Biologics

FDA Allows More, Mixed Booster Vaccines

FDA 10/20 authorized Covid-19 vaccine booster doses for certain Moderna and Johnson & Johnson vaccinated individuals. Additionally, the agency authorized the use of any available Covid-19 vaccine as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available Covid-19 vaccine. The actions come a month after Pfizer-BioNTech won a similar booster authorization for its Covid-19 vaccine (see earlier story).

According to an FDA news release, the agency amended the emergency use authorizations (EUA) for Covid-19 vaccines to allow for:

The use of a single booster dose of the Moderna Covid-19 vaccine that may be administered at least six months after completing the primary doses to individuals: 65 years of age and older; 18 through 64 years of age who are at high risk of severe disease; and 18 through 64 years of age with frequent institutional or occupational exposure to Covid-19.
The use of a single booster dose of the Janssen (Johnson and Johnson) Covid-19 vaccine may be administered at least two months after completing the single-dose primary regimen in individuals 18 years of age and older.

Additionally, Pfizer-BioNTech’s Covid-19 vaccine EUA was amended to clarify that a single booster dose of its vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to Covid-19.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome