BOSTON – Parents of children under the age of 5 will have to wait a little longer to get them vaccinated against COVID-19 following an unexpected delay in federal approval.
Pfizer and BioNTech have announced that they are postponing a request to the U.S. Food and Drug Administration to approve their COVID-19 vaccine for younger children until April. The companies mentioned the need for more data on the effectiveness of a three-shot, lower-dose regimen for children aged 6 months to 4 years.
“Given that the investigation is progressing at a rapid pace, companies will wait for three-dose data, as Pfizer and BioNTech continue to believe that it can provide a higher level of protection in this age group,” Pfizer said in a statement. .
The FDA, which was expected to take up Pfizer’s request on Tuesday, granted the request to delay the process. Dr. Peter Marks, head of the FDA’s vaccine safety department, said the sudden decision to postpone the approval should “assure” parents that the agency will make sure the vaccine is safe and effective for young children.
“We take our responsibility to review these vaccines very seriously because we are also parents,” Marks told reporters in a conference call Friday.
But the delay is likely to frustrate parents and caregivers who have been waiting to have their children vaccinated. Children 5 years of age and under are the only age group who have not been approved to receive the COVID-19 vaccines. Children ages 5 to 11 were the most recent after receiving FDA approval in November to be vaccinated.
While young children have been spared the worst health effects from COVID-19, public health authorities say they can still become infected and spread the disease. They are also vulnerable to pediatric multi-system inflammatory syndrome, a post-infection complication of COVID-19 that may involve severe symptoms.
“Younger children have a very low risk of serious infections and hospitalizations, but they can still become infected and release a lot of viruses,” said Dr. David Hamer, an infectious disease expert and professor at Boston University’s School of Public Health and Public Medicine. “So to have full vaccine coverage, we really need to reach this age group.”
The FDA said the results of clinical trials showed that the pediatric vaccine, approved for 5- to 11-year-olds, is nearly 91% effective in preventing symptomatic COVID-19.
Pfizer said it began studying the third shot after clinical research showed that the first two doses did not produce an adequate immune response in children aged 2 to 4 years.
Hamer says it is not clear why a third dose may be required, but noted that younger children’s immune systems are not fully developed.
The U.S. Centers for Disease Control and Prevention announced over the weekend that it plans to roll out 10 million doses in multiple phases as soon as the FDA approves pediatric doses for children ages 6 months to 4 years. Massachusetts and other states were expected to begin pre-ordering the doses as early as this week.
Overall, the state’s public health surveys have improved as the winter rise, driven by the highly contagious omicron variant, begins to decline.
The latest data from the state Department of Public Health shows that new COVID-19 infections and hospitalizations have dropped in recent weeks.
Despite the improved conditions, the agency noted that of the new virus cases reported in the last two weeks, at least 4,496 children under 5 years of age were involved.
Christian M. Wade covers the Massachusetts Statehouse for the newspapers and websites of the North of Boston Media Group. Email him at [email protected]