European Commission Clears Moderna Vaccine, Authorizing Second Option

The European Commission granted conditional marketing authorization for Moderna’s highly effective COVID-19 vaccine Wednesday, adding a second messenger RNA-based vaccine to its arsenal against the pandemic.

The authorization, which paves the way for Moderna’s double-shot vaccine to be rolled out in EU member states, provides 160 million additional doses of vaccine for use in European countries, said Ursula von der Leyen, the commission’s president. She added that Europe has reserved up to 2 billion doses of potential vaccines so far.

The commission’s OK came after the European Medicines Agency (EMA)’s advisory committee gave its approval for use of the vaccine in patients 18 and older early Wednesday.

“We’ll have more than enough safe and effective vaccines for protecting all Europeans,” von der Leyen said. “And more vaccines will come.”

Moderna will deliver 160 million doses to the EU between the first and third quarters of 2021, with shipments beginning next week, the drugmaker said. The company announced Monday that it estimates producing a global supply of 600 million vaccine doses in 2021, up from a previously anticipated 500 million, and said that it is continuing to work toward producing 1 billion doses this year.

The EU has secured 300 million doses of Pfizer/BioNTech’s vaccine, which was the first vaccine to be authorized in the EU (DID, Dec. 22, 2020) and is currently being administered in member states.

Compared to the Pfizer/BioNTech vaccine, which also uses two doses, Moderna’s offers significant advantages because of it is easier to ship and store. While the Pfizer vaccine must be transported on dry ice at extremely cold temperatures and can be kept for five days at refrigerator temperatures, Moderna’s can be shipped at -4 degrees Fahrenheit and can be stored in a refrigerator for up to six months.

The EMA’s executive director, Emer Cooke, said that the agency “will closely monitor data on the safety and effectiveness of the [Moderna] vaccine to ensure ongoing protection of the EU public.”

The EU authorization is the fourth for the Moderna vaccine, following authorizations in the U.S., Canada and Israel. The shot is currently under review in Singapore, Switzerland and the UK, according to the company. — James Miessler