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EU medicines regulator approves Pfizer/BioNTech COVID-19 vaccine
Published in The Saudi Gazette on 21 - 12 - 2020

The European Medicines Agency (EMA) has recommended the use of the Pfizer-BioNTech COVID-19 vaccine in the European Union.
The authorization will pave the way for a possible start of vaccinations in Europe on Dec. 27.
After EMA scientists concluded that the vaccine is safe, officials at the Amsterdam-based agency recommended its conditional approval for it to be distributed across the 27-nation bloc.
The European Commission must still rubber-stamp the decision before the vaccine can be rolled out.
Head of the European Commission Ursula von der Leyen said the European Commission will now act fast and decide on the authorization tonight.
The pharmaceutical companies will also need to submit follow-up data on their vaccine for the next year.
In the press conference announcing the recommendation, Dr. Harald Enzmann, Chairman of the Committee for Medicinal Products for Human Use (CHMP) said the vaccine study offered an unusually large amount of data on how elderly people react to the vaccine.
More than 1,600 people over 75 took part in the study, which is highly unusual. In that group, the vaccine showed a 95 percent efficacy rate.
EMA, he said, has set the lower limit for vaccination at 16-year-olds.
Moreover, Enzmann said, there is not enough data on how pregnant women react to the vaccine. Thus, "we recommend a case by case decision" dependent on their exposure and risk, he noted. The number of pregnant women in the clinical study is "in the single digits," he added.
Moreover, he said it is still unclear whether those vaccinated may still be able to transmit the virus. Until there is more information with regards to transmission, he recommends that those who have successfully completed their vaccination to "please wear masks and keep your distance."
Sabine Straus, Chair of EMA's Safety Committee noted that more than 80,000 people have received the vaccine during the clinical study. The side effects that have been displayed are similar to those of other vaccines, such as pain at the injection site, tiredness, headache, muscle, and joint pain, or fever. Those symptoms usually last for a day.
Straus also pointed out that there have been very small numbers of allergic reactions to the vaccine. Based on these observations, people will now be closely observed for at least 15 minutes after getting the shot.
She added that generally, vaccines are only authorized if the benefits outweigh the risks, stressing that pharmaceutical companies will also have to send monthly updates about new findings. Usually, they only have to send those updates every six months.
EMA has also commissioned independent scientific studies to monitor the safety of the vaccine in its real-life application.
With regards to the newest strain of COVID-19 currently spreading across the UK and South Africa, the agency stated that this vaccine is likely to offer protection against the new variant.
The European regulator came under heavy pressure last week from countries calling for the vaccine to be granted approval for use as quickly as possible.
EMA had originally set December 29 as the date for its evaluation of the vaccine, made by Germany-based BioNTech, but moved the meeting forward after pressure from Berlin and other member states.
The EU's approval of the vaccine comes roughly three weeks after Britain, which has started administering the jab to its citizens. — Euro news

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