European Union criticises Britain’s ‘hasty’ approval of Pfizer-BioNTech's COVID-19 vaccine

The European Medicines Agency (EMA) on December 2 warned against UK’s “hasty” emergency authorisation of COVID-19 shot developed by Pfizer and BioNTech. British regulator MHRA has announced that the mRNA-based vaccine that showed 95% efficacy, is safe for mass roll out with immunisations in the country starting "early next week" among the high priority groups. Britain has reportedly already placed an order of 40 million doses of Pfizer-BioNTech's COVID-19 vaccine to provide the double-dose immunisation to at least 20 million people. 

However, the EMA, which is in charge of approving COVID-19 vaccines for the European Union, said that its longer procedure to approve vaccines was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by the United Kingdom. The agency reportedly said that EMA considers the conditional marketing authorisation is the “most appropriate” regulatory mechanism for use in the current pandemic emergency. On Tuesday, the European drug watchdog has said that under the procedure it would decide by December 29 whether to authorise Pfizer’s vaccine. 

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Additionally, several EU lawmakers have also criticised Britain’s decision. Peter Liese, who is an EU lawmaker and who is also a member of German Chancellor Angela Merkel’s party, reportedly said that he considers the decision to be “problematic” and recommend that EU member states do not repeat the process in the same way. He added that a few weeks of a thorough examination by the EMA is better than “hasty emergency marketing authorisation of a vaccine”. 

Further, Tiemo Wolken, who is an EU lawmaker from the socialist grouping, acknowledged the “obvious global race” to get the vaccine on the market. However, he also added that he believes that it is better to take time and make sure that the quality, effectiveness and safety of guaranteed and matches EU standards. 

READ: MHRA Says 'no Corners Cut' To Approve Pfizer's COVID-19 Vaccine, Side Effects 'very Low'

All about Pfizer-BioNTech’s COVID vaccine 

Meanwhile, Pfizer's vaccine has been demonstrated to be 95% effective against Covid 28 days after the first dose (i.e. 7 days after the second dose)

i.e. Dose 1 + 21 days + Dose 2 + 7 days -> 95% efficacy

The results were published after the conclusion of the phase 3 study which enrolled 43,661 participants. It found 170 confirmed cases of COVID-19, with 162 observed in the placebo group (those who didn't get the vaccine) versus 8 in the vaccine group.

Pfizer's storage plan is that it has 'developed specially designed, temperature-controlled thermal shippers, utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice.' Essentially, however, the vaccine in its current form needs to be stored at -70°C.

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