Europe Authorizes Pfizer/BioNTech Vaccine, With Shots to Begin After Holidays

Vaccinations using Pfizer/BioNTech’s COVID-19 vaccine are set to begin Sunday throughout Europe, following the European Commission’s landmark authorization of its first coronavirus vaccine.

The European Medicines Agency (EMA) gave its blessing for the highly effective two-dose vaccine Monday for preventing coronavirus in patients age 16 and older, and the commission was quick to issue Conditional Marketing Authorization just hours later, clearing the shot for use in all 27 EU member states. The authorization comes at a critical time during the pandemic, with the UK facing travel bans from EU nations after the UK warned of a new, more contagious strain of coronavirus that’s been identified in the country.

European Commission President Ursula von der Leyen said that the first batches of the vaccine will be shipped out from Pfizer’s Belgian manufacturing site “within the next days” to EU member countries, with vaccinations to kick off Sunday. Shipments will be made based on each country’s population and the countries themselves will decide which patients to prioritize, though the commission recommends putting healthcare and long-term facility workers and the elderly first, among other priority groups.

“We are in this together, so vaccination can start at the same time during the EU vaccination days on Dec. 27, 28 and 29,” von der Leyen said. “This is our first vaccine. More will be approved soon if they prove to be safe and effective.”

The EMA had originally set a date of Dec. 29 for its advisory panel to discuss the Pfizer vaccine but decided to move the meeting forward to Dec. 21 as regulators around the world, including the FDA, authorized the shot ahead of the European agency. According to Pfizer, more than 15 countries have either granted emergency authorization or approval for the vaccine to date.

The EU has secured 200 million doses of the vaccine with an option for 100 million more, reportedly at a price of $18.90 (€15.50) per dose, paying slightly less than the $19.50 the U.S. is being charged per dose. The U.S. government has signed a $1.95 billion deal with Pfizer that nets it 100 million initial doses and provides an option for up to half a billion additional shots, and the drugmaker is working out another 100 million dose allotment for the U.S., set for either the second or third quarter of 2021.

Von der Leyen noted that the EMA’s advisory group will issue an opinion on Moderna’s COVID-19 vaccine on Jan. 6, and the commission will likely move at the same speed in authorizing it.

Pfizer’s COVID-19 vaccine has shown 95 percent efficacy but requires ultra-cold shipping and storage temperatures and dry ice requirements that will likely pose logistical hurdles for European member states. Moderna’s vaccine, on the other hand, also boasts a nearly 95 percent effectiveness but is significantly easier to ship and store due to its more moderate temperature needs. — James Miessler