BioNTech Se (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) have announced the submission of an amended protocol to the US FDA to expand enrollment in the pivotal Phase 3 COVID-19 vaccine trial to 44,000 subjects. This allows the company to enroll in new populations.
BioNTech and Pfizer expanding enrolment in Phase 3 trial
Enrolment in the Phase 3 trials has progressed as planned, and the companies expect to hit the initial 30,000 subjects target by next week. The amendment for the proposed expansion will allow the companies to increase trail population diversity and include adolescents aged 16 years and the population with chronic stable HIV, Hepatitis C, and Hepatitis B. This will also help them to offer more efficacy and safety data.
BioNTech and Pfizer’s pivotal Phase 3 trial is an event-based study that involves many variables that will eventually impact readout timing. Based on the current infection rates, the companies are optimistic that they will have a complete and conclusive efficacy readout by the end of next month.
BioNTech receives €445 million funding
Early this week, BioNTech said that it secured around $450 million in funding from the government to accelerate the development of the COVID-19 vaccine as well as expand its capacity in Germany. The Mainz-based company, which was listed last year in the Nasdaq exchange, said that it received the funding following an application under a scheme that Research Minister Anja Karliczek announced in July.
The company will receive the money upon attaining specific clinical milestones and will use the cash to fund part of the COVID-19 vaccine program, BNT162. BioNTech’s vaccine program is among those using messenger RNA (mRNA). The co-founder and CEO of Ugur Sahin, said that the funding was important in accelerating the development of the COVID-19 program and expansion of production capacity of the vaccine in Germany. BioNTech’s funding was part of three vaccine programs that received funding from a government pot of €750 million to expand production in the country and increasing the number of subjects in late-stage clinical trials.