The two companies said on Wednesday that the Pfizer-BioNTech coronavirus vaccine is highly effective in young teens, and possibly more than adults, a finding that could accelerate the return of normality to millions of American families.
Drug makers said no symptoms were found among children ages 12 to 15 who received the vaccine in a recent clinical trial; The children showed strong antibody responses and did not experience any serious side effects.
Depending on regulatory approval, vaccinations can begin before the beginning of the next school year for middle and high school students, and primary school children soon after.
The companies announced the results in a statement that did not include detailed data from the experiment, which was not reviewed by colleagues and was not published in a scientific journal. However, the news drew praise and excitement from the experts.
“Oh my God, I’m so happy to see this – it’s amazing,” said Akiko Iwasaki, an immunologist at Yale University. If the performance of vaccinations in adults is A-plus, the results in children are “A-plus-plus.”
The good news arrives even as the country records another spike in infections and health officials renew calls for Americans to pay attention to precautions and vaccinations. Dr Rochelle Wallinski, director of the Centers for Disease Control and Prevention, said on Monday that cases were increasing. Leaving her with a feeling of “imminent death”, Meanwhile, President Biden called on government and local officials to re-delegate the mask.
Vaccination efforts are accelerating across the country. As of Tuesday, 29 percent of Americans You have received at least one dose of Coronavirus vaccine, And 16 percent have been fully vaccinated, according to the Centers for Disease Control and Prevention
But the country cannot hope to reach herd immunity – the point at which immunity is so widespread that the coronavirus is slowing its creep in the population – without vaccinating younger Americans, some experts say. Children under the age of 18 represent about 23 percent of the population in the United States.
“The sooner we get vaccines to the largest number of people possible, regardless of their age, the sooner we feel we are ending this epidemic for good,” said Angela Rasmussen, a virologist at Georgetown University. in Washington.
Data from Israel indicate that vaccinating adults alone can significantly reduce the number of cases, but “in the long term, to reach the herd immunity threshold, we will have to vaccinate children,” she said.
The trial included 2,260 adolescents, between the ages of 12 and 15. The children received two doses of the vaccine three weeks apart – the same amounts and schedule used for adults – or a saltwater placebo.
Researchers recorded 18 cases of coronavirus symptoms in the placebo group, and none were recorded among the children who received the vaccine. However, the low number of infections makes it difficult to be more specific about the effectiveness of the vaccine in the general population, Dr. Rasmussen said.
She added: “But it is clear that the vaccine looks good if there are no cases of Covid virus among the people who have been vaccinated.”
Adolescents who got the vaccine produced significantly higher levels of antibodies on average, compared to participants between the ages of 16 and 25 in a previous trial. Children experienced the same minor side effects as older participants, although the companies refused to be more specific.
Dr. Iwasaki said she expected antibody levels in adolescents to be similar to those in young men. “But they are getting better levels of vaccines,” she said. “This is really unbelievable.”
She and other experts have warned that the vaccine may be less effective in children and adults, against some variants that have begun to circulate in the United States.
Pfizer and BioNTech have started a clinical trial of the vaccine in children under 12 years old and have begun vaccination Children from 5 to 11 years old Just last week. The company’s scientists plan to start testing the vaccine next week even on younger children, ages 2 to 5, followed by trials in children ages 6 months to two years.
The results of that three-stage trial are expected to appear in the second half of the year, and companies hope to make the vaccine available to children under the age of 12 early next year.
“We share the urgent need to expand the use of our vaccine to additional populations, and we are encouraged by clinical trial data from adolescents between the ages of 12 and 15,” Albert Burla, president and CEO of Pfizer, said in a statement.
Moderna was as well Vaccine test In children. Results of a trial are expected in adolescents aged 12 to 17 in the next few 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 will wait for trial results in older children before testing its vaccine in children under 12.
Some parents said they are reluctant to have their children vaccinated because the risk posed by the virus is low. Children make up less than 1% of deaths from Covid-19, but about 2% of children who develop the disease require hospital care.
Jennifer Nozo, an epidemiologist at the Johns Hopkins Center for Health Security, said the new findings may not affect all of these parents, but it may reassure parents who have been wary of vaccinations.
“Although I don’t think we have to wait until children are vaccinated to fully reopen schools, being able to vaccinate children may help some families feel safe when they return to school,” she said.
Pfizer and BioNTech are planning to request the Food and Drug Administration for an amendment to the emergency use permit for the vaccine, with hopes 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 publication in a scientific journal.
They will monitor the participants for two years after the second dose to assess the vaccine’s long-term safety and efficacy. Dr. Christine Oliver, a pediatrician and vaccine expert at Mount Sinai Hospital in New York, said that side effects of vaccines usually appear within the first six weeks. “Nevertheless, it is good to know that safety monitoring will continue,” she said.
The CDC recommends that people avoid getting other vaccines for two weeks before and after receiving two doses of the Coronavirus vaccine.
Dr. Oliver indicated that children receive more vaccinations in the few weeks leading up to the school year than at any other time, so pediatricians and parents should seek to obtain other vaccinations earlier than usual.
Dr Oliver added that coronavirus vaccines should ideally be given by pediatricians who have deep experience in immunizing children. “Now is the time to start planning how to implement this proposition in this age group,” she said.