Pfizer and partner BioNTech plan to ask U.S. and European regulators within weeks to authorize a booster dose of its COVID-19 vaccine, based on evidence of greater risk of infection six months after inoculation and the spread of the highly contagious Delta variant.
The European Medicines Agency (EMA) said it was too early to determine whether more than the two shots that are currently required would be called for, saying it was confident for now that the established regimen was sufficient.
The Pfizer-BioNTech vaccine is predominant in many parts of the world. In the European Union, the Pfizer-Vaccine accounts for two-thirds of doses, and in Israel, it is the only vaccine used. In the U.S., it makes up more than half of COVID-19 vaccinations.
Some experts are skeptical about the need for a booster, even in light of the more contagious Delta variant. The Delta variant is believed to be approximately 60% more contagious than the Alpha variant, which originated in the UK, estimated to be twice as contagious as the Wuhan wildtype variant. And there are questions about Pfizer and BioNTech’s seeming conflict of interest on the subject, given their financial benefit from a third dose.
“Pfizer looks opportunistic by hanging an announcement on the back of very early and undigested data from Israel,” John Moore, a virologist at Weill Cornell Medicine in New York, told The New York Times. “When the time is right for using boosters here, the decision isn’t theirs to make.”
Another issue is whether discussing the need for boosters in the U.S. is appropriate when there are still billions worldwide who have yet to receive a single dose.