A nurse, Cindy Mendez, wearing a protective mask, holds a syringe containing a dose of Pfizer-BioNTech COVID-19 vaccine during the coronavirus disease (COVID-19) pandemic at NYC Health + Hospitals Harlem Hospital in the Manhattan neighborhood of New York City. New York, February 25, 2021.
Jeenah Moon | Reuters
Pfizer on Wednesday said its Covid-19 vaccine was extremely effective in children and had shown 100% effectiveness in a Phase 3 clinical trial that tested its shot in teenagers ages 12-15.
Albert Bourla, CEO of Pfizer, said the company hoped to submit the new data on the vaccine, which was being developed in partnership with German drug maker BioNTech, “as soon as possible” to the Food and Drug Administration and other regulatory agencies that children in the EU age group can get vaccinated before the start of the new school year.
“We share the urgency to expand approval of our vaccine for use in younger populations and
are encouraged by clinical trial data from adolescents between the ages of 12 and 15, “Bourla said in a press release.
The study enrolled 2,260 participants in the United States. 18 confirmed Covid-19 infections were observed in the placebo group and no confirmed infections were observed in the group that received the vaccine, the company said. This resulted in a vaccine effectiveness of 100%. The shot is also well tolerated, with side effects generally the same as in adults.
The company also said the vaccine produced a “robust” antibody response in children that was beyond those previously seen in vaccinated participants aged 16-25 years.
Vaccinating children is critical to ending the pandemic, say public health officials and infectious disease experts. The nation is unlikely to achieve herd immunity – if enough people in a given community have antibodies to a given disease – until children can be vaccinated, experts say.
According to the government, children make up around 20% of the US population. According to experts, between 70% and 85% of the US population must be vaccinated against Covid to achieve herd immunity and some adults may refuse to get the shots.
Pfizer’s vaccine has already been approved for use in the United States in people 16 years of age and older. Clinical trials testing the vaccine in children whose immune systems may react differently than adults had yet to be completed.
The Chief Medical Officer of the White House, Dr. Anthony Fauci, speaking to a House committee earlier this month, said the U.S. could start vaccinating older children against Covid-19 from this fall, while elementary school-age children may get their shots early next year.
Moderna, which also has a US-approved vaccine, announced on March 16 that it has started testing its shot in children under the age of 12. Moderna started a study in December testing children ages 12-17.
Johnson & Johnson plans to test its single-shot vaccine in infants and even newborns after it was first tested in older children, according to the New York Times.
Pfizer announced last week that it had started a clinical trial testing its Covid-19 vaccine in healthy children aged 6 months to 11 years.
In the first phase of this study, the company will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. The children will initially receive a dose of 10 micrograms of the vaccine before gradually moving to higher doses, according to the company. Participants also have the option of ingesting 3 microgram doses.
Pfizer said Wednesday it plans to apply to the FDA for an amendment to its current emergency approval to include adolescents ages 12-15. All participants in the study will be monitored for an additional two years after their second dose, the company said.
Pfizer and BioNTech plan to submit the data for scientific review.