FDA closes on authorization after committee shots COVID vaccine for children under 5

A kindergarten student gives a thumbs up to her teacher before starting the first day of kindergarten at Laguna Niguel Elementary School on Tuesday, August 17, 2021 in Laguna Niguel, CA.

Paul Beersbach | MediaNews Group | Getty Images

Moderna’s COVID-19 vaccine for infants through preschoolers has moved a step closer to authorization by the Food and Drug Administration.

The FDA’s committee of independent vaccine experts voted unanimously to recommend the shots for use in the youngest children after weighing how safe and effective the shots are during an all-day public meeting.

The committee will soon vote on Pfizer’s vaccine for infants through preschoolers as well.

The FDA will likely accept the committee’s guidance and authorize the shots quickly. The Centers for Disease Control and Prevention then has to sign off on vaccines before pharmacies and doctors’ offices can start giving them to children.

Parents will likely be able to get their children vaccinated on Tuesday, although appointments may be limited at first as vaccination programs ramp up, according to Dr Ashish Jha, who oversees the White House’s response to the pandemic.

Covid is usually less severe in children than in adults. However, hospitalizations of children under the age of 5 affected the highest levels of the epidemic during the omicron wave. According to the CDC, the hospitalization rate during Omicron was as bad or worse for children than during any recent flu season.

Since January 2020 till now, Kovid has killed 202 children of six months to 5 years. Children under the age of 5 are the only survivors of the age group in the US who are not eligible for vaccination. Many parents have been waiting months for the FDA to authorize the shots.

“We have to be careful that we don’t get numbed by the number of deaths in children because of the huge number of older deaths. Every life is important,” Dr. Peter Marks, head of the FDA’s vaccine division, told the committee.

“For those who have lost children to COVID-19, our hearts go out to them because each child that is lost inevitably breaks up a family,” Marx said.

Pfizer Vs. modern vaccines

Pfizer and Moderna’s vaccines for the youngest children differ in several ways. Based on available data, Pfizer’s three shots appear to be more effective than Modern’s two shots. According to FDA presentations, both vaccines are safe with the same side effects as the common cold.

The Pfizer vaccine is given in three doses to children between the ages of six months and four years. Pfizer’s shots are dosed at 3 micrograms, which is one-tenth of what adults get.

Moderna’s vaccine is given in two doses to children between the ages of six months and five years. Moderna’s shots are dosed at 25 micrograms, which is a quarter of what adults get.

Pfizer’s three-dose vaccine was about 80% effective in preventing disease from Omicron, the major version in US Moderna’s two-dose vaccine was about 51% effective in preventing disease from Omicron for children aged six months to 2 years , and about 37% effective for children ages 2 to 5.

According to Jacqueline Miller, an executive with the company, Moderna plans to publish data on a third dose targeting the Omicron variant in this age group this summer and has asked the FDA for authorization shortly thereafter.

“While children under the age of 4 are most at increased risk of hospitalization due to COVID-19 during the omicron boom, the start of this immunization series is now crucial to begin protecting children this summer. is,” Miller told the committee.

A senior official in the FDA’s Vaccine Division, Dr. Doran Fink said the effectiveness of Pfizer’s vaccine after dose three is an accurate estimate that is subject to change as more data becomes available.

The most common side effects of both vaccines are injection site pain, irritability and crying, loss of appetite, and trouble sleeping. Very few children who were either vaccinated developed a fever over 102 degrees Fahrenheit or 39 degrees Celsius. There were no cases of myocarditis, a type of heart inflammation, in children in Pfizer and Moderna’s trial.

This is a developing story. Please check back for updates.

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