The UK became the first country in the world to approve the coronavirus vaccine developed by Pfizer/BioNTech this week.
According to CNN, UK regulators began their formal review process on Nov. 23 — three days after Pfizer submitted data to the U.S. FDA. But because British regulators used “rolling reviews,” they were able to quickly push it past the finish line first.
The rolling review process allowed the UK to assess data from Pfizer’s late-stage trials as each set was released, starting in October. Thus, when the formal review process began, the data had already been examined in detail.
Although the EU’s regulatory agency — the European Medicines Agency (EMA) — released a statement criticizing the UK’s approach and calling it “hasty,” UK regulators have defended their process, saying that it is equivalent to other international regulatory standards.
The EMA is reportedly taking a similar rolling approach to its review of Pfizer’s vaccine candidate, which began on Oct. 6.
Meanwhile, the pressure has been on the FDA to generate an approval for the U.S. as well. FDA Commissioner Stephen Hahn recently told the Wall Street Journal that the agency has 150 employees working day and night in parallel teams to review Pfizer’s data. The FDA is scheduled to hold a committee meeting on the vaccine on Dec. 10. If approved, the first shipments of vaccines in the U.S. could begin on Dec. 15.
The Pfizer/BioNTech vaccine was approved on an emergency use basis in the UK, which has already ordered 40 million doses of the shot — enough to inoculate 20 million people.
