Europe Starts Real-time Review of Pfizer-BioNTech COVID-19 Vaccine - COVID-19 Clinical Trial
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Europe Starts Real-time Review of Pfizer-BioNTech COVID-19 Vaccine

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. 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 GILD.O remdesivir was conditionally approved as a treatment for COVID-19 patients in July following a similar review.


Pfizer, BioNTech, Regeneron Hit With Patent Lawsuits Over COVID-19 Drugs And Vaccines

Three top names in the fight against the coronavirus and the COVID-19 disease that can result from it have been sued for patent infringement. The trio includes Regeneron Pharmaceuticals , Pfizer , and BioNTech. The plaintiff is privately held Allele Biotechnology and Pharmaceuticals. Allele alleges that the three all used its mNeonGreen fluorescent protein to develop their COVID-19 products without paying royalties for the substance. Medical researchers inject fluorescent proteins into cells to track reactions within those bodies. This tracking is used to help determine the effect of medicines and vaccines on the body.

Regeneron is currently developing REGN-COV2, an experimental cocktail of two antibodies to treat COVID-19. The company became a hot topic last week when it was revealed President Donald Trump was administered REGN-COV2 as part of his treatment for COVID-19. Pfizer and BioNTech have teamed up to develop a coronavirus vaccine; their candidate, BNT162b2, is considered one of the front-runners in the race to bring a vaccine to market.

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