On Monday, May 23, Pfizer released data on the results of a preliminary clinical trial that evaluated a third dose of 3 micrograms of Pfizer / biontech coronavirus vaccine for children aged 6 months to under 5 years. The results showed that the third dose of vaccine caused a strong immune response. The effectiveness of the vaccine was 80.3%, and the children were well tolerated. Most of the side effects were mild to moderate.
Pfizer CEO Albert bourla said in a statement: "the formula we designed for the youngest children is carefully selected by us. The dose intensity is 1 / 10 of the adult dose. It is well tolerated and produces a strong immune response. We are happy about it. We look forward to the early completion of the application to regulatory authorities around the world and hope to provide the vaccine to young children as soon as possible with regulatory authorization." Ugur Sahin, chief executive of biontech, said the company plans to complete their application this week and ask the U.S. Food and Drug Administration (FDA) to authorize the vaccine for emergency use.
Hours after Pfizer released its data, the FDA announced that its independent vaccine expert committee would meet on June 15 to discuss the application of Pfizer and Moderna to authorize them to vaccinate infants to preschool children. In the current global adult dose vaccine surplus, this authorization will open the last big market for the new crown vaccine. If it becomes part of the child immunization plan, it may pave the way for the long-term income of vaccine research and development companies.
The FDA originally planned to evaluate Pfizer's two doses of vaccine in February, but data showed that it did not cause a strong enough immune response in children aged 2 to 4. The FDA then asked to see the test results of the third dose. According to new data, 1678 children were vaccinated with the third dose at least two months after the second dose of vaccine. During this period, Omicron was the main variant strain.
Children under the age of five are the only group in the United States that are not eligible for vaccination. According to the Centers for Disease Control and Prevention (CDC), in the large-scale wave of Omicron infection in winter, the proportion of children under 5 years old hospitalized is five times higher than that at the peak of the epidemic. According to the CDC, as of February, about 75% of children under the age of 11 were infected with the new crown. At present, most countries have not approved the vaccination of children under the age of 5, and many parents are also concerned about whether the vaccine is safe for young children.
Since 2022, the scope of application of Pfizer coronavirus vaccine booster has been expanding. In January, the vaccine was approved for a booster dose of 30 micrograms for people aged 12 to 15 who have completed two doses of Pfizer vaccine. Not long ago, on May 17 local time, FDA revised the emergency use authorization for Pfizer Xinguan vaccine and approved people aged 5 to 11 who have completed two doses of Pfizer vaccine to receive one dose of Pfizer vaccine booster injection at a dose of 10 micrograms at least 5 months after the second dose of Pfizer vaccine.
Pfizer competitor Moderna applied to the FDA for emergency use of its new coronavirus vaccine for children aged 6 months to 5 years at the end of April this year. The data showed that the RNA produced by the vaccine released in March was similar to that of children. The company said two doses of 25 micrograms of vaccine were about 37% effective in preventing infection in children aged 2 to 5 years and 51% effective in children aged 6 months to 2 years.