On May 12, the Centers for Disease Control and Prevention (CDC) gave the green light to the first COVID-19 vaccine for adolescents ages 12 to 15. Trials are underway for younger children, and new research suggests newborn babies are protected by their vaccinated mother’s antibodies.

There are around 17 million people ages 12 to 15 in the United States. Unlike the initial rollout of vaccines for adults, adequate supply is no longer an issue, and the shot is now widely available at no cost nationwide.

“Getting adolescents vaccinated means their faster return to social activities and can provide parents and caregivers peace of mind knowing their family is protected,” said CDC director Rochelle Walensky, MD, MPH.

The Food and Drug Administration (FDA) granted emergency use authorization for the Pfizer-BioNTech vaccine on May 10, followed two days later by a unanimous recommendation from the CDC’s Advisory Committee on Immunization Practices. This was also the first vaccine authorized for adults last December, an approval that included people ages 16 and older.

“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” acting FDA Commissioner Janet Woodcock, MD, said in a press release. "Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic.

As of Mid-May, nearly 60% of adults have received at least one dose of the three authorized COVID-19 vaccines, and 46% are fully vaccinated, according to the CDC’s vaccine tracker. The Pfizer/BioNTech vaccine must be stored at ultra-cold temperatures, making it more challenging to store and distribute, but the kinks have largely been worked out: More than 124 million doses have been administered in the United States.

Children and adolescents, who make up about a quarter of the U.S. population, generally have milder COVID-19 than adults—and many have no symptoms at all. But a small proportion have developed severe illness and died. As of the end of April, approximately 1.5 million cases of COVID-19 among youth ages 11 to 17 had been reported to the CDC. And as more adults are vaccinated and protected, children account for a growing share of COVID-19 cases and hospitalizations.

The Pfizer-BioNTech vaccine, also known as BNT162b2 or Comirnaty, uses messenger RNA (mRNA) to deliver genetic instructions for producing SARS-CoV-2 coronavirus spike proteins—the red protuberances in the iconic image—that trigger an immune response. This is the first ever mRNA vaccine to get the FDA’s nod, but the technology has been under development for many years. The vaccine does not contain live virus, cannot cause COVID-19 and does not alter human genes.

In a Phase III clinical trial that enrolled 2,260 adolescents ages 12 to 15, the participants were randomly assigned to receive two doses of the vaccine at the same dose used for adults, spaced three weeks apart, or placebo injections.

Immune responses in this age group were as good as or better than those previously seen in older people. None of the youth who received the vaccine developed COVID-19 seven days after their second dose, compared with 18 cases among placebo recipients. The 100% effectiveness in this study exceeded even the 95% efficacy at reducing symptomatic COVID-19 in the larger trial for older teens and adults. Follow-up studies in adults have shown that the vaccine also lowers the risk of asymptomatic infection, which in turn reduces virus transmission.

The vaccine was safe and well tolerated in the adolescent study, as it was in the adult trial. Many people develop side effects such as injection site soreness, fatigue, headache and other flu-like symptoms—more common after the second dose—but serious reactions are rare.

Pfizer is now testing its vaccine in children as young as 6 months old. The company announced that it expects to submit data for emergency use authorization for children ages 2 to 5 years and 5 to 11 years in September, followed by results for those ages 6 months to 2 years.

Other vaccines are also being tested in young people. The Moderna mRNA vaccine was 96% effective in the TeenCOVE trial, which enrolled 3,235 youth ages 12 to 17, according to the company; a request for FDA authorization is expected soon. The KidCOVE study for children ages 6 months to 11 years is now underway. The Johnson & Johnson (Janssen) single-shot vaccine is also currently being tested in teens ages 12 to 17, who were added to the ongoing adult trial, the company said.

There’s also some good news for even younger people. Recent research shows that not only are the Pfizer-BioNTech and Moderna vaccines safe and effective for pregnant people, but vaccinated women may also pass protective antibodies to their babies during gestation and breastfeeding. A study by Andrea Edlow, MD, MSc, of Massachusetts General Hospital, and colleagues, published in the American Journal of Obstetrics and Gynecology, found that vaccine-generated antibodies against the coronavirus were present in all tested samples of umbilical cord blood and breastmilk.

“This news of excellent vaccine efficacy is very encouraging for pregnant and breastfeeding women, who were left out of the initial COVID-19 vaccine trials,” Edlow said in a press release. “Filling in the information gaps with real data is key—especially for our pregnant patients who are at greater risk for complications from COVID-19.”

Vaccine Eagerness and Hesitancy Coincide

While many parents have anxiously awaited the opportunity to get their children vaccinated, others are more reluctant. Some are concerned that the vaccines were developed too quickly, but experts stress that despite the speed, no corners were cut.

“Parents and guardians can rest assured that the [FDA] undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.

A survey by ParentsTogether found that parents are less likely to get their kids vaccinated than they are to get the shots themselves, with Black parents and lower-income parents being particularly hesitant. Other polls have found that politically conservative people are less likely to get vaccinated.

“We have to make sure that the pandemic’s unequal impact on communities of color and low-income families doesn’t get repeated when it comes to vaccinating children against COVID-19,” said ParentsTogether co-director Bethany Robertson. “We’re already seeing that parents of color, especially Black parents, are more vaccine hesitant, given legitimate historical and present-day concerns. We need to start the conversation with parents now, to build trust and understanding about how getting kids vaccinated against COVID-19 protects their health, their family’s health, and the health of our communities.”

While many epidemiologists no longer believe herd immunity is possible and the coronavirus is likely to become endemic, the more people of all ages are vaccinated, the less likely the virus is to spread. But most experts agree that vaccination of children and teens is not necessary to reopen schools safely.

“All of the research and experience reinforces that school reopening—having students in person in school—is not dependent on vaccination,” San Francisco Health Officer Susan Philip said at a virtual Youth COVID-19 Vaccine Town Hall on May 12. “We can open [schools] safely with current measures, but more youth being vaccinated will let us do more activities that we miss being able to do with each other.”

Click here for information from the CDC about COVID-19 vaccines for children and teens.
Click here for the FDA’s fact sheet about the Pfizer-BioNTech vaccine for caregivers and providers.
Click here for more news about COVID-19 vaccines.