(MENAFN- NewsBytes) The COVID-19 vaccine developed by Pfizer and BioNTech has been found safe for children between five to 11 years of age and generates a "robust" immune response, the companies said on Monday. They had tested a two-dose regimen of a smaller dosage on the said age group. Meanwhile, the clinical trial data for subjects aged 6-months-old to 5 years old is expected by October-end.
In this article
- 'Side-effects comparable to those in 16-25 demographic'
- Data to be submitted to health regulators ASAP: Pfizer CEO
- Children not prone to severe COVID-19; but Delta heightens worry
- Israel already allows Pfizer for vulnerable kids aged 5-11
- FDA to announce decision on booster doses this week
Statement 'Side-effects comparable to those in 16-25 demographic'
Pfizer and BioNTech said in a statement on Monday that the companies tested a two-dose regimen of 10 micrograms (roughly a third of the dose administered to adults and teenagers). The two doses were administered three weeks apart. The vaccine 's side effects—which include fatigue, headache, muscle pain, chills, fever, and nausea—were comparable to those observed in the 16-25 age group, the companies said.
Regulatory approval Data to be submitted to health regulators ASAP: Pfizer CEO
Pfizer CEO Albert Bourla said the data will be submitted to the US Food and Drug Administration and other health regulators "as soon as possible." Bourla said, "We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children."
Context Children not prone to severe COVID-19; but Delta heightens worry
Children are not as prone to developing a severe case of COVID-19 , however, the more contagious Delta variant could upset the apple cart. Vaccinating kids is also a key step toward reopening schools and resuming normal life. However, several parents are anxious to get their children vaccinated. The Pfizer-BioNTech vaccine has already been approved for those aged over 12 by the US FDA.
Other details Israel already allows Pfizer for vulnerable kids aged 5-11
However, in Israel , children aged 5-11 who are "at significant risk of serious illness or death" from COVID-19 are already being administered vaccines using a lower dose of the Pfizer shot. Vaccine trial data for children aged 6-months-old to 5 years old is expected by October-end. Up to 4,500 children in that demographic have enrolled in trials in Finland, Poland, Spain, and the US.
Information FDA to announce decision on booster doses this week
The companies did not mention whether the kids trialed in the 5-11 age bracket experienced myocarditis , a side-effect that causes inflammation of the heart muscle. Separately, this week, the FDA is expected to announce its decision on which groups are eligible for a booster dose.
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