Pfizer Expected to File FDA EUA Application for COVID-19 Vaccine Today

Pfizer plans to submit an application to the FDA for the emergency use of its COVID-19 vaccine today, according to Health and Human Services Secretary Alex Azar. An Emergency Use Authorization (EUA) filing from Moderna is expected to come shortly after.

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“Pfizer’s (PFE) partner, BioNTech, has announced that tomorrow they intend to file for emergency use authorization at the FDA… We would expect Moderna filing soon also,” Azar noted during a White House coronavirus task force meeting.

Earlier in the week, Pfizer stated that it would submit an application to the FDA “within days” after a final data analysis determined that its vaccine candidate was 95% effective in preventing COVID-19 and had a robust safety profile.

The announcement from Pfizer came only two days after Moderna announced its COVID-19 vaccine was over 94% effective, based on data from the Phase 3 trial.

Both vaccines were developed using messenger RNA (mRNA), with the approach designed to mimic the SARS-CoV-2 virus itself. The vaccine mRNA codes for only the critical fragment of the viral protein, allowing the immune system to develop antibodies against the virus.

Azar previously said that 40 million doses will be available by the end of the year between the two companies, enough for about 20 million people.

Shares of Pfizer have decline 3% so far in 2020, but Wall Street is cautiously optimistic. 4 Buy ratings and 9 Holds result in a Moderate Buy analyst consensus for PFE. With an average price target of $41.31, the upside potential lands at 14%. (See PFE stock analysis on TipRanks)

Yesterday, Goldman Sachs analyst Terence Flynn reinstated coverage of Pfizer with a Hold rating and $40 price target, implying 11% upside potential. He argues that the valuation is fair given the “various puts and takes” of a vaccine and its focus on the pipeline long-term.