On May 12, the Food and Drug administration lowered the age for receiving the Pfizer-BioNTech vaccine to 12 from 16 as an emergency use authorization (EUA) after the Center for Disease Control and FDA’s rigorous testing standards were met.
In efforts to encourage use of the vaccine among middle school and junior high students, acting FDA Commissioner Dr. Janet Woodcock and FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks invited student journalists to ask questions about the vaccine and the announcement at a press conference on Wednesday.
“Vaccinating a younger population brings us closer to returning to a sense of normalcy and towards ending the pandemic, something we’ve all been looking forward to,” Dr. Woodcock said. “The FDA has done everything we can to ensure that the COVID-19 vaccine we’ve authorized has met our high standards for quality, safety and effectiveness. We know that every time someone, including our own families, receives a COVID-19 vaccine, they’re putting their trust in us. We’re working hard every single day to maintain that trust.”
After the FDA reduced the age requirement, the CDC met and voted overwhelmingly in favor to recommend following the change.
Through April, approximately 1.5 million children 11-17 years old were diagnosed with COVID-19, spurring the EUA. Looking at the results of a clinical trial of more than 2000 12-15 year olds, in which half received a placebo and the other half the Pfizer vaccination, the FDA ensured the vaccination’s safety within the age group – following half of the group for more than two months after their second dose for symptoms.
“The side effects were similar to those 16-plus who received the vaccine in earlier trials,” Dr. Marks said. “As part of the authorization, Pfizer is required to continue collecting data about clinical trial patients and other vaccinated people so we can quickly assess any possible safety issues.”
To evaluate effectiveness, the FDA looked at data submitted about how participants’ immune systems respond to the vaccine. Looking at data from 190 vaccinated 12-15-year-olds compared that to the response of 170 individuals aged 16-25, the data showed that “the response was excellent” in the 12-15-year-old group. The FDA also compared the responses within a clinical trial of the Pfizer vaccine, in which of 2,200 12-15-year-olds, 1,005 received the vaccine and 928 received the placebo.
“Out of the 1,005 who got the vaccine, none got COVID-19, whereas 16 of the 928 who got the placebo got COVID-19,” Dr. Marks said. “That essentially calculated out to a 100% effectiveness there – we don’t see that very often with vaccines. To get so lucky, to have this type of highly effective vaccine, we’re very grateful.”
Despite COVID-19 also affecting younger age groups, the FDA was only able to EUA between 12-15 because of the difficulty in testing younger people in short periods of time. Within this group, the dosage of the vaccination would remain the same as it was for those above 16. To further study and get the vaccine approved for younger age groups, the dosage will additionally need to be studied to be changed accordingly.
Also concerning was the rare but present cases of multisystem inflammatory syndrome in children under 10 that often came along with the contraction of COVID-19. Although the FDA is unsure if the vaccine would cause the same effect, younger children would need to be followed longer for possible safety issues, and need more time to be approved for the vaccine. The data is expected within the year, according to Dr. Marks.
“Generally speaking, a vaccine development period, conservatively, might take seven years in the clinic and they work their way down slowly from volunteers and they’re very careful at every step,” Dr. Woodcock said. “We’ve been very careful but you can only compress this so much.”
With the increasing availability of the vaccination, the Coppell ISD plan is full face-to-face instruction in the fall without a face mask requirement.
“Reopening our schools and communities is at the top of the minds of many kids and getting children vaccinated will help our children and families get back to a more normal routine,” Dr. Woodcock said. “The reason for that might be how much virus is circling around in the community, what kind of virus, also how many people generally have been vaccinated in that community – there’s a lot of variability there.”
Also present in Coppell is a minor reluctance to receive the vaccination, for fear of long term effects or sentiments against vaccinations overall. With the expanded age group, more minors whose medical decisions are still under the care of a parent are opened to the vaccine. Dr. Woodcock encourages students who have reluctant parents to talk to a pediatrician about the vaccine and clear up any misconceptions.
There are still many questions left unanswered with the short period of time spent developing and monitoring those who have received vaccinations. One, for instance, is the question of a booster shot. According to Woodcock, the older populations who were first vaccinated serve as the “canary in the coal mines,” signaling whether boosters are necessary or not by looking at how and when their immunity is waning. With the longest follow up of the vaccine’s effects on this age group, seniors will be key in understanding unseen long-term effects.
“The good news is that for the current generation of vaccines, both Pfizer and Moderna, the immune responses are so good that they appear to get all the variants that are currently moving around the U.S.,” Dr. Marks said. “It will be nice if it’ll turn out that it’ll be a year before anyone needs a booster but we don’t know yet.”
With several questions still floating around the vaccine and the recent decision to decrease the age limit, Coppell returns to school fully in-person and with no mask mandate next year. The FDA hopes that by placing faith within the vaccine to curb the spread of COVID-19, a sense of normalcy can return.
“Parents, guardians and adolescents can rest assured that in making its decision, the FDA conducted a rigorous and thorough review of all available scientific data, as we have with all our COVID-19 vaccine authorizations,” Dr. Woodcock said. “I would like to stress that adolescents, parents and communities can have full confidence in our processes for reviewing this vaccine.”
This story was originally published on Coppell Student Media on May 21, 2021.