EU health regulator reviewing Pfizer-BioNTech Covid-19 vaccine in real time

The EU health regulator has launched a real-time review of a Covid-19 vaccine developed by US drugmaker Pfizer and Germany’s BioNTech, it said on Tuesday, following a similar announcement for rival AstraZeneca’s jab last week.

The announcement by the European Medicines Agency (EMA) could speed up the process of approving a successful vaccine in the bloc, by allowing researchers to submit findings in real time, without waiting for studies to conclude.

The Pfizer and BioNTech vaccine, along with AstraZeneca’s, which is being co-developed by Oxford University, are two of the leading candidates in the race for the first jab to get regulatory approval in the West to prevent Covid-19.

Both have been in so-called “phase 3” trials in several countries for several months, typically the final stage before approval, when thousands of patients are given the shots to determine whether they are safe and effective.

The EMA said on Tuesday its human medicines committee was evaluating the first batch of data on the Pfizer vaccine, called BNT162b2, and would continue to do so until enough data is available for a final decision. (https://bit.ly/34mAHiI) The EMA has been using “rolling reviews” to speed up evaluations of promising medicines during the pandemic by studying data as they are submitted. Gilead’s remdesivir was conditionally approved as a treatment for Covid-19 patients in July following a similar review.

Pfizer and BioNTech said in a joint statement the start of the review was based on data from laboratory and animal testing, as well as early testing on humans, which suggested the vaccine produced an immune response.

“We are making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies,” said Pfizer executive Peter Honig.

Pfizer has said in the past it may have some data showing whether its vaccine is effective as soon as this month. It is being evaluated in large, late-stage studies in the United States, Brazil, South Africa and Argentina.

The two leading vaccine candidates use different technology to provoke an immune response with the hope of preventing patients from becoming infected with the novel coronavirus.

AstraZeneca’s jab uses a weakened version of a chimpanzee common cold virus, while BNT162b2 uses a chemical messenger to instruct cells to make proteins that mimic the outer surface of the coronavirus.

Pfizer and BioNTech entered final stage talks with Europe last month to supply the bloc with up to 300 million doses of their potential coronavirus vaccine. AstraZeneca has already signed a deal for up to 400 million doses of its vaccine.

Both also have deals in place to produce hundreds of millions of doses for other countries.

Other companies with vaccine candidates in late-stage trials include Moderna Inc. and Johnson & Johnson.

BioNTech’s US-listed stock was up nearly 8% before the opening bell, while Pfizer’s shares rose 1.5%.