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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #34

U.K. grants Pfizer/BioNTech Emergency Use for their COVID-19 Vaccine.

In our previous report, we had wondered if the U.K. would approve Pfizer/BioNTech’s BNT162b, their COVID-19 vaccine ahead of the European Union, but we had not anticipated that the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) would do so as soon as December 2, a few days after Health Secretary Matt Hancock had authorized the agency to make a call independent of the EU.

This approval marks a historic score for Pfizer and BioNTech with a first Emergency Use Authorisation (EUA) of a COVID-19 vaccine in the western world. China and Russia have already approved their domestic vaccines but both of them did not undergo complete randomized phase 3 results. In addition of being the first COVID-19 vaccine approved, BNT162b is also the first mRNA vaccine authorised in a human use.  Pfizer CEO Albert Bourla called the U.K. decision “a historic moment” and later on: “We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world.”

At a press conference, held on December 2, BioNTech CEO Ugin Sahin said “We believe the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalised”.

During this press conference it became clear that:

• From 19mRNA vaccine programme initiation, on January 27, 2020, to formal submission for CMA in Europe, on December 1, and Emergency Use Approval in the U.K. on December 2, 2020, it took BioNTech “Lightspeed Project” circa 10 months.
• BNT162b had an efficacy of 95% in all subjects and a 94% efficacy in subjects above 65 years old from results gathered in a phase 3 study which had enrolled more than 43 000 participants.
• BNT162b had not been related to severe adverse effects.
• BNT162b activates both T and B cells, generates virus neutralizing antibodies and provides T and B cells immune memory which ensure longer-term protection against SARS-CoV-2.
• BioNTech will be the Marketing Authorisation Holder in the U.K, the U.S and in the EU, while Pfizer will market and distribute BNT162b in most countries except for Greater China, where Fosun Pharma has exclusive rights.
• BNT162b has already been delivered to dedicated storage places in the U.S., with no specific mention for the U.K.
• BNT162b is to be reviewed by a U.S. FDA Advisory Committee on December 10, 2020 and later in the month in the EU.

With soon expected to come EUAs for BNT162b in the U.S. and Europe, followed by the Moderna and then the AstraZeneca/Oxford vaccines, massive vaccination could start in the first quarter of 2021. The U.S. is planning to distribute enough vaccines to immunise 100 million people by the end of February 2021.The EU has not released any figures, but something similar could occur by the end of Q2 2021.  If these assumptions prove to be right, the U.S. could reach herd immunity in June, U.K. Canada, Japan and Europe would do so in August or September 2021.

Bernstein analysts have now figured out that the overall COVID-19 market could be as high as $38.5 billion in sales, whereas Pfizer would be in line for $14.3 billion and Moderna for $10.9 billion in 2021. The analysts predict that the market would then drop down to around $6 billion in 2025, assuming a “booster vaccination” might be needed every three years. It is feasible that this secondary “booster market” would be shared between the players already leading the pack and some of the fast followers, if their jabs are proven to be more efficacious and better tolerated.

Paris, December 3, 2020

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