The Pfizer and BioNTech SE vaccine known as BNT162 looks increasingly in demand as Japan’s Ministry of Health, Labor and Welfare (MHLW) recently agreed to procure in 2021.120 million doses of the investigational mRNA-based vaccine candidate targeting SARS-CoV-2, of course subject to clinical success and regulatory approval. The BioNTech and Pfizer alliance gains momentum as advanced buyers seek the investigational candidate. Could the American-German duo be on to the winning vaccine formula?
No terms, such as finances, were disclosed but the terms were based on the timing of delivery and the volume of the doses. Deliveries of the vaccine, should it be approved, commence in the first half of 2021.
A Discriminating Drug Market that is Japan
The TrialSite has suggested that the most sophisticated pharmaceutical markets in the world, North America, Europe and Japan will showcase which vaccine candidates are most in demand. Put another way, monitor which vaccine candidates countries such as the United States, the UK, Germany, Netherlands and France, not to mention Japan procure and that offers a sense of which are the superior products. Based on TrialSite principals’ extensive experience serving large pharmaceutical companies, the Japanese are highly sophisticated, conservative and mature market that don’t mind paying top dollar for quality. That the Japanese government entered into a deal with the Pfizer/BioNTech BNT162 candidate product is telling; an indicator of the growing confidence these mature buyers have in the vaccine candidate.
And, of course, this fact didn’t get past the Chief of Pfizer, Albert Bourla, commenting, “We are deeply honored to work with the Japanese government and to marshal our scientific and manufacturing resources toward our shared goal of bringing millions of doses of a potential COVID-19 vaccine to the Japanese people as quickly as possible.”
Tokyo will host the 2020 Olympics and Japan is now of course on a mission to ensure this historically important event can occur next year July 23 to August 8, 2021. These important games bring together the world’s best athletes to compete and celebrate the excellence of people and nations from around the world. That COVID-19 would get in the way of this results in an aggressive and ambitious effort to thwart the potential reality.
The BNT162 Program
Consisting of actually four mRNA-based vaccine candidates, BioNTech and Pfizer made a good move to come together to co-development, manufacture and distribute the product should it be approved by regulatory authorities. The program involves at least four experimental vaccine candidates, each of which represents a unique combination of messenger RNA (mRNA) format and target antigen reported Pfizer in a press release. With ongoing clinical trials, the candidates aren’t approved anywhere yet in the world.
However, two of the four candidates (BNT162b1 and BNT162b2) received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies that are currently ongoing in the United States and Germany in addition to animal immunogenicity studies.
The TrialSite summarized these findings based on a review of the results uploaded to medRxiv, revealing a robust immunogenic response and a promising safety profile of the novel BNT162b1 RNA-based vaccine targeting SARS-CoV-2. The promising data set supported the ongoing acceleration of development but of course there wasn’t sufficient data to make any conclusions.
An of course by July 27, Pfizer and BioNTech announced that based on a review of preclinical and clinical data from the Phase 1/2 clinical trials that FDA and other regulators approved the progression to Phase 2/3 clinical trials.
A Very Positive Outlook Should All Go According to Plan
Assuming clinical trials success presently, then the American-German duo are on track to seek regulatory review for BNT 162b2 as early as October 2020 and if regulatory authorization or approval is secured, plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
Health Equity & Access will be Key
Ensuring an equitable distribution of the vaccine, should it be approved, is of paramount concern. This requirements is demanded in rich countries where income polarization continues to grow as well as in low-to-middle income countries and regions worldwide. Hence Pfizer and BioNTech have expressed interest to possibly collaborate and supply product to the COVAX Facility, a mechanism created by GAVI, the Vaccine Alliance, the Collation for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO) that seek to provide governments, including those in low-to-middle income countries, with early access to a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by multiple manufacturers worldwide.