Intern Reporter | Jin Tingfan
On July 13, local time, according to an announcement on the BioNTech official website, two mRNA vaccines against the novel coronavirus jointly developed by U.S.-based Pfizer and Germany-based BioNTech received “Fast Track” designation approval from the U.S. Food and Drug Administration (FDA).
“Fast Track” is one of the four special approval programs of the FDA, designed to facilitate the development and expedite the review of drugs or vaccines that can treat or prevent serious conditions, or address unmet medical needs. Drugs or vaccines granted “Fast Track” designation may benefit from more frequent communication with the FDA during evaluation, clinical trials, and the approval process, receive targeted guidance from the FDA, and be eligible for priority review and accelerated approval upon meeting relevant criteria.
The “Fast Track” designation means that Pfizer and BioNTech will receive more direct assistance from the FDA in their subsequent R&D efforts. Meanwhile, this also signifies that Pfizer and BioNTech are gradually catching up in the coronavirus “vaccine race,” after Moderna’s vaccine development pace slowed due to delays in its Phase III clinical trials.
Regarding the next steps in their research plan, the two companies announced that, pending regulatory approval, they expect to launch a global, large-scale Phase IIb/III clinical trial as early as later this month to evaluate the safety and efficacy of the investigational vaccine. The trial is expected to enroll up to 30,000 participants.
Regarding vaccine production, the two companies stated that once the vaccine is successfully developed and approved by regulatory authorities, they expect to produce 100 million doses by the end of 2020, with the potential to produce over 1.2 billion doses by the end of 2021.
The BNT162 program, jointly conducted by Pfizer and BioNTech, is evaluating at least four experimental COVID-19 vaccine candidates. The two most advanced candidates in this program, which have recently received “Fast Track” designation, are currently named BNT162b1 and BNT162b2. Both are mRNA-based vaccines and are currently undergoing Phase I/II clinical trials in Germany and the United States, with preliminary trial data already available.
On July 1 this year, the two companies released preliminary data from the Phase I/II clinical trials of BNT162b1 conducted in the United States on the medRxiv website, demonstrating that the vaccine exhibited favorable profiles in terms of safety, tolerability, and immunogenicity. These data are currently undergoing scientific peer review in preparation for publication. The two companies also announced that early data from clinical trials conducted in Germany would be released later this month.
In the development of COVID-19 vaccines, U.S.-based Moderna had previously garnered significant attention and once held a leading position. However, with the delay in the Phase III clinical trials of its vaccine candidate earlier this month and the latest progress made by companies such as Pfizer and BioNTech, Moderna now faces the risk of being overtaken.
In the market, Pfizer rose about 3% in pre-market trading on July 13, while BioNTech surged more than 10%. Both companies continued to climb after the market opened, with Pfizer closing at $35.21 (approximately RMB 246.33), a gain of 4.08%, and BioNTech closing at $77.78 (approximately RMB 544.14), up 10.55%.