FDA approves Covid-19 vaccine for young children

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Vaccinations, however, won’t be available until the CDC’s vaccine advisers vote on whether to recommend them (scheduled for Saturday) and CDC Director Dr. Rochelle Walensky supports the recommendation. Vaccinations for young children will begin next week, the White House said.

Moderna’s vaccine is now approved for children 6 months to 17 years old, and Pfizer/BioNTech’s vaccine is approved for children 6 months to 4 years old. About 17 million children under the age of 5 are now eligible for the Covid-19 vaccine.

Previously, Pfizer/BioNTech’s vaccine was approved for use in people 5 years and older and approved for use in people 16 and older, and Moderna’s vaccine was approved for adults only.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called a Covid-19 vaccine for the younger population a “milestone.”

“This is an important step in narrowing the age range for these vaccines,” Marks said Wednesday at a meeting of the FDA’s Advisory Committee on Vaccines and Related Biologics.

At this meeting, committee members voted unanimously to extend the mandate to children over 6 months of age.

Dr. Archana Chatterjee, dean of the Rosalind Franklin University School of Medicine in Chicago and a member of the committee, said: “Being able to vote for the authorization of two vaccines that will protect children under 6 months of age from this deadly disease is a great deal. Very important thing.” . .

She compared the day to December 2020, when the first Covid-19 vaccines were approved for adults and older teenagers.

“I’m really glad we’ve reached such a milestone,” said committee member Dr., previously allowed for other age groups.

“I remember our first vote on Pfizer’s first approval a year or more ago,” Levy said. “I was one of the 17 people who voted yes. I remember those early discussions – and even then, should 16- and 17-year-olds be included? At the time, it was a controversial topic being discussed. As a committee, Our unanimous recommendation here is to allow up to 6 months old. So we’ve come a long way.

Will young children be vaccinated?

Many public health experts worry that although the Covid-19 vaccine is now allowed for younger groups, parents of these children may not bring their children to be vaccinated.

U.S. children have been slow to vaccinate against Covid-19.

“It is very important to provide vaccine options for younger children; however, we have found relatively low rates of Covid-19 vaccination among children in the 5-12 age group, so I am concerned that under 5-year-olds may also have lower rates than ours Expected,” Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

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Barouch, who was not involved in the FDA decision, helped develop and research Johnson & Johnson’s Covid-19 vaccine.

He said there was a “staggering” difference in the number of fully vaccinated adults compared with children and adolescents.

In November, children aged 5 to 11 were the most recently eligible group for the vaccine. But in the U.S., only 29% of children are fully vaccinated with the two-dose primary series, According to the CDCagainst approximately:
  • 60% of 12- to 17-year-olds
  • 64% of adults aged 18 to 24
  • 67% of adults aged 25 to 39
  • 75% of adults aged 40 to 49
  • 82% of adults aged 50 to 64
  • 94% of adults aged 65 to 74
  • 88% of adults 75 and older

“We are planning and preparing to deploy a paediatric vaccine. Of course, there is still a lot of work to be done to check the uptake of this vaccine. Several public opinion polls and surveys have indicated that over time, the The number of parents continues to decline,” said Lori Tremmel Freeman, executive director of the National Association of Health Officials.

Biden administration outlines Covid-19 vaccination plan for children under 5
according to a Kaiser Family Foundation Vaccine Surveillance SurveyIn a report published in May, only 18% of parents of children under 5 said they would vaccinate their children against Covid-19 once a vaccine became available.

“I think the more the pandemic is in the rear-view mirror for some people — or they believe it — the less they’ll be forced to do it, so we have a big game ahead of us,” Freeman said. A public health education campaign on a large scale.” . “Furthermore, health departments at the local level will seek to understand what is happening in their communities, namely the number of providers, pediatricians and pharmacies who are actually registered to distribute vaccines.»

“The benefits appear to significantly outweigh the risks”

Under FDA approval, Moderna’s vaccine is available in a two-dose primary series of 25 micrograms each for infants and children ages 6 months to 5 years. For older children 6 to 11 years, the dose is 50 mcg.

Toddler being filled with a Pfizer/BioNTech vaccine vial.

The Pfizer/BioNTech vaccine is now available as a three-dose primary series of 3 micrograms each for infants and children 6 months to 4 years of age.

FDA advisors vote to approve Moderna's Covid-19 vaccine for ages 6 to 17

FDA vaccine advisors have determined that the benefits of both vaccines outweigh the risks and that children who received the vaccines in clinical trials were “well tolerated.”

“The benefits appear to significantly outweigh the risks, especially for young children who may be in kindergarten or group day care centers,” said Oveta Fuller, associate professor and member of the Microbiology and Immunology Committee at the University of Michigan School of Medicine. “The Moderna vaccine.

Committee member Dr Art Reingold added that although young children have a lower risk of hospitalisation and death from Covid-19 than adults, children have been vaccinated to protect them from lower risk diseases.

Opinion: As US vaccinates youngest child against Covid, a pediatrician steps in

“If we have a vaccine that does more harm than good, then making it available to the public is a reasonable option. I would point out that, as a country, when children die from these diseases or are hospitalized or hospitalized with these diseases the risk is very close to At zero, we will continue to provide children with a lot of vaccines,” such as polio and measles, said Reingold of the University of California, Berkeley.

The number of child hospitalizations and deaths related to Covid-19 is worrying and much higher than flu-related deaths and hospitalizations, Marks said.

“During the Omicron wave, hospitalization rates were still relatively high during this period,” he said. “This hospitalization rate is actually very troubling, and if we compare it to what we’ve seen during the dreaded flu season, it’s even worse.”

In the first two years of the pandemic, the death toll among children 4 and younger was “also horrific compared to the flu we’ve seen in the past,” Marks said.

“We’re dealing with an issue where I think we have to be careful not to be insensitive to paediatric deaths because of the disproportionate number of elderly deaths here. Every life counts,” he said, adding that “vaccine-preventable” Death is what we want to try to do. »

He added that the Covid-19 vaccine is a similar intervention to the flu vaccine, which is widely and regularly used and accepted to prevent deaths in people of all ages.



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