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Johnson & Johnson vaccine: this Friday, a key step for its authorization

2021-02-26T09:49:29.626Z


Advisers to the FDA will meet Friday to discuss possible emergency clearance for Johnson & Johnson's vaccine.


Johnson & Johnson vaccine would protect against variant 0:57

(CNN) -

Vaccine advisers from the U.S. Food and Drug Administration (FDA) will meet this Friday to discuss the possible emergency authorization of a third coronavirus vaccine in the country. , manufactured by Johnson & Johnson's Vaccine Division, Janssen Biotech.

It is the next step in a process that could end with the launch of the new vaccine early next week.

As with the two currently licensed vaccines, advisers and federal agencies will meet for a weekend to try to get the vaccines to the American public as soon as possible.

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The FDA has already reviewed Johnson & Johnson data

The FDA has already considered the advanced data from the phase 3 clinical trials presented by Janssen and says it shows that the vaccine is safe and effective.

The Vaccines and Related Biologics Advisory Committee or VRBPAC is comprised of vaccine experts and other medical professionals, industry representatives and consumers who will consider submissions from the FDA on their findings, as well as from Janssen.

They will also hear the latest news from the Centers for Disease Control and Prevention (CDC) on the spread of the virus, including concerning new variants, and on the CDC's vigilance regarding any safety concerns of currently licensed vaccines, manufactured by Pfizer / BioNTech and Moderna.

The VRPBAC will vote on Friday on whether to recommend FDA emergency use authorization (US), and the FDA will then take that vote into consideration in deciding whether to authorize the vaccine.

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On Sunday, a second advisory group intervenes.

CDC's Advisory Committee on Immunization Practices (ACIP) will look at the same data and discuss whether people should get the vaccine and, if so, by whom and when.

An ACIP vote is expected at 3pm ET.

The CDC then takes the ACIP vote into consideration and the CDC director, currently Dr. Rochelle Walensky, will decide whether the vaccine is approved by her agency.

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When will the distribution of the vaccine begin?

After that, you can start the distribution.

The White House has promised to start immediately, with 2 million doses destined for the states and the rest directly to pharmacies and community health centers.

The federal government has said it expects to have up to 4 million doses of the Johnson & Johnson vaccine on day one.

The company has promised to increase production to deliver 20 million doses by the end of March and 100 million doses by the end of June.

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While the Pfizer and Moderna vaccines require two doses for full efficacy, Johnson & Johnson's vaccine requires only one dose, although the company is testing a two-dose regimen to see if it works better.

Johnson & Johnson data indicates that their vaccine was 66% effective in all global trials in preventing moderate to severe COVID-19 disease 28 days after immunization.

It was 85% effective in preventing serious illness.

No one who received the vaccine died of covid-19.

Johnson and JohnsonCoronavirus vaccine

Source: cnnespanol

All news articles on 2021-02-26

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