And they’re off to the races. BioNTech (BNTX) and its partner, Pfizer (PFE), which are among those racing to bring a COVID-19 vaccine to market, announced last week that they had initiated the rolling submissions for their mRNA-based experimental COVID-19 vaccine, BNT162b2, in both Canada and the E.U.
It should be noted that BNTX and Pfizer have already inked or are close to finalizing supply agreements with the Canadian government and governmental agencies in the E.U. Details regarding the Canadian deal have yet to be provided, but the E.U. agreement could see 200 million doses supplied initially, with an option to purchase an additional 100 million doses, subject to regulatory approval.
Weighing in on this development for H.C. Wainwright, 5-star analyst Robert Burns commented, “Despite the encouraging preclinical and clinical results seen for BNT162b2 thus far, we cannot predict the vaccine's commercial potential with certainty, given the continually evolving epidemiology of COVID-19, and the rapidly changing nature of the competitive landscape.”
Also last week, the FDA released the briefing documents for its Vaccines and Related Biological Products Advisory Committee meeting that is set to take place on October 22. In these documents, the FDA outlined a list of non-binding recommendations for COVID-19 vaccine developers potentially seeking Emergency Use Authorization (EUA).
As a result, Burns argues data from the ongoing Phase 3 trials will most likely need to include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, safety data from a high proportion of enrolled subjects (over 3,000 vaccine recipients) and enough severe COVID-19 subjects to support low risk for vaccine-induced enhanced respiratory disease (a total of five or more severe COVID-19 cases in the placebo group).
All of this is on top of the previous FDA guidance, which established that the bar for any COVID-19 vaccine to be approved is prevention of disease or reduction in disease severity in at least half of the subjects who receive it, with an adjusted lower bound of greater than 30%.
Burns points out that BNTX recently filed an amended protocol to expand the enrollment of its Phase 3 pivotal COVID-19 vaccine trial to up to 44,000 participants, up from the previous target of 30,000 people.
“Given the increased enrollment, and after factoring in the two-dose schedule (day 1 and day 21), we find it highly unlikely that any interim clinical data for BNT162b2 would meet the recommended two-month follow-up by Election Day. Furthermore, the sponsor would also have to provide a detailed description of the manufacturing process and controls in a relevant Investigational New Drug (IND) application or cross-referenced master file(s) as this information becomes available, but not less than one month prior to an EUA approval submission,” Burns explained.
In accordance with all of the above, Burns stays on the sidelines. The analyst reiterated a Neutral rating, without setting a specific price target. (To watch Burns’ track record, click here)
Turning to the rest of the Street, opinions are split almost evenly. 3 Buys and 4 Holds have been published in the last three months, and thus, BNTX is a Moderate Buy. At $84.50, the average price target implies ~3% downside potential. (See BNTX stock analysis on TipRanks)
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