UK First To Authorize Pfizer/BioNTech COVID-19 Vaccine
MHRA Flexes Regulatory Muscles In Preparation For New Role
The UK has used a special legislative process to temporarily authorize the use of the BNT-162b2 vaccine, with the first 800,000 shots expected to be delivered within days.
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Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
The UK’s implementation of a new national licensing framework for biosimilars has been pushed back from the start of 2021, with the MHRA citing “intense COVID-19 activities” as the cause of an indefinite delay in the consultation process.
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