The EU drug regulator dramatically advanced the decision day for the Pfizer-BioNTech coronavirus test on Tuesday under pressure from Germany, which means vaccinations in the bloc could begin by the end of the year.
The announcement by the European Medicines Agency in Amsterdam that it will meet on December 21 instead of December 29 to decide whether to authorize the shooting followed a growing backlash from desperate EU countries.
Europe is lagging behind as post-Brexit Britain – the former home of EMA – became the first country in the world to grant emergency approval for the vaccine, quickly followed by the United States, Canada, Singapore and Bahrain.
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The EMA said in a statement that it had received “additional data” from the company on Monday, which had been requested by the EMA committee examining medicines for human use.
“An exceptional meeting of (the committee) has now been scheduled for December 21 to conclude if possible,” the EMA said in a statement.
The EMA added that it would reach its decision “only after the data on the quality, safety and efficacy of the vaccine are robust and complete enough to determine whether the benefits of the vaccine outweigh its risks”.
The Agency did not announce any changes on the planned date of 12 January for a decision on the Moderna vaccine.
The head of the European Commission, Ursula von der Leyen, welcomed the announcement, saying it means vaccinations are likely to start before the end of the year.
“Every day counts – we are working at full speed to authorize # COVID19 vaccines that are safe and effective,” she said on Twitter.
“I welcome @EMA_News to present their meeting to discuss the @pfizer / BioNTech vaccine before Christmas. The first Europeans will probably be vaccinated before the end of 2020!”
Germany has earlier pressured the EMA, saying it wants to approve the vaccine “before Christmas”.
“The goal is to get approval before Christmas,” German Health Minister Jens Spahn told a news conference in Berlin. “We want to start vaccination in Germany before the end of the year.”
Berlin has added weight to previous calls led by Hungary and Poland for the EMA to move faster.
Hungarian Prime Minister Viktor Orban told public radio on December 4 that Brexit had made Britain “more able to take action” and “assert its interests”.
Then the pressure held a summit of EU leaders last week.
Polish Prime Minister Mateusz Morawiecki said he had asked the EMA to grant the permit “as soon as possible”, adding that “several European leaders” supported it.
He asked the agency to present its decision day, adding: “Every day counts, every day means huge human losses, new infections, huge losses for the economy.”
Italy has joined the growing crisis, Health Minister Roberto Speranza said on Tuesday that he hopes the EMA “will be able to approve the Pfizer BioNTech vaccine ahead of time”.
Criticism of the EMA was further fueled by an agency hack announced earlier in December, in which data were taken from both Pfizer-BioNTech and Moderna vaccines.
The agency previously said the reason the UK, the United States and Canada moved faster was that they approved short-term emergency use without licensing, while intending to obtain a conditional license from a year of the vaccine.
He insisted that staff work 24 hours a day to study laboratory data and the results of large-scale clinical trials as they enter.
“While speed is key, safety is our number one priority. These vaccines will be given to millions of people in the EU and we are aware of the immense responsibility we have,” EMA chief Emer Cooke told MPs last week. .
The Irishwoman, who took over the reins at the agency just a month ago, added that the aim was to ensure that the vaccine was launched in all 27 EU countries at the same time.
“This means that all Member States, large and small, will benefit from joint work at EU level and that all Member States can start preparing for vaccination campaigns,” she said.