.-') _      .-') _  
                      ( OO ) )    ( OO ) ) 
          .-----. ,--./ ,--,' ,--./ ,--,'
         '  .--./ |   \ |  |\ |   \ |  |\  
         |  |('-. |    \|  | )|    \|  | ) 
        /_) |OO  )|  .     |/ |  .     |/  
        ||  |`-'| |  |\    |  |  |\    |   
       (_'  '--'\ |  | \   |  |  | \   |
          `-----' `--'  `--'  `--'  `--'
       lite.cnn.io - on gopher - inofficial
       
       
       ARTICLE VIEW: 
       
       CNN - Breaking News, Latest News and Videos
       CNN | 4/11/2021 | Listen
       FDA advisers to consider third possible Covid-19 vaccine Friday
       By Maggie Fox, CNNUpdated: Fri, 26 Feb 2021 15:25:15 GMTSource: CNN
       
       US Food and Drug Administration vaccine advisers are scheduled to meet
       Friday to discuss the potential emergency authorization of a third
       coronavirus vaccine for the US, 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. As with the two currently
       authorized vaccines, advisers and federal agencies are meeting over a
       weekend to try to get the vaccines to the US public as soon as
       possible.
       
       
       
        
       
       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. 
       
       They'll also hear the latest from the Centers for Disease Control
       and Prevention about the spread of the virus, including worrying new
       variants, and on the CDC's surveillance for any safety worries
       from the currently authorized vaccines made by Pfizer/BioNTech and
       Moderna.
       
       The VRPBAC will vote Friday on whether to recommend FDA emergency use
       authorization (EUA), and the FDA will then take that vote into
       consideration in deciding whether to authorize the vaccine.
       
       That decision could come very quickly after the VPBPAC vote.
       
       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.
       
       
       
       
       
       © 2021 Cable News Network. A Warner Media Company. All Rights
       Reserved.
       
       Listen to CNN (low-bandwidth usage)
       
   DIR  <- back to index