Antibody responses in those given 10 ug doses were equivalent to those seen in a prior Pfizer-BioNTech research in people aged 16 to 25 who were given 30 ug doses
The first results from the highly awaited trial evaluating the efficacy and safety of Pfizer and BioNTech’s COVID-19 vaccine for children aged 5 to 11 years old were promising.
Early results from the pharmaceutical companies’ experiment show that the vaccination is safe for youngsters and induces a high antibody response against the virus.
According to Pfizer and BioNTech, a two-dose regimen of 10 g (micrograms) administered 21 days apart was well tolerated in children aged 5 to 11. The vaccine’s side effects were likewise similar in most cases to those experienced by people between the ages of 16 and 25.
Pfizer dosage in children
The vaccine dose utilised in this trial was 10 micrograms, rather than the 30 microgram dose recommended for people aged 12 and over. For safety and efficacy in young children, this dosage was chosen as the preferred dose.
The findings come as pediatric cases of COVID-19 are on the rise amid a statewide outbreak.
“In the United States, pediatric cases of COVID-19 have increased by roughly 240 percent since July, highlighting the public health importance of vaccination. These trial results provide a solid platform for requesting FDA approval of our vaccine for children aged 5 to 11, and we intend to submit them to the FDA and other regulators as soon as possible “Chairman and CEO of Pfizer Albert Bourla stated.
Hundreds of millions of people aged 12 and older around the world have received our COVID-19 vaccine in the last nine months, and we’re excited to extend the vaccine’s protection to this younger population, subject to regulatory approval, especially as we track the spread of the Delta variant and the significant threat it poses to children,” says the company.
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Despite the positive findings, it will be some time before the immunizations for children aged 5 to 11 are officially rolled out to the entire public. Pfizer and BioNTech will submit the trial’s findings to the Food and Drug Administration for consideration and possibly emergency use authorization once the study is complete.
Even if the FDA provides such authorization, Dr Francis Collins, director of the National Institutes of Health, recently told NPR that a COVID-19 vaccination for young children ages 5 to 11 will most likely not be fully licenced until the end of 2021.
The results of the trials for youngsters under the age of five could be released later this year, according to the pharmaceutical companies.
“We started the study to analyse the immunisation of younger children in March 2021. Before the winter season began, our goal was to collect and submit data for schoolchildren to regulatory agencies all over the world “Ugur Sahin, CEO and co-founder of BioNTech, stated
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