The State of California approves the vaccination of babies at least six months of age against Covid after federal authorization
Sacrament. The State of California authorized the vaccination of babies against Covid.
The Western States Science Safety Review Task Force completed its review of the federal process on Sunday.
The Task Force unanimously concluded that the Pfizer-BioNTech and Moderna vaccines are safe and effective for children up to six months of age.
The specialists delivered their findings on the vaccination of babies against Covid to the governors of California, Nevada, Oregon and Washington on June 19.
Moderna’s two-dose and Pfizer’s three-dose vaccines are available for children 6 months of age and older.
On Friday, June 17, the US Food and Drug Administration (FDA) authorized the use of the vaccines in children up to 6 months of age.
The Centers for Disease Control (CDC) confirmed that decision on Saturday.
The task force reviewed the federal decisions on Saturday and confirmed them on Sunday.
The State indicated that the working group thoroughly reviewed the data on the safety and efficacy of the vaccines.
The group found that either series of vaccines produced antibody levels similar to those achieved in 16- to 25-year-olds.
Reactions among infants 6 to 12 months of age and children 1 to 5 years of age were consistent with those reported to other vaccines for these age groups.
The task force concluded that the benefits of completing either series of vaccines substantially outweigh any known or likely risks.
Immunization can be expected to reduce the number of serious illnesses, hospitalizations, and deaths related to COVID-19 in young children.
At the same time, it is expected to facilitate your participation in normal educational, social and recreational activities.
California Coalition for Baby Vaccination Against Covid
Washington, Oregon, and Nevada joined the COVID-19 Science Safety Review Task Force in October 2020.
The Panel, made up of nationally acclaimed scientists, has reviewed FDA actions related to COVID-19 vaccines.
The group will continue to evaluate other COVID-19 vaccines as they go through the federal process.
California Governor Gavin Newsom considered: “Vaccines are safe, effective and widely accessible; We strongly encourage parents to protect their children from COVID-19 with these vaccines.”
California has pre-ordered nearly 400,000 doses to be administered at more than 8,500 vaccination sites in the state.
The US Food and Drug Administration (FDA) has authorized Moderna and Pfizer-BioNTech vaccines for emergency use in infants six months of age.
For Moderna’s vaccine, the FDA modified the emergency use authorization to include people 6 months through 17 years of age.
The vaccine had already been authorized for use in adults over 18 years of age.
For the Pfizer-BioNTech COVID-19 vaccine, the FDA amended the EUA to include the application of this vaccine in persons 6 months to 4 years of age.
The vaccine had already been licensed for use in people 5 years of age and older.
The FDA’s evaluation and analysis of the safety, efficacy, and manufacturing data for these vaccines were rigorous and comprehensive, and support the emergency use authorizations, the agency said in a statement.
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech vaccines outweigh the known and potential risks in pediatric populations licensed for use of both vaccines.
Prior to making the decision to license these vaccines for the respective pediatric populations, the FDA Advisory Committee on Vaccines and Related Biologics was consulted and, as an independent body, voted in favor of the license.
“Many parents, caregivers and healthcare providers have been waiting for a vaccine for younger children, and this move will help protect children as young as six months of age.
“As with older age groups, we hope that vaccines for younger children will offer protection against severe cases of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert Califf.
“Those entrusted with the care of children can rest assured that the FDA has thoroughly evaluated available data to ensure the safety and efficacy of these COVID-19 vaccines,” Califf said.
Moderna’s vaccine is given in two doses, one month apart, to people ages six months to 17 years.
Administration of a third dose at least one month after the second dose is also authorized for people with certain types of immunosuppression.
The Pfizer-BioNTech COVID-19 vaccine is administered in three doses.
The initial doses are given three weeks apart.
A third dose can then be applied about 8 weeks after the second to children aged 6 months to 4 years.
“By licensing COVID-19 vaccines for pediatric age groups, the FDA is ensuring that our evaluation and analysis of the data is rigorous and comprehensive,” said Peter Marks, director of the Center for Biologics Evaluation and Research. from the FDA.
“In addition to ensuring that the data on these vaccines met the FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparency process that allows the public to have a clear understanding of the vaccine data. safety and efficacy that support the authorization of these two vaccines for the pediatric population,” Marks said.
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