As adults in the United States continue to line up for their COVID-19 vaccines, children and adolescents have been kept out of line. That could change soon.
The country’s leading infectious disease specialist says that in the fall, he hopes to have data showing that children and teenagers aged 12 to 17 can start rolling up their sleeves for COVID-19 injections. Younger children can follow in the first quarter of 2022.
“We project that high school students will most likely be able to be vaccinated by autumn – perhaps not on the first day, but certainly in the early part of autumn for this educational semester,” said Dr. Anthony Fauci on Sunday. “Face the Nation” by CBS.
Children appear to have been largely spared the worst damage from COVID-19, often suffering from mild or minimal symptoms. And vaccinating students is not necessary for the safe reopening of schools, experts say. Still, a large-scale vaccination of children and adolescents in America could offer some peace of mind to families – and would provide welcome help in the effort to achieve collective immunity against the coronavirus.
“When you vaccinate the vast majority of the population, the level of viruses in the community is so low that the risk of infection will be minuscule,” said Fauci this week during a virtual event held by Tufts University.
Currently, no COVID-19 vaccine is authorized for use in children under 16 years of age. But several vaccine manufacturers are already testing their vaccines on younger teens and some pre-teens, and others have pledged to do so soon.
All of this is part of an effort to protect as many Americans as possible from the virus. And it can’t be fast enough for many doctors.
The American Academy of Pediatrics called late last year for manufacturers to include children in their clinical trials, because there is no other way to judge whether vaccines are safe and effective for them.
“If we don’t add children to these research tests very soon, there will be a significant delay when children will be able to access potentially life-saving vaccines. This is unscrupulous, ”said Dr. Sara“ Sally ”H. Goza, the president of the academy at the time, in a statement late last year.
It is true that children seem to be much less impacted than adults, especially the elderly. Despite representing 22% of the US population, on March 9, children under 18 accounted for 11.6% of nearly 22 million cases and less than 0.2% of the nearly 383,000 deaths from COVID-19, according to with the Centers for Disease Control and Prevention. (The United States has more than 29 million cases and more than 527,000 deaths, according to current data from Johns Hopkins University.)
But that still represents a lot of unnecessary suffering and tragedy, said Dr. Robert Frenck, a pediatric infectious disease specialist at the Cincinnati Children’s Hospital Medical Center. CDC data show that 428,502 children aged 4 years and younger have been sick with COVID-19 since the pandemic began, and 94 of them have died. Another 2,078,245 children aged 5 to 17 years had COVID-19 and 194 died.
“These are … healthy children who should have a normal life ahead of them, and COVID has changed that,” said Frenck.
Writing in the journal Clinical Infectious Diseases, several doctors argued that vaccinating children was a critical move in the fight against the pandemic – not to mention crucial in protecting young people from unnecessary suffering and risk of death.
“The direct impact of COVID-19 on children is greater than that seen for a number of other pathogens for which we now have effective pediatric vaccines,” they wrote. “In addition, the role of children in the transmission of SARS-CoV-2 has been clearly underestimated.”
The researchers pointed out several studies that suggest that children can be effective transmitters of the virus. Among them: a series of studies comparing the levels of viruses in the respiratory tract of children with those of adults; and a CDC study of a summer camp in Georgia, where 44% of the 597 participants, interns and employees were infected.
Frenck was one of the authors of this editorial. He stressed that there are about 75 million people under the age of 18 and we will have a hard time obtaining collective immunity without them.
“If you have not vaccinated this group, you will have a large part of the population that has not been vaccinated,” he said in an interview.
Vaccine manufacturers will not have to start from scratch when they test their products on children, because they will take as a starting point the proven safety and efficacy of vaccines in adults.
For starters, companies will start with teenagers, whose responses to the vaccine should be the most similar to those seen in young adults. Then, they will work in increasingly younger groups, even babies, said Dr. Yvonne Maldonado, a pediatric infectious disease vaccinologist at Stanford University.
Pfizer, which included 16- and 17-year-olds in its Phase 3 clinical trial, has now fully entered its trial for 12-15 year olds. Younger age groups would follow.
Fauci said in an interview last month that vaccine testing for 12-year-olds aged 5 to 6 years is likely to begin around April, although it will probably take a year for the results to arrive.
“This is how we do all vaccine testing,” said Maldonado. “We always start with adults and then work with children”.
Although the researchers do not expect big surprises when it comes to the safety and efficacy of the vaccine in children, the data needs to be collected.
“Sometimes children respond to vaccines in the same way as adults, but sometimes they don’t,” said Maldonado. “It is very different for each organism, each type of disease, each vaccine – so there is no answer to that question, which is why you have to do a test each time.”
The COVID-19 vaccines from Moderna and Johnson & Johnson have been tested in adults only; as such, its use is only authorized after 18 years. Like Pfizer, Moderna began testing its vaccine on minors, while Johnson & Johnson pledged to do so in the first half of 2021. (The same happened with AstraZeneca, although its vaccine has not yet been authorized for use in any age group in the U.S.)
Dr. Richard Malley, a specialist in pediatric infectious diseases at Boston Children’s Hospital, said tests on minors will check whether vaccines are capable of inducing an immune response. Basically, the researchers will vaccinate half of their minors and give the other half a placebo and, weeks later, test their blood for antibodies to the coronavirus. These results will be compared to the levels of antibodies seen in adults.
This is slightly different from the way clinical trials are done on adults, where tens of thousands of participants received vaccines or placebos and the researchers simply watched and waited to see how many cases of COVID-19 emerged in each group. (Vaccines were found to be effective because people who took them were much less likely to get sick than people who took placebos.)
But it would take a long time to recruit enough children for this type of trial and then wait for enough COVID-19 cases to draw conclusions about its effectiveness, said Malley. So-called immunogenicity assays are much more time-efficient, in part because they are based on the idea that if vaccinated children produce antibodies at approximately the same level seen in the blood of vaccinated adults, it is reasonable to assume that children would have approximately the same level of protection.
“That is a little bit of faith,” said Malley, “but it is reasonable.”
This story originally appeared in the Los Angeles Times.