(Reuters) – Pfizer Inc. and BioNtech SE on Saturday proposed to the US Food and Drug Administration (FDA) to expand its Phase 3 Pustal COVID-19 vaccine trial to approximately 44,000 participants, increasing the diversity of the test population.
The initial target figure for the test was up to 30,000 participants, which the companies said they expected to reach by next week.
He said the proposed expansion would allow companies to recruit people under 16 and those suffering from chronic, stable HIV, hepatitis C and hepatitis B.
Druggmakers enlisted a diverse set of volunteers to develop a safe and effective coronavirus vaccine mortgaged in July to ensure their large clinical trials.
Pfizer Chief Business Officer John Young said at a US Congressional hearing in July, “Diversity in clinical trials is a priority for Pfizer and it is important that COVID-19 adversely affects communities of color in the US.”
If the study is successful, companies can submit the vaccine for regulatory approval in early October, which will put them on track to supply 100 million doses by 2020 and 1.3 billion by the end of 2021.
“As previously stated, based on current transition rates, companies are expected to have a conclusive readout on efficacy by the end of October,” the joint statement said on Saturday.
The vaccine candidate uses chemical messenger RNA to mimic the surface of the coronavirus and to identify and neutralize the immune system. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA) vaccine.
Reporting by Shubham Kalia; Editing by Chizu Nomiyama