Pfizer Inc. (PFE - Free Report) and Germany-based biotech partner BioNTech SE (BNTX - Free Report) announced that they have submitted an amended protocol for their late-stage pivotal study evaluating their coronavirus vaccine candidate, BNT162b2, to the FDA for approval. Per the amended protocol, the companies are looking to increase their enrolment target for the study from 30,000 to 44,000 patients to further increase study population diversity, if approved. The companies plan to add patients as young as 16 years of age and people with chronic, stable HIV, Hepatitis C, or Hepatitis B infection. Moreover, additional patients will provide additional safety and efficacy data.
Please note that the companies remain on track to achieve their earlier enrolment target of 30,000 by the end of this month.
Although the companies are planning to enroll additional patients in their pivotal study, they continue to expect a conclusive readout on efficacy by the end of October.
Pfizer selected BNT162b2 as its lead coronavirus vaccine candidate, which moved to late-stage development in July. Data from a phase I study demonstrated that immunization with two 30μg doses of the candidate elicited 3.8 times and 1.6 times SARS-CoV-2–neutralizing geometric mean titers compared to sera of SARS-CoV-2 convalescent patients in younger and in older patients, respectively. The candidate was well tolerated.
The early-stage clinical data announced earlier underlines the promise and validity of Pfizer and BioNTech’s mRNA-based vaccine program against the COVID-19 infection.
Shares of Pfizer have declined 8% so far this year compared with the industry’s decrease of 0.2%.
Apart from Pfizer/BioNTech, COVID-19 vaccine candidates of Moderna (MRNA - Free Report) and AstraZeneca (AZN - Free Report) /Oxford University are also in late-stage development. AstraZeneca resumed its late-stage study on its COVID-19 vaccine candidate, AZD1222 this week after halting it last week. Reportedly, Moderna has slowed enrollment in its late-study on its coronavirus vaccine candidate, mRNA-1273, presumably to diversify its patient population.
Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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