The United Nations has criticized the BUK government for its hastened approval of Pfizer and BionNTech’s COVID-19 vaccine on Wednesday. The EU stated that its own procedure was much more thorough. The UK is the first western country to endorse the use of a COVID19 vaccine eve though both China and Russia have also approved the use of vaccines to prevent the spread of the disease in their countries.
Many has stated this to be based on political motivation since the UK left the EU under the administration of Prime Minster Boris Johnson who has earned criticism over his handling of the coronavirus outbreak in the country.
The emergency-use authorization was made under a really fast process which allowed the British drugs regulator to temporarily authorize the vaccine only 10 days after it started examining data from large-scale trials.
The European Medicines Agency (EMA) which is in charge of approving COVID-19 vaccines for the EU in a statement said its longer approval procedure was more appropriate as it was based on more evidence and also required more checks compared to emergency procedure which is the route taken by the British government.
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According to the agency, it said it would decide by Dec. 29th on whether to provisionally authorize the vaccine from U.S. pharmaceutical company Pfizer and its German partner BioNTech.
A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.
Pfizer UK Country Manager Ben Osborn said, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”
Meanwhile the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) June Raine said “The way in which the MHRA has worked is equivalent to all international standards.
“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.
As for the EMA on the other hand, the agency began rolling out preliminary data from Pfizer trials back in October 6th with an emergency procedure aimed at speeding up a possible approval which would usually take about 7 months rom the time of reception of full data.
The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.
“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference. Jehs further added when asked about the emergency procedure used by Britain, he stated the EU countries had opted for a more thorough procedure in order to boost confidence in vaccines.
“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.
“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.
EU lawmakers were even more explicit in their criticism of Britain’s move.
“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.
“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.
Under EU rules, the Pfizer vaccine must be authorised by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use and not to forget that Britain is still subject to EU rules until it fully leaves at the end of the year.
“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.
“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”
For mroe information on the COVID-19 pandemic, please visit the CDC website for more information.