Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech ( BNTX Quick Quote BNTX - Free Report) announced that the European Commission has granted conditional marketing authorization (CMA) to their mRNA-based coronavirus vaccine candidate, BNT162b2, making it the first COVID-19 vaccine to be approved in Europe. BNT162b2 will be marketed by the trade name of Comirnaty in 27 EU member states for people 16 years of age and older. The companies will initiate delivery of the first vaccine doses immediately across Europe.
The authorization came the same day the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending CMA of the vaccine. Pfizer/BioNTech had filed the CMA on Dec 1. A CMA allows companies to seek approval for medicines/vaccines that fulfil an unmet medical need based on less complete data than needed. Pfizer/BioNTech had initiated a rolling submission for the vaccine in October. The formal CMA submission completed the rolling review process.
Pfizer/BioNTech already have an agreement to supply 200 million vaccine doses to EU member states in 2020/2021 with the EU having an option to purchase an additional 100 million doses in 2021. The vaccine doses will be manufactured at BioNTech's manufacturing facilities in Germany and at a Pfizer site in Belgium.
BNT162b2 was granted emergency use authorization (EUA) by the FDA on Dec 11. With the approval in EU, the vaccine is now approved for emergency/temporary use in more than 40 countries including United Kingdom, Bahrain, Mexico, Singapore, Switzerland and Canada.
Pfizer’s stock is down 4.9% this year against 3% increase for the
BioNTech’s shares are up 214.3% this year compared with the
industry’s increase of 9.8%.
The emergency approvals are 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.
However, a new and highly infectious strain of COVID-19 has been identified in the United Kingdom, leading to an emergency lockdown in the country. Meanwhile, there is no proof that the COVID-19 vaccines will work against the new variant of the coronavirus.
Also, a few cases of allergic reactions to Pfizer/BioNTech’s vaccine have been reported in the United Kingdom and the United States in people who received the first shot of the vaccine.
Other than Pfizer/BioNTech,
Moderna ( MRNA Quick Quote MRNA - Free Report) , AstraZeneca ( AZN Quick Quote AZN - Free Report) /Oxford University and J&J are the lead players in the COVID-19 vaccine development race.
Pfizer/BioNTech’s close competitor is Moderna, which has also applied for emergency use in the EU for its coronavirus vaccine candidate, mRNA-1273. It uses the same mRNA-based technology as Pfizer/BioNTech. Moderna’s candidate was granted EUA by the FDA last week. 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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