Pfizer Inc and BioNTech SE, on Saturday, made a proposal to the US Food and Drug Administration (FDA) to expand the Phase 3 trials of their COVID-19 to about 44,000 participants, while making efforts to increase the diversity of the trial population.
The pharmaceutical giants, hope to get to the initial target figure of 30,000 participants for the vaccine trial by next week.
The proposed expansion would also allow the two drugmakers to include participants as young as 16 years, and also those with chronic, stable HIV, hepatitis C, and Hepatitis B.
Pfizer’s Chief Business Officer, John Young, during a US congressional hearing in July said, “Diversity in clinical trials is a priority for Pfizer, and is critical, given that COVID-19 disproportionately impacts communities of color in the U.S.’’
The companies are expected to submit the vaccine for regulatory approval next month. If the trial becomes successful, there are plans to supply 100 million doses of the vaccine by the end of 2020, and 1.3 billion doses by the end of 2021.
In a joint statement on Saturday, they said, “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.’’
The vaccine candidate makes good use of chemical messenger RNA to imitate the surface of the coronavirus, and teach the immune system to recognize and neutralize it. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA) vaccine.