Pfizer has begun testing its Kovid-19 vaccine in children under 12, an important step to bring back the epidemic. The first participants of the trial, a pair of 9-year-old twin girls, were immunized at Duke University in North Carolina on Wednesday.
Sharon Castillo, a spokesman for the pharmaceutical company, said the results of the test are expected to come in the second half of the year and the company hopes to vaccinate young children early next year.
Modern is also starting a trial of its vaccine in children from six months to 12 years. Both companies are testing their vaccines in children 12 and older, and those results are expected in the next few weeks.
AstraZeneca began testing its vaccine in children six months and older last month, and Johnson & Johnson says it has plans Expand its vaccine Young children after assessing its performance in young children.
Vaccinating children will help reopen schools as well as help end the epidemic, Drs. Emily Erbelding, an infectious diseases physician at the National Institutes of Health who oversees testing of Kovid-19 vaccines in special populations.
An estimated 80 percent of the population may need vaccination for the United States to access herd immunity, the threshold at which coronovirus originates to infect people. Some adults may refuse vaccination, and others may not produce a strong immune response.
About 23 percent of the population in the United States has children under the age of 18, even though a large proportion of adults opt for vaccination, “it can be difficult to get herd immunity without vaccinating children,” Dr. Irbeling said.
Pfizer initially stated that it would wait for data on older children before starting its vaccine test in children under 12 years of age. But Ms. Castillo said, “We were encouraged by data from the 12 to 15 group, which do not go into detail about this.” Results so far.
The scientists will test three doses of the Pfizer vaccine – 10, 20 and 30 micrograms – in 144 children. Each dose will be assessed first in 5-year-old children aged 5, then in children aged 4 to 2 years, and finally in children from the youngest age of six months to 2 years.
After determining the most effective dose, the company will test the vaccine in 4,500 children. About two-thirds of participants will be randomly selected to receive two doses 21 days apart; The remainder will get two placebo shots of Khara. Researchers will assess children’s immune responses in the blood seven days after the second dose.
“It sounds like a good plan, and it’s exciting that another Kovid-19 vaccine is moving forward with testing in children,” said pediatrician and vaccine specialist Dr. Mount Sinai Hospital in New York. Kristin Oliver said.
Dr. Oliver said that in practice about half of his parents are waiting impatiently for vaccines, and even waiting for clinical trials of their children, while all the rest are skeptical Because comparatively few children become seriously ill with coronovirus infection.
Both groups of parents will benefit from knowing how safe and effective vaccines are in children.
Children represent 13 percent of all reported cases in the United States. More than 3.3 million children have tested positive for the virus, at least 13,000 have been hospitalized and at least 260 have died, Drs. Mentioned by Yvonne Maldonado, who represents the American Academy of Pediatrics on the Federal Advisory Committee on Immunization Practices.
The figures do not fully capture the damage to children’s health. “We don’t know what the long-term effects of the Kovid infection are going to be,” Drs. Maldonado said.
Other vaccines have helped control many dreadful childhood illnesses that can lead to long-term complications, she said: “For some of us who have seen this, we don’t want to go back to those days.”
Children often react to vaccines more strongly than adults, and infants and children in particular may experience high fever. Experts have said that any side effects are likely to be seen immediately after the shot.
Some vaccines are tested only in animals before being evaluated in children, and should be carefully monitored for side effects.
“But it’s a little different, because we already have millions of people with these vaccines,” Dr. Maldonado said. “So there is now more confidence in giving this vaccine to children.”
Some experts suggested that the Food and Drug Administration may require six months of safety data from children’s studies before authorizing Kovid-19 vaccines. But a spokeswoman said the agency did not expect six months of safety data in support of the vaccine’s authorization.
The Pfizer-BioNotech vaccine is authorized for 16-to-18-year-olds, and the authorization for that age group was based on only two months of safety data, she said.
Parents would like to know how the companies and the FDA plan to monitor and disclose side effects from vaccines, and how long they will continue to follow test participants after vaccine authorization, Drs. Oliver said.
“I think everyone has learned it all,” he said. “The more transparent you can be, the better.”