October 5, 2021

Positive vaccine findings have been reported by Pfizer and BioNTech in children aged 5 to 11

Pfizer and its German partner BioNTech reported good findings from studies of its Covid-19 vaccination in children aged 5 to 11 years old on Monday, September 20.

According to a joint statement from the companies, the Phase 2/3 study revealed “a good safety profile and strong neutralizing antibody responses.”

The study utilized a two-dosage regimen of 10 micrograms given 21 days apart, which is one-third of the 30 microgram dose given to individuals aged 12 and above.

“Pediatric Covid-19 cases have increased by approximately 240 percent in the United States since July, highlighting the public health urgency for immunization,” said Pfizer Chairman and CEO Albert Bourla in a statement.

“We are keen to expand the vaccine’s protection to this younger group, subject to regulatory approval,” he said, “particularly as we monitor the development of the Delta version and the significant danger it presents to youngsters.”

Trial data for school-aged children will be presented to regulatory authorities before the start of the winter season, according to Ugur Sahin, BioNTech’s co-founder, and CEO.

“The safety profile and immunogenicity results in children aged 5 to 11 years immunized at a lower dosage are similar with what we’ve seen with our vaccine in other older groups at a larger dose,” said Sahin, a Turkish immigrant who grew up in Germany.

The data will be shared with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other authorities as soon as feasible, according to the companies.

The Delta variation has resulted in an increase in pediatric Covid cases, and within-person school starting and more people spending time inside this autumn and winter, there has been a drive to extend immunization to school-age children.

According to Johns Hopkins University in the United States, the pandemic has claimed the lives of over 4.69 million people in at least 192 nations and territories, with over 228.6 million cases recorded globally since December 2019. It revealed that approximately 5.9 billion vaccine doses had been given.

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