The two companies stated in a statement that the vaccine will be given at a lower dose for this category, than that given to adults, 12 years and older. They confirmed that they will submit their statements to the regulatory bodies in the European Union, the United States and around the world “as soon as possible.”
Today with @BioNTech_Group, we are proud to announce positive topline results from the pivotal trial of our COVID19 vaccine in children 5-11 years of age. https://t.co/a1mSEgxNHQ pic.twitter.com/9xGfYEzFuy
— Pfizer Inc. (@pfizer) September 20, 2021
These are partial results of a study of 4,500 children between the ages of six months and 11 years in the United States, Finland, Poland and Spain.
And Pfizer Pharmaceutical Industries was planning to apply for approval by the US Food and Drug Administration “FDA”, to be able to give the vaccine against the emerging corona virus to children between 6 months and 5 years, in November.
According to a document presented by the company during a health conference, it was planning to apply for approval to use the vaccine for children between 5 and 11 years, in early October.
This is the first clinical data issued for this age group.
The document pointed out that applying for a license to give the vaccine to those aged between 6 months and 5 years will come within a few weeks of applying for the 5-11-year-old category, if all the necessary data were positive.
“Since July, pediatric cases of COVID-19 have increased by nearly 240 percent in the United States, which highlights the public health need for vaccination,” Pfizer CEO Albert Burla said in a press release.
“These trial results provide a strong basis for seeking authorization for our vaccine for children aged 5-11 years, and we intend to file applications with the FDA and other regulators expeditiously.”
The two companies’ vaccine, called Kommernati, has already been approved for use with children from the age of 12 in many countries, including the United States.
Children in the age group of five to 11 years will be given two doses equivalent to one-third of what was given to individuals 12 years of age and older.
The two companies expect data on the effectiveness of the vaccine in children aged two to five years, and children from six months to two years old, during the last quarter of this year at the earliest.
Pfizer, the pharmaceutical company, plans to apply for approval by the US Food and Drug Administration to give the vaccine against the emerging coronavirus to children between 6 months and 5 years old, in November.
Pfizer is the only vaccine that managed to obtain a full license for use from the US Food and Drug Administration.
The United States is adopting three vaccines in its campaign to vaccinate its citizens, which were manufactured by Pfizer, Moderna and Johnson & Johnson.
The Pfizer vaccine works by relying on mRNA technology, a mechanism that was not used in vaccines previously.
The technology helps the human immune system to recognize the spinal cord of the emerging corona virus, and create antibodies that provide immunity against it.