Pfizer, BioNTech Vaccine to Get Rolling Data Review in Europe

Thursday, 08 Oct, 2020

The World Health Organisation (WHO) has offered hope that a Covid-19 vaccine may be available by the end of the year.

Called a "rolling review", the review will allow the European Medicines Agency (EMA) to look at how the vaccine is performing in real time as data emerges from patient trials, instead of waiting for the drugmakers to submit everything at once.

Data will be submitted by researchers in real-time rather than when all findings are completed. No medicinal product can go onto the Swiss market without Swissmedic's approval.

Swiss drug authority Swissmedic has begun evaluating the so-called "Covid-19 Vaccine AstraZeneca". BioNTech and Pfizer have linked BNT162b2, which encodes a SARS-CoV-2 spike glycoprotein, to antibody and T-cell responses in people dosed in early-phase trials.

"Potentially through this emergency use listing the quality and safety of these vaccines and efficacy could be assessed.and then this could be made available for our licensees", Escalante said.

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Despite this, Escalante said that China and Russian Federation are conducting their own clinical trials on potential vaccines, suggesting the medicine may be commercially available at an earlier time if the two countries become successful. The pressing need for COVID-19 vaccines potentially makes the mechanism important to the current crisis. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the investigational medicine or vaccine should be authorized. AstraZeneca has already signed a deal for up to 400 million doses of its vaccine.

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

Over 35 million people around the world have tested positive for COVID-19 and more than 1 million have died, according to the Johns Hopkins University tracker.

US President Donald Trump's administration has strongly criticised the WHO's role in the crisis, accusing it of being too close to China and not doing enough to question Beijing's actions late previous year when the virus first emerged in Wuhan.