Sunday, October 17, 2021

FDA panel discusses booster approval for Moderna COVID-19 vaccine

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October 14 (News) – A Food and Drug Administration advisory committee will meet for two days starting Thursday to review requests from Johnson & Johnson and Moderna to approve booster doses for Americans.

The meeting begins on Thursday at 8:30 a.m. EDT and lasts for several hours. The panel is expected to decide on Thursday afternoon whether to recommend the Moderna booster. At the meeting on Friday, the additional dose of Johnson & Johnson, which is produced by subsidiary Janssen, will be weighed.

Last month, the FDA approved a third vaccination of the Pfizer-made vaccine for people over 65 and recipients between 18 and 64 who are at high risk of developing severe COVID-19 and who are often institutionally or professionally exposed to COVID-19 are. 19th

The agency recommended the Pfizer booster dose six months after the second injection.

Nearly 9 million people in the United States have received a booster dose of the Pfizer vaccine in the past few weeks, according to the Centers for Disease Control and Prevention.

FDA scientists announced results for Johnson & Johnson and Moderna boosters this week.

On Tuesday, they said the data shows that Moderna’s two-dose regimen provides sufficient immunity to preclude the need for a third dose. You said a Moderna booster seemed unnecessary to protect against the more contagious Delta variant.

A study published by Moderna in August showed that the vaccine remained 93% effective in volunteers six months after the second dose, and that a third vaccination produced a “robust antibody response” against the Delta variant

In their remarks on Wednesday’s Johnson & Johnson shot, FDA scientists said that a booster appears to offer additional protection, but they aren’t sure when the best time to get the extra dose is. Johnson & Johnson recommends the additional dose two to six months after the first injection.

The Johnson & Johnson vaccine, unlike those from Moderna and Pfizer, only requires one dose.

In their rating for a booster, the scientists said some of the data provided by Johnson & Johnson was incomplete. For example, they said the company only offered a small sample of recipients who received a booster dose after six months.

Johnson & Johnson reported in September that a two-month booster vaccination was 100% effective against severe COVID-19 and 75% effective in preventing symptomatic COVID-19 in recipients worldwide.

The company said the booster had a greater 94% effectiveness in preventing symptomatic COVID-19 in the US.

Johnson & Johnson also found that a dose of the vaccine between March and late July was 79% effective against infections and 81% effective in preventing hospital stays in the United States.

Another development that could affect the distribution of booster doses came Wednesday when one was spearheaded by the National Institutes of Health to learn concluded that “mixing and matching” booster doses appears to be effective and is also being reviewed by the FDA advisory committee.

In fact, the study said that people who received the Johnson & Johnson vaccine are better off receiving a booster dose of the Moderna or Pfizer formulation.

That means the FDA and CDC can ultimately approve a Moderna booster for people who received the Pfizer vaccine, and vice versa. It is not yet known when the FDA panel will make its recommendation on this possibility.

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