US trials of Pfizer/BioNTech coronavirus vaccine start

The first US patients have been dosed with an mRNA-based coronavirus vaccine in development at Pfizer and BioNTech, shortly after testing got underway in Germany last month.

The vaccine – actually four different vaccine variants with slightly different characteristics – has been given to subjects at the NYU Grossman School of Medicine and University of Maryland School of Medicine in the phase 1/2 trial.

The US trial is part of a global development programme for BNT-162 to see if it can prevent COVID-19, say the partners. The dosing of the first cohort in Germany was completed last week, and when fully enrolled will include 200 healthy volunteers.

The US arm has a recruitment target of 360 people, including one group aged 18-55 and a second aged 65-85, said Pfizer in a statement. The trial gets underway as the number of confirmed coronavirus cases in the US in early May has headed north of 1m, with more than 68,000 deaths.

Pfizer licensed rights to BioNTech’s COVID-19 vaccine development programme in March, buying into one of only a few coronavirus vaccine candidates that have reached the clinical testing stage.

According to the World Health Organization’s latest coronavirus vaccine update, dated 5 May, there are eight COVID-19 vaccines in clinical testing and another 100 in preclinical development.

Furthest ahead is an adenovirus type 5-based candidate developed by China’s CanSino Biological and the Beijing Institute of Biotechnology – which is in phase 2, a little ahead of Moderna’s mRNA-based candidate and three Chinese inactivated virus shots, all three of which are in phase 1/2 studies.

Another adenoviral vaccine developed by the University of Oxford and partnered with AstraZeneca is in phase 1/2 testing in the UK, while US biotech Inovio Pharma has a DNA plasmid-based candidate in phase 1. Other companies and research groups say they could be ready to start trials in the next few weeks.

Pfizer and BioNTech’s programme consists of two vaccines based on nucleoside modified mRNA (modeRNA), one with a uridine containing mRNA (uRNA) structure, and a fourth that uses self-amplifying mRNA (saRNA). All of the are formulated in lipid nanoparticles to improve delivery.

“The short, less than four-month timeframe 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,” said Albert Bourla, Pfizer’s chief executive.

“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 also said it is working with BioNTech to scale-up production capacity to millions of doses in 2020, and hundreds of millions next year.