The EU Medicines Agency on Tuesday pushed the decision day for the Pfizer BioNTech coronavirus bite dramatically under pressure from Germany, so that the vaccinations in the block could begin by the end of the year.
The Amsterdam-based European Medicines Agency’s announcement that it would meet on December 21 instead of December 29 to decide whether to approve the shot followed a growing backlash from desperate EU countries.
Europe lagged behind when the UK became the first country in the world to grant emergency vaccine approval after Brexit – the former home of the EMA – followed by the US, Canada, Singapore and Bahrain.
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The EMA said in a statement that it received “additional data” from the company on Monday, which was requested by the EMA committee investigating medicines for human use.
“An extraordinary meeting of the (committee) is now scheduled for December 21st to conclude if possible,” the EMA said in a statement.
The EMA added that it will make its decision “only when the data on the quality, safety and efficacy of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.”
The agency did not announce a change to the scheduled January 12 deadline for a decision on the Moderna vaccine.
The head of the European Commission, Ursula von der Leyen, welcomed the announcement and said that vaccinations are expected to start before the end of the year.
“Every day counts – we are working at full speed to get # COVID19 vaccines safe and effective,” she said on Twitter.
“I welcome @EMA_News, who are presenting their pre-Christmas meeting to discuss the @pfizer / BioNTech vaccine. The first Europeans will likely be vaccinated before the end of 2020!”
Germany had previously put pressure on the EMA and said it wanted to approve the vaccine “before Christmas”.
“The aim is to get approval before Christmas,” said Federal Health Minister Jens Spahn at a press conference in Berlin. “We want to vaccinate in Germany before the end of the year.”
Berlin had reinforced its earlier demands from Hungary and Poland for a faster EMA.
Hungarian Prime Minister Viktor Orban told the public broadcaster on December 4th that Brexit had “enabled Great Britain to take action” and “to assert its interests”.
Then the pressure reached a summit of EU leaders last week.
Polish Prime Minister Mateusz Morawiecki said he had urged the EMA to give approval “as soon as possible”, adding that “several European leaders” had backed him.
He urged the agency to bring its decision day forward, adding, “Every day counts, every day means huge human losses, new infections, huge losses to the economy.”
Italy joined in the growing noise, and Health Minister Roberto Speranza said Tuesday he hoped the EMA “can approve the Pfizer BioNTech vaccine ahead of schedule”.
Criticism of the EMA was further fueled by a hack announced by the agency in early December that took data from both the Pfizer BioNTech and Moderna vaccines.
The agency had previously stated that the UK, United States and Canada were moving faster by approving short-term emergency use without a license, while seeking full one-year conditional licensing of the vaccine.
It insisted that staff work around the clock to examine laboratory data and results from large clinical trials as soon as they were received.
“While speed is of the essence, safety is our top priority. These vaccines are given to millions of people in the EU and we are very aware of the huge responsibility we have,” said EMA chief Emer Cooke last week towards the MPs.
However, the Irishwoman, who took over the management of the agency just a month ago, added that the aim is also to introduce the vaccine in all 27 EU countries at the same time.
“This means that all Member States, large or small, benefit from working together at EU level and that all Member States can prepare for vaccination campaigns,” she said.