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

SPECIAL REPORT #20.26

COVID Treatments (continued)

After weeks of intensive and public struggle between the White House and the the FDA over COVID-19 vaccine guidelines, the US Health agency has released its new vaccine recommendations. On October 6, instead of publishing the guidelines through the usual White House process, the FDA went an original route in releasing briefing materials to the experts of the Vaccines and Related Biological Products Advisory Committee appointed to meet on Thursday, October 22.  The committee is set to discuss pre-and post-licence clinical trials needed to further evaluate the immunogenicity and duration of effectiveness of COVID-19 vaccines. The committee will also be asked to discuss the need for post-marketing studies following full approval of a COVID-19 vaccine and the requirements for active safety follow-up after emergency uses authorisation (EUA).  For EUA the agency has now recommended phase 3 data with “a median follow-up duration of a least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine benefit-risk profile”. In the early pushing back by the Trump Administration, White House officials cited concerns raised by the biopharmaceutical industry. Former FDA commissioner Scott Gottlieb, now a Pfizer board member, said he is not aware of any such objections. Albert Bourla, Pfizer CEO also tweeted “Pfizer has never discussed US FDA’s COVID-19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.” The White House has not reacted since and current FDA commissioner Stephen Hahn said, at a medtech conference, earlier this week, that the organisation within the FDA that regulates vaccines will have the authority to “make assessment around safety, effectiveness and quality manufacturing”.

A few days after European Medicines Agency (EMA) has agreed to a rolling review of the application for AstraZeneca and the University of Oxford’s AZD1222/ChAdOx1, their COVID-19 investigational vaccine, Pfizer and BioNTech have also started a similar rolling submission for BNT162b, their mRNA COVID-19 experimental vaccine, to the EMA. The EMA uses rolling reviews to start assessing data on experimental candidates before all the evidence needed to make a final decision is available. The rolling review format provides opportunities to file additional data before the complete application. Each cycle typically requires a two-week review.  The EMA accepted BNT162b2 for rolling review on the strength of the preclinical and early clinical data on the vaccine. The trial has now enrolled 37,000 participants in various countries around the world and Pfizer and BioNTech are now having an enrolment target of 44,000 subjects far beyond the originally planned 30,000 subjects.

AstraZeneca is resuming its pivotal safety and efficacy results in Japan but the US study still remains on hold.

Vir Biotechnology and GlaxoSmithKline have reported the global expansion to phase 3 for VIR-7831/GSK4182136, their anti-SARS-CoV-2 monoclonal antibody, in the treatment of COVID-19 in high risk patients, after an initial trial raised no safety concerns. The early study enrolled 20 subjects and the COMET-ICE study will now target to enroll up to 1,300 globally in expanding sites in Europe, North and South America. The phase 3 study will assess the safety and efficacy of a single intravenous injection of VIR-7831/GSK4182136. Results are expected in January 2021. Both companies intend to start a phase 1b/2a clinical trial with VIR 7832, a second investigational SARS-CoV-2 neutralizing antibody.

Allele Biotechnology and Pharmaceuticals filed two lawsuits against Regeneron and against Pfizer and BioNtech, alleging that the three companies have developed their COVID-19 drugs using Allele’s mNeonGreen fluorescent protein without the company’s permission. Allele is seeking damages compensations through a reasonable royalty. In a statement Regeneron said it disagrees with Allele’s claims on infringement and that it will “vigorously defend our position against this lawsuit”.  Allele claims that Regeneron antibody cocktail was developed using the mNeonGreen technology, pointing to academic papers co-authored by Regeneron employees citing information on how the COVID-19 antibodies were tested with the fluorescent protein.  Fluorescent proteins are injected into living cells in order to visualise molecular changes when cells are exposed to drugs. mNeonGreen is one of the brightest and most stable monomeric florescent proteins available and allows for rapid and accurate detection of changes, according to Allele. 

Pfizer has not responded immediately to the infringement claim.

Paris, October 7, 2021

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