Pfizer Inc. (PFE - Free Report) and Germany-based biotech partner BioNTech SE (BNTX - Free Report) announced that they have concluded exploratory talks with the European Commission (EC), proposing to supply 200 million doses of their mRNA-based COVID-19 vaccine candidate BNT162b2 to its EU member states. There is also an option to supply another 100 million doses of the vaccine.
All the 27 EU member states are expected to get the vaccine upon potential approval. Pfizer/BioNTech plans to begin the delivery of the vaccine by this year-end, if approved. Both companies will now enter into contract negotiations with the EC.
In Europe, the vaccine will be produced at BioNTech’s manufacturing sites in Germany as well as at Pfizer’s manufacturing site in Belgium.
BNT162b2 is Pfizer’s selected lead coronavirus vaccine candidate, which moved to late-stage development in July. Notably, Pfizer and BioNTech expect to file regulatory applications for BNT162b2 by October. Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.3 billion doses by 2021 end.
Shares of Pfizer have declined 7.7% so far this year compared with the industry’s decrease of 1%.
In a separate press release, Pfizer and BioNTech announced encouraging data from a pre-clinical study on BNT162b2 against SARS CoV-2, the virus that causes COVID-19. Data from the study showed that immunization with the candidate in non-human primates (rhesus macaques) led to strong anti-viral effects against COVID-19 infection.
In the pre-clinical program, immunization with BNT162b2 prevented complete lung infection in 100% of the SARS-CoV-2 challenged rhesus macaques, a species of monkeys. Meanwhile, no viral RNA was detected in the lower respiratory tract of immunized and challenged animals.
This pre-clinical data combined with the clinical data announced earlier underlines the promise and validity of Pfizer and BioNTech’s mRNA-based vaccine program against the COVID-19 infection.
Pfizer/BioNTech is conducting late-stage studies on BNT162b2 in the United States and several other countries, which will include up to 30,000 participants. The event-driven study enrolled more than 25,000 participants to date.
We note that several drugmakers are working relentlessly to develop a vaccine for the deadly coronavirus disease, which infected 27.9 million people globally and killed more than 0.9 million.
Apart from Pfizer/BioNTech, COVID-19 vaccine candidates of Moderna (MRNA - Free Report) and AstraZeneca (AZN - Free Report) /Oxford University are also in late-stage development.
Earlier this week, AstraZeneca hit a roadblock when the company decided to temporarily pause its late-stage studies on its COVID-19 vaccine candidate AZD1222, which it is developing in partnership with the Oxford University after a patient in the U.K. suffered an unspecified illness.
We note that AstraZeneca’s COVID-19 vaccine candidate is viewed as the most advanced in terms of development and one of the first candidates to reach the market, if approved. The voluntary suspension may delay the timeline of the studies and subsequently, the vaccine’s approval. This could be a push for Pfizer/BioNTech as the companies can now potentially place their COVID-19 vaccine candidate as a frontrunner in terms of approval, which can reap huge profits for the company.
Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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