Pfizer-BioNTech’s Covid-19 Vaccine Wins FDA Panel Vote; Shares Rise

Shares of Pfizer and BioNTech rose in Thursday’s extended market session after an advisory panel to the US Food and Drug Administration (FDA) voted in favor of approving the emergency use of their mRNA vaccine candidate, BNT162b2, against COVID-19.

Pfizer (PFE) rose 2.8% and BioNTech gained 3.4% in after-market trading.

Specifically, the so-called Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in favor of the FDA granting Emergency Use Authorization (EUA) for the companies’ COVID-19 vaccine. Alhtough the vote is not binding, it is widely anticipated that the FDA will adopt the VRBAC’s recommendation for EUA approval in the coming days. If authorized, BNT162b2 would be the first COVID-19 vaccine available in the US. This week, the UK rolled out and started to supply the mRNA vaccine after becoming the first country to approve the COVID-19 vaccine.

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the US government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” said Pfizer CO Albert Bourla. “We are pleased with the committee’s strong majority vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

Pfizer and BioNTech (BNTX) have previously 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.

The VRBAC’s decision was based on the safety and efficacy data from an ongoing phase 3 randomized, double-blinded and placebo-controlled trial of BNT162b2 in about 44,000 participants. The Phase 3 data showed a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection and also in participants with and without prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose. No serious safety concerns related to the vaccine were reported. Efficacy was consistent across age, gender, race and ethnicity demographics.

Commenting on the FDA panel vote, J.P. Morgan analyst Cory Kasimov said that he was not surprised by the overall support or the fact that there are still many unknowns around the data.

Kasimov added that he expects the FDA emergence use authorization imminently “post the panel’s rubber stamp.”

However, the analyst stuck to his Hold rating on BNTX, as the “Bigger picture, the possibility of multiple future COVID-19 vaccines (some at potentially much cheaper prices) and the uncertain duration of pandemic leave us relatively cautious on the substantial amount of value that the market is already ascribing to BNT162b2.” (See BioNTech stock analysis on TipRanks).

Meanwhile, the rest of the Street is cautiously optimistic on the stock with a Moderate Buy analyst consensus, which is divided between 3 Buys and 4 Holds. With BNTX shares up a whopping 282% so far this year, analysts now forecast downside potential of 14% lies ahead over the coming year, setting the average price target at $111.17.