Pfizer/BioNTech Target Fall 2020 for COVID-19 Vaccine Availability

by TVR Staff

Published May 3, 2020 | Vaccination, Future Vaccines

In recent weeks Inovio Pharmaceuticals of Pennsylvania and representatives of the German biotechnology firm CureVac AG and the University of Oxford in the United Kingdom have announced that their experimental COVID-19 vaccines will be ready for use by September 2020. On Apr. 29, 2020, Pfizer, Inc. of New York stated in a news release that it also plans to have a COVID-19 vaccine (BNT162) available by this fall.^{1 2 3 4 5 6}

Plans to Supply “Millions of Doses” by End of 2020

According to Pfizer, which is developing BNT162 in collaboration with the German pharmaceutical
BioNTech, “The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020 … and the potential to rapidly scale up the capacity to produce hundreds of millions of doses in 2021.”^{2 3 4 5}
Pfizer and BioNTech began a Phase 1 and Phase 2 clinical trial on BNT162 on Apr. 23, 2020 in Germany with a total of 12 volunteers. In a joint statement, the companies said that the “dose escalation portion of the trial will consist of about 200 volunteers between 18-55 years old. The trial will “target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine.”⁶
Pfizer and BioNTech noted that:

The study will also assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that contain uridine containing mRNA (uRNA) or nucleoside modified mRNA (modRNA). … A fourth vaccine candidate, which contains self-amplifying mRNA (saRNA) will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study.⁶

Pfizer and BioNTech plan to begin human clinical trials in the United States as soon as they receive regulatory approval by the U.S. Food and Drug Administration (FDA).^{2 3 4 5 6}

Accelerated Fall 2020 Timeframe

The accelerated fall 2020 timeframe targeted by Pfizer/BioNTech for delivering their COVID-19 vaccine, a timeframe set by Inovio, CureVac and Oxford for their new COVID-19 vaccines as well, is far less than the minimum 12-18 month timeframe estimate made by public health officials and the Coalition for Epidemic Preparedness Innovations (CEPI) of Oslo, Norway, which is funding numerous COVID-19 vaccine research programs. This has raised some concerns about the possibility of short-cuts being taken that could compromise demonstration of safety.⁷
Richard Hatchett, MD, who is the CEO of CEPI, said he understands these concerns and that he believes researchers working on COVID-19 vaccine candidates are aware that accelerated vaccine development efforts in the past “unfortunately led to bad outcomes.”⁷
“We take it with the utmost seriousness. We cannot cut corners. It’s absolutely critical that we ensure safety and efficacy,” Dr. Hatchett said.⁷

Public Concerns About Fast Tracking COVID-19 Vaccine to Market

When asked by the Financial Times about development of COVID-19 vaccines, National Vaccine Information Center (NVIC) co-founder and president Barbara Loe Fisher said, “Our organization is very concerned about fast-tracking the vaccine without proper study. We are worried that corners will be cut and the proper human and animal testes won’t be carried out.”⁸

---

Reference