Pfizer says its Kovid vaccine is safe, effective for children aged 5-11 years

“Antibody responses given a 10 microgram dose in participants were similar to those reported in a previous Pfizer-BioNTech study immunized with a 30 microgram dose in people aged 16 to 25 years. Safety in children 5 to 11 years of age, The 10 µg dose was chosen as the preferred dose for tolerability and immunogenicity,” US Pharma Head pfizer and its German partner said in a joint statement on Monday.

“We are delighted to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO of BioNtech. The safety profile and immunogenicity data in the years vaccinated at low doses are consistent with those we have seen with our vaccine at higher doses in other older populations.”

Pfizer-BioNtech plans to submit its data to regulatory bodies The European Union, “as soon as possible” in the United States and around the world.

The test results are the first of its kind for children under 12, with the Moderna trial still ongoing for children aged six to 11. Both Pfizer and Modern jabs are already being offered to teens and adults over the age of 12 in countries around the world.

Although children are thought to be at low risk of severe COVID, there are concerns that the highly contagious delta variant could lead to more severe cases. Innocent children are also seen as a key to keeping schools open and helping end the pandemic.

“We are eager to expand the protection afforded by the vaccine to this young population,” said Pfizer CEO Albert Bouerla, noting that “as of July, pediatric cases of COVID-19 in the U.S. have approximately 240 percentage has increased.

Initially 4,500 children aged 6 months to 11 years were enrolled from more than 90 clinical trial sites in the United States, Finland, Poland and Spain for the trials. Pfizer-BioNTech. was designed to evaluate the safety, tolerability and immunogenicity of covid vaccine on a two-dose schedule (approximately 21 days apart) in three age groups – ages 5 to 11; 2 to 5 years of age; And age from 6 months to 2 years.

Based on the Phase 1 dose-escalation portion of the trial, children 5 to 11 years of age received a two-dose schedule of 10 micrograms, while children younger than 5 years of age received each injection in the Phase 2/3 study. Received a lower 3 microgram dose. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

The company’s statement said the side effects were “compared to those commonly seen in participants aged 16 to 25”.

The most commonly reported side effects in the past have included pain and swelling at the injection site as well as headache, chills, and fever.

Israel has already given special authorization to vaccinate children aged 5-11 years “at significant risk of serious illness or death” from COVID, using the Pfizer jab at a low dose.

Pfizer and BioNTech are also testing their vaccines on infants between the ages of six months and two years and those between the ages of two and five.

The companies said top results for those tests are expected “soon” in the fourth quarter of this year.

In total, 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNtech trials in the US, Finland, Poland and Spain.

Like its modern rival, the Pfizer jab is based on novel mRNA technology that gives cells genetic instructions to make a coronavirus spike protein, so that the body can produce antibodies when it encounters the actual virus.