NEW YORK: Drugmaker Pfizer is expanding its late-stage COVID-19 vaccine trial to include children as young as 12, in a bid to better understand the safety and efficacy of the vaccine across more age groups.
The company said on Monday (Oct 12) that it had received permission from the Food and Drug Administration to include adolescents between 12 and 15 in its global COVID-19 vaccine study.
New York-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people.
That increase was made to boost diversity in the trial population, specifically by including teenagers as young as 16, as well as patients with chronic infections such as hepatitis B, hepatitis C and HIV.
The Pfizer-BioNTech vaccine is one of the leading candidates in the race to be the first to get regulatory approval in the United States and Europe.
If regulatory approval or authorisation is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021.
"Even though we are moving with extraordinary speed, preservation of high quality and safety standards is critically important throughout development," Pfizer said on its website.
"Participant safety is paramount ... As with all of our trials, we are following all of the rules and regulations in place to ensure participant safety," it added.
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The head of the World Health Organization (WHO) said earlier this month that a vaccine against COVID-19 may be ready by the end of the year.
Nine experimental vaccines are in the pipeline of the WHO's COVAX global vaccine facility that aims to distribute 2 billion doses by the end of 2021.
More than 180 countries have also committed to participate in WHO's effort to finance COVID-19 vaccines to be distributed fairly to both rich and poor countries, the group's chief scientist said on Monday.