Btobioinnovation.com

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

SPECIAL REPORT #31

BioNTech et Pfizer have submitted an emergency use authorisation for BNT162b their Covid-19 vaccine candidate

On Friday November 20, in an exclusive TIME 100 Talks, Pfizer CEO Albert Bourla announced that his company has submitted a file to the U.S. FDA requesting an emergency use authorisation (EUA) for BNT162b the COVID-19 vaccine it has co-developed with BioNTech, its German partner. Bourla indicated that BNT162b, an mRNA vaccine, was shown to be 95% effective in the overall population and in 94% in the population aged over 65 years, which makes the new mRNA platform a highly valuable one and a serious contender for future vaccines. At this stage it is worth noting that BNT162b was tested for its effectiveness in protecting against symptoms of COVID-19, and not protecting against infection with the coronavirus. In the FDA submitted file, Pfizer said that the full report involved more than 43,000 participants and found 170 cases of COVID-19 whereas 162 occurred in the placebo group and eight in the group of participants who received the two-dose vaccine. The vaccine was also protecting against severe cases: of the 10 subjects who experienced severe symptoms of COVID-19, only one had received the vaccine. In the interview with Alice Park, Bourla said that if the FDA authorises the vaccine, Pfizer will be ready “within hours” to start distributing the vaccine and that the company is on track to deliver the 50 million doses promised to the U.S. government by the end of the year, with an additional 1.3 billion doses in 2021.

When asked on how long the FDA might take to decide on the EUA request, Bourla said he would not speculate, but given the high effectiveness of the vaccine and the urgency of the pandemic, the decision should come soon. A few hours after Bourla’s interview, the U.S. FDA has set a December 10 date for the meeting of an advisory committee to discuss the request of Pfizer/BioNTech’s EUA. The FDA will make background materials available to the public 48 hours before the meeting. It is highly feasible that the advisory committee will be handling both Pfizer/BioNtech and Moderna’s (also an mRNA vaccine shown to be 94.5% effective) simultaneously on December 10. “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in the COVID-19 vaccines” said FDA Commissioner Stephen Hahn. “I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible”.

The issue of the vaccine pricing was also brought forward. Bourla stated again that Pfizer had not requested or received any money from the U.S. government and does not share the opinion of some of his colleagues to make the vaccine available for non-profit everywhere, but he said Pfizer will do so in lower-income countries through the WHO vaccine distribution coalition run by GAVI (Global Vaccine Alliance). “For developed countries we have elected to give the vaccine at a very low price, around $19.50 per dose. We believe this price allows governments all over the world to give the vaccine for free” Bourla said. “If you think about the economic value of a vaccine- I’m not speaking about the human value because there is no way to measure human life- I think the millions of jobs that will not be lost, that hopefully will come back, and the billions in economic value that a successful vaccine will enable, I think it is not appropriate to discuss if we sell it at $19.50 per dose”.  The U.S. government has already agreed to buy 100 million doses at that price. The only other company who came up with a price is Curevac, based in Germany. It had initially asked for €12 and the EU Commission, its first customer, has agreed to pay €10 ($11.84) per dose, or €2.25 billion ($2.6 billion) in total for an initial supply of 225 million doses. To the best of our knowledge the EU now has secured access to more or less the same COVID-19 vaccine developers than Operation Warp Speed (OWS) in the U.S. namely: Pfizer/BioNTech, Moderna, Johnson & Johnson, AstraZeneca/Oxford University and Sanofi/GSK. Novavax is currently the only OWS candidate that the EU has not expressed interest in dealing with.

Paris, November 21, 2020

This document has been prepared by btobioinnovation and is provided to you for information purposes only.  The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change.  btobioinnovation has no obligation to update its opinions or the information in this document.