FDA To Expand Pfizer Covid-19 Vaccine Eligibility To 12-15-Year-Olds
As early as later this week, the Food and Drug Administration (FDA) may expand eligibility of the PfizerBioNTech Covid-19 vaccine to individuals ages 12-15 years. Until now, this two-dose vaccine has been approved for teens ages 16 and older. As of April 19, 2021, all Americans ages 16+ have been eligible to receive this vaccine in all 50 states. The two-dose Moderna vaccine and the single-dose Johnson & Johnson vaccine are currently approved for use in the U.S. for people ages 18 years and older. All approvals for these vaccines remain under EUA, or emergency-use authorization, pending formal approval by the FDA.
The clinical trial for 12-15-year olds was completed months ago, and results of the Phase 3 trial in this age group were released in March 2021. The study included 2,260 participants, and was placebo-controlled, double-blinded and prospective. In other words, half (1,129) received a two-dose placebo vaccine, half (1,131) received a two-dose SARS-CoV2 (Covid-19) vaccine, and neither the researchers nor the participants knew which one they were receiving. Both groups were followed for several months after the final injection. There were 18 cases of participants contracting Covid-19 infections. All of these cases were in the placebo group. There were no cases of Covid-19 infections in the vaccine group. Those in the treatment arm demonstrated antibodies to SARS-CoV2 at one month following receipt of the second dose. As individuals did not know whether they received placebo or vaccine, risks of Covid-19 exposure was similar in both groups. The majority of the trial period was conducted during the Fall and Winter of 2020/2021, when transmission and infection rates in the U.S. were uniformly quite high.
Side effects in the vaccine group (and in many cases, in the placebo group) were no different from those in 16-25-year-olds, and included arm soreness, fever, body aches, and fatigue.
While some may be reluctant to vaccinate younger adolescents, this age group does have a risk of not only contracting Covid-19 infections, but they are also very efficient at spreading it amongst each other as well as to vulnerable adults and younger infants and children. As vaccines have become more widely available to older individuals, we are seeing a relatively higher percentage of younger people contracting Covid-19. Hospitalizations in the U.S. have plummeted in many areas of the country, yet the average age of hospitalized patients has had a continual downward trend.https://8b80355babbc046a389b05bc6073a5bf.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html
Clinical trials for children ages 6 months-11 years have begun, also using the Pfizer-BioNTech vaccine as a two-dose regimen, each dose given 21 days apart. This study will be divided into subgroups, ages 6 months to 2 years, 2-5 years, and 6-11 years. The youngest groups will be tested with lower doses of the vaccine. Serial outcomes, as well as Covid-19 antibody testing, will be included to better assess both safety, appropriate dosing, and efficacy in younger children. Results for these age groups will likely be available in the Fall/Winter of 2021/2022.
While children in general have had a lower risk of severe illness due to Covid-19, there have been moderate as well as severe cases in all age groups. The entity MIS-C, or multi-system inflammatory syndrome in children, has been a devastating illness, seen in children as well as adolescents as old as age 20 years. This entity is a severe illness involving the heart, lungs, brain and kidneys, as well as other organ systems, usually presenting after an asymptomatic Covid-19 infection. Over 3,000 children have suffered from this in the U.S. alone, most of who required hospitalizations. There have been 36 pediatric deaths due to MIS-C, many in previously healthy children.
Aside from the direct impact of acute Covid-19 infections, adolescents in isolation over the past 14 months have experienced high levels of anxiety and depression. Fully vaccinated (”fully vaccinated”= no less than 14 days after the final dose of a Covid-19 vaccine) adults are beginning to see the faces of one another, as masks and seclusion gradually lift. Younger teens will hopefully be able to more safely move back into their previous routines as well.