Pfizer, Biotech Look to Expand Late-Stage COVID-19 Vaccine Trial


Pfizer and BioNTech intend to extend the enrollment of their Phase 3 COVID-19 vaccine trial to approximately 44,000 participants after the proposal was submitted to the Food and Drug Administration on Saturday.

According to a press release, the proposed expansion will help companies increase the diversity of trial participants, including teens up to 16 years old and those with chronic HIV, hepatitis C or hepatitis B infection, as well as harm. Will also provide. Additional safety and efficacy data.

The anchor Security The last Change Change %
PFE Pfizer Inc. 36.07 0.42 + 1.18%
BNTX BIONTECH 65.13 3.93 + 6.42%

The companies said it expects to reach an initial enrollment target of 30,000 participants by the next week of testing.

The CEO of PFIZER at Best-Lead Scieno said, “We will not respond until the end of” OCTOBER “on the Coronaires vaccine.

Pfizer and BioNTech reiterated that the results of a late-stage trial of their vaccine candidate may be available in early October.

“Breakthrough testing is event-based and there are many variables that will ultimately affect read-out timing, Pfizer and BioNotech said.” Based on current infection rates, as previously stated, companies expect that there is a decisive readout for efficacy. It is likely by the end of October. ”

The federal government announced in July that it had reached a $ 1.95 billion agreement with Pfizer and BioNotech for at least 100 million doses following FDA approval. Under the agreement, an additional 500 million doses could be acquired, and US citizens would receive the vaccine for free.

The move came as part of the White House’s Operation War 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 announcement of the expansion comes less than a week after the CEO of major coronavirus vaccine developers made a joint pledge to refrain from applying for FDA approval, even for emergency use, unless Some safety and efficacy standards are not met.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and ultimately approved.” ”

The joint statement stated that scientific evidence for regulatory approval “must derive from large, high-quality clinical trials that have been randomized and observer-blinded, with significant numbers of participants in diverse populations as appropriate.” Looks forward to studies designed. ”

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Two other vaccine candidates are involved in late-stage trials, one by Modern Inc. and the other by AstraZeneca and the University of Oxford.

The anchor Security The last Change Change %
AZN ASTRAZENECA PLC 53.73 0.66 + 1.24%
mRNA MODERNA INC. 59.34 1.78 + 3.09%

AstraZeneca and Oxford vaccines began testing on Saturday due to safety concerns. AstraZeneca’s chief executive, Pascal Soriot, said this week that despite the stagnation, the company should still know before the end of the year whether its vaccine is effective against candidate COVID-19.

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