About a year and a half after Covid vaccines were approved for emergency use in adults, these vaccines are still not available to the youngest and oldest populations. In recent months, however, in the wake of the Emicron wave, four-year-olds’ hospitalization rates have plummeted, and many parents have lost patience with immunizing their children.
“There is a sense of widespread frustration and anger because the children are the last group left,” said Sallie Permar, director of pediatrics at Will Cornell Hospital in New York.
Vaccine manufacturers are now looking to close the gap in vaccine access. On April 28, Modrena applied to the Food and Drug Administration (FDA) for an Emergency Use Permit (EUA) to make its vaccines available to children 6 months to 6 years old.
Pfizer and Bioantek plan to file a similar application for children 6 months to 5 years old by early June. Children 5 to 11 years old and adolescents between 12 and 17 years old can now receive the Pfizer and Bivantec vaccines.
The FDA recently approved a booster dose for children ages 5 to 11; Adolescents 12 to 17 years of age could already receive a booster dose. The modern vaccine is available in children over 6 years of age in some countries except the United States.
The FDA reportedly plans to consider applications from two other companies before approving the modern vaccine for American children – an issue that has sparked a wave of criticism.
Colorado Gov. Jared Polis wrote in a letter to Joe Biden: “The delay and lack of urgency on the part of the FDA and vaccine developers in approving the vaccine for children under five is a matter of concern.”
“We understand that parents are anxious to vaccinate their young children, and although the FDA cannot predict how long the data and information evaluation will take, we take every EUA request in the shortest possible time with a scientific approach,” said one FDA expert. We will review.”
To get an overview of the possible time to approve a pediatric vaccine, we review the views of academic, government, and pharmaceutical industry experts on the following questions.
When is the Covid vaccine likely to be available to children under five?
Assuming the documents are acceptable to the FDA, probably in June. Modernizers and Pfizer have been sending data to the FDA immediately for months. The FDA, after reviewing these data, provides them for Advisory Committee on Vaccines and Related Biological Products (VRBPAC) for general evaluation.
The VRBPAC is made up of independent experts in vaccine, virology and other fields and provides advice to the FDA for decision making. VRBPAC members plan to hold meetings in June to update their views on the expansion of EUAs to the child population.
EUAs are likely to be issued a few days after these meetings are concluded, but there is no guarantee.
“We may recommend more limited permits,” said Arnold Monto, president of VRBPAC and epidemiologist at the University of Michigan. “For example, we might recommend that the vaccine only be given to children whose pre-existing conditions make them worse off when they get Covid.”
Children are less likely than adults to develop severe cavitation, so the risk-benefit equation is different for them. VRBPAC members may find the vaccine risk lower for healthy children.
Why have vaccination licenses for children under the age of five been extended?
There are several reasons for this delay. Because the risk of death and serious illness was higher in adults, early clinical trials first prioritized vaccine development for older age groups.
According to Kathryn Edwards, a pediatrician at Vanderbilt University, testing new safety methods on preterm adults is the standard contract for vaccine development. “We have to be very careful about giving new vaccines to healthy children.”
Pfizer, Bivantec and Moderna have been trying for months to balance their immunity against Quid and their possible side effects by testing their vaccines at different doses and changing their number. Moderna received two 25-microgram vaccines for young children, while the Pfizer and Bivantek vaccines included three consecutive doses of three micrograms.
The FDA held a meeting with the VRBPAC in February to evaluate the Pfizer-Bivantec request, but the meeting was postponed because only double-entry data was available.
“We were asked to assume the third dose would be more effective, when it might or may not be true,” said Paul Offit, a Philadelphia Children’s Hospital specialist and a member of the VRBPAC.
Do vaccines cause side effects or health concerns in young children?
Messenger RNA (mRNA) vaccines are somewhat reactive and can cause fever, pain, restlessness, and other inflammatory reactions. Fever is a particular concern, as it can cause seizures in children.
However, the evidence so far shows that children with very low doses of the vaccine become highly resistant to the SARS-CoV-2 virus. “This is very important to reduce side effects,” Permar said.
Another concern is the low-risk but growing risk of myocarditis (inflammation of the heart muscle), which is most common in adolescents 12 to 17 years of age. However, according to Afit, more than eight million children between the ages of 5 and 11 in the United States have been vaccinated with Pfizer-Bivantek vaccine, and there is no evidence of myocarditis among them.
“Whether or not the absence of myocarditis is seen in younger vaccinated children is a matter for us to wait and see,” he said. “But the data so far has been promising.”
What are the benefits of vaccinating young children?
More than 1,000 children have died in the United States from Covid, and thousands more have been hospitalized. “We are also concerned about Covid’s effects on brain development,” says Permar, referring to Covid’s effects on smell and taste in adults (which may be related to the effect of SARS-CoV-2 on the central nervous system).
Emphasizing the need for vaccines for all age groups, Permar adds that vaccine doses can provide resistance to another side effect of Quid: Polycystic Inflammation Syndrome in Children (MIS-C), which in some cases has been fatal. .
Is the FDA waiting to evaluate the modern data after the Pfizer data arrives?
FDA official Robert Califf has denied in an interview that the FDA is waiting to consider modern and Pfizer applications at the same time. “Certainly there is no reason for the FDA to wait,” he said.
The FDA also notes that it is preparing VRBPAC sessions to expand vaccine age groups. The meetings will take place in June, when Pfizer and Bivantec are scheduled to submit their applications.
What data will the FDA consider for decision?
Aside from safety, one of the main considerations will be how the vaccine will work against symptomatic diseases.
In December 2020, when the vaccines were first approved, the Pfizer-Bivantec vaccine provided 95% resistance to severe diseases, and the modern vaccine provided 94.1%. According to Moderna, the company’s vaccines have a much lower rate of effectiveness in children under the age of six: 37 to 51 percent.
Pfizer and Bivantek recently announced that three doses of their vaccine in children under the age of five provide 80% resistance to symptomatic disease.
Both vaccines target older strains of the virus that have long been replaced by newer strains. Species such as Amicron and their subspecies are better able to escape vaccine safety – this explains why the rate of effectiveness in pediatric trials is lower.
“Fortunately, we still see tremendous immunity to severe disease in all age groups of vaccinated people, and that immunity is stable against all warts of the virus,” says Afit.
It remains to be seen whether the modern vaccine will be less effective than the FDA’s strict standards. But in his interview, Calif noted that despite this rate, the possibility of modernizing the vaccine could not be ruled out.
There are also secondary considerations to evaluate the vaccine’s effectiveness in removing neutralizing antibodies against the disease. However, Ofer Levy, a member of the VRBPAC and head of the precision vaccination program at Boston Children’s Hospital, emphasizes that the degree of correlation between antibodies and immunity to the disease is unclear.
Why do some parents whose children qualify for the vaccine delay getting vaccinated?
Research on US Quid vaccines in the United States shows that about one-third of parents are willing to vaccinate their 5- to 11-year-olds immediately, one-third refuse to do so, or only if forced to, and one-third. Others are in the range between the two groups.
Opposition parents say the Covid vaccine is unnecessary for children, or that they are skeptical of the technology used by pharmaceutical companies or their profit motives, according to Levy.
At the same time, recent data show that 75% of US children and adolescents are already infected with the SARS-CoV-2 virus. But Monto says that number should not deter parents from immunizing their children.
“The immunity you get from getting sick is the immunity you get from getting sick,” he says. And “It’s not vaccination.”