Pfizer Inc. and BioNTech’s mRNA vaccine candidate, BNT162b2, against COVID-19, was found to be safe and effective, according to the latest analysis by the US Food and Drug Administration (FDA).
Specifically, the vaccine candidate’s efficacy and safety data met expectations for emergency use authorization (EUA), FDA staff concluded ahead of a Dec. 10 meeting by the US regulator’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee is expected to review Pfizer (PFE) and BioNTech’s EUA request filed on Nov. 22 and advise on whether to recommend its approval.
According to the FDA staff analysis, the COVID-19 vaccine data showed a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an emergency use authorization.”
“Available safety data from all participants enrolled through the November 14, was consistent with the safety profile for the approximately 38,000 participants with median follow-up of 2 months and also did not raise specific safety concerns,” the report stated.
This week, the UK rolled out and started to supply the mRNA vaccine after becoming the first country to approve the COVID-19 vaccine. The approval was 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.
Commenting on the FDA staff report, Mizuho Securities analyst Vamil Divan, who reiterated a Buy rating on the stock with a $44 price target, said that the initial review did not reveal any surprises.
“The Committee has previously warned against moving too quickly with an EUA, but given the vaccine’s profile, and the urgent unmet need that exists, we expect the Committee to support granting an EUA at Thursday’s meeting and believe the FDA will grant EUA within the next week or so,” Divan wrote in a note to investors. “Pfizer shares have performed well recently, but we see room for further upside on an EUA and successful vaccine rollout.” (See Pfizer stock analysis on TipRanks)
Shares of Pfizer have surged 8% over the past five days, taking the year-to-date gain to 15%. From the Street, the stock scores a cautiously optimistic Moderate Buy consensus. That’s based on 4 Buys vs 9 Holds. The average analyst price target stands at $41.46, putting the downside potential at 2.6% over the next 12 months.
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