a vaccine is approved or authorized as a booster, an immune response will arise regardless of the primary Covid-19 vaccination regimen.”

Which boost is best?

Discussions during the meeting will include whether there are differences in the quality and quantity of antibodies generated with promoting someone with a different type of vaccine – and whether waiting for the different time matters.

Pfizer was granted emergency use authorization for booster doses of its vaccine last month for some people who are at least six months out from their initial two doses.

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Moderna has asked its authorization request to reflect the EUA given to Pfizer. It is seeking the EUA for half the dose, but for a booster in people who got their first two doses at least six months ago and who are 65 and older, at high risk of severe Covid-19. are in or whose work is at risk or in their setting puts them at higher risk of serious complications from infection.

Moderna has far less data than Pfizer showing The immunity to its vaccine is decreasing. In fact, several studies have indicated that Moderna’s vaccine offers somewhat stronger protection than Pfizer’s.
a head-to-head study A lead by the US Centers for Disease Control and Prevention found that Moderna’s vaccine was slightly more effective than Pfizer at keeping people out of hospital in real life.

Does Moderna Vaccine Reduce Immunity?

FDA staff were attentive to documents posted ahead of Thursday’s meeting. “Some real-world effectiveness studies have suggested a decline in the effectiveness of the modern COVID-19 vaccine against symptomatic infections or against the delta variant over time, while others have not. Overall, however, the data indicates that currently US-licensed or authorized COVID-19 vaccines still provide protection against serious COVID-19 illness and death in the United States,” they wrote.

“There are several potentially relevant studies, but the FDA has not independently reviewed or validated the underlying data or their findings.”

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Like Pfizer’s application, Israeli researchers will provide insight into what’s happening there. Israel is conducting intensive studies on weakened immunity, although most people in Israel have received the Pfizer vaccine. Sharon Alroy-Preis, director of public health services at Israel’s Ministry of Health, and Ron Milo, a professor at Israel’s Weizmann Institute, both in support of Pfizer’s booster application, are due to speak to VRBPAC on Thursday.

Committee will vote on Moderna’s application scheduled to postpone Thursday at 4:45 p.m. ET.
Johnson & Johnson has been less accurate in its application for the booster dose.

The company has said it wants to leave the details up to the FDA.

“Based on recent data, it can be assumed that the administration of a booster dose will result in increased protection against symptomatic infection, an increase in the strength and breadth of the immune response against existing forms, and against severe disease in the population. The amount of protection will increase,” the company says in its application.

CDC data shows more people are getting Covid-19 vaccine boosters than their first shot

“Booster doses may also increase the likelihood of protection against future forms of anxiety. A booster dose at 6 months or later is recommended depending on the strength of immune responses, although a booster dose is administered as early as 2 months The need and/or timing of a booster dose will depend on the local/epidemiological situation and the needs of individuals/specific populations.”

The FDA said it did not have time to verify J&J’s analysis and would ask the committee to decide whether the company had submitted enough information to recommend a booster in two or six months.

committee is set to vote On Friday at 3:15 p.m. ET on the question of whether Johnson & Johnson recommends authorizing booster doses of the Janssen vaccine, and if so, for whom and when.

waiting can pay off

“In general, the longer you wait, the better the boost,” Dr. Dan Baroch of Harvard Medical School and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center told CNN. Barouch is scheduled to speak to VRBPAC on Friday.

The committee will meet again on Friday at 3:30 p.m. to discuss the question of the mix and match booster – although a vote on that question is not scheduled.

Johnson & Johnson asks FDA to authorize Covid-19 vaccine booster shots

Branche of Rochester said she thinks the data may indicate that mixing vaccine types for boosters may be of benefit.

But Baroch, who is also studying mixed booster doses, said there isn’t enough data to say yet.

“I think there is a lot of potential for mix and match regimens, but the data sets to date are very small,” he told CNN.

Moderna and Pfizer both use mRNA technology – genetic material called messenger RNA is delivered directly to cells to instruct the body to make small pieces of the virus to stimulate an immune response. The Janssen vaccine is a vector vaccine that uses another virus called adenovirus, which is crippled so it cannot replicate, carrying pieces of the coronavirus to stimulate a response.

These two different delivery methods stimulate the immune system slightly differently, Brunch said.

“I think the data will show that boosting is certainly likely to be very effective in providing additional and longer protection,” she said.

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