The U.S. regulators informed COVID-19 vaccine manufacturers Thursday that any booster shots for fall will need to include protection against the new omicron relatives.
According to the Food and Drug Administration, vaccines from the beginning would still be available for those who have not received their first series. The FDA decided that boosters for fall needed to be updated due to waning immunity and super-contagious variants of the omicron omicron virus.
The combination shots are protection against the omicron cousins BA.4 or BA.5 that were added to the original vaccine. These mutants now account for nearly half of all new U.S. illnesses.
It’s still a risky gamble because it’s impossible to predict if an omicron-related omicron will still be a threat when cold weather approaches, or if a newer mutation will replace it. The current Pfizer vaccines and Moderna vaccines offer strong protection against COVID-19’s worst outcomes, provided that people have received recommended boosters.
Scientists call this “bivalent” shots. This combination would allow boosters to keep the proven benefits of the original vaccine and increase its protection. This is a common strategy for vaccination: Flu shots can be used to protect against four strains of influenza and are adjusted annually according to what’s in circulation.
After its scientific advisors recommended earlier this week that any boosters for fall campaigns should contain some form of omicron “aEUR”, but they left it undecided if it should be the omicron mutation that caused last winter’s surge or one of its genetically distinct siblings.
Moderna and Pfizer were already brewing boosters against the first omicron mutation in preparation for an October rollout. They discovered that adding extra protection was safer than simply getting another dose of the vaccine.
Pfizer began work on a new experimental dose to target the more recent strains that the FDA had settled on.
In an email message, Jerica Pitts, a spokesperson for Pfizer, stated that they are continuing to collect data from the study on BA.4/5. She will contact you as soon as possible.
Moderna informed FDA’s advisors that switching to newer strains could delay the booster update by another month. Moderna did not immediately respond to our requests for comment on Thursday.
Although the FDA has issued an order, it doesn’t mean that these combo shots will be available in the fall. The FDA still requires manufacturers to submit key data before it decides whether modified boosters are aEUR” and then the Centers for Disease Control and Prevention would decide how they will be used.
All Americans over 5 years old are urged to get a first booster of the current vaccine. A second booster is available for those 50 years and older. Authorities believe that the protection against COVID-19 hospitalization has been reduced by omicron shots. A second booster may be able to restore this protection.
