Modern Pfizer vaccines for children under 5 years of age approaching FDA approval

A kindergarten student thanks her teacher before starting her first day of kindergarten at Laguna Niguel Elementary School in Laguna Niguel, California on Tuesday, August 17, 2021.

Paul Bersebach | MediaNews Group | Getty Images

Modern and pfizer Covid-19 vaccines for infants and preschoolers are one step closer to being approved by the Food and Drug Administration.

The FDA’s Committee of Independent Reviewers on Vaccines voted unanimously to recommend vaccinations for the youngest children after evaluating their safety and effectiveness during an all-day public meeting.

The FDA will likely accept the committee’s recommendations and quickly authorize vaccinations. The Centers for Disease Control and Prevention then must approve the vaccines before pharmacies and doctors’ offices can start giving them to children.

Parents will likely be able to get their kids vaccinated as early as Tuesday, although appointments may be limited initially as the vaccination program picks up pace, Dr. Sheil said. Ashish Jha, overseeing the White House’s response to the pandemic.

Covid is usually less severe in children than in adults. However, the number of hospitalizations of children under 5 years of age increased dramatically during the micromicron wave, reaching the highest level of a pandemic. Hospitalization rates during micromicron treatment for these children have been as bad or worse than any recent flu season, according to the CDC.

Since January 2020, Covid has killed 202 children between the ages of six months and 5 years. Children under the age of 5 are the only remaining age group in the US not eligible for vaccination. Many parents have waited months for FDA clearance for vaccinations.

“We must be careful not to become indifferent to the number of child deaths due to the overwhelming number of deaths of the elderly. Every life is important,” the doctor said. This was reported to the committee by Peter Marks, head of the FDA’s vaccine division.

“Our hearts go out to those who have lost children due to Covid-19, because every lost child, in fact, destroys the family,” Marks said.

Pfizer 3-dose vaccine

Pfizer and Moderna vaccines for very young children differ in a number of ways, including the number of shots used, dosage levels, and age of eligibility.

The Pfizer vaccine is given in three doses to children aged six months to 4 years. The injections are dosed at 3 micrograms, which is one tenth of what adults receive.

The Pfizer 3-dose vaccine was approximately 75% effective in preventing omicron disease in children 6 months to 2 years of age and 82% effective against omicron in children 2 to 4 years of age.

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

The third shot is critical for the Pfizer vaccine because two doses provide little protection. The FDA initially sought to expedite the receipt of the first two doses in February, but Pfizer delayed filing the application because the data was not accurate enough. Two doses were approximately 14% effective in children under 2 years of age and 33% effective in children 2 to 4 years of age.

Dr. Paul Offit, an FDA committee member, said Pfizer’s 3 microgram doses might be too small. Offit said it’s important for parents to know that their children are not protected after two doses and should get a third Pfizer shot.

“I’m really worried that parents won’t necessarily know that after two doses they may not be protected at all and will be engaging in activities that put their child at risk,” said Offit, a pediatrician at Children’s Hospital of Philadelphia. .

Modern two-dose vaccine

Moderna vaccine is given in two doses to children aged six months to 5 years. The injections are dosed at 25 micrograms, which is a quarter of what adults receive.

Moderna’s two-dose vaccine was approximately 51% effective in preventing omicron disease in children aged six months to 2 years and approximately 37% effective in children aged 2 to 5 years. Moderna expects two doses to protect against severe omicron disease at the same levels as in adults, said Jacqueline Miller, chief executive of the company.

Moderna plans to release data on a third dose targeting the omicron variant in this age group over the summer and ask the FDA to review the data as soon as possible, Miller said.

“However, as children under 4 were at the highest risk of hospitalization due to Covid-19 during the omicron surge, starting this vaccination series now is vital to start protecting children this summer,” Miller told the committee.

Panel member Dr. Jay Portnoy said he was disappointed that Moderna’s vaccine does not do a better job at preventing Covid infections. However, Portnoy said the vaccines would prevent the children from becoming seriously ill.

“The evidence is pretty clear on the prevention of serious illness, hospital admissions and emergency visits,” said Portnoy, professor of pediatrics at the University of Missouri-Kansas City. “This vaccine is very effective. It is also very safe to use,” he said.

Safety

According to FDA presentations, the most common side effects of both vaccines are injection site pain, irritability and crying, loss of appetite, and drowsiness. Very few children who received one of the vaccines have had a temperature above 102 degrees Fahrenheit or 39 degrees Celsius. In the Pfizer and Moderna studies, there were no cases of myocarditis, a type of inflammation of the heart, in children.

However, committee member D. Cody Meisner said the safety profile of vaccines in children under 5 years of age is not as well understood as in adolescents and adults. Meisner, a professor of pediatrics at Tufts University, believes vaccines should be an option for parents, not a requirement. He said the FDA and CDC should continue to closely monitor the safety of vaccines.

Marks, head of the FDA’s vaccine division, said agency experts are working day and night to understand the safety profile of vaccines and will continue to do so. He said the FDA would alert the public to any rare side effects, as they did with myocarditis in teenage boys.

“We at the FDA are very concerned about the safety and efficacy of these vaccines, and we will continue to monitor these vaccines as they are rolled out,” Marks said.

Marks also cautioned the public against inferring vaccine safety from the FDA and CDC database known as VAERS. Anyone can submit a report to the database, which is open to the public, he said, but experts have to look at the raw data to determine if there really is a link between the side effect and the vaccines.

“For rare adverse events, we will make sure the public is aware of them,” Marks said.

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