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Politicians, healthcare professionals and commentators in Europe and the United States have questioned Britain’s decision to accelerate approval of a coronavirus vaccine and have criticized what some saw as the jingoistic tone of its announcement.
On Wednesday, the UK became the first country in the world to approve a Covid-19 vaccine when the Medicines and Healthcare Products Regulatory Authority (MHRA) granted emergency authorization for Pfizer / BioNTech for clinical use.
But several countries have suggested that a longer and more comprehensive regulatory process may be preferable, arguing that more time to fully analyze the trial data will minimize risk and increase public confidence in the safety of the vaccine.
Germany’s Health Minister Jens Spahn said that while he expected a swift decision from the EU’s medical regulator, the Amsterdam-based European Medicines Agency (EMA), there was a clear difference between the approach Britain had taken. (limited emergency approval) and what Germany was looking for.
“We could have chosen that path too, but we consciously decided not to,” Spahn said. The EMA approval process, expected to be completed by the end of the month, was “more complete” and necessary “to strengthen citizens’ confidence in the vaccine,” he said, adding that a short delay between approval in the UK and the rest of Europe “was not that dramatic.”
In Spain, César Hernández, head of the department of medicines for human use at the national agency for medicines and health products, said he thought it was unlikely that other countries in Europe would follow Britain’s example.
“In a situation that, epidemiologically speaking, does not seem to be getting worse, there has to be a very large potential benefit to overcome the risk of advancing vaccination in a week or two,” Hernández told El País.
“All drug decisions are made on that basis. You can take a really big risk if you are going to see a profit that outweighs it. Similarly, you can accept a small benefit if there is no risk. But here the risk is uncertain and given that there are only two weeks left before full authorization, that risk does not seem very justified. “
In France, Bruno Lina, a virologist and member of the French government’s scientific advisory council, called Britain’s move “a political decision.” But he added that it would be “difficult to quickly organize a mass vaccination campaign. The British have taken some risk. “
He said a delay of two or three weeks “wouldn’t make a big difference. It’s better to wait a little longer to be sure that we can carry out our vaccination program in the best possible conditions. But it would be “interesting to see how Britain fares,” he said.
Another French virologist, Yazdan Yazdanpanah, told French radio: “It is not because they are starting next week that they will do better than the rest. I think we have to take the time to properly analyze all the data. “
French experts also suggested that the relatively low level of vaccinations in the UK compared to many European countries may have encouraged the government to act faster, as emergency authorization was less likely to hurt the success of the program. vaccination.
In the United States, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the way the Food and Drug Administration (FDA) was proceeding was “the right way” and the United Kingdom “did not do so as much. watch out”.
Dr. Fauci told Fox News that the FDA “really looks at the data very carefully to assure the American public that this is a safe and effective vaccine. I think if we did less, we would add to the already existing hesitation on the part of many people because … they are concerned that we have gone too fast. “- Guardian
