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September 15, 2020 Bioscience

Pfizer, BioNTech seek to expand COVID-19 vaccine trial


Pfizer Inc. and BioNTech are seeking to expand enrollment in a late-stage trial of their proposed COVID-19 vaccine to include an additional 14,000 patients.

The pharmaceutical giant and the German biotech said they submitted an amended protocol to the U.S. Food & Drug Administration Saturday to expand the trial to 44,000 participants. 

The companies said the expansion would allow them to include more diverse populations in the trial, including adolescents as young as 16 and people with chronic, stable HIV, Hepatitis C or Hepatitis B infection. It would also provide additional safety and efficacy data. 

The companies expect to reach their initial target of 30,000 participants next week and said results could be available as early as the end of October.

Pfizer’s potential vaccine takes a different approach than others. Instead of using inactive virus to create immunity, it uses a genetic code (modified RNA) to make the body generate proteins resembling the spike protein of the SARS-CoV-2 virus, so the body develops antibodies against it. 

Pfizer, which has a large Connecticut presence, is partnering with Yale New Haven Health to test the vaccine. Yale officials said in late August that they hoped to enlist up to 2,000 people from the region to participate in the trial locally.

The companies have said previously that if they can secure all required approvals, they aim to supply up to 100 million doses globally by the end of 2020 and 1.3 billion doses by the end of 2021.

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