Germany’s BioNTech submits vaccine candidate to regulators for review

Berlin (dpa) – German biotechnology company BioNTech and its US partner Pfizer announced on Tuesday that their lead candidate for a coronavirus vaccine has been submitted to EU regulators for a rolling review, an expedited process that could lead to the drug’s approval.

This is the second potential vaccine to be submitted to the European Medicines Agency (EMA) for review, after a drug developed by the British-Swedish multinational AstraZeneca in collaboration with the University of Oxford.

BioNTech is the first German company to reach this late stage in the search for a vaccine, and was the first German company to get approval to start clinical testing in the country back in April.

The EMA’s Committee for Medicinal Products for Human Use has begun evaluating data generated in pre-clinical trials, according to a statement from BioNTech.

The Mainz-based firm has lauded its potential vaccine, dubbed BNT162b2, for yielding “encouraging preliminary results from pre-clinical and early clinical studies in adults.”

In a statement, the EMA noted that a conclusion cannot be reached yet on the vaccine’s safety and effectiveness, “as much of the evidence is still to be submitted to the committee.”

Large-scale clinical trials of the BioNTech drug, involving several thousand people, are still ongoing.

A rolling review is used by EMA during a public health emergency to speed up the assessment of a promising medicine or vaccine, according to the regulatory body.

“It is our duty to ensure that while we are working to develop a potential vaccine at unprecedented speed to help address this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles,” BioNTech chief executive Ugur Sahin said in a statement.

BioNTech’s vaccine candidate is one of about a dozen that are currently in the third phase of clinical trials worldwide, according to the World Health Organization.

Russia caused controversy in August when it announced that its “Sputnik V” coronavirus vaccine would be rolled out – before phase-3 testing had begun.

China has also already started vaccinating certain groups, such as military personnel and health workers, with drugs that have not yet completed all phases of clinical testing. Tens of thousands of people are thought to have been vaccinated in the country already.