Within the next week, Pfizer (NYSE: PFE) And BioNTech (NASDAQ: BNTX) 30,000 participants in the Phase 2/3 clinical trial are expected to test their coronovirus vaccine, BNT162D2, to reach their goal of enrollment.
How are they planning to celebrate? By nominating another 14,000 participants.
While Pfizer and BioNotech have zoomed into the front-runner spot in the coronovirus race, they are smartly playing the tall game, realizing that safety and efficacy data in different populations will drive sales beyond patients’ initial bids Will run
On Saturday, drug makers said they submitted a proposal to the Food and Drug Administration to amend the protocol for their study, increasing enrollment to 44,000 participants.
Pfizer and BioNotech plan to use expanded anonymity to test the coronavirus vaccine in patients infected with HIV, hepatitis C, or hepatitis B virus, as well as to increase the diversity of clinical trials. The expanded population would also allow for additional evaluation of the safety and efficacy of BNT162b2.
Enrollment of additional participants will help determine if the population has a particular problem with efficacy and safety, but it should not affect the initial data readout – companies are still expected to have data by the end of October, at present Assuming infection rates hold.
Pfizer and BioNotech manage to enroll faster than their Phase 2/3 clinical trial Moderna (NASDAQ: mRNA), Which as of its latest update on Friday, enrolled 23,497 participants out of an expected 30,000 in a Phase 3 study testing its 30,000 coronovirus vaccine, mRNA-1273. Modernism has slowed enrollment to increase the diversity of participants in its clinical trials, perhaps giving it an edge in subpopulation such as Pfizer and BioNTech would like to do with its expanding population.