Pfizer Inc's COVID-19 vaccine Photograph:( Reuters )
EU regulator has finally approved the coronavirus vaccine by Pfizer-BioNTech for usage in the European Union countries
EU regulator has finally approved the coronavirus vaccine by Pfizer-BioNTech for usage in the European Union countries, EMA chief reported on Monday.
In a breakthrough statement, the European Medicines Agency (EMA) chief Emer Cooke also reassured people that the existing vaccine can work against the new variant of the novel coronavirus — a claim nobody had made till now.
"At this moment there is no evidence to suggest this vaccine will not work against the new variant," Cooke said in a press conference.
"EMA's scientific opinion paves the way for the first marketing authorisation of a #COVID19vaccine in the EU with the corresponding safeguards, controls and obligations," she further said.
Thanking the efforts of numerous scientists and health experts from around the world, Cooke said, "I am delighted to announce that the EMA scientific committee met today and recommended a conditional marketing authorisation in the EU for the vaccine developed by Pfizer and BioNTech."
Emer Cooke, EMA's Exec. Director: EMA's scientific opinion paves the way for the first marketing authorisation of a #COVID19vaccine in the EU with the corresponding safeguards, controls and obligations.— EU Medicines Agency (@EMA_News) December 21, 2020
She added, "EMA’s scientific assessment is based on the strength of the scientific evidence on the vaccine’s safety, quality and efficacy, and nothing else. The evidence convincingly shows that benefits are greater than the risks of this COVID-19 vaccine."
Harald Enzmann, head of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) also revealed that the clinical trial conducted for this vaccine has been one of the biggest in the history of EMA. "The main clinical trial for this vaccine, which enrolled over 43,000 people, is one of the largest we have ever evaluated for a vaccine," he claimed.
The new decision taken by the EU regulator will cover all the 27 countries.
Cooke called it a historic moment for the world, especially the EU, as "within less than a year a vaccine will have been developed and authorised against this disease."
The decision came a few days after the European Union leader Ursula von der Leyen set a target start date of December 27-29 to vaccinate the masses in the EU. Ursula also took to Twitter to express her happiness over the decision taken by EMA. "It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!The @EMA_News just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine.Now we will act fast. I expect a @EU_Commissiondecision by this evening," she tweeted.
It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!— Ursula von der Leyen (@vonderleyen) December 21, 2020
The @EMA_News just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine.
Now we will act fast. I expect a @EU_Commission decision by this evening.
Meanwhile, BioNTech and Pfizer said they were "standing by ready" to deliver the vaccine across the continent once they receive the orders. "We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light," said the German company's co-founder Ugur Sahin.
"Today is a particularly personal and emotional day for us at BioNTech. Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic," he expressed his happiness over the EMA's approval for usage of the coronavirus vaccine in the EU.