- Pfizer Inc. and BioNTech SE said a late-stage clinical trial showed that their COVID-19 vaccine was safe and generated strong antibody responses in children 5 to 11 years old. However, the companies don’t yet know how well the shot protects against COVID-19 for children in that age group. Pfizer said it will ask U.S. regulators to authorize the shots as soon as possible. (Articles here, here, here, and here)
- An FDA advisory committee voted Friday to recommend emergency authorization of the additional Pfizer-BioNTech shots for Americans 65 and older and those at high risk of severe illness. The FDA and CDC are expected to authorize a third booster shot of the Pfizer-BioNTech COVID-19 vaccine for that same group early this week. The panel had earlier decided against recommending broader approval, saying there was not enough evidence to support broad use. (Articles here, here, here, here, here, here, and here)
- Anthony Fauci said he expects Moderna Inc. and Johnson & Johnson to submit data on COVID-19 booster shots within a few weeks. He also urged patience with the Biden administration’s plan to roll out the extra doses, saying people can expect “an evolution of this process” in the coming weeks and months. Meanwhile, NIH Director Dr. Francis Collins said he expects that eligibility for booster shots will be expanded in the coming weeks, but declined to say whether he thought another dose would be recommended for everyone. (Article here)
September 20, 2021
Life Sciences