Pfizer Inc. and its German partner BioNTech are planning to apply for US emergency use authorization (EUA) for their COVID-19 vaccine candidate in coming days after the final results from the Phase 3 study showed it to be 95% effective against SARS-CoV-2 infection. Shares of Pfizer were up 3.4% and BioNTech jumped 7.2% in Wednesday’s pre-market session.
More specifically, Pfizer (PFE) and BioNTech said that their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints and demonstrated a vaccine efficacy rate of 95% in participants with and without prior SARS-CoV-2 infection. Efficacy was consistent across age and ethnicity demographics. The efficacy in adults over 65 years of age was over 94%. To date, the study has not reported any serious safety concerns related to the vaccine, the companies said.
In addition, Pfizer and BioNTech (BNTX) said that the safety milestone required by the US Food and Drug Administration (FDA) for EUA has been achieved. As a result, the companies will file a request within days to the FDA for an EUA. All the data collected to date will also be submitted to other regulatory agencies around the world.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Pfizer CEO Albert Bourla. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
The companies said that they expect to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer’s facilities are part of the global manufacturing and supply chain, as well as BioNTech’s German sites.
Shares of Pfizer are down 3% on a year-to-date basis, and the stock scores a cautiously optimistic Moderate Buy analyst consensus. That’s based on 4 Buys vs 8 Holds. The average analyst price target stands at $41.42, putting the upside potential at 15% over the next 12 months.
This week, JP Morgan analyst Chris Schott, reiterated a Hold rating on the stock 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 commented 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)
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