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

SPECIAL REPORT #21.1

We wish all our readers and friends a Happy and Healthy Year 2021.

COVID-19 Vaccines: Update 1

The past year has been unusual through many aspects but the emergence, in January 2020, of the SARS-CoV-2 virus and its many unforeseeable worldwide consequences has clearly been on top of the agenda of the entire biopharmaceutical industry and COVID-19 treatments will still remain their major topic in the first months of 2021.

At the start of the Year we felt it would be of more than passing interest to present a quick update of the current situation related to the availability of COVID-19 vaccines

Pfizer/BioNTech’s BNT162b or COMIRNATY has shown an efficacy of 95% across various populations. It received an Emergency Use Application (EUA) on December 3^rd in the U.K. and by the U.S. FDA on December 13 after a positive assessment by the Vaccine and Related Biological Products Advisory Committee (VRBPAC) the day before. The vaccine has also received EUAs in Canada and from the EMA on December 21 and has since received similar authorisations in Dubai, Saudi Arabia, Israël, Quatar, Oman and Kuwait. To the best of our knowledge the vaccine has not yet been fully investigated by the Japanese Health Authorities. Pfizer and BioNTech have announced that they will supply an additional 100 million doses of COMIRNATY to the 27 European Union member states, bringing the total number of doses delivered to the EU to 300 million at the end of 2021.

Moderna’s COVID-19 Vaccine  has been shown to be effective at 94% in the published Phase 3 results. The vaccine was positively reviewed by the VRBPAC and received an EUA from the U.S. FDA on December 20. For the time being, the U.S. are the only country were the Moderna vaccine is available. U.S. officials are considering giving some people half a dose of Moderna’s vaccine in order to speed up vaccination. Talks are ongoing with the U.S. FDA which has to approve the concept.

AstraZeneca/Oxford AZD 1222. The U.K. has delivered an EUA for AZD1222 on December 30, in spite of the lack of clarity on the active dose. “We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else”, said Pascal Soriot, the CEO of AstraZeneca. The U.K. has started rolling out AZD 1222 as of today.   

India has also given an EUA for AZD 1222 on January 3, 2021.

The AstraZeneca/Oxford vaccine will not be approved in the EU and the USA in the forthcoming weeks according to several sources. “They have not filed an application with us yet” said Wathion, the Deputy Executive Director of the European Medicines Authority (EMA). “Not even enough to warrant a conditional marketing licence”, he said. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply”. This made it improbable that an approval could already be granted next month”, Wathion said. In other words, the twenty first million doses available will be reserved for the sole use of U.K. citizens, a clear victory for Brexiters.

SinoPharma. A preliminary report from a clinical study performed in the United Arab Emirates had stated that the vaccine was 86% effective. SinoPharm, a subsidiary of the China National Pharmaceutical Group, has filed for a EUA, on December 20, with the Chinese Health Authorities, with results claiming a 79,4% efficacy in its Chinese trials.

Ocugen and development partner Bharat Biotech received and EUA for COVAXIN, their virion inactivated COVID-19 vaccine, from the Indian Government on January 3, 2021. The approval came with strong critics who alleged that the EUA was given despite the lack of efficacy of COVAXIN.  "On what basis was this approval given when Bharat Biotech has NOT shown enough data proving safety & efficacy?" transparency activist, Saket Gokhale, wrote on Twitter

Johnson & Johnson is believed to disclose its Phase 3 results within the next weeks and submit EUAs immediately thereafter.

Sanofi has disclosed that his experimental COVID-19 vaccine initial results from a phase 1/2 trials showed an adequate immune response in adults aged 18 to 49 years but a low immune response in older adults. The company is considering launching a phase 2b study with an optimised candidate vaccine in February 2021, using a comparison with an authorised COVID-19 vaccine. If the new jab shows the required activity in elderly patients, Sanofi expects a positive answer from regulatory authorities in the fourth quarter of 2021. To many analysts this  plan now seems highly optimistic. If several other vaccines were to be authorised in the meantime, there would be no reason to consider applying for an EUA but rather for a full BLA (Biologics Licence Application) with the associated delay in obtaining such an approval.

As of today, the U.S., the U.K. and India are the only countries where two different vaccines are already available. Except for Germany, Israël and the U.K., most countries are short of their initial immunisation plans. In the U.S. and in France the plans to distribute the jabs and vaccinate their populations “are falling far behind” according to several officials. “Israël is leading the world. They have already vaccinated 20% of their population over the age of 60, .. as if the U.S. had already vaccinated about 15 million Americans over the age of 60” said Jonathan Reiner, Professor of Medicine and Surgery at George Washington University.

An increasing number of countries, international and national institutions are considering the issuing of a COVID-19 vaccine passport. Israël plans to launch a pilot of its “green passport” program on January 5 to residents who have received a COVID-19 vaccine in order to lift some restrictions including mandatory quarantines. Travel bans could also become less restrictive for people holding a “green passport”. Nevertheless the legal issues related to such a passport are a hot debate in several countries.

Paris, January 4, 2021

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.