German drugmaker BioNTech and U.S. pharmaceutical giant Pfizer have begun human trials of a potential coronavirus vaccine that could supply millions by the end of the year, the two firms said on Wednesday.
From its part, Pfizer said it would begin testing its experimental vaccine in the United States as early as next week, adding that a vaccine could be ready for emergency use in the fall, the Wall Street Journal reported on Tuesday.
BioNTech said the first cohort of participants had been given doses of the potential vaccine, BNT162, in a Phase 1/2 clinical study in Germany.
“Twelve study participants have been vaccinated with the vaccine candidate BNT162 in Germany since the start of the study on April 23, 2020,” the company said in a statement.
BioNTech said around 200 healthy volunteers aged between 18 to 55 years old would be given doses ranging from 1µg (microgram) to 100µg to find the optimal dose for further studies.
“In addition, the safety and immunogenicity of the vaccine will be investigated,” noted the German biotech company.
Pfizer and BioNTech plan to initiate trials for BNT162 in the U.S. on regulatory approval, expected shortly, the joint statement read.
The German Federal Institute for Vaccines and Biomedical Drugs has given the green light for the trial — the country’s first clinical experiment for a vaccine against coronavirus on April 22.
“The two companies plan to jointly conduct clinical trials for the COVID-19 vaccine candidates initially in Europe and the U.S., across multiple research sites,” Pfizer announced in its first quarter report, released online on Tuesday.
“Pfizer and BioNTech also plan to conduct trials for BNT162 in the U.S. upon regulatory approval, which is expected shortly,” the report said.
“The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020, subject to technical success of the development program and approval by regulatory authorities, and the potential to rapidly scale up the capacity to produce hundreds of millions of doses in 2021.”
