BioNTech & Pfizer look for FDA approval on new booster shot for kids

BioNTech & Pfizer look for FDA approval on new booster shot for kids

Pfizer Inc. and its German partner BioNTech SE have reportedly submitted an application, seeking approval for an Omicron-tailored COVID-19 vaccination booster for children aged 5 to 11 years, from the U.S. Food and Drug Administration (FDA) on Monday i.e., 26th September.

Interestingly, the request was filed a few days after its competitor Moderna Inc. asked the FDA to approve the use of its Omicron-targeting injection in children between the ages of 6 & 11 years and adolescents aged 12 to 17 years.

For those unversed, the applications are an important step in vaccinating kids with a so-called bivalent vaccine, which protects against both the primary viral strain and the circulating BA.4 & BA.5 variants of Omicron.

However, with 4.4 million doses of the first booster shots provided to the older age group so far, the United States launch of bivalent booster vaccines has relatively slowed down.

The actions come as COVID-19 cases in the United States continue to decline and are at their lowest level since late April, though the actual number is probably higher, given that many people are using home-test kits, where information is often not collected.

As per New York Times tracker, the daily average for fresh cases was 54,239 on Sunday i.e., 25th September, down 18% from two weeks ago. The tracker reveals that there is an increase in cases in 20 states, including New York, New Jersey, Massachusetts, and Washington, D.C.

In similar news, French pharmaceutical company Valneva SE announced recently that it is in talks with a potential partner to get finance for a COVID-19 vaccination of the second generation.

According to Valneva, it plans to release any leftover inventory into international markets within the next year. It is also in the midst of regulatory processes and ongoing negotiations with other governments. In the fourth quarter of the year, the business is anticipated to release additional clinical data, including heterologous booster data.

Source Credit: https://www.reuters.com/business/healthcare-pharmaceuticals/pfizerbiontech-seek-fda-nod-new-covid-boosters-children-2022-09-26/