Pfizer will start testing its coronavirus vaccine on children as young as 12, a crucial step to bringing the shot to more people



a woman in glasses looking at the camera: Steve Parsons-WPA Pool/Getty Images


© Steve Parsons-WPA Pool/Getty Images
Steve Parsons-WPA Pool/Getty Images

  • Pfizer is expanding its massive coronavirus vaccine clinical trial, opening the study to include children as young as 12.
  • The company is poised to become the first major drugmaker to start testing a COVID-19 shot in kids in a large-scale study.
  • The New York pharma giant said it got permission to boost the study’s overall size to as many as 48,400 volunteers.
  • Pfizer broadened the study last month to include 16- and 17-year-olds as well as people with HIV, hepatitis B, or hepatitis C. 
  • While early clinical results were promising, it remains to be seen if Pfizer’s vaccine — or any other experimental shot — can prevent COVID-19.
  • Pfizer CEO Albert Bourla has said he expects data from this study before the end of October. 
  • Visit Business Insider’s homepage for more stories.

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Pfizer Announces Positive Phase 3 Top-line Results for Once-Weekly Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

NEW YORK & MIAMI–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that C0311002, a Phase 3, randomized, multicenter, open-label, crossover study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency (GHD), met its primary endpoint of improved treatment burden compared to GENOTROPIN® (somatropin) for injection administered once-daily.

Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). The point estimate of the treatment difference was -15.49 (-19.71, -11.27 (95% CI); p<0.0001) in favor of somatrogon at the nominal 0.05 level. In addition, key secondary endpoints showed an overall benefit in treatment experience with the somatrogon once-weekly dosing regimen compared to the somatropin once-daily dosing regimen.

“We’re encouraged by findings to date that

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