The Food and Drug Administration (FDA) plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of Emergency Use Authorization (EUA) requests in the coming months for COVID-19 vaccines.
The FDA provided the following tentative dates for the VRBPAC meetings pending complete submissions of EUA requests:
- On June 7, the advisory committee intends to discuss an EUA request for Novavax’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
- On June 8, 21, and 22, the advisory committee intends to discuss updates to the Moderna and Pfizer-BioNTech EUAs for their COVID-19 vaccines to include younger populations.
- On June 28, the panel intends to discuss whether the SARS-CoV-2 strain composition of COVID-19 vaccines should be modified and if so, which strain(s) should be selected for fall 2022.
“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” said Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research. “We are providing a tentative schedule for discussion of these submissions, as these meetings will cover a number of topics that are of great interest to the general public.”
Moderna recently submitted an EUA request to the FDA for its COVID-19 vaccine, mRNA-1273, in children 6 months to under 6 years of age. The Company expects to complete the EUA submission for this patient population by next week.
Pfizer and BioNTech have also submitted an EUA application to the FDA for a 10µg booster dose of their COVID-19 vaccine for children 5 through 11 years of age.
The Novavax COVID-19 vaccine candidate, NVX-CoV2373, is engineered from the genetic sequence of SARS-CoV-2 using the Company’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine candidate contains the Company’s saponin-based Matrix-M™ adjuvant technology to enhance and prolong immune responses. The clinical development program included a trial that enrolled approximately 30,000 participants in the US and Mexico and a study with almost 15,000 participants in the UK.
Coronavirus (COVID-19) update: FDA announces tentative advisory committee meeting schedule regarding COVID-19 vaccines. News release. US Food and Drug Administration. Accessed April 29, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding-covid-19-vaccines-301536312.html