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The European Medicines Agency (EMA) officially recommended approval of the BioNTech and Pfizer vaccine on Monday afternoon. It said the approval will apply to all persons 16 years of age and older and to all EU member states at the same time.
“This is a significant milestone in the fight against the pandemic,” Marie-Agnes Heine, head of EMA’s communications department, said in an opening statement. The EMA’s scientific opinion now paves the way for the first approval of the Covid 19 vaccine by the European Commission. The latter, meanwhile, has announced it will formally decide on the matter later today, Monday.
“Starting signal for a turnaround”
Chancellor Sebastian Kurz welcomed the approval, saying it was a “starting signal of a still challenging turnaround in the Corona pandemic.” Now a decision by the EU Commission is still pending, he said, after which distribution and the first vaccinations can begin swiftly in Austria from December 27. “Right next Sunday, the EU-wide joint vaccination start, we will also begin vaccinations in Austria.” He said today’s approval is “very positive news for all of us, especially before Christmas and at the end of this challenging year.”
In the first quarter, Austria will receive 900,000 vaccine doses from Biontech/Pfizer. In December and January, there will be 240,825 doses, followed by 331,500 in February and 375,375 in March, meaning that around 450,000 people can be vaccinated in Austria in the first quarter.
Accordingly, the EMA Committee for Medicinal Products for Human Use (CHMP) agrees that sufficient robust data on the quality, efficacy and safety of the vaccine are now available to support conditional approval. Reliability Medicines at all levels has been a top priority, said Emer Cooke, head of the European Medicines Agency: “The vaccine will be administered to millions of people in the EU, and we recognize that responsibility.”
The effectiveness of the active ingredient from German biotechnology company BioNTech and its U.S. partner Pfizer was tested in about 44,000 people aged 16 and older (including people over 75). All of them showed no signs of previous infection. The study showed a 95 percent reduction in the number of symptomatic Covid 19 cases in people who received the vaccine compared with people who received a placebo injection. Thus, the vaccine demonstrated 95 percent efficacy in the clinical trial. The high efficacy applies equally to men and women.
For the latter, the EMA (like the U.S. Food and Drug Administration before it) recommends: in the event of pregnancy, to decide in consultation with medical specialists whether to administer a vaccination. Data on expectant mothers will be collected on an ongoing basis and the EMA recommendation will be adjusted in this regard – if necessary.
The EMA expects the Pfizer and Biontech vaccine to be effective against the newly emerged coronavirus variant as well. “At this stage, there is no evidence to suggest that the vaccine may not be effective against the new variant,” EMA Director Cooke said. However, more information would need to be gathered about the new viral variant.
Benefits outweigh risks
“The side effects that occurred in the clinical trials were similar to those of other vaccines,” said Sabine Straus, chair of the EMA’s pharmacovigilance risk assessment committee. “The most common were pain at the injection site, headache, muscle aches, chills and fever. Symptoms were usually mild and lasted only a few days. Nonetheless, safety data must continue to be closely monitored.” Ultimately, she says, the benefits of the Pfizer-Biontech vaccine outweigh the risks.
They reached this milestone, Cooke says, thanks to the dedication of scientists, physicians, developers and volunteers, as well as many experts from all EU member states. “Today’s positive news is an important step forward in our fight against this pandemic that has caused suffering and hardship to so many people.”
However, EMA’s work does not stop there, he said. “We will continue to collect and analyze data on safety and efficacy – to protect the people who receive the vaccine in the EU.”
- hp, Source: diepresse.at. Picture: pixabay.com
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