FDA gives the go-ahead to vaccinate 12-15-year-olds

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On Monday 5/10/2021, the US Food and Drug Administration announced it was expanding Pfizer’s emergency use authorization for its Covid-19 vaccine to include 12-15-year-olds. Previously its vaccine was authorized only for people 16 and older. Expanding the authorization opens up vaccination to another 5% of the US population.

Last week, President Joe Biden said that as soon as the FDA authorization happened, thousands of federal pharmacy sites across the country would be ready to vaccinate this age group. Biden added that the goal was to make vaccination as easy as possible -- so if teens were moving from one state to another, it wouldn’t be a problem to get one dose in one state and the second in another state. A recent poll from the Kaiser Family Foundation found only 29% of parents of children under age 18 said they would get their children vaccinated as soon as they were eligible. An additional 32% said they would wait to see how the vaccine was working before getting their children inoculated. The remaining parents said either that their child would be vaccinated only if their school required it (15%) or definitely wouldn't be vaccinated (19%). While the FDA has expanded the authorization, it doesn’t mean that teens will automatically be vaccinated. When and where this will happen will depend on where they live, since states regulate medical practice, including the administration of vaccines.

 Doctors are technically not supposed to administer the vaccine until the US Centers for Disease Control and Prevention makes a recommendation. The CDC’s advisory group is scheduled to meet Wednesday and vote on using it in the younger age group. However, since some pediatricians already have the vaccine on hand for older teens, some doctors may choose to exercise their own judgment and begin vaccinating 12-15-year-olds right away.

Pfizer submits to FDA for full approval of its vaccine

 On Friday, Pfizer became the first company to seek full FDA approval for a Covid-19 vaccine. More than 170 million doses of the vaccine have been distributed across the US to date.

 To apply for full FDA approval, Pfizer/BioNTech submitted a Biologics License Application, or BLA. The FDA requires vaccine manufacturers to submit data on manufacturing processes, facilities and additional information that demonstrates the vaccine can be produced reliably and consistently.

 Pfizer is also required to submit all pre-clinical and clinical trial data, which it will provide to the FDA over the next few weeks on a rolling basis. Once all the required information is submitted, a goal date will be set for a decision by the FDA. Pfizer/BioNTech has requested priority review, which asks the FDA to take action within 6 months, compared to the 10 months designated under standard review.

 The company will also submit for full approval for 12-15-year-olds once all the essential data has been collected six months after administering second doses.

 Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for at least six months. In addition, recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech are currently testing booster and variant-specific vaccines.

 For most people, there won’t be much of a distinction between full approval and authorization. Some experts believe that full approval will give more people confidence in the vaccine and help decrease hesitancy. Other experts believe approval may make mandating the vaccine in schools more feasible, similar to other childhood vaccines.

 Source: CNN Health <resultsarein@newsletters.cnn.com>

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