Biologics

Senators Want More Covid Vaccine Data

Sens. Susan Collins (R-ME) and Richard Burr (R-NC) are asking FDA and the Centers for Disease Control (CDC) for more efficacy data on Covid-19 vaccines and breakthrough cases. In a 10/20 letter, the two say that while CDC has started to make some additional information available in tracking the rates of Covid-19 cases and deaths by vaccination status and vaccine product, data on hospitalizations by vaccine product remain unavailable to the public. They also say that only a few public health departments appear to be reporting information to CDC on breakthrough cases that result in hospitalizations or death.

“We have heard from vaccinated healthcare professionals, seniors, and individuals who are immunocompromised or have certain chronic conditions who have questions about the data surrounding serious breakthrough infections and how the different vaccine products compare in protecting against hospitalizations and deaths,” the senators wrote. “They also have questions about how these data have informed the recent FDA and CDC announcements on booster shots and how they will be taken into account on recommendations on the mixing and matching of vaccines. At a time when there has already been public confusion on the decision-making process around boosters, it is crucial that CDC and FDA be trusted sources of accessible information on the efficacy of the three vaccines. The public would benefit from more robust data on which vaccine was received by fully vaccinated individuals who are hospitalized due to a breakthrough case, in addition to more data overall on breakthrough cases.”

Collins and Burr asked the two agencies:

whether they collect nationwide data on which vaccine was received by fully vaccinated individuals who nevertheless contract Covid-19 and are hospitalized;
if the data are not collected, what are the barriers to collecting and disseminating the information;
whether there are limitations on the agencies’ ability to make such data publicly available; and
how the agencies are assessing trends in breakthrough infections and the variant or variants that are resulting in such breakthroughs.

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