EU to Start Covid Vaccinations Two Days After Christmas
(Bloomberg) -- European authorities are pushing for a compressed approval timeline for the Covid-19 vaccine from Pfizer Inc. and BioNTech SE to start an immunization campaign across the continent just after Christmas.
European Commission President Ursula von der Leyen pointed to Dec. 27 as the date for the first vaccinations, saying in a tweet that it’s “Europe’s moment.”
The European Union is pushing for speed after national leaders have struggled to explain to residents why they’re still waiting for shots already being rolled out in the U.S. and U.K. -- a particular sore spot given that the Pfizer-BioNTech vaccine was pioneered in Germany.
On Wednesday, the European drugs agency said the key advisory committee meeting, originally planned for as late as Dec. 29, would take place Monday. Should the vaccine win the agency’s backing, the Commission is planning for a sign-off as soon as the same day, two people familiar with the process said.
“Our employees will be working over Christmas,” BioNTech Chief Executive Officer Ugur Sahin said during a conference call with German Chancellor Angela Merkel. “If we get approval from European authorities, we can begin deliveries of our vaccine soon. We’re optimistic that we can have a normal life again already by next winter.”
Approval will depend on the timing of the European Medicines Agency’s announcement and the need for the assessment to be seen as independent from political interference, an EU official said. Still, the best-case scenario would compress three levels of EU bureaucracy into as little as a single day: review by the EMA’s drugs panel, EMA acceptance of the panel’s recommendation and finally the Commission’s seal of approval.
Within Two Days
The first batches of vaccine can only be shipped after the Commission’s sign-off. The Commission signaled it would give the official go-ahead for the distribution of the Pfizer-BioNTech vaccine no later than Dec. 23.
“As soon as EMA has adopted a positive recommendation, the commission will take a decision authorizing the vaccine on the market within two days,” Stefan de Keersmaecker, health-policy spokesman at the Commission, the EU’s executive arm in Brussels, said on Wednesday. An EMA spokeswoman declined to comment further.
Unlike the U.S. and U.K., which conducted emergency authorizations, the EMA is reviewing the vaccine for a conditional marketing authorization. That process requires a higher evidence level, the EU commission’s directorate-general for health said this week.
Debate Over Timing
Debate over the timing of the approval was long and at times heated during an EU summit last week, with several leaders demanding to know why the approval process was taking so much time compared to the U.K., according to three EU officials familiar with the discussion. One of the explanations given was that several national experts had been slow in getting back to the EMA, the officials said. No specific countries were named.
The European process means shipping millions of doses throughout the continent, where countries are making their own distribution plans.
The EU has ordered up to 300 million vaccine doses on behalf of member states. It has also inked supply agreements with other front-runners including Moderna Inc., whose shot will may be cleared in the U.S. this week. The Commission on Thursday struck a preliminary agreement with Novavax Inc. for as many as 200 million doses of its experimental vaccine.
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