Advisory panel recommends FDA approve Johnson & Johnson vaccine for emergency use

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Advisory panel recommends FDA approve Johnson & Johnson vaccine for emergency use

Above video: California expects 1.1 million J&J vaccines in next 3 weeksU.S. health advisers endorsed a one-dose COVID-19 vaccine from Johnson & Johnson on Friday, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic. The Food and Drug Administration is expected to quickly follow the recommendation and make J&J’s shot the third vaccine authorized for emergency use in the U.S. Vaccinations are picking up speed, but new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans.Food and Drug Administration advisors have recommended another COVID-19 vaccine for emergency use, saying the benefits outweigh the risks for those 18 and older.FDA vaccine advisers met Friday to discuss the potential emergency authorization of a third COVID-19 vaccine for the U.S., this one made by Johnson & Johnson’s vaccine arm Janssen Biotech.It’s the next step in a process that could end with the new vaccine’s rollout early next week. The FDA has already considered the advanced, Phase 3 clinical trial testing data presented by Janssen and says it shows the vaccine is safe and effective. The Vaccines and Related Biological Products Advisory Committee or VRBPAC is made up of vaccine experts and other medical professionals, industry and consumer representatives who will consider presentations from FDA about its findings, as well as from Janssen.The FDA will then take the vote into consideration in deciding whether to authorize the vaccine.That decision could come very quickly.On Sunday, a second advisory group weighs in. The CDC’s Advisory Committee on Immunization Practices will look at all the same data and will discuss whether people should get the vaccine and if so who, and when. A vote is expected by 3 p.m. ET from ACIP.The CDC then takes the ACIP vote into consideration and the CDC director — who is currently Dr. Rochelle Walensky — will decide whether the vaccine has her agency’s OK.Typically, this is a slow and deliberative process, but the schedule was sped up because of the urgency of the pandemic. The authorization and subsequent CDC nod for the Pfizer/BioNTech and Moderna vaccines in December each took place over a period of days.After that, distribution can begin. The White House has promised to begin immediately, with 2 million doses going to 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 Johnson & Johnson vaccine on the first day. The company has promised to ramp up production to deliver 20 million doses by the end of March and 100 million doses by the end of June.While Pfizer and Moderna’s vaccines require two doses for full efficacy, the Johnson & Johnson vaccine requires only one dose, although the company is testing at two-dose regimen to see if it works any better.Johnson & Johnson’s data indicates its vaccine was 66% effective across all global trials in preventing moderate to severe Covid-19 disease 28 days after immunization. It was 85% effective in preventing severe disease. No one who got the vaccine died from COVID-19.The Associated Press and Hearst TV contributed to this report.

Above video: California expects 1.1 million J&J vaccines in next 3 weeks

U.S. health advisers endorsed a one-dose COVID-19 vaccine from Johnson & Johnson on Friday, putting the nation on the cusp of adding an easier-to-use option to fight the pandemic.

The Food and Drug Administration is expected to quickly follow the recommendation and make J&J’s shot the third vaccine authorized for emergency use in the U.S. Vaccinations are picking up speed, but new supplies are urgently needed to stay ahead of a mutating virus that has killed more than 500,000 Americans.

Food and Drug Administration advisors have recommended another COVID-19 vaccine for emergency use, saying the benefits outweigh the risks for those 18 and older.

FDA vaccine advisers met Friday to discuss the potential emergency authorization of a third COVID-19 vaccine for the U.S., this one made by Johnson & Johnson’s vaccine arm Janssen Biotech.

It’s the next step in a process that could end with the new vaccine’s rollout early next week.

The FDA has already considered the advanced, Phase 3 clinical trial testing data presented by Janssen and says it shows the vaccine is safe and effective. The Vaccines and Related Biological Products Advisory Committee or VRBPAC is made up of vaccine experts and other medical professionals, industry and consumer representatives who will consider presentations from FDA about its findings, as well as from Janssen.

The FDA will then take the vote into consideration in deciding whether to authorize the vaccine.

That decision could come very quickly.

On Sunday, a second advisory group weighs in. The CDC’s Advisory Committee on Immunization Practices will look at all the same data and will discuss whether people should get the vaccine and if so who, and when. A vote is expected by 3 p.m. ET from ACIP.

The CDC then takes the ACIP vote into consideration and the CDC director — who is currently Dr. Rochelle Walensky — will decide whether the vaccine has her agency’s OK.

Typically, this is a slow and deliberative process, but the schedule was sped up because of the urgency of the pandemic. The authorization and subsequent CDC nod for the Pfizer/BioNTech and Moderna vaccines in December each took place over a period of days.

After that, distribution can begin. The White House has promised to begin immediately, with 2 million doses going to 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 Johnson & Johnson vaccine on the first day. The company has promised to ramp up production to deliver 20 million doses by the end of March and 100 million doses by the end of June.

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

Johnson & Johnson’s data indicates its vaccine was 66% effective across all global trials in preventing moderate to severe Covid-19 disease 28 days after immunization. It was 85% effective in preventing severe disease. No one who got the vaccine died from COVID-19.

The Associated Press and Hearst TV contributed to this report.

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