European Medicines Agency (EMA) and the European Commission agreed the BioNTech-Pfizer coronary virus vaccine on Monday. It means the great vaccine of around 450 million people across the EU one step closer.
Advanced EMA evaluation of the vaccine was widely expected. EU countries are currently embarking on a second wave of the virus.
The drug regulator based in Amsterdam was under pressure from European countries, including Germany, to hasten his decision, which was first recorded for 29 December
“We granted a temporary market license for the vaccine made by BioNTech and Pfizer,” European Commission President Ursula von der Leyen said in a statement, just hours after the EMA’s recommendation to approve the vaccine. “I always said through this pandemic that we are here together.”
Agreement celebrates ‘historical scientific achievement’
The EMA recommendation applies to those 16 and older, said EMA head Emer Cooke.
“It is a major step forward in our fight against this pandemic, which is causing suffering and hardship to so many people, not just in Europe but on all over the world, “she said.” This is a real scientific achievement. In less than a year, a vaccine will be developed and authorized against a new disease. “
In addition to age, limits also apply to pregnant women. With only limited data available for that group, it should be evaluated on a case – by – case basis whether it would be safe to give an injection, said Harald Enzmann, Chair of the EMA Human Medicines Committee.
“Today is particularly personal and emotional for us at BioNTech,” said Ugur Sahin, the company’s chief executive and co-founder. “Being at the heart of the EU, we are delighted to be one step closer to delivering the first vaccine in Europe to help fight this pandemic. “
What are the next steps?
German Health Minister Jens Spahn called the agreement a “milestone in fighting the pandemic.”
He said on Twitter that more than 1.3 million doses of vaccine should be given to 16 German states by the end of this year. The first to receive the vaccine in a campaign starting on December 27 will be those over the age of 80, nursing home staff and residents, as well as health care workers is at high risk of infection.
Preparations for the roll-out of the vaccine come as the identification of a new infectious strain of the coronavirus in Britain has caused chaos across the region, with countries closing travel links with the UK and disrupting free trade. Christmas days.
EMA officials told a press conference that it was very likely that the vaccine would work against the new version of the coronavirus.
“It is very likely that the vaccine will also protect against this new variant,” said Marco Cavaleri, Head of Biological Health Risk and Vaccination Strategy for EMA.
Although they acknowledge that the group had no evidence yet of the new strain, the vaccine generated antibodies that could neutralize various changes with mutations.
“At this point, we’re not too worried,” he said.
The pharmaceutical companies also have to submit follow-up data about their vaccine for the next year.
EMA said it worked around the clock but needed to make sure the the vaccine was safe and effective before consent.
Which countries have already agreed on the vaccine?
EMA diagnosis has grown after both UK and US regulators gave the vaccine the green light and began their immunization campaigns in recent weeks. The US has now agreed a second vaccine, manufactured by the pharma company Moderna.
The EMA said it would expedite its licensing decision Moderna vaccine to January 6, six days earlier than expected.
What is the BioNTech-Pfizer vaccine?
The vaccine made together by German company BioNTech and American drug giant Pfizer,
It has been proven to be 95% effective against COVID-19 in global experiments. It includes two doses sin injected three weeks apart.
Transportation can be a supply challenge, as it is it must be stored at -70 degrees Celsius (-94 degrees Fahrenheit), a temperature much lower than conventional freezers and which led the company to develop special vessels for transport.
jf, jcg / sms (dpa, AFP)