UK Drug Safety Group Preparing to Conduct Surveillance Study of COVID-19 Vaccines

The UK’s Drug Safety Research Unit (DSRU) is gearing up to start an active surveillance study of COVID-19 vaccines following the country’s emergency clearance of Pfizer’s highly effective coronavirus vaccine, the group announced.

The DSRU, a pharmacovigilance group independent from the government, said that its study will continuously monitor patients vaccinated with authorized COVID-19 vaccines so that effectiveness can continue to be evaluated and near-immediate action can be taken if safety incidents occur.

While the group lauded the Medicines and Healthcare products Regulatory Agency (MHRA)’s temporary emergency authorization of Pfizer’s vaccine as a “triumph for biomedical science,” it cautioned that an approval doesn’t mean the finish line has been crossed.

“Approval by medicines regulators is a milestone in the development of the vaccines, not the end of the process,” DSRU said. “While these post-authorization studies are essential for all new vaccines and medicines, they are even more important for the new COVID-19 vaccines which have been fast-tracked through the clinical trial stages of development prior to approval.”

The drug safety group didn’t specify when its surveillance study would begin, but it is likely to start not long after the first vaccinations are given in the UK next week. The unit recommended that a range of post-authorization safety studies be conducted for COVID-19 vaccines to fully understand their effects and the successfulness of the UK’s vaccination strategy.

The European Commission criticized the UK’s opting to approve the vaccine through emergency authorization rather than by conditional marketing authorization, which it said is a more strict and thorough process (DID, Dec. 3).

Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, also said the UK’s evaluation was “much less deep than … is being done by the FDA.”

“We put the data through a very, very stringent process of literally, point by point, analyzing the data. The UK has decided to do it a little bit differently. They’ve gone over it very quickly,” Fauci said.

MHRA Chief Executive June Raine has defended the regulator’s authorization, saying that it took no shortcuts and painstakingly evaluated the available data.

“It’s very clear that separate teams have been working in parallel to deliver the most rigorous review of this vaccine. No corners have been cut,” she said. “Our expert scientists and clinicians have worked ‘round the clock, carefully, methodically poring over tables and analyses and graphs on every single piece of data.” — James Miessler