FDA recommends changing composition of Covid-19 vaccines for this fall

FDA recommends changing composition of Covid-19 vaccines for this fall   Your Covid-19 booster in the fall will likely look a little different.   The US Food and Drug Administration decided Thursday to advise manufacturers that when they update Covid-19 vaccine boosters, they should add an Omicron BA.4/5 component to the current vaccine mix. This would create what's known as a bivalent, or two component, booster.   "We have advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, so that the modified vaccines can potentially be used starting in early to mid-fall 2022," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said Thursday in a statement.   Member of the FDA's Vaccines and Related Biological Products Advisory Committee voted last week to support recommending inclusion of an Omicron-specific component for a Covid-19 booster.   The committee felt that a modified vaccine would offer broader protection to match the coronavirus strains that are in circulation now. The committee was not asked to vote on what sublineage to include or whether the booster should be a monovalent vaccine or a bivalent vaccine.   Two Omicron subvariants, BA.4 and BA.5, are now dominating transmission of Covid-19 in the United States, according to the US Centers for Disease Control and Prevention. The levels of neutralizing antibodies that a previous infection or vaccinations elicit are several times lower against these subvariants compared with the original coronavirus, studies suggest. This means while the current vaccines still provide substantial protection against severe disease, these subvariants could likely lead to surges of new infections.   The FDA said Thursday that it considers this coming year to be a "transitional period." It has not advised manufacturers to change the primary vaccination for those who still haven't gotten a Covid-19 shot. The FDA said the primary series of shots created to fight the virus that first emerged in 2019 still provides a base of protection against serious Covid-19 symptoms -- even with the version of the virus that is currently in circulation.   The new formulation would instead go into a booster shot that may be introduced in the fall.