Pfizer-BioNTech File For European Covid-19 Vaccine Authorization

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Pfizer Inc. and its German partner BioNTech have filed a formal application to the European Medicines Agency (EMA) for conditional marketing authorization (CMA) of their mRNA vaccine candidate, BNT162b2, against COVID-19. Pfizer shares advanced 2.7% in Tuesday’s pre-market trading, while BioNTech declined 1%.

Pfizer (PFE) said that the submission completes the rolling review process initiated on Oct. 6, 2020 adding that if the EMA concludes that the vaccine candidate is safe and effective in protecting against COVID‑19, it could potentially enforce the use of BNT162b2 in Europe before the end of 2020. The application to the EMA comes after the two companies applied for US emergency use authorization (EUA) for their vaccine candidate with the Food and Drug Administration (FDA) on Nov. 20. The FDA is expected to review the EUA request on Dec. 10.

“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” said Pfizer CEO Albert Bourla. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”

Last month, Pfizer and BioNTech (BNTX) released clinical data, which demonstrated a vaccine efficacy rate of 95% in the Phase 3 trial in participants without prior SARS-CoV-2 infection, as well as in participants with and without prior SARS-CoV-2 infection. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. The analysis was based on 170 cases of COVID-19. In the trial, BNT162b2 also showed an overall tolerability with no safety issues reported.

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The companies stated that in addition to the recent emergency use requests in Europe and the US, they have initiated rolling submissions globally, including in Australia, Canada and Japan.

Shares of Pfizer jumped 12% over the past month, taking the year-to-date gain to 3.2%. The stock scores a cautiously optimistic Moderate Buy consensus from the Street. That’s based on 4 Buys vs 9 Holds. The average analyst price target stands at $41.31, putting the upside potential at 7.8% over the next 12 months.

Mizuho analyst Vamil Divan, who recently reiterated a Buy rating on the stock with a $44 price target, said that he expects approval and initial administration of the vaccine to high-risk individuals this month.

“The durability of the vaccine’s impact remains outstanding and can only be answered over time, but the initial efficacy appears about as good as could be expected and certainly better than investors (and scientists) had been expecting,” Divan wrote in a note to investors. “We estimate sales of ~ $875M in 2020, ~$7.25Bn in 2021 and then trending down to ~$700M-$800M annually in the outer years of our model.”

“Beyond the numbers, vaccines sales and cash should provide Pfizer with additional options in terms of investing in their business, pursuing acquisition or licensing opportunities, or returning cash to shareholders,” the analyst summed up. (See Pfizer stock analysis on TipRanks)

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