Pfizer has begun testing its COVID-19 vaccine in children
younger than 12, a significant step in turning back the pandemic. The trial’s
first participants, a pair of 9-year-old twin girls, were immunized at Duke
University in North Carolina on Wednesday.
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Results from the trial are expected in the second half of
the year, and the company hopes to vaccinate younger children early next year,
said Sharon Castillo, a spokeswoman for the pharmaceutical company.
Moderna also is beginning a trial of its vaccine in children
6 months to 12 years of age. Both companies have been testing their vaccines in
children 12 and older, and expect those results in the next few weeks.
AstraZeneca last month began testing its vaccine in children
six months and older, and Johnson & Johnson has said it plans to extend
trials of its vaccine to young children after assessing its performance in
older children.
Immunizing children will help schools to reopen as well as
help to end the pandemic, said Dr. Emily Erbelding, an infectious diseases
physician at the National Institutes of Health who oversees testing of COVID-19
vaccines in special populations.
An estimated 80 percent of the population may need to be
vaccinated for the United States to reach herd immunity, the threshold at which
the coronavirus runs out of people to infect. Some adults may refuse to be
vaccinated, and others may not produce a robust immune response.
Children younger than 18 account for about 23 percent of the
population in the United States, so even if a vast majority of adults opt for
vaccines, “herd immunity might be hard to achieve without children being
vaccinated,” Erbelding said.
Pfizer had initially said it would wait for data from older
children before starting trials of its vaccine in children younger than 12. But
“we were encouraged by the data from the 12 to 15 group,” said Castillo, who
did not elaborate on the results so far.
Scientists will test three doses of the Pfizer vaccine — 10,
20 and 30 micrograms — in 144 children. Each dose will be assessed first in
children 5-11, then in children 2-4, and finally in the youngest group, 6
months to 2 years.
After determining the most effective dose, the company will
test the vaccine in 4,500 children. About two-thirds of the participants will
be randomly selected to receive two doses 21 days apart; the remaining will get
two placebo shots of saline. The researchers will assess the children’s immune
response in blood drawn seven days after the second dose.
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, noted Dr.
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 COVID infection
are going to be,” Maldonado said.
Other vaccines have helped to control many horrific
childhood diseases that can cause long-term complications, she added: “For some
of us who’ve seen that, we don’t want to go back to those days.”
Children often react more strongly to vaccines than adults
do, and infants and toddlers in particular can experience high fevers. Any side
effects are likely to appear soon after the shot, within the first week and
certainly within the first few weeks, experts have said.
Some vaccines are tested only in animals before being
assessed in children and have to be monitored carefully for side effects.
“But this is a little different, because we’ve already had
experience with tens of millions of people with these vaccines,” Maldonado
said. “So there’s a higher degree of confidence now in giving this vaccine to
kids.”
Some experts suggested that the Food and Drug Administration
may require up to six months of safety data from studies of children before
authorizing the COVID-19 vaccines. But a spokeswoman said the agency did not
expect six months of safety data to support the vaccines’ authorization.
The Pfizer-BioNTech vaccine is authorized for children
16-18, and the authorization for that age group was based on just two months of
safety data, she said.