UK in Final Review Stage for Pfizer’s COVID-19 Vaccine Candidate

UK regulators are reviewing the latest data on the Pfizer/BioNTech COVID-19 vaccine candidate and aim to decide on an approval “in the shortest time possible, without compromising the thoroughness of our review,” the agency’s top official said yesterday.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) could reportedly grant regulatory approval to the vaccine as soon as this week — and the country’s National Health Service has been told to be ready to start giving shots by Dec. 1.

The MHRA has been conducting a rolling view of the study as the data become available, explained June Raine, the agency’s interim chief executive. It has also sought advice from the Commission on Human Medicines, a UK government advisory group that is assessing the safety, quality and effectiveness data on all potential vaccines, she said.

The Pfizer/BioNTech messenger RNA-based vaccine has shown an efficacy rate of 95 percent in its late-stage trial, but it poses distribution challenges because it must be shipped at -94 Fahrenheit (-70 Celsius).

Pfizer declined to “speculate on the duration of the review process or possible outcome” and said it would “leave the regulators the time and space they need to do their work.”

An MHRA spokesperson confirmed to FDAnews that the review time should be “quicker than usual.”

The Pfizer/BioNTech vaccine could receive an Emergency Use Authorization from the FDA in just a few weeks, according to HHS Secretary Alex Azar (DID, Nov. 19), and initial doses of its vaccine could be deployed to high-risk populations possibly as soon as Dec. 11.

In July, the company entered into a $1.95 billion deal with the U.S. for 100 million doses initially, with an option for 500 additional doses (DID, July 23).

Pfizer last week launched a delivery and distribution pilot program for the vaccine in four U.S. states — New Mexico, Rhode Island, Tennessee and Texas — but said they will not get any special treatment when the actual distribution begins (DID, Nov. 18). — Martin Berman-Gorvine