Pfizer Inc., and BioNTech SE have reportedly announced unitedly commencing a study on the immunogenicity and safety of a third dose of their developed COVID-19 vaccine to understand the effect of a booster on the immunity against existing as well as new variants of the coronavirus.
It has been speculated that the evaluation will draw upon participants from the Phase 1 in the U.S who will be given the opportunity to receive a 20 microgram booster of the latest vaccine within 6 to 12 months post receiving their initial two-dose specimens. Moreover, the evaluation stands to be a part of the companies’ clinical development strategy to identify the effectiveness of a 3rd dose against evolving variants.
According to official sources, the novel move could position both the companies to scale up the current vaccine quickly if the need arises for protection against COVID-19 from circulating strains. Additionally, in line with the updated guidance issued by the FDA regarding emergency use of vaccine to prevent COVID-19, the organizations are seeking to pursue authentication of future modified mRNA vaccines with a regulatory framework similar to what is has been currently developing in place for flu vaccines.
Speaking on the recent move, Chairman and CEO of Pfizer, Albert Bourla, cited that the company is undertaking numerous steps to act decisively and be well prepared in case a strain becomes resilient to the protection offered by the vaccine.
He added that Pfizer is also making crucial investments and engaging in the proper conversation with regulators to help position the company to develop and seek authorization for an updated mRNA booster or vaccine if needed.
Meanwhile, Co-Founder and CEO of BioNTech- Ugur Sahin, has mentioned that the firm’s proactive clinical development strategy aligns with the company’s mission and aims to develop the foundation of clinical trial of COVID-19 vaccines which will enable it to address the challenges of the future. He stated that BioNTech is also looking forward to evaluating a second booster in the latest specimen while also preparing for a potential rapid adoption of the vaccine.