[News] European Medicines Agency (EMA) approves Pfizer / BioNTech vaccine against COVID-19

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The European Medicines Agency (EMA) announced on Monday that it approved the Pfizer / BioNTech vaccine against the coronavirus and further stated that "there is no evidence" that this antidote is ineffective against the new strain of coronavirus detected in the United Kingdom.

"I am pleased to announce that the EMA scientific committee met today and was in favor of a conditional marketing authorization in the European Union (EU) for the vaccine developed by Pfizer and BioNTech," stated EMA CEO Emer Cooke, at an online press conference.

The EMA's decision opens the way for vaccination campaigns in the EU in the coming days.

The EMA's Committee for Medicinal Products for Human Use (CHMP), based in Amsterdam, brought forward the meeting initially scheduled for December 29 by one week, under pressure from Germany and other countries, who wanted to see make a decision quickly.

"It is an important step in the fight against this pandemic, which is causing so much suffering and hardship," Cooke said.
"This is really a historic scientific achievement, in less than a year a vaccine against this disease has been developed and licensed," she said.

In addition, Cooke added that so far there is no evidence that the Pfizer / BioNTech vaccine is ineffective against the new strain of coronavirus detected in the United Kingdom and that, according to the British government, it could be up to 70% more contagious.

"At the moment, there is no evidence to indicate that this vaccine will not work against the new strain" of coronavirus, said the official.

Countries such as the United States, the United Kingdom, Canada, Mexico, Costa Rica, Ecuador, Saudi Arabia, Israel, Singapore and Switzerland are part of the fifteen states that have already authorized the Pfizer-BioNTech vaccine, giving the starting signal to the campaigns vaccination.

According to the European Commission, the EU Member States plan to start the vaccination campaign on December 27.

 

95% efficient
The EMA originally planned to make a decision on Moderna's competitor vaccine on January 12, but has also brought it forward a week, as it has done with Pfizer-BioNTech's.

The vaccine developed by the American giant Pfizer and the German company BioNTech has shown an efficacy of 95% in international clinical trials in which two doses have been administered three weeks apart.

The regulator conducted a "continuous review" of the data from laboratory analysis and clinical trials as they arrived. In normal time, the agency only examines the data once it has been fully collected.

Pfizer-BioNTech submitted a request for authorization on December 1, and the EMA responded that it would make its decision on December 29 during an expert meeting.

But the United Kingdom, the United States and Canada gave their green light in an emergency procedure, which has allowed the vaccination campaigns to start earlier.

Several States had complained about the slowness in making a decision. The leaders of Poland and Hungary urged acceleration during the last European summit last week, seconded by Berlin.

The European regulator also suffered a cyber attack in which data on Pfizer / BioNTech and Moderna was stolen, although it has not had any impact on the calendar, according to the EMA.

Following the green light from the EMA, the European Commission is expected to quickly approve the decision to start vaccination throughout the European Union, where some 450 million inhabitants live.

The EU ensures that it has established a coordinated vaccination program in the 27 member countries to allow fair access to the doses of the vaccine.