Pfizer’s Covid vaccine was 100% effective in children in a long-term study – Community News
Covid-19

Pfizer’s Covid vaccine was 100% effective in children in a long-term study

pfizer and BioNTech announced Monday that their Covid-19 vaccine was 100% effective in preventing infection in 12 to 15-year-olds, measured from seven days to four months after receiving the second dose of the vaccine.

The companies said the new data — a long-term analysis of a Phase 3 study conducted in 2,228 participants — will form the basis for an application to the Food and Drug Administration for an extension of their Covid-19 vaccine license for young people of this age group.

“These are the first and only longer-term publicly available data demonstrating the safety and efficacy of a Covid-19 vaccine in individuals aged 12 to 15 years,” said Ugur Sahin, CEO and co-founder of BioNTech, in a statement. . “The growing body of data we have collected to date from clinical trials and real-world surveillance strengthens the evidence base supporting the strong efficacy and favorable safety profile of our Covid-19 vaccine in adolescent and adult populations.”

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The long-term analysis of the data from the phase 3 study showed no serious safety concerns over a follow-up period of at least six months after the second dose of the vaccine.

The additional data “provide further confidence in the safety and effectiveness profile of our vaccine in adolescents. This is especially important as we see the rate of COVID-19 in this age group rising in some regions while vaccine uptake has slowed,” Albert Bourla, Pfizer chairman and CEO, said in the statement.

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The vaccine has been in use in this age group since May, when the FDA extended emergency authorization for the vaccine to 12 to 15-year-olds. In August, the vaccine, which the companies are marketing under the name Comirnaty, was the first Covid vaccine to be fully licensed for those aged 16 and over.

The companies said they will also use the data to pursue regulatory approvals in other countries where the vaccine has been used in emergency situations.

The phase 3 data saw 30 Covid infections – all in the placebo arm. Efficacy was consistent across racial and ethnic demographics, gender and underlying disease status, including obesity, the companies said.