Pfizer and BioNTech’s coronavirus vaccine is more than 90% effective in human trial participants, early data released Monday suggested, after development with animal models.
The mRNA-based vaccine candidate, BNT162b2, proved effective at preventing COVID-19 in trial volunteers who had no prior known SARS-CoV-2 infection.
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” Dr. Albert Bourla, chairman and CEO of U.S. pharmaceutical company Pfizer, said in a press statement Monday.
This is a first but critical step as we continue our work to try to deliver a safe and effective #COVID19 vaccine.
— Pfizer Inc. (@pfizer) November 9, 2020
This news about the two-dose vaccine follows prior promising results from preclinical studies with mice and nonhuman primates, specifically rhesus macaque monkeys.
Dr. Ugur Sahin, CEO and co-founder of German drugmaker BioNTech, said results the companies shared in September included “key animal studies that were the basis for our clinical programs.”
“[Data] have enabled us to advance BNT162b2 into Phase 3 evaluation. This is another development milestone for providing a safe and effective potential vaccine to the global community to help end this pandemic,” he said in a press statement on Sept. 9.
The vaccine protected rhesus macaque monkeys against SARS-CoV-2 infection during preclinical studies, Pfizer and BioNTech announced in September; immunized mice also had a strong immune response.
Animal activists have touted certain vaccines like BNT162b2 for their fast-track development, which they claim bypasses animal research and testing. However, like other mRNA-based COVID-19 vaccines in development, preclinical animal research paved the way to preliminary BNT162b2 clinical trials and the current Phase 3 study.
Human trials in the U.S. started in May, with the late-stage trial kicking off in July. (RELATED: 2 US Coronavirus Patients Survive Double Lung Transplants. Thank You, Animal Research)
The preliminary Phase 3 trial evaluation is based on 94 confirmed cases of COVID-19 identified among the 43,538 trial participants. The companies will continue the Phase 3 trial of the vaccine until 164 confirmed COVID-19 cases have accrued.
(Featured image credit: MarsBars/ Getty Images)