Pfizer to ask FDA for approval for vaccines for children aged 5 and up.
In an effort to expand who can ge the vaccine, Pfizer and BioNTech have asked the Food and Drug Administration for approval for its COVID-19 vaccine. This comes after the results for the trial for the 5-11 age group have been released.
Promising to meet quickly, the F.D.A is scheduled to meet on October 26, with their decision expected not long after, possibly as early as Halloween.
In a joint release by both companies, put out on September 20th, Albert Bourla, Pfizer’s Chairman and Chief Executive Officer said: “Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,”
BioNTech’s CEO expressed similar hopes, adding that the vaccine for children would be dosed at 10 µg, “…consistent with those we have observed with our vaccine in other older populations at a higher dose.”
Starting in December 2020, the Pfizer vaccine has been under Emergency Use Authorization, starting with approval for individuals aged 16 and older, before being expanded to include those aged 12 and up on May 10, 2021.
Delivering mRNA into the body, that mRNA is then used by by the body to mimic the protein in the Coronavirus, the virus that causes COVID-19, ultimately resulting in an immune system that would react to the virus defensively.
Marketed by Pfizer-BioNTech as Cormirnaty, the FDA stressed in a press release dated August 23, 2021, that the “mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.”