Jeenah Moon | Reuters
Pfizer CEO Albert Bourla said the company plans to submit the new data on the vaccine, which is being developed in partnership with German drug maker BioNTech, to the Food and Drug Administration and other regulatory bodies. “As soon as possible”, with the hope that children in the age group will be able to get vaccinated before the start of the new school year.
“We share the urgency to extend the authorization of our vaccine to the use of younger populations
are encouraged by data from clinical trials in adolescents aged 12 to 15, ”Bourla said in a press release.
The trial recruited 2,260 participants in the United States. There were 18 confirmed Covid-19 infections seen in the placebo group and no confirmed infections in the group that received the vaccine, the company said. This resulted in the vaccine being 100% effective, he said, adding that the vaccine was also well tolerated, with side effects generally consistent with those seen in adults.
The company also said the vaccine elicited a “robust” antibody response in children, surpassing those recorded earlier in vaccinated participants aged 16 to 25.
Immunizing children is crucial to ending the pandemic, say public health officials and infectious disease experts. The country is unlikely to achieve herd immunity – when enough people in a given community have antibodies to a specific disease – until children can get vaccinated, experts say.
Children make up about 20% of the U.S. population, according to government data. Between 70% and 85% of the U.S. population must be vaccinated against Covid to gain herd immunity, experts say, and some adults may refuse to be vaccinated.
Pfizer’s vaccine has previously been approved in the United States for people 16 years of age and older. Clinical trial studies testing the vaccine in children, whose immune systems may respond differently from adults, have yet to be completed.
White House chief medical adviser Dr Anthony Fauci told a House committee earlier this month that the United States may start vaccinating older children against Covid-19 this fall, while that elementary-aged children could start getting vaccinated early next year.
Johnson & Johnson plans to test its single-injection vaccine in infants and even newborns, having first tested it in older children, according to the New York Times.
Pfizer announced last week that it had launched a clinical trial to test its Covid-19 vaccine on healthy children aged 6 months to 11 years.
For the first phase of this trial, the company will identify the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and 5 to 11 years. Children will start with a 10 microgram dose of the vaccine before gradually switching to higher doses, according to the company. Participants also have the option of taking 3 microgram doses.
Pfizer said on Wednesday that it plans to seek an amendment to its current emergency use authorization from the FDA to include adolescents ages 12 to 15. All trial participants will continue to be monitored for an additional two years after their second dose, the company said.
Pfizer and BioNTech said they plan to submit the data for scientific peer review.