Pfizer and BioNTech asks EMA to authorize new boosters


LONDON –

Pfizer and BioNTech have asked the European Medicines Agency to authorize their updated coronavirus booster vaccine that includes the most recent omicron subvariants.

In a statement Friday, Pfizer said it is requesting that the EU drug regulator OK its combination COVID-19 vaccine that targets the original coronavirus and BA.4 and BA.5, the latest versions of omicron, which are causing the vast majority of infections globally now. Pfizer and BioNTech are asking that the vaccine be given the green light for people aged 12 and over.

The European Medicines Agency is currently reviewing whether to clear updated versions of vaccines made by Moderna and Pfizer that target the subvariant BA.1, an earlier version of the virus that has since been overtaken by BA.4 and BA.5; that decision is expected next week.

If both of Pfizer’s updated COVID-19 boosters are authorized, the company said its adapted vaccines would be available in Europe “as early as September.”

Last week, the UK cleared Moderna’s updated COVID-19 booster targeting the BA.1 version of omicron and said it would be included in the country’s vaccination campaign for people aged 50 and over beginning next month.

Pfizer and rival Moderna both asked US regulators this week to authorize modified versions of their booster vaccine — shots that are half the original recipe and half protection against BA.4 and BA.5.

Health authorities hope that the tweaked boosters might blunt the expected surge of COVID-19 this winter, but it’s still unclear how effective they might be. The gamble is that BA.5, or something similar, still will be circulating this the winter and that immunization with these latest vaccines will still offer significant protection.