As federal authorities take steps toward Emergency Use Authorization for a COVID-19 vaccine for adults, the American Academy of Pediatrics continues call for children and adolescents to be included in vaccine trials
ITASCA, IL -- Today, the Vaccine and Related Biological Products Advisory Committee (VRBPAC) issued a recommendation to the U.S. Food and Drug Administration in favor of an Emergency Use Authorization for Pfizer-BioNTech's COVID-19 vaccine. While we wait for the FDA to consider the request, the American Academy of Pediatrics recognizes this action as an important step in making a vaccine available but urges continued, robust research on vaccines for children and adolescents.
“Today marks another milestone in the pandemic and brings us one step closer to having a vaccine that will be broadly available to physicians, health care workers, and other front-line medical staff,” said Sally Goza, MD, FAAP, president of the American Academy of Pediatrics. “This is a light at the end of the long tunnel of this pandemic, which has placed heavy burdens on everyone in the medical community, and we look forward to having a vaccine available to protect everyone who has put their own health and safety at risk in order to care for others.”
After the VRBAC recommendation, the application for EUA must be considered and approved by the FDA before the vaccine can be offered outside of clinical trials. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to make recommendations regarding the use of the vaccine. Several pediatricians are members of both VRBPAC and ACIP and have been participating in these important ongoing discussions and decisions.
The FDA advisory committee today voted that the benefits of the Pfizer-BioNTech vaccine outweighed its risks for use in individuals 16 years of age and older. The data demonstrated that vaccine efficacy 7 days after receiving the second dose was 95% in participants without prior evidence of a COVID-19 infection. While the Academy is hopeful that the Pfizer vaccine represents a big step for controlling the virus, the AAP again urges manufacturers to include children in their COVID-19 vaccine trials, including younger children, as soon as it is safe to do so.
“We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12 through 15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group,” Dr. Goza said. “We strongly encourage other COVID-19 manufacturers to add adolescents, and then for all manufacturers to expand these trials to include younger children. Trials in children must keep pace with the tremendous amount of data being generated in adult trials, and this should be initiated safely and as soon as possible so there could be a vaccine authorized for younger children before the next school year begins.”
Nearly 1.5 million children have been infected with the virus since the beginning of the pandemic, according to data compiled by AAP and the Children’s Hospital Association. Children have suffered in other ways, including disruptions to their education, financial well-being, and mental health. AAP has called for transparency and scientific rigor in research on potential COVID-19 vaccines and renews the call to not leave children out of important vaccine trials.
“Before a vaccine can be offered to children, we must study it in diverse populations of children and adolescents to ensure it is both safe and effective,” Dr. Goza said. “We know that children can become sick from COVID-19, and they can spread the virus to others. In order to control this pandemic, we must include children and teens in the national vaccination program."
Dr. Goza points out that even after a vaccine is available, communities must continue the public health measures that have been proven to reduce the spread of the virus.
“We should expect to continue to practice social distancing and wearing masks well into 2021, even after people begin getting the vaccine,” Dr. Goza said. “This virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”
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The American Academy of Pediatrics is an organization of 67,000 primary care pediatricians, pediatric medical subspecialists and pediatric surgical specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. For more information, visit www.aap.org.