Md. Ashraful Islam: The US-based pharmaceutical company claims that the Kovid-19 vaccine, made by Pfizer-Biotech, has been shown to be 90.8% effective in the body of children between the ages of five and 11.
Pfizer made the claim in a document submitted to the US Food and Drug Administration (FDA) on the results of the trial application of the vaccine, Reuters news agency reported on Friday.
The pharmaceutical company says that 17 children who received a placebo in their experimental vaccine were infected with Covid-19, while only three of those vaccinated were infected.
The test, conducted on 2,026 participants, found that more than twice as many children were vaccinated with the Covid-19 vaccine as with placebo. As such, its effectiveness is more than 90 percent.
Pfizer’s experiment, which was performed on 5- to 11-year-olds, was not intended to measure efficacy against the virus. Rather the price objective was to compare the number of antibodies that became ineffective under the effects of the vaccine in the bodies of children and adults.
Based on those results, Pfizer and Biotech said last month that their Covid-19 vaccine created widespread immunity in children.
The 5 to 11-year-olds were vaccinated in two doses of 10 micrograms, while the 12-year-olds and above were given one-third of the dose.
A meeting of the FDA’s external advisers is scheduled for Tuesday to decide whether to recommend the administration of the drug to children in this category.
A review by FDA officials on the evidence submitted by Pfizer is expected to be released on Friday.
Pfizer claimed on Friday that the number of children covered had more than doubled by expanding clinical trials to develop safety data.
According to the documents, reviewing the adverse reactions of those children who were later added did not match anything of concern for the safety of the vaccine. In this age group, 18 to 25-year-olds are usually comparable with different aspects of safety.
The children in the second group were kept under observation for a slightly shorter period of time. All of them received a second dose of the vaccine, and more than 80 percent of them passed two weeks after receiving the second dose.
Pfizer / Biotech and Modern Ticker have been found to have a ‘rare’ association with myocarditis, especially in children and adolescents.
Pfizer says the rate of myocarditis among 12- to 15-year-olds is lower than in the 5- to 11-year-old age group. The company estimates that the number of cases of myocarditis is far higher than the number of possible myocarditis cases due to the use of vaccines to prevent Covid complications.
The Pfizer / Biotech vaccine, with full FDA approval last August for those 18 years of age and older, was approved for emergency use for at least 12 years of age.
About 190 million people in the United States have been fully vaccinated, with 11 million people between the ages of 12 and 18 receiving the Pfizer vaccine.
If the FDA had given Pfizer permission for the emergency use of the vaccine for children between the ages of 5 and 12, advisers to the US Centers for Disease Control and Prevention (CDC) would meet on November 2 and 3 to decide on the procedure.
Most states are awaiting the CDC’s recommendation on how to apply before vaccination begins.