The FDA has authorized COVID-19 vaccines for children as young as six months old, manufacturers announced Friday morning. The expected move comes after the Food and Drug Administration’s (FDA) top advisory panel voted to recommend both the Pfizer and Moderna vaccines for approval earlier this week.
Now, the Centers for Disease Control and Prevention (CDC) will be left to greenlight the shots ahead of their targeted rollout date on June 21. A CDC advisory panel is scheduled to meet over the weekend.
The move makes America the nation with the youngest eligible COVID-19 vaccine age, an odd move as data points to children suffering limited risk from the virus and vaccine uptake among children aged five to 13 being low.
According to CDC data, children make up 0.1 percent of the nation’s total deaths from the virus and are also less likely to suffer a severe case or hospitalization from Covid.
The FDA has approved both the Pfizer and Moderna COVID-19 vaccines for use in children aged six months to five years old. The jab is set to become available on Tuesday, pending approval from the CDC as well. Pictured: A young child in San Jose, Costa Rica, receives a shot 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 those down to 6 months of age,’ Dr Robert Califf, commissioner of the FDA said in a statement.
‘As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death.’
Pfizer revealed preliminary data last month showing the vaccine was 80 percent effective at preventing infection from Omicron, though the efficacy rate may change as more trial participants need to be infected before the figures can be finalized.
The Pfizer jab will come in three doses, unlike the two dose standard set for older age groups. It will also be only three micrograms, a tenth of the size of the standard adult dose, and a third of dosage for children five through 12.
The switch was made towards the end of last year when early data showed that only two doses of the jab provided little protection against the virus.
‘We know many parents in the U.S. have been eagerly awaiting an authorized vaccine for their children under 5 and we are proud to now offer them a vaccine option with a favorable safety profile,’ Albert Bourla, CEO of New York City-based Pfizer, said in a statement.
Moderna will use a two-dose jab for young children, with each shot being 25 micrograms – a fourth the size of its adult sized shots.
In clinical trials, the Moderna shot was 50 percent effective at preventing mild infection from the virus.
The Cambridge, Massachusetts-based company recruited 260 children aged two to five years old for their trial.
Pain, redness and swelling at the injection site, fever and swelling of the groin and underarm were the most common reported side-effects of the shots.
‘We are thrilled that the FDA has granted Emergency Use Authorization of Moderna’s COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children,’ Stephane Bancel, CEO of Moderna, said in a statement.
Both of the shot’s were deemed safe and effective by both the FDA and by a panel of outside advisors, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
‘In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations,’ Dr Peter Marks, the FDA’s top regulator, said in a statement.
The most concerning, and most publicized, side-effects of the COVID-19 vaccines are the heart inflammation conditions myocarditis and pericarditis.
The FDA reports that the risk of these conditions is low in this age group, though, instead striking 12 to 17 year olds the most with the Pfizer shot, and 18 to 24 year olds with the Moderna jab.
If the CDC gives the expected green light this weekend, then the shots will likely be available on the White House’s targeted rollout date of June 21.
Dr Ashish Jha, who was recently appointed as the White House’s COVID-19 response coordinator, said during a briefing at the start of this month that it would be the first day the shots are available.
There are some doubts over whether these shots are even needed, though. Deaths from the virus are notably extremely rare among minors in the U.S.
A study from the University of Utah last year found that 50 percent of pediatric Covid cases are asymptomatic. The study was performed before the more-mild Omicron variant emerged, meaning the risk for children to even feel symptoms is likely lower now.
Children may also be less likely to spread the virus when infected, with a German study finding that they release as little as only 25 percent of virus particles as adults do.
It is also not clear how much demand there will initially be for the shots. A recent survey suggests only 1 in 5 parents of young children would get their kids vaccinated right away.
Vaccines have been available since November for older U.S. schoolchildren, yet less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.
The federal government already negotiated the purchase of the shots, and is set to distribute them to states to handle the rollout. Not every state will make the new jabs available, though.
Gov Ron DeSantis (pictured) chose not to order COVID-19 vaccines for children aged six months to four years old in Florida, saying that parents are only worried about the virus because of media hysteria
Florida is the only state in America that has not pre-ordered shots of COVID-19 vaccines for children aged six months old to five.
The Miami Herald reports that the state missed a Tuesday filing deadline to request the shots be delivered into to roll them out starting June 21. In every other state, the jabs will be distributed to vaccine providers, pharmacies and pediatric clinics starting next week.
It comes after state health officials said in March that children and teens in the state do not need to get vaccinated because of the comparatively limited risk they face from Covid when compared to adults.
Governor Ron DeSantis reaffirmed his state’s stance Thursday, blaming media hysteria for the fear some parents have of the virus, despite limited evidence children are at risk from the virus.
‘Our department of health has been very clear, the risks outweigh the benefits.,’ DeSantis said at a news briefing Thursday morning.
‘That’s not the same as banning it, people can still access it if they want to, and patents can to, but if you look at when they were doing the hearing, we had one physician say parents are really really frightened and we know that the risk is low, we’re not sure how this is gonna work, but parents are frightened about Covid for their kids.’
He said that fear, not science, is not a reason to approve the shots for kids, and pointed at the mainstream media as the reason for budding fear among parents.
‘Why would they be frightened about 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 forking over the needed cash to acquire the shots. Then, states are to request allotments of the shots based on expected need, for which the federal government will fulfill to the best of its ability.
Floridians will not be able to access the shots unless the governor puts in an order, though the option to cross into another state and receive the shot there will exist for families that are 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 convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,’ Jeremy Redfern, said in a statement.
‘It is also no surprise we chose not to participate in distribution of the COVID-19 vaccine when the Department does not recommend it for all children.
‘Doctors can order vaccines if they are in need, 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 be a surprise, it follows guidance previously laid out by officials in the Sunshine state. In March, state Surgeon General Joseph Ladapo officially recommended healthy residents aged five to 17 not to get jabbed.
‘Based on currently available data, healthy children aged 5 to 17 may not benefit from receiving the currently available COVID-19 vaccine,’ he said in a statement.
‘…in general, healthy children with no significant underlying health conditions under 16 years old are at little to no risk of severe illness complications from COVID-19.’
The guidance also says that 16 and 17 year old children may face more risk from the vaccine than from the virus, a claim that is disputed by many health experts and officials worldwide.
Florida officials do not give a blanket recommendation for children with underlying health conditions or comorbidities to get the shot either.
‘For children with underlying health conditions or comorbidities, COVID-19 vaccines should be considered in consultation with your health care practitioner,’ the letter reads.
‘Parents are encouraged to discuss the risks and benefits with their children’s health care practitioner when evaluating whether their child should receive a COVID-19 vaccine, particularly for children with underlying health conditions or comorbidities.’