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9 Dec, 2020 20:57

EU medicines regulator to use Pfizer Covid vaccine data from UK & states outside bloc in deciding approval

EU medicines regulator to use Pfizer Covid vaccine data from UK & states outside bloc in deciding approval

The European Medicines Agency (EMA) will use data from the UK and other countries on the safety of the Pfizer-BioNTech vaccine before giving it the go-ahead, after some concerns were flagged in Britain over allergic reactions.

It comes after Britain’s own drug regulator warned on Wednesday that people with a ‘significant’ history of allergic reactions should not receive the vaccine following adverse effects in two medics who were inoculated a day earlier. 

Also on rt.com Do not take Pfizer’s Covid-19 vaccine if you have a ‘significant history of allergic reactions,’ UK regulator warns

“All available information on the quality, safety and efficacy of the vaccine will be taken into account,” the EU drug regulator said on Wednesday. “This will include safety data generated from the use of the vaccine outside the EU.” 

Earlier in the day, the agency said it was subject to a cyberattack, and Pfizer-BioNTech said some of the documents it submitted as part of the approvals process had been accessed, but they were not aware of “any personal data of study participants being accessed" by hackers.

Canada’s regulator gave the vaccine the green light on Wednesday, while the US Food and Drug Administration (FDA) will meet on Thursday to discuss emergency-use authorization for the Pfizer jab. 

Also on rt.com Pfizer-BioNTech Covid vaccine documents ‘unlawfully accessed’ in cyberattack on EU medicines regulator

Ahead of its meeting, the FDA said that four participants in trials for the vaccine had developed facial paralysis, although it stressed that there is no clear evidence to link the condition to the vaccine. 

The UK, which is currently in the late stages of negotiating a post-Brexit trade deal with Brussels, was panned by both the EU and US over what critics said was its rushed approval of the Pfizer-BioNTech vaccine.

The first Britons were inoculated with the jab on Tuesday amid much fanfare from government ministers, while the Canadian public is likely to start receiving it from next week.

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