Pfizer PFE/BioNTech BNTX announced that it has signed a second agreement with the U.S. government for supplying its mRNA-based coronavirus vaccine, BNT162b2. The U.S. government has ordered 100 million additional doses of the vaccine, bringing total doses for the United States to 200 million.
The U.S. government had, in July, ordered 100 million doses with an option to acquire up to 500 million additional doses. This leaves the U.S. government with an option to secure an additional 400 million doses of BNT162b2 in the future.
The 200 million doses, which will allow 100 million Americans to be vaccinated, are expected to be delivered by Jul 31 to U.S. government’s Operation Warp Speed (OWS).
For the second 100 million doses, U.S. government will pay an additional $1.95 billion, same as for the first 100 million doses. These payments are expected to boost Pfizer/BioNTech’s revenues/profits for the next few quarters.
Pfizer has similar supply agreements with other governments around the world. In the EU, Pfizer/BioNTech have an agreement to supply 200 million vaccine doses to member states in 2020/2021 with the EU having an option to purchase an additional 100 million doses in 2021.
BNT162b2 is now approved for emergency/temporary/conditional use in more than 40 countries including the United States, 27 EU member countries, United Kingdom and Canada.
Pfizer’s stock is down 4.5% this year against 0.9% increase for the industry.
BioNTech’s shares are up 186.4% this year compared with the industry’s increase of 10%.
The emergency approvals were based on data from a phase III study announced last month, which showed that BNT162b2, a two-shot vaccine, was 95% effective in preventing COVID-19 after two doses were given three weeks apart. The study included more than 44,000 participants. The emergency/temporary approvals for its BNT162b2 came in less than a year since the companies started developing it, which is probably the fastest in the history of vaccines.
Other than Pfizer/BioNTech, Moderna MRNA, AstraZeneca AZN/Oxford University and J&J are the lead players in the COVID-19 vaccine development race.
Pfizer/BioNTech’s close competitor is Moderna, whosecoronavirus vaccine, mRNA-1273 has been approved for emergency use in the United States and Canada. It uses the same mRNA-based technology as Pfizer/BioNTech. The candidate achieved efficacy rate of 94.1% in primary efficacy analysis.
Meanwhile, AstraZeneca/Oxford University’s potential COVID-19 vaccine candidate, AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies. AstraZeneca has begun submission of data to regulatory authorities around the world for early approval. If the necessary approvals are obtained, it may be able to launch its vaccine early next year.
J&J’s single-dose COVID-19 vaccine candidate, JNJ-78436735 is being evaluated in the ENSEMBLE phase III study, which is now fully enrolled with approximately 45,000 participants. J&J expects to report interim efficacy data from the ENSEMBLE study by the end of January 2021. If the data are positive, J&J will file an application for EUA from the FDA in February.
While Pfizer has a Zacks Rank #3 (Hold), BioNTech has a Zacks Rank #4 (Sell).
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