FDA says Moderna vaccine for youngest children is safe and effective
Source: Washington Post
Scientists at the Food and Drug Administration on Friday said Modernas coronavirus vaccine for infants and young children was safe and effective, setting the stage for a review by the agencys outside advisers Wednesday and a potential authorization by the end of the week.
The analysis was released in briefing documents ahead of next weeks meeting, when the independent advisers also will consider whether a vaccine by Pfizer and its German partner, BioNTech, should be authorized for the youngest children. Babies and children younger than 5 a group numbering 19 million remain the only age group in the United States still not eligible for a coronavirus vaccine.
Moderna has asked the FDA for permission to use its vaccine in children 6 months through 5 years old. The Pfizer-BioNTech request is for children 6 months through 4 years old. The FDA is expected to release its assessment of the Pfizer-BioNTech vaccine in the next few days.
The FDA said the Moderna two-shot regimen for the youngest children met the main requirement set by regulators that it generate an immune response at least as strong as the protection afforded young adults. The vaccine, according to data from the company and confirmed by the FDA, was only somewhat effective in preventing illness among the youngest group of recipients, reflecting the impact of the highly transmissible omicron variant, which has blunted the power of the vaccine in adults as well.
Read more: https://www.washingtonpost.com/health/2022/06/10/moderna-coronavirus-vaccine-young-children-fda-analysis/
FDA is scheduled to discuss/vote on the final EUA for Moderna's request for both infants (6 months) - 5 years old and subsequently in another meeting for children/adolescents 6 - 17 years old.
Currently Pfizer is the only brand with an EUA for ages 5 - 17.
greatauntoftriplets
(175,731 posts)My 4 1/2 year-old great niece currently has COVID for the third time. She caught it from her vaxxed and boosted mother, who has it for the second time.
BumRushDaShow
(128,748 posts)Sorry to hear that. Omicron has really been a mess.
greatauntoftriplets
(175,731 posts)All three of her kids had it in January. Her older girls caught it at school. She was fine that time. This time she likely caught it at work. She's an NP.
MyOwnPeace
(16,925 posts)My daughter has a 5yr. old and a 2yr. old - and yet another one due any day now.
This REALLY opens up their ability to be somewhat 'reasonable' regarding public appearances with the family - precautions taken regardless - but still - a somewhat 'relaxed' way to have a 'normal' life (whatever 'normal' is anymore!).
Rhiannon12866
(205,110 posts)And that's what I got as well!
weissmam
(905 posts)orleans
(34,044 posts)i have a grandbaby under two years
this does not quell my daughter's concern regarding her child getting covid and possibly being one of the unfortunates that develop long-haul covid
TomSlick
(11,096 posts)I would love to see my three year old grandson and his two infant sisters vaccinated as soon as possible.