The UK on Tuesday created history when Margaret Keenan, a 90-year-old grandmother from Britain, became the first person in the world to receive the Pfizer Covid-19 vaccine outside of a trial. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave Pfizer authorization for emergency use at a record speed, just three weeks after Pfizer published the first data from the final stage of its clinical trial.
Hours after it gave authorization, both the European Union (EU) and the United States gave out statements saying more thorough work is needed before any kind of permission can be given. Dr Anthony Fauci, head of the US National Institute of Allergies and Infectious Diseases commented that the US regulator, the Food and Drug Administration (FDA), was proceeding in “the correct way” and the UK “did not do it as carefully”
How did Britain authorize a vaccine before the US and EU?
The US and UK adopt different strategies in vetting vaccines. US regulator FDA does not accept the findings of vaccine makers as proof. They analyze raw data from vaccine trials and summon committees of experts for advice. It will hold these meetings on December 10 and December 17 — to discuss the findings for the Pfizer and Moderna vaccines, respectively. These findings are made public and put out in the public domain. The MHRA, on the other hand, relies on analysis and findings provided by the vaccine makers. They do not undertake data analysis unless there are doubts or anomalies.
The European Medicines Agency (EMA), the agency in charge of approving medicinal products, unlike the MHRA, is in favour of granting “conditional marketing authorisation”, which is a long-term authorization that needs to be substantiated by more evidence than the kind supported by Pfizer for temporary approval.
A temporary approval means MHRA will have to approve each batch of vaccine separately. A market authorization, on the other hand, lasts for four years.
EMA is further constrained by the need for approval from all 27 EU member states. Even though the process has been accelerated, it still takes several days for all the countries to weigh in with their analysis and opinions.
Did Brexit help UK expedite the process?
Under EU law, the EMA has to authorize vaccines for use but countries can apply an emergency procedure that allows temporary distribution of vaccines in their domestic markets. Moreover, the UK is still subject to EU rules till the end of this year.
UK health minister Matt Hancock and many other Conservative Party politicians claimed on December 2 that the MHRA could rapidly approve the vaccine because of UK’s departure from the EU, but the MHRA pointed out to the emergency provision in EU’s laws as a reason for the quick approval.