Experts: Vaccine trial a ‘win-win’
Pfizer says shots found to be 100% effective for adolescents
Connecticut health experts say a new PfizerBioNTech trial showing its COVID-19 vaccine had 100 percent efficacy among adolescent participants could be a path to fully reopening schools, but state officials say they are not ready to consider whether students will be required to get the shot.
Pfizer-BioNTech announced the results Wednesday of the trial involving 2,260 children between the ages of 12 and 15, and said the companies plan to submit the results to the U.S. Food and Drug Administration.
“Even though kids may not get as sick as adults, they can transmit the virus and get others sick,” said
Onyema Ogbauagu, a Yale New Haven Hospital infectious disease physician and associate professor of medicine at Yale University who led the first Pfizer-BioNTech vaccine trial at the Yale Center for Clinical Investigation.
Ogbauagu enrolled 20 Connecticut children ages 12 to 15 in the trial. He said these latest findings could “put us closer to herd immunity.”
The FDA approved the PfizerBioNTech vaccine in December under an emergency use authorization for those ages 16 and older.
The companies said the new trial showed that vaccinated individuals ages 12 to 15 had “100 percent efficacy and robust antibody responses,” exceeding numbers reported in a trial of vaccinated participants ages 16 to 25 during earlier analysis.
Pfizer and BioNTech plan to submit the trial data to the FDA and the European Medicines Agency “as soon as possible” to request emergency authorization to provide the vaccine to children in this age group.
Albert Bourla, chairman and CEO of Pfizer, said the companies hope to receive approval to vaccinate children in this age group “before the start of the next school year.”
Dr. Zane Saul, chief of infectious diseases at Bridgeport Hospital, called the latest research a “win-win,” which could be a crucial step forward.
“This is good news,” Saul said. “This is a way to get everybody back to school, so moms and dads can go back to being moms and dads instead of teachers.”
However, it remains uncertain whether Connecticut will require eligible students to receive the COVID vaccine if it’s approved.
“No one is talking about mandating these vaccines as of right now,” said Maura Fitzgerald, a spokeswoman for the state Department of Public Health.
Peter Yazbak, a spokesman for the state Department of Education, declined to say whether COVID-19 vaccines could be a requirement for eligible students.
Yazbak said Connecticut is in the “early planning stages” of holding vaccination clinics for high school students ages 16 and older and college students.
“Connecticut is conducting direct outreach to district superintendents, in coordination with local departments of health, to discuss hosting additional high school clinics later this spring,” Yazbak said.
The pharmaceutical companies said 18 COVID-19 cases were observed during the trial in a placebo group of 1,129 adolescent participants versus none in the vaccinated group of 1,131 participants. One month after receiving their second dose, the study showed adolescent participants had COVID-neutralizing antibodies.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Bourla said. “We plan to submit these data to FDA as a proposed amendment to our emergency use authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
Ugur Sahin, CEO and cofounder of BioNTech, said the results for the adolescent studies suggest children are “well protected” by the vaccination.
“Across the globe, we are longing for a normal life. This is especially true for our children,” Sahin said. “It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”
Side effects observed were consistent with those seen in individuals ages 16 to 25, the study indicated.
Testing continues among groups of young children to monitor the vaccine’s safety and effectiveness in children ages 6 months to 11 years old. The study started dosing individuals ages 5 to 11 last week, and those ages 2 to 5 will be vaccinated next week. A third age group, with children ages 6 months to 2 years, will also participate in the study.
At least one expert cautioned that expansion of the vaccine to lower age groups is still in its early stages.
“For now, it is very promising, but we still need the final review by the FDA to assure all claims of 100 percent (efficacy) are accurate,” said Michael Urban, director of occupational therapy at the University of New Haven. “I would hope the FDA will move quickly to review this.”
“Across the globe, we are longing for a normal life. This is especially true for our children. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones.”
Ugur Sahin, CEO and co-founder of BioNTech