Pfizer and Moderna’s Vaccines Could Get European Approval ‘Within Weeks’

The European Medicines Agency (EMA) on Tuesday received emergency vaccine clearance applications from Pfizer and Moderna and said that it could approve the highly effective coronavirus vaccines within weeks, if the data support it.

The EMA said that its Committee for Medicinal Products for Human Use (CHMP) will convene on Dec. 29 at the latest to discuss Pfizer/BioNTech’s mRNA-based vaccine, the frontrunner in the research race that was also first to file for FDA Emergency Use Authorization (EUA). The vaccine, BNT162b2, which has shown an incredible 95 percent effectiveness, is now awaiting a decision on emergency clearance in the U.S.

The agency said the CHMP will also review Moderna’s mRNA-based vaccine, mRNA-1273 — a strong candidate that demonstrated 94.1 percent efficacy (DID, Dec. 1) — in a meeting that is slated to occur by Jan. 12. Moderna is also eagerly awaiting an FDA decision on an EUA.

The EMA meetings will conclude the agency’s safety and efficacy assessments of the two vaccines and will hopefully culminate in a recommendation for conditional marketing authorization. Should that occur, the European Commission (EC) is expected to give the final go-ahead for vaccine distribution within days, according to a commission spokesperson.

“[Authorization] will hinge largely on the decision taken by the EMA. Once we’re past that … the commission will act swiftly. I think it’s going to be an issue of days. The goal is to do it rapidly,” the spokesperson said in a press briefing.

European Commission President Ursula von der Leyen said that the initial round of vaccinations could begin in Europe by the end of the year, assuming things go smoothly.

“If everything goes well, the first European citizens might already be vaccinated before the end of December, and this will be a huge step forward toward our normal life,” von der Leyen said. “There is a light at the end of the tunnel, but we still have to be disciplined until we have reached finally a vaccination that is appropriate to eradicate this virus.”

The EMA has also begun a rolling review of Johnson & Johnson’s (J&J) COVID-19 vaccine, Ad26.COV2.S. Though not nearly as far along as the Pfizer and Moderna vaccines, J&J’s late-stage global trial began a second arm testing a double-dose regimen midway through November, and early-stage trial data have shown the vaccine was well-tolerated and produced immune responses (DID, Nov. 17). — James Miessler