Pfizer Inc (PFE) and BioNTech SE (BNTX) have announced an agreement with the UK to supply 30 million doses of their BNT162 mRNA-based coronavirus vaccine candidate, currently in development. The agreement is subject to clinical success and regulatory approval for the vaccine.
Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.
“We’re harnessing our scientific expertise, and we’re marshaling our manufacturing resources to ensure that the vaccine would be available as soon as possible,” said Albert Bourla, CEO of Pfizer. “This agreement is a testament to our shared goal to have millions of doses of a vaccine against COVID-19 available before the end of the year.”
The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities.
The Pfizer/BioNTech vaccine development program is evaluating at least four experimental vaccines, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen.
On July 1, Pfizer and BioNTech announced preliminary data from BNT162b1, the most advanced of the four mRNA formulations. The early data demonstrate that BNT162b1 is able to produce neutralizing antibodies in humans at or above the levels observed in the plasma from patients who have recovered from COVID-19, and this was shown at relatively low dose levels. No serious adverse events were reported.
Recently, two of the companies’ four investigational vaccine candidates (BNT162b1 and BNT162b2) received Fast Track designation from the US Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the US and Germany as well as animal immunogenicity studies.
Further data from the ongoing Phase 1/2 clinical trials of the four vaccine candidates will enable the selection of a lead candidate and dose level for an anticipated large, global Phase 2b/3 safety and efficacy study that may begin as early as later this month, pending regulatory approval.
If the ongoing studies are successful, Pfizer and BioNTech expect to be ready to seek Conditional Marketing Authorization or some form of regulatory approval as early as October 2020.
The companies currently expect to manufacture globally up to 100 million doses by the end of 2020 and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from the clinical trial.
Shares in Pfizer are down 7.5% year-to-date, while BioNTech has exploded over 150%. Looking forward, analysts take a cautiously optimistic Moderate Buy consensus on both stocks. However, due to the recent rally, BioNTech’s average analyst price target of $60 now indicates 30% downside potential from current levels.
Mizuho Securities analyst Vamil Divan has a buy rating on Pfizer and $38 price target (5% upside potential). That’s slightly under the stock’s average analyst price target of $42 (16% upside potential).
“We had several discussions with investors today on the back of the initial data, with much of the discussion focused on the commercial potential for a successful SARS-CoV-2 vaccine” the analyst wrote.
“The company has mentioned that it will look to price a potential vaccine in line with other commercially-available vaccines, suggesting to us a potential blockbuster commercial opportunity, depending on the vaccine’s clinical profile and the ultimate competitive landscape” he told investors, after the release of ‘encouraging’ early data. (See Pfizer stock analysis on TipRanks)
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