Pfizer modifies protocol for virus vaccine study

Diversity aimed at providing information on how safe and effective the experimental vaccine

is in people of different ages and backgrounds

Drugmaker Pfizer has again modified the protocol for its late-stage study of its vaccine against

the new coronavirus, this time to include more young participants.

The company said on Monday that it's received permission from the Food and Drug

Administration to include adolescents aged 12 through 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 16- and 17-year-old teens, as well as stable patients with some

common chronic infections: hepatitis B, hepatitis C and HIV.

Pfizer's trial also includes significant numbers of Hispanic, Black, Asian and Native American

participants, plus many people aged 56 through 85. The diversity is aimed at providing

information on how safe and effective the experimental vaccine is in people of different ages

and backgrounds.

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