Pfizer upbeat on Covid-19 vaccine candidate’s early results

As the race for a vaccine against Covid-19 continues to power ahead, multinational drugmaker Pfizer and BioNTech SE have revealed preliminary data from their “Project Lightspeed”.

The BNT162 mRNA-based vaccine programme is evaluating at least four experimental vaccines, each with a unique combination of an mRNA format and target antigen, the companies said. “Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose-dependent immunogenicity,” they said, of data that was undergoing scientific peer review that comes before publication.

A clutch of multinational companies, including AstraZeneca (AZ) — which is working with the Oxford University on a potential vaccine — Johnson & Johnson and GlaxoSmithKline are also in the fray in search of a suitable candidate. Indian vaccine major Serum Institute is in alliance with AZ on the Oxford candidate and has other candidates under development with partners Codagenix and Themis, respectively. Zydus Cadila is another early entrant from India. Last month, Panacea Biotec announced its vaccine candidate with partner Refana Inc. And this month, Bharat Biotech said it was starting human trials on its home-grown vaccine candidate in India.

According to the vaccine landscape mapped by the World Health Organisation, AZ’s candidate is ahead in Phase III trials. There are 17 vaccine candidates in clinical evaluation, including CanSino Biological Inc/Beijing Institute of Biotechnology, US-based Moderna, Wuhan Institute of Biological Products/Sinopharm and Sinovac, for instance. Another 132 candidate vaccines are in preclinical evaluation.

Pfizer trial plans

Kathrin U Jansen, Pfizer’s Senior Vice-President and Head of Vaccine Research & Development, said of their candidate: “We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings.”

The ongoing US Phase 1/2 randomised, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1, the company said. The initial part of the study included 45 healthy adults aged between 18 and 55 years. Preliminary data for BNT162b1 was evaluated for 24 subjects who received two injections of 10 µg and 30 µg; 12 subjects who received a single injection of 100 µg; and nine subjects who received two doses of placebo control, it added.

The preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select from among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial. This could involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received, they said.

The vaccine candidate is under clinical study and is not currently approved for distribution anywhere in the world. But if the trials proceed well and the candidate eventually received regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021, they added. In fact, BioNTech and Pfizer would distribute the potential vaccine worldwide (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialisation), the company said.

The vaccine development is also supported by partners like Acuitas Therapeutics, a Canadian company that provides lipid nanoparticles for the formulation of various mRNA vaccines, it said.