The FDA has approved COVID-19 vaccines for children as young as six months old, manufacturers announced Friday morning.
Now, the Centers for Disease Control and Prevention (CDC) is left to green-light for their target rollout date of June 21. A CDC advisory panel will meet over the weekend.
This move makes America the nation with the youngest eligible COVID-19 vaccine age, an odd move given that data indicates that children are at limited risk for the virus and vaccination coverage in children ages five to 13 is low.
According to CDC data, children make up 0.1 percent of total deaths from the virus in the country and are also less likely to have a serious case or hospitalization from Covid.
The FDA has approved both the Pfizer and Moderna COVID-19 vaccines for use in children six months to five years old. The shot will be available Tuesday, pending approval from the CDC as well. Pictured: A young child in San Jose, Costa Rica, receives an injection of a COVID-19 vaccine
“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect children up to 6 months of age,” FDA Commissioner Robert Califf said in a statement.
“As we’ve seen in older age groups, we expect the vaccines for younger children will protect against the most serious consequences of COVID-19, such as hospitalization and death.”
Pfizer released preliminary data last month showing that the vaccine was 80 percent effective at preventing infection from Omicron, although the efficacy rate may change as more trial participants need to be infected before the numbers can be rounded up.
The Pfizer shot comes in three doses, as opposed to the standard two-dose for older age groups. It will also be just three micrograms, one-tenth the standard adult dose and one-third the dose for children ages five to 12.
The switch was made late last year, when early data showed that just two doses of the shot offered little protection against the virus.
“We know that many parents in the US are eagerly awaiting an approved vaccine for their children under 5 and we are proud to now offer them a vaccine option with a favorable safety profile,” said Albert Bourla, CEO of the New York Times. York City-based Pfizer. said in a statement.
Moderna will use a two-dose injection for young children, with each injection being 25 micrograms — one-fourth the size of the adult injections.
In clinical trials, the Moderna injection was 50 percent effective at preventing mild infection from the virus.
The Cambridge, Massachusetts-based company recruited 260 children, ages two to five, for their trial.
Pain, redness and swelling at the injection site, fever and swelling of the groin and forearm were the most commonly reported side effects of the injections.
“We are pleased that the FDA has granted emergency clearance for Moderna’s COVID-19 vaccine for children and adolescents, especially for our vulnerable, youngest children,” said Stephane Bancel, CEO of Moderna, in a statement.
Both injections were considered safe and effective by both the FDA and a panel of outside advisors known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
“In addition to ensuring data for these vaccines met stringent FDA standards, convening an advisory committee was part of a transparent process to provide the public with a clear understanding of the safety and efficacy data required by the authorization of vaccines.” support these two vaccines. for pediatric populations,” Dr. Peter Marks, the FDA’s chief regulator, said in a statement.
The most worrisome and widely publicized side effects of the COVID-19 vaccines are the inflammatory heart conditions myocarditis and pericarditis.
The FDA reports that the risk of these conditions is low in this age group, but instead affects 12 to 17 year olds most with the Pfizer injection and 18 to 24 year olds with the Moderna shot.
If the CDC gives the expected green light this weekend, the footage will likely be available on the White House’s target rollout date of June 21.
dr. Ashish Jha, who was recently appointed as the White House’s Covid-19 response coordinator, said at a briefing early this month that it would be the first day the footage will be available.
However, there are doubts as to whether these recordings are necessary. Deaths from the virus are particularly rare among minors in the US
A study of the University of Utah found last year that 50 percent of pediatric Covid cases are asymptomatic. The study was conducted before the milder Omicron variant emerged, meaning that children’s risk of even feeling symptoms is probably lower now.
Children are also less likely to spread the virus if they are infected, with a German study find that they release only 25 percent of virus particles as adults.
It is also not clear how much demand there will be for the shots in the first instance. A recent study suggests that only 1 in 5 parents of young children would have their children vaccinated right away.
Vaccines have been available to older American schoolchildren since November, but less than a third of 5 to 11-year-olds have received the two recommended doses, according to government figures.
The federal government has already negotiated the purchase of the shots and plans to distribute them to states to handle the rollout. However, not every state will make the new jabs available.
Gov Ron DeSantis (pictured) chose not to order COVID-19 vaccines for children aged six months to four years in Florida, saying parents are only concerned about the virus because of media hysteria
Florida is the only state in America that has not reserved shots of COVID-19 vaccines for children ages six months to five.
The Miami Herald reports that the state missed a filing deadline Tuesday to request that the shots be delivered to begin rolling out June 21. In every other state, the shots will be distributed to vaccine suppliers, pharmacies and pediatric clinics starting next week.
It comes after state health officials said in March that children and teens in the state should not be vaccinated due to the relatively limited risk they face from Covid compared to adults.
Governor Ron DeSantis confirmed his state’s position on Thursday, blaming the media hysteria for fears some parents have of the virus, despite limited evidence that children are at risk from the virus.
“Our health department has been very clear, the risks outweigh the benefits,” DeSantis said at a news conference Thursday morning.
“That’s not the same as banning it, people can still access it if they want to, and patents can, but if you look at when they did the hearing, we had a doctor who said parents are really, really scared and we know that the risk is low, we’re not sure how this will work, but parents are afraid of Covid for their children.”
He said that fear, not science, is not a reason to approve the injections for children, pointing to the mainstream media as the reason for the nascent fear in parents.
‘Why should they be afraid of it? It’s because of media hysteria. It’s because of a lot of misinformation, that’s why they’re scared,” he added.
Shots are purchased at the federal level, with the White House paying the money needed to obtain the shots. Next, states must request allocations of the shots based on the expected need, which the federal government will meet as best it can.
Floridians will not be able to access the shots unless the governor gives an order, although the option to cross over to another state and receive the shot there will exist for families desperate to receive it.
“The Florida Department of Health has made it clear to the federal government that states do not need to be involved in the complicated vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” says Jeremy. Redfern, said in a statement.
It is also no surprise that we have chosen not to participate in the distribution of the COVID-19 vaccine when the ministry does not recommend it for all children.
“Physicians can order vaccines if they need to, and there are currently no orders in the department’s ordering system for the COVID-19 vaccine for this age group.”
While the move may come as a surprise, it follows guidelines previously drawn up by officials in the Sunshine state. In March, State Surgeon General Joseph Ladapo officially advised healthy residents ages 5 to 17 not to get stung.
“Based on currently available data, healthy children ages 5 to 17 may not benefit from receiving the currently available COVID-19 vaccine,” he said in a statement.
“…in general, healthy children under the age of 16 without significant underlying health problems have little to no risk of serious disease complications from COVID-19.”
The guidance also says that 16- and 17-year-old children are more at risk from the vaccine than from the virus, a claim disputed by many health experts and officials around the world.
Florida officials also do not provide a general recommendation for children with underlying health conditions or co-morbidities to receive the shot.
“For children with underlying health conditions or co-morbidities, COVID-19 vaccines should be considered in consultation with your healthcare provider,” the letter reads.
“Parents are encouraged to discuss the risks and benefits with their children’s healthcare providers when evaluating whether their child should receive a COVID-19 vaccine, especially for children with underlying health conditions or co-morbidities.”
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