Pfizer and BioNTech are looking to expand the enrollment of their Phase 3 COVID-19 vaccine trial to approximately 44,000 participants after submitting a proposal to the Food and Drug Administration on Saturday.
According to a press release, the proposed expansion would allow companies to increase the diversity of study participants, including 1
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The companies noted that the trial is expected to hit the initial enrollment target of up to 30,000 participants by next week.
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Pfizer and BioNTech reiterated that the results of the late-stage trial of their vaccine candidate may be available as early as October.
“The fundamental study is event-based and there are many variables that will ultimately impact reading times, Pfizer and BioNTech said.” As stated earlier, based on current infection rates, companies continue to expect a concluding reading on effectiveness to be likely by the end of October. “
The federal government announced in July that it had reached a $ 1.95 billion deal with Pfizer and BioNTech for at least 100 million doses after its FDA approval. Under the agreement, an additional 500 million doses can be purchased and US citizens would receive the vaccine for free.
The move came as part of the White House’s Operation Warp Speed initiative, which aims to deliver 300 million doses of a safe and effective COVID-19 vaccine by January 2021.
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The expansion announcement comes less than a week after CEOs of major coronavirus vaccine developers jointly pledged to avoid requiring FDA approval, even for emergency use, until certain safety and efficacy standards.
“We believe this commitment will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and can ultimately be approved,” the companies said in the statement.
The joint statement found that scientific evidence for regulatory approval must come from “large, high-quality clinical trials that are randomized and observer-blinded, with the expectation of appropriately designed trials with a significant number. of participants in different populations “.
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Two other candidate vaccines are in an advanced stage of testing, including one made by Moderna Inc. and another made by AstraZeneca and Oxford University.
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The AstraZeneca and Oxford vaccine resumed testing Saturday after being suspended due to safety concerns. AstraZeneca CEO Pascal Soriot said this week that, despite the hiatus, the company should still know before the end of the year whether its vaccine candidate is effective against COVID-19.
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