BioNTech is working with US pharma giant Pfizer and China’s Fosun Pharma to develop its mRNA vaccine program BNT162 for the US and Chinese markets. This program is one of three the BMBF initiative is supporting. Altogether, the researchers are eligible to receive funding of up to €750 million. Fosun holds Chinese rights to BioNTech’s mRNA program through a $135 million agreement.

Goal of the German government initiative is the expansion of vaccine development and manufacturing capabilities in the country well as the widening of the number of participants in late-stage clinical trials.

BioNTech co-founder and CEO Ugur Sahin said the state aid is helping it to provide a safe and effective vaccine as soon as possible following regulatory approval and also represents an important contribution to accelerate the development and scale-up of its vaccine manufacturing capacities.

In part, the German grant will go toward advancing the clinical evaluation and potential marketing authorization as soon as possible, the biotech said, adding that Pfizer will continue to independently fund its share of development costs for BNT162 without use of this or other government funding.

Milestones defined by BMBF include preclinical evaluation of the vaccine candidates, initiation and implementation of clinical Phase 1 and Phase 2/3 trials and the scale-up of production capacities to supply the clinical trials and the general population when the vaccine is approved. This is in addition to the submission for regulatory approval and future marketing authorization.

BioNTech said it has already achieved five of the eight defined milestones, most recently receiving approval from the German regulatory authority Paul-Ehrlich-Institut to initiate the German arm of the global Phase 2/3 trial. Patient recruitment has commenced on three continents and over 28,000 participants have already been enrolled worldwide with study sites in the US, Brazil, Argentina and Europe.

In the US, Pfiizer is spearheading Phase 3 trials with one of the joint vaccine candidates. No official data has been released from these studies, although in a presentation late last month, the US drugmaker said that most participants who had received the first or second dose experienced mild flu-like symptoms, but some reactions were more severe.

Pfizer and BioNTech, which claim to be the only partnership with end-to-end capabilities ranging from research to manufacturing to delivery, have pledged to deliver 100 million doses of a Covid-19 vaccination in 2020 and 1.3 billion in 2021.

Author: Dede Williams, Freelance Journalist