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With the order in force – as reported by Reuters – they are the first to do so in the United States of America (USA).
The announcement of the order with the FDA (Food and Drug Administration), the US federal agency responsible for the control and supervision of the food and pharmaceutical sector, comes just days after the pharmaceutical company Pfizer and BioNTech (German biotechnology company) announced that your vaccine is 95% effective in preventing covid-19 disease, with no serious side effects, according to the results of a clinical study.
The clinical trial of the vaccine, developed since July, involved 44,000 volunteers in different countries.
The FDA has not indicated how long it will take to evaluate the data, but the US administration in charge expects the authorization to be approved in the first half of December.
Initially, and in accordance with prescribed procedures, the FDA will give emergency use authorization, a kind of conditional “green light” due to the ongoing health emergency, and likely reserved for certain groups.
“The order in the United States represents a crucial step in our search for a covid-19 vaccine for the world, and we now have a more complete picture of our vaccine’s efficacy and safety, which gives us confidence in its potential. “Pfizer executive chairman Albert Bourla said, quoted by international agencies.
“Companies will be ready to distribute the vaccine within hours of authorization,” Pfizer and BioNTech said in a joint statement.
The speed of these developments is unprecedented in vaccine history.
For example, it took an average of eight years to develop for vaccines authorized over the past decade in the United States.
The incumbent US administration, led by President Donald Trump, plans to vaccinate 20 million people in December, and then jump to 25-30 million people per month.
The US is the most affected country, both in terms of deaths and cases, with a total of 252,419 deaths out of 11,698,661 confirmed cases of new coronavirus infection, according to the most recent report from the American University Johns Hopkins.
The Pfizer / BioNTech vaccine has also been under continuous evaluation for several weeks from the European Union (EU), but also from Australia, Canada, Japan and the UK.
Europe will be able to follow quickly, taking into account the statements made on Thursday by the President of the European Commission, Ursula von der Leyen.
According to the leader of the EU executive, the European Medicines Agency (EMA) could grant a first commercial authorization to the vaccines for covid-19 developed by BioNTech and Pfizer and also by the American company Moderna (another company that has announced few days ago to have a vaccine with 94.5% effectiveness in preventing the disease) in the second half of December.
The official also assured that all vaccines “will be rigorously evaluated by the EMA before being authorized” in the EU, namely the five that the EU executive has already contracted with several pharmaceutical companies.
To date, the European Commission has signed five contracts with pharmaceutical companies to ensure vaccines for Europe when they prove effective and safe: AstraZeneca (300 million doses), Sanofi-GSK (300 million), Johnson & Johnson (200 million) and BioNTech and Pfizer (300 million) and CureVac (405 million).
“So far we have adopted five contracts […] and we are still in talks with Moderna and now we are in talks with Novavax ”, added Ursula von der Leyen.
In the same press conference, the community executive leader said EMA is in “daily contact” with the North American pharmaceutical regulator to “synchronize evaluation” of vaccines, namely those developed by BioNTech and Pfizer and Moderna.
According to a report by the French agency AFP, the covid-19 disease pandemic has already resulted in at least 1,360,914 deaths resulting from more than 56.8 million cases of infection worldwide.
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