EU Seeks To Fast-Track Approval Process For COVID-19 Vaccine Developed By Pfizer, BioNtech

The European Medicines Agency, or EMA, said it will commence a second “rolling review” of data on a COVID-19 vaccine jointly developed by German biotech firm BioNTech (BNTX) and U.S. pharma giant Pfizer (PFE).

The EMA defines a “rolling review” as a tool it uses to “speed up the assessment of a promising medicine or vaccine during a public health emergency.”

Data will be submitted by researchers in real-time rather than when all findings are completed.

The vaccine, known as BNT162b2, will be evaluated by the EMA’s Committee for Medicinal Products for Human Use. The EMA is itself an agency within the European Union that evaluates and supervises medicinal products.

“The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies -- non-clinical data,” the EMA stated. “This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.”

The EMA suggested the assessment of the data may be fast-tracked, citing that the review process “should be shorter than a regular evaluation due to the time gained during the rolling review.”

Preliminary results from non-clinical and early clinical studies in adults suggest that the vaccine triggers the production of antibodies and T cells which target the virus, the EMA said.

The companies behind the vaccine assured that a speedy approval process will not compromise safety.

“It is our duty to ensure that while we are working to develop a vaccine at unprecedented speed to help break this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles,” said BioNTech’s co-founder, Ugur Sahin.

The EMA noted that results from ongoing large-scale clinical trials involving several thousand people will become available over the coming weeks and months. These results will offer clues on the vaccine’s effectiveness in protecting people against COVID-19.

“We are making every effort to develop a safe and effective vaccine following the guidance of regulatory agencies,” stated Peter Honig, Pfizer’s senior vice president of global regulatory affairs.

Pfizer already said it may receive emergency approval for the vaccine from the U.S. Food and Drug Administration sometime this month. Pfizer and BioNTech claimed they have capacity to manufacture 100 million doses of their vaccine this year and at least 1.3 billion doses next year.

The EU recently commenced a similar evaluation process of a COVID-19 vaccine developed by British drugmaker AstraZeneca (AZN) in collaboration with Oxford University. AstraZeneca has already agreed to supply up to 400 million doses of its vaccine in Europe by the end of the year.

In July, remdesivir, a drug developed by Gilead Sciences (GILD), was conditionally approved by the EU as a treatment for COVID-19.

Drug companies have come under political pressure to find a vaccine for an illness that has now killed more than 1 million people around the world.

In the U.S., President Donald Trump -- who recently tested positive for COVID-19 – has called for quick approvals for a vaccine. Some 210,000 people in the U.S. have died from the virus.