Pfizer, BioNTech to expand COVID-19 vaccine trial; final results by October
Pfizer says trial is event-based and there are many variables that will ultimately impact read-out timing; adds if trials are successful, these companies would submit vaccines for approval as early as October
- Sep 13, 2020,
- Updated Sep 13, 2020 11:33 PM IST
The US pharma giant Pfizer Inc and BioNTech SE have sought permission from the US Food and Drug Administration to expand the enrolment of their Phase 3 COVID-19 vaccine trial to 44,000. Pfizer said in a statement that enrolment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week.
"The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data," Pfizer said.
The trial is event-based and there are many variables that will ultimately impact read-out timing, Pfizer said.
Pfizer said if trials are successful, the companies would submit the vaccines for approval as early as October. "As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October," it added.
Pfizer and its German partner BioNTech last month said they would take their COVID-19 vaccine candidate with the fewest side effects into final-stage testing, as reported by Associated Press. The companies also compared data from early-stage testing of two vaccine candidates. The initial results showed both of them improved immune systems and did not cause side effects.
The US pharma giant Pfizer Inc and BioNTech SE have sought permission from the US Food and Drug Administration to expand the enrolment of their Phase 3 COVID-19 vaccine trial to 44,000. Pfizer said in a statement that enrolment in the trial has been proceeding as planned and the company expects to reach its initial target of up to 30,000 participants next week.
"The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data," Pfizer said.
The trial is event-based and there are many variables that will ultimately impact read-out timing, Pfizer said.
Pfizer said if trials are successful, the companies would submit the vaccines for approval as early as October. "As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October," it added.
Pfizer and its German partner BioNTech last month said they would take their COVID-19 vaccine candidate with the fewest side effects into final-stage testing, as reported by Associated Press. The companies also compared data from early-stage testing of two vaccine candidates. The initial results showed both of them improved immune systems and did not cause side effects.