FDA issues emergency approval for use of COVID vaccines for US children under 5

(ORDO NEWS) — On Friday, the U.S. Food and Drug Administration issued an emergency approval for the use of Pfizer and Moderna’s COVID-19 vaccines for very young children, the last age group to be immunized in most countries.

The agency, whose approval is considered the gold standard worldwide, has authorized two doses of Moderna for children aged six months to five years and three doses of Pfizer for children aged six months to four years.

“Many parents, caregivers and clinicians have been waiting for a vaccine for young children, and this decision will help protect children under six months of age,” FDA chief Robert Kaliff said in a statement.

“We expect vaccines for young children to provide protection against the most severe consequences of COVID-19, such as hospitalization and death.”

Pfizer said it plans to file approval requests with other regulatory bodies around the world in early July, including the European Medicines Agency.

“Parents in the US now have the option to vaccinate their children as young as 5 years old, and we are working to ensure that other countries around the world follow us,” said Ugur Sahin, CEO and co-founder of the German company BioNTech, which developed the vaccine with Pfizer. .

The Centers for Disease Control and Prevention (CDC) must now also recommend vaccines before they go into use in the US – a final green light will be given after an expert advisory committee meeting is due to take place soon.

However, the government has said that once the FDA’s decision is made, 10 million doses could be distributed immediately across the country, followed by millions more in the weeks ahead.

Successful tests

Both vaccines are based on messenger RNA, which delivers the genetic code for the coronavirus spike protein to human cells, which then grow it on their surfaces, training the immune system to be ready. This technology is currently considered the leading COVID vaccination platform.

The vaccines have been tested in trials on thousands of children. They have been found to cause the same level of mild side effects as in older age groups and produce the same level of antibodies.

Effectiveness against infection was higher at Pfizer, which rated it at 80 percent, compared to Moderna’s estimates of 51 percent for children aged six months to two years and 37 percent for children aged two to five.

However, Pfizer’s data is based on a very small number of cases and is therefore considered preliminary. In addition, three doses are required to achieve protection, with the third vaccination given eight weeks after the second, which is given three weeks after the first.

Moderna’s vaccine should provide strong protection against severe disease after two doses given four weeks apart, and the company is exploring the possibility of adding a booster that would improve efficacy against mild disease.

However, Moderna’s decision to use a higher dose is associated with higher rates of fever in response to the vaccine compared to Pfizer.

“We are thrilled that the FDA has granted Emergency Use Authorization for Moderna’s COVID-19 vaccine for children and adolescents, especially for our vulnerable, youngest children,” Moderna CEO Stephane Bancel said.

“Children need to live in a highly social environment in order to develop and thrive,” Bansel added. “With this authorization, caregivers of young children aged 6 months to 5 years are finally able to protect themselves from the risks associated with COVID in classrooms and kindergartens.”

The U.S., home to 20 million children aged four and under, has recorded 480 COVID deaths in this group during the pandemic far more than even during a bad flu season, according to the FDA.

As of May 2022, there were 45,000 hospitalizations in this group, almost a quarter of which required intensive care.

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