Pfizer chief executive Albert Bourla said Thursday clinical trials should reveal by October whether the company’s vaccine against the Coronavirus strain Covid-19 is safe and effective.
The top executive at one of the world’s largest drug makers said the 30,000 patients in a final-stage “phase 3” clinical trial for its Covid-19 vaccine should be enrolled by the end of August. Enrollment in phase 3 clinical trials for Pfizer’s vaccine and another in development from Moderna began in July. Half, or about 15,000, in each company’s trials are getting the vaccine while the other 15,000 are receiving placebo.
“October is coming,” Bourla said Thursday afternoon in an interview with the Washington Post Live. “In October, the truth will be revealed.”
The update from Pfizer comes less than a month after the U.S. Department of Health and Human Services and the Department of Defense announced a $1.95 billion agreement with Pfizer and its German biotech partner to deliver 100 million doses of a Covid-19 vaccine by December. The agreement announced July 22 also allows the U.S. government to acquire an additional 500 million doses.
On Thursday, Bourla said Pfizer, which is working with the Germany biotech company BioNTech to develop Covid-19 investigational vaccines, expects to submit a vaccine to the U.S Food and Drug Administration in October for possible approval. That will then trigger what is expected to be an expedited approval process that could even win Pfizer’s vaccine an emergency use authorization based on comments FDA commissioner Dr. Stephen Hahn made last week.
In an interview last week with JAMA, Hahn said the FDA would “consider an emergency use authorization if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine and the potential benefit of having a vaccine.”
Both the Moderna and Pfizer-BioNTech products are using a new technology that those involved say speeds the development and manufacturing of the vaccines. Both use a synthetic version of genetic material known as messenger RNA, or mRNA, that teaches the patient’s immune system to recognize – and then attack – the coronavirus Covid-19.
In the Pfizer vaccine, Bourla said it will require two doses 21 days apart. Over time, the technology allows for a patient to get a boost of the vaccine if needed to protect against the virus.
“We will follow the patients for two years,” Bourla said in the Washington Post Live interview. “If the virus changes this technology allows us to change the vaccine in weeks rather than months.”- Forbes