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

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

However, EMA, which is in charge of approving COVID-19 vaccines for 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 emergency procedure chosen by United Kingdom. ncy reportedly said that EMA considers conditional marketing authorisation is “most appropriate” regulatory mechanism for use in current pandemic emergency. On Tuesday, European drug watchdog has said that under procedure it would decide by December 29 wher to authorise Pfizer’s vaccine. 

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ditionally, 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 decision to be “problematic” and recommend that EU member states do t repeat process in same way. He ded that a few weeks of a thorough examination by EMA is better than “hasty emergency marketing authorisation of a vaccine”. 

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

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All about Pfizer-BioNTech’s COVID vaccine 

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

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

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

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

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