Thursday, October 28, 2021

FDA panel to discuss authorizing booster dose for Moderna COVID-19 vaccine

October 14 (NWN) – The FDA’s advisory committee will meet for two days starting Thursday to evaluate requests from Johnson & Johnson and Moderna to authorize booster doses for Americans.

The meeting will begin on Thursday at 8:30 am ET and will run for several hours. The commission is expected to decide on Thursday afternoon whether to recommend the Moderna booster. Friday’s meeting will weigh in an additional dose of Johnson & Johnson, which is being produced by a Janssen subsidiary.

Last month, the FDA approved the third vaccine injection given by Pfizer for people over 65 and recipients between the ages of 18 and 64 who are at high risk of serious COVID-19 and often face COVID infection in institutions or at work. 19.

The agency recommended a booster dose of Pfizer six months after the second shot.

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

This week, FDA scientists announced the results for the Johnson & Johnson and Moderna boosters.

They said on Tuesday that the data shows Moderna’s two-dose regimen provides sufficient immunity to eliminate the need for a third dose. They said the Moderna launch vehicle seems unnecessary to defend against the more infectious Delta variant.

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

In their comments on Johnson & Johnson’s vaccination on Wednesday, FDA scientists said the booster appears to offer additional protection, but they are unsure when is the best time to take the extra dose. Johnson & Johnson recommends giving an additional dose two to six months after the first injection.

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The Johnson & Johnson vaccine, unlike the Moderna and Pfizer vaccines, requires only one dose.

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

Johnson & Johnson reported in September that booster vaccinations two months later were 100% effective in protecting recipients from severe COVID-19 and 75% effective in preventing symptomatic COVID-19 in recipients worldwide.

The company said the booster was more effective in the United States, 94%, in preventing symptomatic COVID-19.

Johnson & Johnson also noted that a single dose of the vaccine was 79% effective against infection in the United States between March and the end of July and 81% effective in preventing hospitalization.

Another event that could affect the distribution of booster doses occurred on Wednesday when the National Institutes of Health study concluded that “mixing and matching” booster doses appears to be effective and this will also be reviewed by an FDA advisory committee.

In fact, research has shown that people who receive the Johnson & Johnson vaccine are better off getting a booster dose of Moderna or Pfizer.

This means that the FDA and CDC may eventually approve a booster dose of Moderna for people who have received the Pfizer vaccine, and vice versa. It is not yet known when the FDA team will make its recommendation regarding this possibility.

Nation World News Desk
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