Sunday, October 17, 2021

FDA scientists give positive tone to J&J Covid booster photos before voting this week

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Food and Drug Administration officials applied a more comfortable tone to Johnson and Johnson Covid-19 booster shots on Wednesday, saying it might be beneficial to send a second dose two months after the first dose.

Employees admitted, but data is limited to support supporters and the agency is still checking all the information.

“Although the data set has not been independently verified by the FDA, the conclusion of the data is that it is beneficial to use a second dose approximately 2 months after the main dose, compared with the efficacy seen in the COV3001 primary study. shows that it can happen, ”they wrote. The 54-page document was released on Wednesday.

They also reported that a single J&J dose was consistently ineffective in clinical trials and real studies compared to mRNA vaccines produced by Pfizer and Moderna.

“During clinical trials and real efficacy studies evaluating the Janssen COVID-19 vaccine, the highest efficacy ratings (including for more severe COVID-19 disease) were not higher than the efficacy of mRNA COVID-19 vaccines,” they said. .

Overall, the disposable J&J vaccine “protects against severe COVID-19 disease and death in the United States.”

The FDA scientists report is scheduled to inform the Advisory Committee on Vaccines and Related Biological Products, which will convene on Friday to discuss information on the safety and efficacy of the second J&J stroke in adults. The published documents reflect the agency’s approach to additional staffing.

Unlike the two-axis mRNA vaccines of Pfizer and Modern, J&J hoped to offer a one-time solution that would adequately protect the public from helping end the pandemic. But in the U.S., its protection was considered 72% lower than that of Moderna and Pfizer vaccines, both of which rated it as more than 90% effective.

The second dose of J&J, which has similar performance to mRNA vaccines, increases protection against symptomatic infection by 94% two months after the first dose in the U.S., the company said in a Sept. 21 release. to stimulate adenovirus immunity, the agency was asked to approve a booster picture of a single vaccine for people 18 and older on Oct. 5.

The FDA advisory group is scheduled to discuss information on the safety and effectiveness of Moderna’s booster in adults on Thursday, and J&J on Friday. The agency may make a final decision within a few days of the meeting and submit its decision to the Centers for Disease Control and Prevention and its Advisory Committee on Vaccines next week.

FDA scientists on Tuesday relinquished their position in support of photographing the Moderna Covid vaccine in an unusual move, according to which now authorized vaccines prevent serious illness and death in the United States. protects.

Last month, U.S. regulators allowed Covid to vaccinate Pfizer and BioNTech against a large number of Americans, including the elderly, sick adults, health and food workers, or those living or working in high-risk conditions.

Norman Baylor, a former director of the FDA’s Office of Vaccines, said he wouldn’t have recommended taking the Moderna vaccine to an advisory committee last week because it uses a platform similar to Pfizer’s stroke, which has already been approved for boosters. But J&J is different.

“It’s going to be a little more complicated, because the second dose of the J&J vaccine is boosting‘ very well, ’” Baylor said. “Maybe it should have been two doses [vaccine] at first.”

It’s an evolving story. Please check back for updates.

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