Pfizer-BioNTech announced Monday that three modified doses of its COVID-19 vaccine offer strong protection for children ages six months to five years, a crucial step, said Long Island heath experts, toward vaccinating the youngest against the disease.
The roughly 18 million children under the age 5 are the only group in the United States not yet eligible for the shot.
"It's important that we get a vaccine for this age group," said Dr. Sharon Nachman, chief of pediatric infectious diseases at Stony Brook Children's Hospital. "It would be very bad medicine to have a vaccine for adults and older children, and nothing for the most vulnerable children."
With vaccine hesitancy for children ages 5 to 12 still high on Long Island — even as COVID-19 cases spike across the country — it remains unclear how many parents will ultimately vaccinate their infants, toddlers and preschoolers.
What to know
- Pfizer-BioNTech said that three modified doses of its COVID-19 vaccine offer strong protection for children ages six months to five years.
- The roughly 18 million children under the age of 5 are the only group in the United States not yet eligible for the shot.
- Children under five would receive three 3-microgram doses, with each one equal to one-tenth the amount adults receive.
Children between 5 and 11 have been eligible to receive the Pfizer shot since November.
In New York State, less than 42% of children between 5 and 12 have been vaccinated, according to state health department data. In Nassau, that number is 43.6%, while in Suffolk, it's considerably lower at less than 31%.
Preliminary data released by Pfizer-BioNTech of 1,678 children found its three-dose series is 80% effective in preventing symptomatic COVID-19, with a majority of side effects being mild to moderate.
Children under five would receive three 3-microgram doses, with each equal to one-tenth the amount adults receive. The trials occurred when omicron was the dominant variant nationwide.
Pfizer-BioNTech trials from earlier this year were less successful as youngsters receiving two doses of the pediatric COVID-19 vaccine did not garner strong protection against the virus, the company said.
"We look forward to soon completing our submissions to regulators globally with the hope of making this vaccine available to younger children as quickly as possible," said Albert Bourla, Pfizer-BioNTech's chairman and chief executive.
The company cautioned its test results are based on just 10 COVID-19 cases diagnosed among study participants through the end of April. At least 21 cases are needed to formally determine effectiveness, and Pfizer said an update will come as more data is available.
The Food and Drug Administration has also begun evaluating data from drugmaker Moderna, which hopes to begin offering two modified COVID-19 shots by the summer for children six months to five years
The FDA announced Monday that its committee of independent vaccine experts would meet June 15 to discuss Pfizer-BioNTech's and Moderna’s applications and make a recommendation whether to authorize the shots.
“We know parents are anxious for us to determine if these vaccines are safe and effective,” the agency wrote on its Twitter page. “We are working as quickly as possible to carefully review all the data.”
While many young children who contract COVID-19 develop only mild symptoms, some do get severely ill and run the risk of passing the virus on to vulnerable, older adults, said Dr. Matthew Harris, medical director of the Northwell Health Vaccine Program.
"In the last omicron surge, children under the age of five represented a majority of pediatric infections; the majority of children presented to the emergency room and the majority of children getting admitted," Harris said. " … So this really is the last group that we need to target for vaccination. And the numbers for this three-dose regimen seem more promising than the prior two-dose regimen."
A recent national survey by the Kaiser Family Foundation showed that approximately 18% of parents of children under 5 were “eager” to get them vaccinated right away, while about 38% said they wanted to wait and see how the vaccine works with others.
Nachman said she anticipates a pediatric COVID-19 vaccine will eventually become routine, particularly as parents take their children to pediatricians before school in the fall.
"It's going to change over time," she said. "I think there are parents that clearly recognize the importance of the vaccine and will get it right away. And then I think we will see a shift of the vaccine moving into routine pediatric practice and being prescribed and administered in August before school starts again."
Last week, the FDA approved a Pfizer-BioNTech booster shot against COVID-19 for children ages 5 to 11 who had their second dose at least five months ago.
The COVID-19 positivity rate on Sunday was 9.1% statewide, or just over 8% on a 7-day average, according to state health department data. On Long Island, the positivity rate was 10.4% with 632 new cases in Nassau and 592 in Suffolk. There were 24 COVID-19 deaths statewide Sunday, including one in Suffolk.
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