FDA Vaccine Committee Meets About COVID-19 Vaccines
The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.
In a blog post on FDA’s website dated Oct. 20, 2020, Peter Marks, MD, PhD, director of the agency’s Center for Biologics Evaluation and Research (CDER), previewed a meeting scheduled to be held on Oct. 22, 2020 by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) where committee members and experts will discuss COVID-19 vaccine development and authorization. Topics planned for the meeting include studies needed for authorization or approval, post-marketing safety studies needed after approval, and ongoing safety monitoring after an emergency use authorization is issued.
In his blog post, Marks stressed that transparency in agency processes can help make the public more confident in taking a COVID-19 vaccine if and when one becomes available; however, FDA is limited in what it can share with the public about unapproved drugs and vaccines. “But one important—and transparent—part of our regulatory and scientific evaluation process is to seek advice from outside experts through meetings of FDA advisory committees,” Marks stated. The VRBPAC committee, according to Marks, includes external scientific and public health experts that specialize in immunology, virology, infectious diseases, pediatrics, vaccine development, and vaccine safety.
Members of the public will be able to provide input, which will be followed by a discussion by committee members. “Discussions by this committee will help ensure clear public understanding of the data needed for FDA authorization or approval of COVID-19 vaccines, as well as plans for their continued evaluation following authorization or approval,” Marks stated.
The October 22 meeting will be streamed on FDA’s YouTube channel. Additional meetings of the VRBPAC are planned for the future, as needed, according to Marks. “Facilitating the development of safe and effective COVID-19 vaccines is a high priority for the FDA. We recognize that being transparent about the data that we will evaluate in support of the safety and effectiveness of these vaccines and discussing this data with members of the VRBPAC in a public forum is critical to build trust and confidence in their use by the public,” Marks stated.
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
