American parents Those who want to vaccinate their young children against Covid-19 could face a growing set of challenges this fall.
The U.S. Food and Drug Administration may not renew Pfizer’s Covid-19 vaccine approvals for children under the age of five, the Centers for Disease Control and Prevention told state and local health officials Friday.
“This decision will affect Pfizer’s pediatric COVID-19 vaccine for children aged 6m to 4 during the 2025-2026 season,” the CDC’s National Center for Vaccinations and Respiratory Diseases said in an email obtained by CNN.
In May, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer recommend the Covid-19 vaccine to healthy children and pregnant women. The CDC’s vaccination schedule was updated to reflect the availability of children with vaccines after consultation with health care providers. This is known as “shared decision making.”
However, without FDA permission, Pfizer’s Covid-19 vaccine will no longer be available to children under the age of five, and Moderna’s Covid-19 vaccine, another option available to healthy children without underlying conditions in this age group, must be given a “label” by an aspiring pharmacist or physicist.
Dr. Paul Offit, pediatrician and director of the Center for Vaccine Education at the Children’s Hospital of Children’s Hospital, said this is inconsistent with shared clinical decision-making intentions.
“Shared clinical decisions assume you are making decisions for that child, whether they are healthy or not.
The Covid-19 vaccine was first made available to Americans during a pandemic under an emergency use permit known as the EUA.
Pfizer has fully approved FDA approval for the COVID-19 vaccine for individuals aged 12 and older since 2022. The company expects the approval to expand from age 5 to 11 for the upcoming respiratory virus season, according to an email sent Friday to the CDC’s National Vaccination Centre and local health officials.
However, access to the vaccine for the youngest children, the most vulnerable to severe illnesses caused by Covid-19 infection, will be significantly limited if the FDA does not renew emergency approval for the Pfizer vaccine for children under the age of 5.
Pfizer confirmed to CNN that the FDA may not renew the emergency use permit or Pfizer BioNTech COVID-19 vaccine for children aged 6 months to 4 years.
“We are currently discussing potential path advancements with our agents and are calling for the EUA in this age group to remain in existence for the 2025-2026 season,” Pfizer said in a statement. “It is important to note that these deliberations have no relation to the safety and efficacy of vaccines that continue to demonstrate a favorable profile.”
Fatima Khan, co-founder of the nonprofit grassroots group, said in a statement that sheltering the future of advocating access to vaccines for children, “It’s pointless to take a proven, safe and effective vaccine away from vulnerable children.”
“The science is clear. Infants face a Covid-19 hospitalization rate comparable to those over 65 years old. They don’t protect them if they refuse to allow it for children under the age of five. “Parents are already struggling to protect the youngest, as they have limited access to vaccines. Now, once schools reopen, protections could disappear completely this fall.
Modanya also has a Covid-19 vaccine available to children under the age of 11. It was fully approved by the FDA in July, but was given only to people who are “at high risk of Covid-19 disease.”
Moderna plans to increase vaccine supply for children “helps reduce potential supply gaps,” according to a CDC email sent Friday, but Moderna We are still deciding on a specific volume and timing.
Like influenza vaccines, Covid-19 vaccines are usually updated with formulations that best target the circulating virus strains each season. However, the FDA has not yet approved the development of the 2025-2026 season.
“I think the bottom line means that kids are likely to be less likely to take this vaccine, which is contrary to the data,” Offit said.
At a meeting in April, the CDC’s Vaccine Advisory Committee heard evidence that children accounted for around 4% of Covid-19 hospitalizations over the respiratory virus season last year.
According to CDC data, the rate of Covid-19 hospitalization in children is the highest for the youngest age group. During the last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under the age of five. It was almost seven times more than older children, and more than twice as many adults under the age of 50.
“That’s the war with mRNA vaccines. Why? Because mRNA vaccines are political now,” Offit said. “It’s a war on science, a war on data, and we’ll suffer from this, and here’s what I fear most:
According to the CDC, Covid-19 levels are rising in the US, with transmissions increasing in at least 45 states.
In a statement to CNN, the U.S. Department of Health and Human Services said the agency had not commented on potential regulatory changes.
“The Covid-19 pandemic ended with the expiration of the federal public health emergency in May 2023,” spokesman Andrew Nixon said in an email. “Unless it is officially announced by the HHS, any discussion of future institutional actions should be considered pure speculation.”
