The Pfizer-BioNTech coronavirus vaccine is extremely effective in adolescents 12 to 15 years old, possibly even more so than in adults, the companies reported on Wednesday. No symptomatic infections were found in children who received the vaccine in a recent clinical trial, the drugmakers said; the children produced strong antibody responses and suffered no serious side effects.
The results, if they hold up, can speed things up for millions of American families. According to regulatory approval, vaccinations could begin before the start of the next school year for middle and high school students, and for elementary school students soon after.
The companies announced the results in a press release that did not include detailed data from the trial, which has not yet been peer reviewed or published in a scientific journal. Still, the news drew praise and enthusiasm from experts.
“Oh my god, I’m so happy to see this – it’s amazing,” said Akiko Iwasaki, immunologist at Yale University. While vaccine performance in adults was A-plus, results in children were “A-plus-plus”.
The good news comes even as the country sees a further rise in infections and health officials renew calls for Americans to heed precautions and get vaccinated. On Monday, Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, said the spike in cases had left him with a sense of ‘impending doom’, while President Biden called on state and local authorities to restore warrants mask.
Immunization efforts are accelerating across the country. As of Tuesday, 29% of Americans had received at least one dose of a coronavirus vaccine and 16% had been fully inoculated, according to the CDC
But the country cannot hope to achieve collective immunity – the point at which immunity becomes so widespread that the coronavirus slows its crawl through the population – without also inoculating younger Americans, some experts say. Children under the age of 18 make up about 23% of the population of the United States.
“The sooner we can get as many people vaccinated as possible, regardless of their age, the sooner we can really feel like we are ending this pandemic for good,” said Angela Rasmussen, an affiliated virologist at the University. of Georgetown. in Washington.
Data from Israel suggests that vaccination of adults alone can drastically reduce the number of cases, but “in the long term, to reach the threshold of herd immunity, we will have to vaccinate the children,” she said.
The trial included 2,260 adolescents aged 12 to 15 years. The children received two doses of the vaccine three weeks apart – the same amounts and on the same schedule as the adults – or a saltwater placebo.
The researchers recorded 18 cases of symptomatic coronavirus infection in the placebo group, and none among the children who received the vaccine. Still, the low number of infections makes it difficult to be too specific about the effectiveness of the vaccine in the general population, said Dr Rasmussen.
“But obviously it looks good for the vaccine if there were no cases of Covid among those vaccinated,” she added.
Adolescents who received the vaccine produced much higher levels of antibodies on average, compared to participants aged 16 to 25 in a previous trial. The children experienced the same minor side effects as the older participants, although the companies declined to be more specific.
Dr Iwasaki said she expected antibody levels in adolescents to be comparable to those in young adults. “But they’re getting even better levels from the vaccines,” she said. “It’s really unbelievable.”
She and other experts have warned that the vaccine may be less effective in children and adults against some of the variants that have started circulating in the United States.
Pfizer and BioNTech began a clinical trial of the vaccine in children under 12 and began immunizing children aged 5 to 11 last week. Company scientists plan to start testing the vaccine next week in even younger children, ages 2 to 5, followed by testing in children ages 6 months to 2 years.
The results of this three-phase trial are expected in the second half of the year, and the companies hope to make the vaccine available to children under 12 early next year.
“We share the urgency to expand the use of our vaccine to additional populations and are encouraged by the data from clinical trials in adolescents aged 12 to 15,” said Albert Bourla, President and CEO from Pfizer, in a statement.
Moderna has also tested its vaccine in children. The results of a trial in adolescents aged 12 to 17 are expected in the coming weeks and in children aged 6 months to 12 years in the second half of this year.
AstraZeneca began testing its vaccine in children 6 months and older last month, and Johnson & Johnson said it would wait for the results of trials on older children before testing its vaccine in children under. 12 years.
Some parents have said they are reluctant to vaccinate their children because the risk from the virus is low. Children represent less than 1% of deaths from Covid-19, but around 2% of children with the disease require hospital care.
The new findings may not sway all of these parents, but they may reassure parents who have been wary of vaccines, said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.
“While I don’t think we have to wait until children are immunized to fully reopen schools, being able to immunize children can help some families feel safer going back to school,” he said. she declared.
Pfizer and BioNTech plan to apply to the Food and Drug Administration for an amendment to the emergency use authorization for their vaccine, hoping to begin vaccinating older children before the start of the next school year. The companies also plan to submit their data for peer review and publish it in a scientific journal.
They will monitor participants for two years after the second dose to assess the safety and long-term effectiveness of the vaccine. Side effects from vaccines are usually noticeable within the first six weeks, said Dr Kristin Oliver, pediatrician and vaccine specialist at Mount Sinai Hospital in New York City. “Still, it’s good to know that the security oversight is going to continue,” she said.
The CDC recommends that people avoid getting vaccinated for two weeks before and after receiving the two doses of the coronavirus vaccine.
But children receive more vaccines in the few weeks leading up to the school year than at any other time, noted Dr Oliver, so pediatricians and parents should strive to get those other vaccinations done earlier. than usual.
Coronavirus vaccines should ideally be given by pediatricians who have extensive experience immunizing children, Dr Oliver added. “Now is the time to start planning how this rollout is going to take place in this age group,” she said.