FDA advisers move a step closer on COVID vaccines for kids under 5

FDA advisers move a step closer on COVID vaccines for kids under 5

COVID-19 vaccine shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday. The Food and Drug Administration’s outside vaccine advisors gave a thumbs up to Moderna’s 2-shot vaccine and to Pfizer BioNTech’s 3-shot vaccine series for young children.

The panel of experts voted unanimously that the benefits of Moderna’s and and Pfizer’s shots outweigh any risks for children under 5 — a group that includes roughly 18 million youngsters.

They are the last group left in the U.S. to be vaccinated, and many parents have been anxious about protecting their children. Once all regulatory steps have been completed, shots should be available next Wednesday.

“This vaccine has been a long time coming,” said Dr. Jay Portnoy, a panel member from Children’s Hospital in Kansas City. “There are so many parents who are desperate to get this vaccine. I think we owe them the right to give them the option to have it if they choose.”

Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the Omicron wave, and noted 442 children under the age of 4 have died during the pandemic. He said that while this is far less than the adult deaths, it should not be ignored when considering the importance of vaccinating children under 4.

” Each child that is lost essentially fractures families,” Marks stated.

FDA reviewers stated that both brands are safe and effective for children as young at 6 months in analyses. was posted before the all-day meeting. Side effects such as fatigue and fever were less common in children than in adults.

Although both vaccines use the same technology, there are some differences. Experts in vaccines spoke to reporters earlier this week and noted that they haven’t been tested against one another, so it’s impossible to tell parents which is better.

” This is a really important point,”‘ Dr. Jesse Goodman, Georgetown University, who was formerly the FDA vaccine chief, said. “You cannot compare the vaccines directly. ”

If the FDA agrees to its advisors and authorizes shots, there is one more step. After its Saturday meeting with its advisers, the Centers for Disease Control and Prevention will make a formal recommendation. If the CDC approves, shots may be available Monday or Tuesday at doctors’ offices, hospitals, and pharmacies. Moderna’s vaccine is only for children aged 6 months to 5 years.

Moderna shots contain one-quarter of the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna is working on a booster and hopes to offer it soon.

Pfizer’s shots are only one-tenth of the adult dose. Pfizer and BioNTech discovered that two shots weren’t enough to protect against coronavirus infections. A third shot was added during the Omicron Wave.

Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; the calculation could change as more cases occur in the company’s ongoing studies.

The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. It would be the second option for these age groups if it is approved by the FDA. Pfizer vaccine is currently their only option.

Free COVID-19 vaccine by Childrens Hospital Los Angeles
Alden Lee, 6, after getting his first dose of Pfizer-BioNTech COVID-19 vaccine, gets a fist bump from nurse Pedro Elizarraraz at Children’s Hospital Arcadia Speciality Care Center onJan. 8, 2022 in Arcadia, California.

Irfan Khan / Los Angeles Times via Getty Images

The nation’s vaccination campaign started in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents first in line. Last year, school-age and teenage children were added.

Moderna stated in April that it is seeking regulatory approval outside of the U.S. to provide its little kid shots. According to the World Health Organization, 12 other countries already vaccinate kids under 5, with other brands. It is not clear how many parents want their children to be vaccinated in the United States. While COVID-19 is generally less dangerous for young children than older kids and adults, there have been serious cases and some deaths. Parents have taken steps to ensure their children are safe by avoiding family trips and enrolling them in daycare or preschool to help.

Some estimates say that three quarters of all children are already infected. Only about 29% of children aged 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November, a rate far lower than public health authorities consider ideal.

Dr. Nimmi Rajagopal is a family medicine physician at Cook County Health, Chicago. She said she has been preparing parents for months.

” We have some that are hesitant and some that want to go,’ she said.

Read More