Pfizer/BioNTech target April vaccine trial launch

New York-based global pharmaceutical giant Pfizer Inc is teaming up with BioNTech to rapidly develop the Mainz, Germany-based firm’s BNT162, a messenger RNA-based potential vaccine for COVID-19. The compound is expected to enter clinical testing by the end of April 2020, according to the two companies. If successful, it would prevent contraction of COVID-19 in patients not previously exposed to the SARS-Cov-2 coronavirus that causes the disease. BNT162 builds on BioNTech’s 2018 research and development collaboration with Pfizer to develop mRNA-based influenza vaccines. The method does not use neutralised virus to prompt host immune systems to develop antibodies to the live disease virus, as with traditional vaccines. Instead, mRNA from the virus is used to produce proteins in the body that are similar enough to the target virus to stimulate production of antibodies that will attack the actual virus should it appear. “By pairing Pfizer’s development, regulatory and commercial capabilities with BioNTech’s mRNA vaccine technology and expertise as one of the industry leaders, we are reinforcing our commitment to do everything we can to combat this escalating pandemic, as quickly as possible,” said Mikael Dolsten, Pfizer’s chief scientific officer and president for Worldwide Research, Development & Medical. While details of the arrangement have yet to be finalised, work on BNT162 has begun in USA and German sites operated by both firms, and the agreement calls for joint distribution of any product that results around the world outside China. BioNTech is partnering with Shanghai-based Fosun Pharma to develop and potentially distribute the vaccine in China. mRNA vaccines for COVID-19 and other diseases are in development by several firms around the world, though none have yet been approved for market distribution. If trials are successful, BNT162 could be commercially available in 12 to 18 months. Moderna says COVID-19 vaccine could be available on emergency basis by autumn In a call with investment bank Goldman Sachs on Friday, Moderna Pharmaceuticals CEO Stephen Bancel said the firm’s COVID-19 vaccine, the first to enter human trials, may be available on an emergency basis by autumn. This could include healthcare workers who are at increased risk of exposure to the SARS-Cov-2 virus that causes the disease. The plan will depend on FDA approval for this limited use, as well as demonstration of safety and efficacy in early clinical trials. The potential vaccine will not be commercially available for at least 12 to 18 months.