Biologics

Evolving Covid Variants Challenge Future Vaccines: Marks

Constantly changing Covid-19 transmissible variants present a “major challenge” for current Covid vaccines, and continuing to develop variant-specific vaccine boosters is “inadequate as a long-term strategy for addressing Covid-19 in populations globally,” writes CDER director Peter Marks and two researchers from Brown University in a 1/9 JAMA Viewpoint article.

“Serious consideration therefore needs to be given to the development of a distinctly improved generation of SARS-CoV-2 vaccines offering longer protection with greater scope,” their article says. “Based on experience to date with Covid-19 and other vaccines, a variety of approaches to the development of new vaccines will need to be explored by academic and industrial researchers and sponsors, as well as government agencies. One potential model for approaching such development was used successfully at the beginning of the pandemic when Operation Warp Speed evaluated numerous global vaccine types and focused on advancing several promising candidates, knowing full well that most would ultimately not be found to meet the criteria set forth for a safe vaccine with adequate efficacy.”

Marks et al conclude that unless “correlates of protection that are strongly associated with duration of protection against Covid-19 can be identified, it is likely that rather than relying on immunobridging to infer vaccine effectiveness, large randomized clinical trials similar to the initial trials of the currently authorized or licensed vaccines for Covid-19 will be required to ascertain the effectiveness of these new vaccines.”

The authors say future Covid vaccines should demonstrate a 75% effectiveness in preventing illness, show durable protection that lasts at least one year and suitability for use in all age groups. “Aiming even further, the vaccines would ideally not only protect against hospitalization, death, and symptomatic disease leading to increased health care use but would also reduce viral transmission,” they write. “Even using the criterion for success of a moderate 40% to 60% reduction in transmission is predicted to have a notable positive impact on outbreak control.”

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