FDA To Review Pfizer-BioNTech Covid-19 Vaccine On Dec. 10

The US Food and Drug Administration (FDA) will review Pfizer Inc. and BioNTech’s request for emergency use authoriziation (EUA) of their COVID-19 vaccine candidate on Dec. 10.

The meeting of the US regulator’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10, comes after Pfizer (PFE) on Nov. 22, confirmed that it submitted an application to the FDA for the emergency use of its COVID-19 vaccine. The submission is backed by final results from the Phase 3 study of the vaccine candidate, which showed it to be 95% effective against SARS-CoV-2 infection.

“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” FDA Commissioner Stephen M. Hahn commented in a statement. “A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate in order to make a decision about whether to authorize a vaccine for emergency use for the prevention of COVID-19.”

Although the VRBPAC provides advice to the agency, including advice on the safety and effectiveness data submitted in the EUA request, final decisions on whether to authorize the vaccine for emergency use are made by the FDA. Meanwhile, Pfizer and BioNTech (BNTX) expect their mRNA vaccine candidate, BNT162b2, to be granted EUA by the FDA by the middle to the end of December 2020.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Pfizer CEO Albert Bourla. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”

Pfizer and BioNTech confirmed that they have a combined manufacturing network for the supply of up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021.

Shares of Pfizer are down 1.2% on a year-to-date basis, and the stock scores a cautiously optimistic Moderate Buy analyst consensus. That’s based on 4 Buys vs 9 Holds. The average analyst price target stands at $41.31, putting the upside potential at 13% over the next 12 months.

Commenting on PFE, J.P. Morgan analyst Chris Schott, reiterated a Hold rating with a $36 price target, saying that although the progress made on the COVID-19 program has been impressive, financial implications also need to be considered.

“As we think about what this means from a commercial perspective, we expect significant sales (albeit at low margins) for BNT162 in 2021 (~$11bn) and 2022 (~$9bn) with revenues declining from there,” Schott wrote in a note to investors. “However, from a valuation standpoint, we believe PFE shares reflect something closer to our best case scenario for the vaccine ($4/share of value, ~$25bn of market value) vs our base case estimates (~$2/share, ~$10bn of value).” (See Pfizer stock analysis on TipRanks)