(Reuters)-Wednesday (June 15), the U.S. Food and Drug Administration (FDA) Advisory Board said Moderna Inc’s Covid-19 vaccine for children under the age of 6 and Pfizer Inc for children under the age of five. It was unanimously approved to recommend BioNTech SE. ..
Below are some important details you need to know about these two messenger RNA (mRNA) vaccines for this age group.
How many doses do you need?
Moderna has asked the FDA to approve a two-dose vaccine regimen for children aged 6 months to 6 years. The 25 mg dose is given at 28-day intervals. Adults received 100 mg per shot in the first two doses.
Pfizer and BioNTech are seeking a three-dose vaccine for children aged 6 months to under 5 years.
The first two doses are given at 21-day intervals, and the third dose is given at least 2 months after the second dose. Each dose is 3 mg, less than 10 mg for children 5-11 years and less than 30 mg for children 12 years and older.
Both companies were looking for a low-dose version for infants to reduce the side effects of the vaccine.
How effective is the vaccine?
The Moderna vaccine is a clinical trial in more than 5,000 subjects to prevent symptomatic infections in children aged 6 months to under 2 years, 50.6%, and to prevent children aged 2 to 6 years. It was estimated to be 36.8% effective.
It is not yet known how effective the Pfizer / BioNTech vaccine is in preventing infections in people under the age of five. This is due to the low number of symptomatic Covid-19 cases in children under study. An early analysis based on 10 symptomatic Covid-19 cases suggested 80.3 percent vaccine efficacy in this group. Once the 21 children of Covid-19, a symptomatic treatment, have signed a study agreement, the company will be able to confirm the effectiveness of the vaccine.
Both studies by the company have shown that the vaccine produces an immune response similar to that found in the elderly.
Is the vaccine safe for children?
Neither vaccine has caused significant safety issues in the trial.
Inflammation of the heart, known as myocarditis and pericarditis, has been found to be a rare side effect of the vaccine in young men, but few cases have been reported in children aged 5 to 11 years in the United States. The youngest age group in any of the exams.
What are the side effects?
Some children reported pain and swelling at the injection site after vaccination with both vaccines.
Pfizer’s low-dose vaccines were generally well tolerated, with slightly more participants receiving the vaccine complaining of fever, irritability, or fatigue compared to participants receiving placebo. At ages 2-4 years, 33.7% of participants who received the second vaccination reported one of these side effects compared to 32.2% who received placebo.
For the modelna vaccine, 58.9% of 3-5 year olds had some reaction such as fever, headache, fatigue after the second dose compared to 37.2% of the participants who received the placebo. I reported.
Why do you vaccinate your baby?
Covid-19 is generally milder in children than adults, according to FDA officials, but there were more than 440 US Covid-19 deaths among children under the age of five.
According to Dr. Matthew Harris, a pediatric emergency physician at Northwell Health in New York, the data show that vaccines prevent hospitalization and death in older children and adults.
People infected with Covid-19 and received booster shots were the most defensive against Covid-19, he said.
