Here’s how the EU and the UK bicker about Covid vaccines
London approves Pfizer-Biontech's Covid vaccine, while EMA (the European Medicines Agency) takes more time to evaluate the data. Here are also institutional facts and tensions
Pfizer's vaccine will be distributed in the UK as early as next week. The UK authorities have approved the drug developed by the American Big Pharma in collaboration with the German Biontech. But the appeal to EMA for greater precaution comes from Germany.
And Ema herself replies that her approval procedure, which is longer, is more appropriate. Let's go step by step.
LONDON APPROVES PFIZER VACCINE
Great Britain, which with Brexit has left the EU regulatory umbrella for public health emergencies, has granted emergency authorization to Pfizer's anti-Covid vaccine. Also anticipating the US, it becomes the first Western country to allow mass vaccinations against Covid-19.
AN UNPRECEDENTED CAMPAIGN
The vaccine will be available from next week: an unprecedented vaccination campaign is being set in motion these days . Pfizer's vaccine will need to be stored at minus 94 degrees Fahrenheit, transported on ultra-cold dry ice and glass vials.
40 MILLION DOSES
The UK has ordered 40 million doses of the Pfizer-Biontech vaccine, which has been shown to be 95% effective in Phase 3 clinical trials , according to the company. It is not clear, however, how many doses of the drug will arrive by the end of the year.
PETER LIESE: THE EMA CURRENCY BETTER
The vaccine's approval in record time leaves Europe by surprise. And from the German Peter Liese, MEP who represents the CDU in Brussels, comes the call for caution: "I consider this decision problematic and I recommend to EU member states not to repeat the process in the same way," Liese said . "A few weeks of in-depth review by the EMA is better than a hasty authorization to put a vaccine on the market."
EVALUATIONS IN PROGRESS
In fact, any evaluations are still ongoing at the EMA. As reported by Reuters , in fact, the EMA is expected to make a decision on the approval of the vaccine of Pfizer and BioNTech by December 29th. On the vaccine developed by Moderna, however, the decision will be made by 12 January.
EMA: OUR PROCEDURE IS MORE APPROPRIATE
For the EMA, the European Medicines Agency, in fact, more time is needed to make all the necessary assessments. The Agency, in fact, replying to the London move said that its longer approval procedure is more appropriate as it is based on more evidence and required more checks than the emergency procedure chosen by Great Britain.
RASI: THAT OF GREAT BRITAIN IS A POLITICAL DECISION
Guido Rasi, former executive director of the European Medicines Agency, also criticized the speed of the United Kingdom, according to whom the approval of Pfizer's vaccine seems to have a "political" value and to be "irrelevant to EMA procedures".
"It is an emergency authorization to extend use to the general population of the batch currently available for clinical trials," Rasi told Radio Capital, adding: "Of course if you only evaluate the partial data, as they are doing, you get even a minimum of risk. Personally, I would have expected a robust review of all available data ”.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/come-bisticciano-ue-e-uk-sui-vaccini-anti-covid/ on Wed, 02 Dec 2020 15:17:57 +0000.