The FDA has approved COVID-19 vaccines for children up to six months old, manufacturers announced Friday morning.
The expected move comes after the Food and Drug Administration (FDA) senior advisory group voted to recommend Pfizer and Moderna vaccines for approval earlier this week.
Now, the Centers for Disease Control and Prevention (CDC) will be giving the green light to the shots before the scheduled release date on June 21st. A CDC advisory panel is scheduled to meet over the weekend.
The move makes the United States the nation with the youngest eligible vaccination age for COVID-19, a strange move, as data indicate that children at limited risk for the virus and the absorption of vaccine among children aged five to 13 years is low.
According to the CDC, children account for 0.1 percent of the country’s total deaths from the virus and are also less likely to have a serious case or hospitalization for Covid.
The FDA has approved Pfizer and Moderna vaccines for COVID-19 for use in children six months to five years of age. The jab is scheduled to be available on Tuesday, pending CDC approval as well. In the photo: a small child in San José, Costa Rica, receives a vaccine against COVID-19
“Many parents, caregivers and doctors have been waiting for a vaccine for younger children and this action will help protect children under 6 months,” said FDA Commissioner Dr. Robert Califf in a statement.
“As we have seen with older age groups, we expect vaccines for younger children to provide protection against the most serious outcomes of COVID-19, such as hospitalization and death.”
Pfizer revealed preliminary data last month showing that the vaccine was 80% effective in preventing Omicron infection, although the effectiveness rate may change as more test participants become infected. before the figures can be finalized.
The Pfizer jab will come in three doses, as opposed to the two-dose standard set for older age groups. It will also be just three micrograms, one-tenth the size of the standard dose for adults and one-third the dose for children ages five to twelve.
The change came late last year, when initial data showed that only two doses of jab provided little protection against the virus.
“We know that many parents in the United States have been eagerly awaiting a licensed vaccine for their children under the age of 5, and we are now proud to offer them a vaccine option with a favorable safety profile,” said Albert Bourla, CEO of Pfizer, based in New York City. he said in a statement.
Modern will use a two-dose shot for young children, with each injection of 25 micrograms, a quarter the size of their adult-sized doses.
In clinical trials, the Modern vaccine was 50% effective in preventing mild infection with the virus.
The Cambridge, Massachusetts-based company recruited 260 children between the ages of two and five for trial.
Pain, redness, and swelling at the injection site, fever, and swelling of the groin and armpits were the most common side effects of the injections.
“We are delighted that the FDA has granted emergency authorization for the modern COVID-19 vaccine for children and adolescents, especially for our youngest and most vulnerable children,” said Stephane Bancel, CEO of Moderna. Modern, in a statement.
Both the FDA and a group of external advisors, known as the Advisory Committee on Vaccines and Related Biological Products (VRBPAC), considered both vaccinations safe and effective.
“In addition to ensuring that the data on these vaccines meet strict FDA standards, the agency’s convening of an advisory committee was part of a transparent process to help the public gain an understanding. “The safety and efficacy data that support the authorization of these two vaccines for pediatric populations are clear,” said Dr. Peter Marks, the FDA’s chief regulator, in a statement.
The most worrying and most publicized side effects of COVID-19 vaccines are conditions of heart inflammation, myocarditis, and pericarditis.
The FDA reports that the risk of these conditions is low in this age group, however, instead of getting 12- to 17-year-olds more affected by the Pfizer vaccine, and 18-24. years with the jab Moderna.
If the CDC gives the expected green light this weekend, the shots are likely to be available on the White House’s scheduled release date on June 21st.
Dr Ashish Jha, who was recently appointed as the White House’s COVID-19 response coordinator, said during a briefing earlier this month that it would be the first day vaccinations would be available.
However, there are some doubts as to whether these features are even necessary. Deaths from the virus are very rare among children in the United States
A University of Utah study last year found that 50% of pediatric cases of Covid are asymptomatic. The study was conducted before the milder Omicron variant appeared, meaning that the risk of children even feeling symptoms is likely to be lower now.
Children may also be less likely to spread the virus when they become infected, with a German study finding that they release only 25% of the virus’s particles as adults do.
It is also unclear how much demand there will initially be for the shootings. A recent survey suggests that only 1 in 5 parents of young children would vaccinate their children immediately.
Vaccines have been available since November for older U.S. schoolchildren, but less than a third of those ages 5 to 11 have received the two recommended doses, according to government figures.
The federal government has already negotiated the purchase of the shots and is willing to distribute them to the states to handle the launch. However, not all states will make the new jabs available.
Gov. Ron DeSantis (pictured) decided not to order COVID-19 vaccines for children six months to four years old in Florida, saying parents are only concerned about the virus because of media hysteria.
Florida is the only state in the United States that has not reserved COVID-19 vaccines for children between the ages of six months and five years.
The Miami Herald reports that the state missed the deadline to file on Tuesday to request that the vaccines be delivered for release from June 21. In all other states, the punctures 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 be vaccinated because of the relatively limited risk they suffer from Covid compared to adults.
Gov. Ron DeSantis on Thursday reaffirmed his state’s position, blaming media hysteria on the fear some parents have of the virus, despite limited evidence that children are at risk for the virus.
“Our health department has been very clear, the risks outweigh the benefits,” DeSantis told a news conference Thursday morning.
“This is not the same as banning it, people can still access it if they want to, and patents can do it, but if we look at the hearing, we had a doctor who said that parents are very We are not sure how this will work, but parents are afraid of Covid for their children. “
He said fear, not science, is not a reason to approve of traits for children, and pointed to the media as the reason for the nascent fear among parents.
‘Why would they be so scared? It’s because of media hysteria. It is because of a lot of misinformation, that is why they are afraid ‘, he added.
The shots are bought at the federal level, and the White House is given the money to acquire the shots. States must then request firing assignments based on the expected need, for which the federal government will do its best.
Florida residents will not be able to access the shots unless the governor makes an order, although there will be the option to cross into another state and receive the shot for families who 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 complicated vaccine distribution process, especially when the federal government has a history of developing inconsistent and unsustainable COVID-19 policies,” Jeremy said. . Redfern said in a statement.
“It is also not surprising that we have chosen not to participate in the distribution of the COVID-19 vaccine when the Department does not recommend it for all children.
“Doctors can order vaccines if they need them, and there are currently no orders in the Department’s ordering system for the VOCID-19 vaccine for this age group.”
While the measure may come as a surprise, it follows guidelines previously set by Sunshine State officials. In March, state surgeon general Joseph Ladapo officially recommended healthy residents between the ages of five and 17 not to be punctured.
“According to currently available data, healthy children between the ages of 5 and 17 may not benefit from receiving the currently available COVID-19 vaccine,” it said in a statement.
“… in general, healthy children without significant underlying health problems under the age of 16 have little or no risk of serious complications from COVID-19 disease.”
The guide also says 16- and 17-year-olds may be at greater risk for the vaccine than for the virus, a claim that is being debated by many experts and health officials around the world.
Florida officials also do not give a general recommendation to children with underlying health conditions or comorbidities to receive the vaccine.
“For children with health conditions or underlying comorbidities, COVID-19 vaccines should be considered in consultation with your doctor,” the letter says.
“Parents are encouraged to discuss the risks and benefits with their child’s health care professional when assessing whether their child should receive a vaccine against COVID-19, especially for children with health or underlying comorbidities “.