The Food and Drug Administration on Monday cleared Pfizer-BioNTech’s coronavirus vaccine for adolescents 12 to 15 years old, enabling millions of more Americans to get the two-shot regimen.
Five months after the agency authorized Pfizer’s vaccine for emergency use in people 16 and older, Acting FDA Commissioner Janet Woodcock said the expansion represented a major advance in the fight against the virus.
“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,” she said. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”
From March 1, 2020 through April 30 of this year, about 1.5 million COVID-19 cases in people 11 to 17 years old were reported to the Centers for Disease Control and Prevention, the FDA said. Young children and adolescents generally have milder cases compared with adults.
An advisory committee to the CDC is scheduled to meet Wednesday to recommend precisely how the vaccine should be used in the 12-to-15-year-old age group, as the panel did after the vaccine was first cleared for use.
New York-based Pfizer and its German biotech partner, BioNTech, reported on March 31 that their vaccine prevented 100 percent of symptomatic infections in a late-stage clinical trial of 2,260 adolescents between the age of 12 and 15. The vaccine generated antibody responses at least as robust as those seen in recipients 16 to 25 years old, the companies said, and appeared to be as well tolerated.
Albert Bourla, Pfizer’s chief executive and chairman of the board, credited the adolescents who volunteered for the trial and their families, saying their “courage helped make this milestone possible.”
“Together, we hope to help bring a sense of normalcy back to young people across the country and eventually around the world,” he said.
Cambridge-based Moderna’s two-shot mRNA vaccine was authorized for emergency use in mid-December, a week after Pfizer’s became the first one OK’d for use, but Moderna’s is approved only in people at least 18 years old. Moderna is conducting a clinical trial in volunteers 12 to 17 years old and is talking to federal regulators about expanding its authorization as well, according to a company spokesman.
In February, Johnson & Johnson’s single-shot vaccine was the third cleared for emergency use, in people 18 and older. The New Brunswick, N.J.-based health care giant is testing that vaccine, which uses technology developed at Beth Israel Deaconess Medical Center, on adolescents 12 to 17 years old. It uses a harmless cold virus to deliver genetic instructions into cells to build the coronavirus spike protein and stimulate an immune response.
The expansion of Pfizer’s vaccine is likely to buoy parents who want to safeguard their children for summer activities and before school resumes in the fall. It comes as the the pace of the rollout has slowed dramatically in recent weeks, with the supply of vaccines in many places now outstripping demand. Increasingly, health officials are focusing on persuading reluctant people to get vaccinated.
More than 115 million people in the United States have been fully vaccinated against COVID-19, according to CDC data on Monday, and more than 152 million have received at least one dose. But the daily average number of people getting a first or single dose has dropped by about 50 percent since the peak on April 13.
Indeed, some states that initially experienced supply shortages are now shuttering mass vaccination sites because vaccine doses were going unclaimed.
Governor Charlie Baker said last Monday that Massachusetts plans to close four of the state’s seven mass vaccination sites by the end of June. Massachusetts and other New England states were leading the nation in the rate of people who have received at least the first shot of a COVID-19 vaccine.
With the closings, the state plans to shift its resources to 22 regional sites and expand mobile clinics to reach more people of color and other populations that have shown lower rates of vaccination.
Some parents are wary about vaccinating younger adolescents, who are at far lower risk for developing serious cases of COVID-19.
The Kaiser Family Foundation reported last week that it had found substantial vaccine hesitancy specifically among parents of 12-to-15-year-olds in a poll conducted in the last two weeks in April.
The foundation found that 23 percent of those parents said they would definitely not get their children vaccinated, 18 percent would only vaccinate if the school requires it, and 26 percent would wait to see how the vaccine is working. Only 30 percent said they would get their child vaccinated right away.
“Perhaps unsurprisingly, parents’ intentions for vaccinating their kids largely line up with their own intentions for getting the COVID-19 vaccine themselves,” said the study.
But adolescents can easily spread the virus to one another and to vulnerable adults and younger children. As vaccines have become widely available to older people, younger people are making up a higher percentage of COVID-19 cases.
Some pediatricians and school officials said they were eager to get adolescents vaccinated as soon as doses become available.
“I feel we should be able to give our patients the COVID vaccine,” said Dr. Robyn Riseberg, founder of Boston Community Pediatrics, a practice that treats many Black and Hispanic children. “Otherwise, I feel like I’m not able to do my job. If I tell parents everyone should get vaccinated but I don’t have the vaccine, it doesn’t sit well.”
Boston Community Pediatrics installed a new refrigerator last week that will enable it to hold the Pfizer vaccine at required ultracold storage temperatures. The practice has requested doses from the state Department of Public Health, but is still waiting to hear if it will receive them.
Riseberg said many of the parents whose children she treats trust her and her partners to administer vaccines, but won’t ― or can’t ― go elsewhere to get inoculated when the vaccine becomes available.
“Patients from more affluent areas are more willing and able to take their kids to CVS or even a mass vaccination site,” she said. “But it’s different for people who are working two jobs and don’t have good Internet access and don’t have access to transportation.”
Some high schools, including Boston International and Newcomers Academy, North Quincy High School, and Leominster High School, have already begun hosting vaccination clinics for 16- to 18-year-olds.
Many school administrators and vaccinators are hoping to open such clinics for younger adolescents if the vaccine is authorized for them in time to give both doses three weeks apart, before the school year ends in mid-June. But it’s unclear how many will be able to get vaccine shipments.
“We’d love to do it,” said John Chen, who’s leading the Last Mile Vaccine Delivery Coalition that’s vaccinating older students at Leominster High on Tuesday afternoon. “You get a higher vaccination rate in the schools because of ease of access. And if kids see their friends and neighbors and classmates getting vaccinated, the adoption rate is higher.”
At the two Quincy high schools, which held first-dose clinics for those who qualified in recent days, only 145 of the 2,059 students who are 16 to 18 years old were vaccinated. Other students who were eligible may have already been vaccinated at doctors’ offices, pharmacies or other sites, according to school officials.
“Some parents were hesitant, and some were very anxious to get their students vaccinated,” said Kevin Mulvey, the Quincy superintendent of schools.
Because it’s so close to the end of the school year, however, Mulvey said it’s unlikely the city’s high schools or middle schools would vaccinate 12- to 15-year-olds on site. He said school officials would be more likely to refer parents to their partner, Manet Community Health Center, which ran the clinics at the high schools.