FDA advisers call for Omicron update for COVID boosters

The Food and Drug Administration (FDA) outside advisory committee today recommended that new booster shot versions include an Omicron variant component, as newer subvariants expand their footprint and the nation faces an uncertain fall and winter with the virus.In its weekly update today, the Centers for Disease Control and Prevention (CDC) said the proportion of BA.4 and BA.5 subvariants increased sharply last week, mainly due to BA.5.Progress on complex issuesDuring today's hearing, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the group heard from vaccine producers, including Novavax, which is still waiting for the FDA to act on VRBPAC's recent emergency use recommendation.

The experts also heard from federal health officials, its own staff, and an expert on modeling to gain insight on how virus spread might unfold over the fall and winter.Before the advisers approved the booster recommendation by a 17-to-2 vote, they heard from Kanta Subbarao, MD, from the World Health Organization (WHO) flu research collaborating center in Australia, who walked them though a WHO technical group's recent deliberations.

On Jun 17, the WHO group weighed in on modified vaccines, saying they may need to be updated with the Omicron variant to prompt a broader immune response.Subbarao emphasized today that VRBPAC shouldn't shoot for a perfect match with subvariants, but should focus on broadening the immune response by including Omicron, which is the furthest phylogenetic distance away from the original strain.The voting question was whether to include an Omicron component in COVID-19 booster shots, but the committee was also asked to assess the possibility of including more recent BA.4 and BA.5 subvariants and