Pfizer, BioNTech Propose Expansion Of Phase 3 Covid-19 Vaccine Trial


Pfizer and BioNTech announced that they have proposed the expansion of the enrollment in their Phase 3 pivotal COVID-19 vaccine trial.

On September 12, Pfizer (PFE) and BioNTech revealed that they have submitted an amended protocol to the US FDA (Food and Drug Administration) to expand the enrollment in their Phase 3 COVID-19 vaccine trial to up to 44,000 participants from the initial target of 30,000.

Pfizer and BioNTech (BNTX) believe that the proposed expansion would “further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.”

Earlier this month, CNBC reported that Moderna (MRNA), one of the pharma companies in the race to develop COVID-19 vaccine, is slowing enrollment slightly in its large clinical trial to ensure sufficient representation of minorities most at risk for the COVID-19 disease.

In the latest update, Pfizer also announced that the enrollment in the trial has been proceeding as planned and it expects to reach its initial target of up to 30,000 participants next week. The company also reaffirmed that it expects a conclusive readout about the vaccine being effective or not likely by the end of October.

Pfizer and BioNTech are on track to seek regulatory review of their BNT162b2 vaccine candidate as early as October 2020 and, if regulatory authorization is obtained, then the two entities plan to supply up to 100 million doses worldwide by the end of this year and approximately 1.3 billion doses by the end of 2021.

On September 8, Mizuho Securities analyst Vamil Divan reiterated his Buy rating for Pfizer stock with a $43 price target. The analyst feels that the market isn’t giving Pfizer enough credit for its drug pipeline and that there is reason to like the stock that goes beyond the current crisis.

Speaking about Pfizer’s upcoming Investor Day, Divan said “Pfizer is evolving into a pure-play innovative biopharma company and, as such, can use this opportunity to showcase a company with a more productive R&D engine that can support the company as it approaches multiple large patent expirations.” (See PFE stock analysis on TipRanks)

The Street has a cautiously optimistic Moderate Buy consensus for Pfizer based on 5 Buys, 6 Holds and No Sells. Pfizer stock has declined about 8% so far this year. The average analyst price target of $43.13 implies an upside potential of over 19% ahead.

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