UK didn’t scrutinize Pfizer coronavirus vaccine trial data as carefully as US FDA is, Fauci says
The UK became the first Western country to authorize a Covid-19 vaccine on Wednesday, marking a pivotal moment in the global fight against coronavirus.
The Pfizer/BioNTech vaccine has been granted emergency authorization by British regulators, and the first doses are expected to be rolled out from early next week.
Britain has been one of the countries hardest hit by the pandemic, with the highest death toll in Europe, and its government has been heavily criticized for its handling of the crisis.
But it has now leapfrogged both the European Union and the United States with this announcement.
Why was the UK first? The vaccine was granted emergency authorization in the UK by its independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), which has played a crucial part in the process.
The MHRA began a rolling review of Pfizer and BioNTech data from October, with each “package” of data reviewed as soon as it became available. This allowed regulators to examine the data in detail before a final authorization application was submitted.
According to the MHRA, a rolling review “can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible.”
This approach helped accelerate the authorization process and a formal review of all the necessary information began in the UK on November 23, leading to Wednesday’s announcement.
Read the full story:
