A health worker administers the Pfizer-Bioentech Covid-19 vaccine at a vaccination site in San Francisco, California, USA, on Monday, January 10, 2022.
David Paul Morris | Bloomberg | Getty Images
According to the results of a clinical trial published on Monday, the three-dose Covid vaccine was 80% effective for children 6 months to 5 years of age of Pfizer and Bioentech in preventing illness during omicon waves.
According to the companies, the third dose of the vaccine developed a strong immunity and was well tolerated by children with most side effects, according to the companies.
Ugur Sahin, CEO of Bioentech, said the companies plan to complete their application this week to ask the Food and Drug Administration to approve vaccines for emergency use. Pfizer CEO Albert Borla said he hopes the vaccine will be available for young children as soon as possible.
Safety data is based on 1,678 children under the age of 5 who received a third shot at least two months after the second dose when Omicron was the main variant of circulation. Pfizer tested a subset of children under 5 years of age to determine their immunity.
Children under 5 take 3-microgram shots, one tenth of the dose level for adults.
Pfizer and the FDA originally sought the first two doses of fast-track approval in February so parents could begin vaccinating their children while the results of the clinical trial from the third shot were still pending.
However, Pfizer delayed its application to wait for data from the third dose after the first two shots were only 30% to 40% effective, Borla said in a podcast interview last month.
Children under the age of 5 are the only group in the United States who are not yet eligible for vaccination Parents have been waiting months for FDA shots to be approved.
During the massive wave of Omicron infection during the winter, according to the Centers for Disease Control and Prevention, children under 5 years of age were admitted to the hospital with covido compared to the peak of the epidemic. As of February, about 75% of children under the age of 11 were infected with Kovid, according to the CDC.
Moderna has asked the FDA to approve the emergency use of its two-dose vaccine for children under 6 years of age. Its vaccine is about 51% effective against Omicron in children under 2 years of age and about 37% effective for children under 2 years of age. 6 years old. However, Moderna says vaccine-induced antibody levels should translate into higher levels of protection against serious illness.
The FDA’s committee of independent vaccine experts is scheduled to meet in June to consider Pfizer’s and Moderna’s applications, with interim dates set for June 8, 21 and 22. Bourla said he hopes the Pfizer vaccine for children under 5 will be approved in June.