Pfizer Inc. and BioNTech SE’s COVID-19 vaccine has been cleared for use in younger teens in the U.S., paving the way for the mass vaccination of middle- and high-school students before the start of summer camps and the next school year.
The Food and Drug Administration said in a statement Monday that it had expanded the shot’s original emergency use authorization to include adolescents age 12 to 15.
"It was a relatively straightforward decision,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, at a news conference. The vaccine generated a strong immune response, there were no cases of COVID-19 in the vaccinated group, and there were no signs of any new or worrisome side effects, he said.
A group of advisers to the Centers for Disease Control and Prevention will meet on Wednesday to make recommendations for administering the shots. Children could begin receiving them as soon as Thursday, Marks said.
Acting FDA Commissioner Janet Woodcock said at the briefing that pharmacies and other vaccine distribution centers can now easily "extend down to the younger age group” given the new authorization is for the same vaccine dose and formulation being administered to those 16 and up.
Pediatricians’ offices, however, would need to make specific arrangements to be able to administer the vaccine given its ultra-cold storage requirements, Woodcock said.
Marks added that ultimately distribution decisions will be left to the states.
While adolescent cases tend to be milder, children can still spread the disease and child cases are responsible for a growing proportion of the U.S. total as more adults get vaccinated. Children may be a "remaining engine fueling the pandemic,” said William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, in an interview. "It’s important for us to attack that.”
Pfizer’s two-shot vaccine was authorized in the U.S. for those age 16 and up last year. Shots made by Moderna Inc. and Johnson & Johnson are available to those age 18 and older. Canada cleared use of the Pfizer-BioNTech shot for adolescents as young as 12 on Wednesday.
There are almost 17 million people age 12 to 15 in the U.S., according to the Kaiser Family Foundation, or 5.3% of the U.S. population. Nearly half are people of color.
Expanding vaccine access to younger adolescents is expected to accelerate the immunization campaign, as public-health officials seek to curb fast-spreading variants and open schools. Other studies are exploring the vaccine’s use in even younger children. Those are expected to produce data toward the end of this year or early 2022.
"It’s extremely, extremely important from a public health perspective to be able to vaccinate them,” Pfizer Chief Executive Officer Albert Bourla said in an interview before the clearance. "It’s important they’re protected against disease, but also so they will not pass the disease to their households.”
Pfizer began recruiting younger adolescents into its final-stage vaccine trial in the late fall, before it secured efficacy results from those age 16 and older. That early enrollment work meant the drugmaker was able to evaluate the shot in teens over the holiday season, when new cases of the virus were surging in the U.S., Gruber said.
In March, Pfizer and BioNTech said their vaccine was 100% effective in the 12-to-15 age group in a final-stage trial. In the 2,260 adolescents included in the trial, the shot produced antibodies exceeding the level seen in vaccinated young adults.
All 18 cases of COVID-19 recorded in the study were in adolescents who received a placebo, the companies said. Side effects were consistent with those experienced by 16-to-25 year olds.
Since 12 to 15 year olds will be given the same vaccine as adults, the two-shot regimen will be priced the same. In the U.S., the Pfizer-BioNTech vaccine costs $39 (about ¥4,200) for a full course. Currently, the shots are paid for by the U.S. government, with no out-of-pocket cost for vaccine recipients.
New York-based Pfizer and Germany-based BioNTech launched vaccine studies in children age 6 months to 11 years old in March. The trials are broken into three age groups: 5 to 11 years, 2 to 5 years, and 6 months to 2 years, and they are more complicated to complete as they involve testing new, lower doses in young children.
Other drugmakers are also studying their vaccines in children, but are further behind. Moderna expects results from a trial of its vaccine in adolescents "in a matter of weeks,” leading to an application for U.S. authorization shortly after that, Moderna Chief Executive Officer Stephane Bancel told Bloomberg TV on April 29.
J&J began testing in 16 and 17 year olds on April 2. It plans to review that data before working its way down to the 12-and-up population.
For children under 12, Pfizer will likely focus on studies that emphasize whether the vaccine produces an immune response, according to Gruber. That’s because it will be difficult to accumulate symptomatic COVID-19 cases as the pandemic subsides in the U.S. Also, many infected children show no symptoms.
Gruber expects the companies to report safety and immunogenicity data on the vaccine’s performance in 2 to 12 year old studies in September or October, paving the way for U.S. regulators to clear the shot for that cohort before year-end.
For those 6 months old to 2 years old, data is likely to become available in the first quarter of 2022, he added.
Pediatricians will soon become a critical part of the vaccine rollout, particularly in boosting confidence among wary parents.
"Parents of young children, they are used to this concept of vaccinating their kids,” said Yvonne Maldonado, medical director of Infection Prevention and Control at Packard Children’s Hospital at Stanford University and an investigator for Pfizer’s pediatric trials. "What they need to be convinced of is how is this different or similar to all of the other vaccines their children get.”
In the meantime, Maldonado said it’s critical that adolescents catch up on their other immunizations before the fall school year. Current CDC guidance suggests COVID-19 vaccines should be administered alone, with a interval of at least 14 days before or after administration of any other vaccine.
Many in the 12-and-up cohort have had their appointments delayed, she said. Parents should seek to get their other immunizations taken care of immediately, so as not to conflict with upcoming COVID-19 appointments.
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