Covid-19 vaccine availability for children faces FDA roadblock -……
Parents could discover it tough to get their youngsters vaccinated (Image: Getty)
As Autumn rolls around, dad and mom in the US who need to vaccinate their younger children against COVID-19 could discover it trickier to do so this 12 months.
According to the US Centres for Disease Control and Prevention, the US Food and Drug Administration could not renew authorization for Pfizer’s COVID-19 vaccine for children youthful than 5.
In an e-mail despatched on Friday that was obtained by GWN, the CDC’s National Centre for Immunisation and Respiratory Diseases said: “This determination would have an effect on Pfizer’s pediatric COVID-19 vaccine for children aged 6 months to 4 years for the 2025–2026 season.”
Earlier in May this 12 months, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer suggest vaccines for healthy children or pregnant girls.
The CDC’s immunization schedule has now been up to date so that children can only get vaccines after consulting with a health care supplier, a course of called “shared decision-making.”
This poses important adjustments to the way in which the vaccine is made obtainable, and without the FDA’s approval, Pfizer’s Covid-19 vaccine would no longer be obtainable to any children youthful than 5. Additionally, Moderna’s Covid-19 vaccine, would have to be given “off label” by a pharmacist or doctor.
According Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, this contradicts the thought of the shared determination making course of.
He told GWN, “Shared clinical decision-making assumes that you’re making a decision for that child, whether they’re healthy or not healthy. So now it’s confusing.”
Since 2022, Pfizer has secured full FDA approval for its vaccine for people aged 12 and above. Based on the CDC’s Friday e-mail, the company now anticipates this approval will lengthen to younger children aged 5 to 11 for the approaching respiratory virus season.
Last virus season there have been 48 Covid-19 hospitalizations for every 100,000 children under 5 (Image: Getty)
As Autumn rolls around, dad and mom in the US who need to vaccinate their younger children against COVID-19 could discover it trickier to do so this 12 months.
According to the US Centres for Disease Control and Prevention, the US Food and Drug Administration could not renew authorization for Pfizer’s COVID-19 vaccine for children youthful than 5.
In an e-mail despatched on Friday that was obtained by GWN, the CDC’s National Centre for Immunisation and Respiratory Diseases said: “This decision would affect Pfizer’s pediatric COVID-19 vaccine for children aged 6 months to 4 years for the 2025–2026 season.”
Earlier in May this 12 months, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would no longer suggest vaccines for healthy children or pregnant girls.
The CDC’s immunization schedule has now been up to date so that children can only get vaccines after consulting with a health care supplier, a course of called “shared decision-making.”
Covid 19 is still current and infecting people (Image: Getty)
However, vaccine availability for the youngest children, who face the best risk of extreme sickness from Covid-19 infection, might be dramatically restricted if the FDA chooses not to renew emergency authorization for the Pfizer vaccine for those under 5.
Pfizer confirmed to GWN that the FDA has indicated it may not lengthen the emergency use authorization for the Pfizer-BioNTech Covid-19 vaccine for children aged 6 months to 4 years.
In a assertion, Pfizer said, “We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season.
“It is important to notice that these deliberations will not be associated to the protection and efficacy of the vaccine which continues to show a favorable profile.”
Meanwhile, Moderna plans to boost the supply of vaccines for children to “help mitigate any potential provide hole,” according to the CDC email sent on Friday. However, the specific volume and timing are still being determined.
Similar to flu vaccines, COVID-19 vaccines have routinely been updated with formulations that best target the virus strains circulating each season.
However, the FDA has not yet approved the formulation for the 2025-2026 season.
Worryingly, CDC data reveals that the youngest age groups are experiencing the highest rates of COVID-19 hospitalizations. During the last respiratory virus season, there were 48 Covid-19 hospitalizations for every 100,000 children under 5 – nearly seven times the rate for older children and more than twice the rate for adults under 50.
US Department of Health and Human Services spokesperson Andrew Nixon said in an email to GWN, “The COVID-19 pandemic ended with the expiration of the federal public health emergency in May 2023. Unless formally announced by HHS, dialogue about future company motion needs to be regarded as pure hypothesis.”
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