Pfizer/BioNTech to seek Covid vaccine EUA for children under age 5

/pfizer-biontech-to-seek-vaccine-authori

  • Pfizer is expected to ask the F.D.A. to authorize its #Covid vaccine for children under 5.
    https://www.nytimes.com/2022/01/31/us/politics/children-covid-vaccine.html

    #Pfizer and its partner BioNTech are expected as soon as Tuesday to ask the Food and Drug Administration to authorize a coronavirus #vaccine for children under 5 years old as a two-dose regimen while they continue to research how well three doses work.

    Federal regulators are eager to review the data in hopes of authorizing shots for young children on an emergency basis as early as the end of February, according to multiple people familiar with the discussions, who were not authorized to speak publicly. If Pfizer waited for data on a three-dose regimen, the data would not be submitted until late March and the vaccine might not be authorized for that age group until late spring.

    • Experts question unusual authorization plan for Covid vaccine for kids under 5
      https://www.statnews.com/2022/02/02/worry-vaccinating-under-5-could-backfire

      The idea of authorizing use of the first two doses while the third-dose data are pending is being framed as a way to allow parents eager to vaccinate children 4 and under to get a head start on the process, with a third dose to follow after review of the results of that part of the study.

      None of the experts STAT spoke to for this article could recall a precedent for this approach. And several worried going down this path could erode willingness on the part of parents of young children to get them vaccinated.

      [...] “I don’t think authorizing two doses in children ages 2 to 4 years of age where effectiveness in this age group hasn’t been confirmed is going to convince the majority of parents to vaccinate their children,” said Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines. “If the vaccine in this age cohort is a three-dose vaccine, #FDA should review the data from the three-dose series before authorizing the vaccine.”

    • What’s Holding Up the COVID Vaccines for Children Under 5?
      https://www.propublica.org/article/whats-holding-up-the-covid-vaccines-for-children-under-5

      Here’s the good news: Two companies could have data on vaccines in kids under 5 in a matter of weeks. Pfizer has said it’ll have data on three doses “in spring” and Moderna has said it’ll have data by the end of March. If the data looks good, there’s nothing to stop the FDA from authorizing a vaccine for kids of a certain age group, even if an older cohort misses the mark or hasn’t yet gotten the green light. Creech, who is also a principal investigator for Moderna’s pediatric vaccine trials, and Spearman both told me they expect authorization by April or, in a worst-case scenario, May.

    • Moderna to ask FDA to authorize Covid-19 vaccine in children 6 months to 6 years
      https://www.statnews.com/2022/03/23/moderna-to-ask-fda-to-authorize-covid-19-vaccine-in-children-6-months-to-6

      #Moderna said the studies — in children aged 6 months to 23 months and 2 to 6 years — showed the vaccine generated similar immune responses as those seen in adults aged 18 to 25 who received two doses of Moderna’s adult Covid vaccine.

      [...] In children 6 months to 2 years cases of Covid were decreased 43.7%; they were decreased by 37.5% in the 2 to under 6 years age group. Moderna said that the efficacy was on par with what would be expected of a two-dose vaccine against the Omicron variant, which predominated during the trial. The Omicron variant contains mutations that allow it to evade immunity built up by both vaccination and prior infection.

    • Pfizer/BioNTech to seek Covid vaccine authorization for children under age 5
      https://www.statnews.com/2022/05/23/pfizer-biontech-to-seek-vaccine-authorization-for-children-under-age-5
      Pfizer va soumettre une demande d’autorisation à la FDA d’ici la fin de la semaine (pour 3 doses, donc), le verdict devrait être rendu mi-juin et permettre une utilisation fin juin.
      Bien meilleure efficacité que le Moderna pour la même tranche d’âge, mais Moderna n’a pas encore publié les résultats avec booster.

      The vaccine was well-tolerated, induced a strong immune response, and was 80.3% effective at preventing Covid infections at a time when the Omicron variant of the SARS-CoV-2 virus was circulating.