Moderna wants to give FDA ‘flexibility’ in deciding eligibility for 4th Covid shot, CEO says
Moderna CEO Stephane Bancel told CNBC on Thursday the drugmaker wanted to provide U.S. regulators “flexibility” in determining eligibility for a fourth Covid vaccine dose.
Moderna submitted its application last week for a so-called second booster, asking the Food and Drug Administration to clear the additional shot for all Americans ages 18 and up.
The biotech firm’s request was considerably more broad than competing mRNA vaccine maker Pfizer, whose fourth-dose application covered only people 65 and older.
“I think we wanted to give the regulators, the FDA and regulators in other countries, the flexibility,” Bancel said an interview on “Squawk Box.” “You have people that are younger adults that have comorbidity factors, and they might need [a] sooner fourth dose to protect them.”
Underlying medical conditions such as asthma, chronic lung disease and diabetes can make people at higher risk of getting severely ill from Covid.
People who are immunocompromised already are eligible for four Covid vaccine doses. Their recommended regimen consists of three primary doses, with a booster given at least three months afterward.
Some doctors have questioned the necessity of four Covid shots for the general public in the near term. Moreover, less than half of fully vaccinated people have received their initial booster shot, Centers for Disease Control and Prevention data shows, and some experts suggest the focus should be increasing that uptake percentage.
“We submitted all the data that we have to give [the FDA] the best possible information to make the best possible decision,” Bancel said.