BioPharma

Pfizer, BioNTech dose first U.S. patients in Covid-19 vaccine trial

The Phase I/II study dosed its first cohort in Germany last week. The trial is enrolling 7,600 participants who will be randomized to receive one of four vaccine candidates or placebo.

The entrance to a Pfizer office in Cambridge, Massachusetts

Another potential vaccine against the virus that causes Covid-19 hit the clinic in the U.S. Tuesday as the companies sponsoring its development gave the first Stateside shots in their clinical trial.

New York-based Pfizer and Mainz, Germany-based BioNTech said they had dosed the first American participants in the Phase I/II trial of BNT162, as part of a global clinical development program. The participants were taking part at the medical schools of New York University and the University of Maryland, in Baltimore. The first cohort of participants in Germany completed dosing last week, Pfizer and BioNTech said.

The trial is designed to determine safety, immunogenicity and optimal dose of four vaccine candidates. The study, of which BioNTech is the main sponsor, is enrolling 7,600 participants and randomizing them to receive one of four vaccine candidates – BNT162a1, BNT162b1, BNT162b2 and BNT162c2 – or placebo. The companies said the two medical schools are dosing participants, though the ClinicalTrials.gov page for the study, last updated Tuesday, still listed NYU Langone Health as not yet recruiting as of midday, while two other University of Maryland sites were also listed as not yet recruiting. The announcement stated that two additional sites not listed on the trial page – the University of Rochester in upstate New York and Cincinnati Children’s Hospital Medical Center – would begin enrollment shortly.

“With our unique and robust clinical study program underway, starting in Europe and now in the U.S., we look forward to advancing quickly and collaboratively with our partners at BioNTech and regulatory authorities to bring a safe and efficacious vaccine to the patients who need it most,” Pfizer CEO Albert Bourla said in a statement. “The short, less than four-month time frame in which we’ve been able to move from preclinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against Covid-19.”

The vaccines Pfizer and BioNTech are developing are messenger RNA vaccines, of the same class as the vaccine currently furthest along in development in the U.S., Moderna’s mRNA-1273, for which that company recently filed for Food and Drug Administration authorization to start Phase II testing.

Experts have said vaccines would be slower to develop than drugs, and indeed the Food and Drug Administration last week gave an emergency use authorization to Gilead Sciences’ antiviral remdesivir as a treatment for Covid-19. However, the Trump administration has launched an effort to shorten vaccine development, as Bloomberg News reported last week, with the aim of making one available as early as January.

Photo: Dominick Reuter, AFP/Getty Images

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