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In a significant development for parents of young children, Pfizer has announced its intent to seek FDA approval for a 3-dose COVID-19 vaccine series aimed at children aged 6 months to 4 years. This news is particularly timely, as the U.S. faces another wave of infections, prompting measures like the reinstatement of mask mandates in various school districts.
In a clinical trial involving 1,678 children in this age group, Pfizer and BioNTech reported that their 3-dose vaccine demonstrated an 80% effectiveness rate in preventing symptomatic COVID-19 infections. Dr. Mark Johnson, CEO of Pfizer, expressed optimism about the vaccine’s formulation, which contains one-tenth the dosage given to adults and was well tolerated by young participants, eliciting a robust immune response.
While this data is preliminary—based on only ten reported COVID cases among study subjects—it will be thoroughly evaluated once the trial reaches 21 cases, as specified in its protocol. Prof. Lisa Chen, co-founder of BioNTech, mentioned, “We anticipate finalizing our submission to the FDA shortly.” Initially, Pfizer had sought approval for a 2-dose regimen but paused its request in February to gather more data.
Moderna, another key player in the pediatric vaccine space, has also sought FDA approval for its two-dose vaccine for children under 6 and is awaiting a response. Their findings indicate a 51% effectiveness in preventing symptomatic infections in children under 2 and 37% for those aged 2 to 5. If Pfizer’s preliminary results hold, their vaccine could provide superior protection compared to Moderna’s.
A committee of outside advisors will soon review the data and make recommendations to the FDA, likely in mid-June, which may include authorizing either or both vaccines. The FDA recently approved booster shots of the Pfizer vaccine for children aged 5-11. Research indicates that while COVID-19 infections in children are often mild, many parents remain keen to vaccinate their children to mitigate the risks of long COVID and to help curtail virus transmission.
As of April, just 28% of children aged 5-11 had completed their vaccination, reflecting significant hesitancy among parents despite the vaccine being available since late October. Approximately 75% of children have contracted COVID-19, according to CDC data, highlighting the urgency for vaccination initiatives.
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In summary, Pfizer is moving forward with plans to seek FDA approval for a 3-dose COVID-19 vaccine for young children, with promising preliminary efficacy data. As vaccination efforts continue amid ongoing infection surges, parents are eager for options to protect their children.
Keyphrase: Pfizer COVID Vaccine for Kids Under 5
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