Pfizer has teamed up with BioNTech to co-develop and distribute a mRNA vaccine against COVID-19 outside of China. The partners plan to use multiple R&D sites in the U.S. and Germany to accelerate the progress of a vaccine that is due to begin clinical testing in humans by the end of April.
BioNTech and Pfizer have both referred to talks about a COVID-19 partnership in recent weeks, most recently yesterday when the German mRNA specialist issued a statement on the status of its vaccine and related deal-making. The latest advance in the partnering discussions clears BioNTech and Pfizer to immediately start working together on a vaccine against the novel SARS-CoV-2 coronavirus.
To initiate the alliance, Pfizer and BioNTech have executed a material transfer and collaboration agreement and agreed on a letter of intent covering the co-development and distribution of the vaccine, code-named BNT162, outside of China. Fosun Pharma is partnered on the vaccine in China.
The paperwork signed by BioNTech and Pfizer to date lacks details that ordinarily would be central to a co-development agreement, most notably the final financial terms of the relationship. However, with the number of COVID-19 cases rising rapidly in countries around the world, Pfizer and BioNTech have decided not to let the financial details hold up the collaboration.
Over the next few weeks, BioNTech and Pfizer will finalize the financial terms and details of how the development, manufacturing and commercialization will work. The execution of the collaboration agreement means a joint effort to push the vaccine forward will advance in parallel to those talks.
While full details of how the partnership will work are still being finalized, the broad plan is for Pfizer and BioNTech to commit resources at multiple R&D sites in the U.S. and Germany to the project. The involvement of Pfizer, a far larger company than BioNTech, could potentially unlock resources that accelerate the progress of the vaccine.
“We believe that 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,” Mikael Dolsten, Pfizer’s chief scientific officer, said in a statement.
BioNTech expects to start testing the vaccine in humans late next month and already has capacity in place to produce materials for the global clinical trial. The partnerships with Fosun and Pfizer are intended to ensure the program retains momentum right through to commercial availability.
Having a vaccine in the clinic by late April would represent a fast turnaround by historical standards. Yet, the timeline puts BioNTech well behind another of the main mRNA companies, Moderna, which began testing its vaccine in healthy volunteers this week. Both companies have benefited from mRNA vaccine platforms that are faster than conventional ways of developing prophylactic shots.
By Nick Paul Taylor
Source: Fierce Biotech
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