On September 20, Pfizer made public that a phase 2/3 trial had shown that its COVID-19 vaccine was safe and effective for children between the ages of 5 and 11. The vaccine had generated a “robust” antibody response.
2268 children between the ages of 5 and 11 participated in the trial. They have been given two doses of the vaccine 21 days apart. The doses were 10 micrograms , less than the 30 micrograms that has been used in people older than 12 years. “The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer stated in a news release.
Pfizer said the levels compared well to those of older people who received a higher dose, demonstrating a ” strong immune response in this cohort of children one month after the second dose.” In the statement, Pfizer also stated that “the COVID-19 vaccine was well tolerated, with side effects generally comparable to those seen in participants aged 16 to 25 years.” According to a Pfizer spokesperson, the trial produced no cases of myocarditis , a type of inflammation of the heart that has been linked to mRNA vaccines.
CNN has noted that the study data has not yet been peer-reviewed or published . These are the first results of the vaccine to be obtained in this age group in the United States.
The company plans to send the results soon, specifically at the end of this month, to the US Food and Drug Administration (FDA) for an emergency use authorization.
” Since July, pediatric COVID-19 cases have increased by approximately 240% in the US , underscoring the need for public health vaccination. The results of these trials provide a solid basis for requesting authorization from our vaccine for children ages 5 to 11, and we plan to send them to the FDA and other regulators urgently, “said Albert Bourla, Pfizer president and CEO, in the statement.
As the most feasible date, it is expected that children between the ages of 5 and 11 can start getting vaccinated later this year or early 2022.
In the United States, only 54.6% have the complete guideline. 63.9% in people over 12 years old.
