Just a day after the launch of the first Phase III study of a vaccine against the virus that causes Covid-19, two other companies have launched their own late-stage trial.
New York-based Pfizer and Mainz, Germany-based BioNTech said Monday evening that they had chosen one of their four vaccine candidates, BNT162b2, to lead their vaccine-development program and launched their Phase II/III trial of it, with the aim to enroll up to 30,000 participants.
Shares of BioNTech were up 2% in pre-market trading on the Nasdaq Tuesday morning. Shares of Pfizer were up 2.7% pre-market on the New York Stock Exchange.
The vaccine used in the Phase II/III trial is different from the one for which the companies announced preliminary data at the beginning of the month, BNT162b1. Both BNT162b1 and BNT162b2 were shortlisted as the lead vaccine candidates, with the latter being ultimately selected based on preclinical and clinical data.
“We selected BNT162b2 as our lead candidate for this Phase II/III trial upon diligent evaluation of the totality of data generated so far,” BioNTech CEO Ugur Sahin said in a statement. “This decision reflects our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated Covid-19 vaccine portfolio.”
The announcement comes just days after the companies said they had signed a deal with the defense and health and human services departments to supply 100 million doses of vaccine for $1.95 billion under the Operation Warp Speed program. The government has the option to acquire an additional 500 million.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Cambridge, Massachusetts-based Moderna said Monday that it had launched a Phase III study of its own vaccine, mRNA-1273. Like the Pfizer-BioNTech vaccines, mRNA-1273 is a messenger RNA vaccine. However, Moderna’s trial is U.S.-only, while Pfizer and BioNTech’s study is global. AstraZeneca and the University of Oxford’s AZD1222 and Sinovac’s vaccine are also in late-stage development.
Photo: Teka77, Getty Images
