Biopharmaceutical companies Pfizer and BioNTech have agreed to immediately co-develop and distribute (with the exception of China) a potential mRNA-based coronavirus vaccine aimed at preventing COVID-19 infection.
The commitment builds on the R&D collaboration into which the companies entered in 2018 to develop mRNA-based vaccines for the prevention of influenza.
BNT162 is expected to enter clinical testing by the end of April 2020, subject to regulatory approval as part of a global clinical development program. The vaccine candidate is the first from 'Project Lightspeed', BioNTech's accelerated development program encompassing the prevention and treatment of COVID-19 infection.
The program leverages BioNTech’s proprietary mRNA platforms for infectious diseases, its fully-owned GMP manufacturing infrastructure for mRNA vaccine production and its global clinical development capabilities, drawing on the company's broad network of global collaborators.
Pfizer and BioNTech expect to use multiple R&D sites from both companies, including in the United States and Germany, to house the activities identified by the collaboration agreement.
BioNTech additionally entered into a strategic alliance with China-based Fosun Pharma to jointly develop its COVID-19 vaccine in China. Clinical trials will be conducted in China leveraging Fosun Pharma's clinical development, regulatory and commercial capabilities, whlie BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilties in Europe.
Five-point plan to combat COVID-19
Pfizer had earlier issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to fight COVID-19. They pledged to:
- Share tools and insights. The company is committed to making vital tools available on an open source platform to the scientific community, and to sharing data and learnings with other companies to advance therapies and vaccines to patients
- Marshall people. Pfizer has created a "SWAT team" to fight the pandemic, that includes leading virologists, biologists, chemists, epidemiologists, vaccine experts and other specialists
- Apply drug development expertise. The company will share clinical development and regulatory expertise with smaller biotech companies
- Offer manufacturing capabilities. Pfizer is committed to using excess manufacturing capacity to ensure that a therapy or vaccine reaches patients' hands as quickly as possible
- Improve future rapid response. Pfizer is reaching out to federal agencies in the US to build a cross-industry rapid response team of scientists, clinicians and technicians
Vaccine development efforts are supported by the World Health Organisation (WHO), whose director-general Dr Tedros Adhanom Ghebreyesus cautioned in February at a global research and innovation forum that the availability of a vaccine could be 18 months away.