FDA expected to approve Vaccine for ages 12 – 15

By May 5, 2021November 3rd, 2022Covid-19 News

The US FDA is expected to authorize the Pfizer-BioNTech SARS-CoV-2 vaccine for adolescents ages 12 to 15 late this week or early next week, according to an anonymous federal official. An amendment to the vaccine’s existing Emergency Use Authorization would open the US vaccination campaign to millions more people, reaching a younger population key to raising levels of immunity. If authorization is granted, the US CDC’s Advisory Committee on Immunization Practices (ACIP) would meet soon after to review data and make recommendations for the vaccine’s use among adolescents. According to data from Pfizer released at the end of March, a clinical trial involving 2,260 participants aged 12 to 15 showed the vaccine was well-tolerated and 100% efficacious. The Pfizer-BioNTech vaccine is currently authorized for people ages 16 and older. The companies are conducting clinical trials using the vaccine in people as young as 6 months old. BioNTech Chief Executive Ugur Sahin last week told German magazine Spiegel that the company expects first results in July for the group ages 5 to 12 and in September for the youngest age group.

The spike protein of SARS-CoV-2 helps the virus latch onto and invade healthy cells. It also plays a key role in damaging vascular endothelial cells, according to a study published in Circulation Research. The findings show COVID-19 is a vascular disease and provide a clear link to disease processes that lead to blood clots and stroke, researchers from the Salk Institute and colleagues said. Notably, this is the first research to show the spike protein causes damage on its own, without viral replication. The researchers hope the findings can lead to more effective therapies to interrupt the spike protein’s mechanisms for damaging cells.

CSSE is reporting 32,510,422 positive cases in the U.S. and 578,403 deaths. DOH reported 2,249,535 confirmed cases in Florida today, with 35,399 deaths.