US approves Pfizer and Moderna vaccines for youngest children

• US FDA approves use of Pfizer and Moderna Covid-19 vaccines in infants and toddlers.
• Babies and toddlers are the last age group in most countries that has not been immunised.
• Pfizer aims to submit authorization requests to various regulators around the world.

The US Food and Drug Administration granted emergency approval on Friday for the use of Pfizer and Moderna Covid-19 vaccines in infants and toddlers, the last age group in most countries that has not been immunised.

Moderna’s two-dose vaccine for children aged six months to five years and three doses of Pfizer’s injections for children aged six months to four years were approved by the FDA, which is considered the global gold standard.

“Today is a day of tremendous relief for parents and families across America,” said President Joe Biden in a statement, adding that immunising young children will allow “our nation continue to move forward safely.”

“Vaccines for younger children will give protection from the most severe effects of Covid-19, such as hospitalisation and death,” FDA Commissioner Rober Califf said.

In early July, Pfizer aims to submit authorization requests to various regulators around the world, including the European Medicines Agency.

“Parents in the United States now have the option to vaccinate their children under the age of five, and we’re striving to ensure that other nations across the world will follow,” said Ugur Sahin, CEO and co-founder of BioNTech, a German company that developed the vaccine alongside Pfizer.

Thousands of youngsters were used in trials to test the immunizations. They were discovered to have equal degrees of moderate side effects and elicited similar amounts of antibodies in older age groups.

Pfizer’s efficacy against infection was higher, at 80 percent, compared to Moderna’s estimations of 51 percent for children aged six months to two years and 37 percent for children aged two to five years.

However, the Pfizer statistic is based on a small number of patients and should be regarded as preliminary. It also requires three doses to ensure protection, with the third injection administered eight weeks after the second, which was administered three weeks earlier.

After two years, the vaccine developed by Moderna should provide excellent protection against severe disease.

In comparison to Pfizer, Moderna’s decision to use a greater dose is linked to a higher rate of fevers in response to the vaccine.

Moderna CEO Stephane Bancel remarked, “We are happy that the FDA has granted Emergency Use Authorization of Moderna’s Covid-19 vaccination for children and adolescents, particularly for our vulnerable, youngest children.”

“In order to thrive and flourish, children must live extremely social lives,” Bancel added. “With this approval, caregivers of young children aged 6 months to 5 years have a solution to protect their children from Covid dangers in the classroom and childcare context.”

According to the FDA, the United States, which has 20 million children aged four and under, has recorded 480 Covid deaths in that age group during the pandemic, significantly more than even a terrible flu season.

There have been 45,000 hospitalizations in the group as of May 2022, with about a quarter requiring intensive care.