Washington — Food and Drug Administration approved Both Moderna and Pfizer-BioNTech corona virus vaccines for the youngest children in the United States on Friday. Relief for parents who have waited 18 months to protect babies, toddlers and preschoolers since Shot was first available.
Regulators followed the recommendations of an independent expert on the Advisory Board, which voted in favor of both vaccines on Wednesday. All Americans, except about 20 million children under the age of 5, have the option of protecting themselves from Covid-19 for months and are eligible for booster shots.
Moderna’s two-dose vaccine is for children aged 6 months to 5 years, and Pfizer’s three-dose vaccine is for children aged 6 months to 4 years.
Another Advisory Board to the Centers for Disease Control and Prevention We started a two-day meeting on this issue on Friday.. Vaccine use is permitted by FDA measures, but doctors are asking the CDC advisory board for details on how to use the vaccine, and vaccine acceptance depends in part on the strength of the FDA’s recommendations. To do. After Saturday’s panel vote, CDC Director Rochelle P. Walensky will publish her own recommendations, the final step before her distribution.
The Biden administration began shipping vaccines on Friday. However, uptake in the coming weeks may be low.
Studies by both Pfizer and Moderna have shown that Omicron variants of the virus significantly reduce the power of vaccines to prevent symptomatic infections in infants, as in adults.
Pfizer states that two doses of the vaccine were only about 28% effective in preventing the disease, while three doses were 80% effective. However, that 80% estimate was based on only 10 of the subset of 1,678 study participants.
The Moderna vaccine was approximately 51% effective in children aged 6 months to 2 years and 37% in children aged 2 to 5 years.
CDC advisors, like the FDA’s independent panel I was hardly worried about the side effects of either vaccine.. They also emphasized unmet needs. Drexel University School of Medicine panelist and infectious disease expert Dr. Sarah Long said, “The myth that this infectious disease is not life-threatening in this age group should be thinned out with data on the effects of Omicron on infants. “.
But they shared the FDA’s panel concerns Pfizer vaccine efficacy, And the dose required to achieve it. Dr. Matthew Daily, Principal Investigator at Kaiser Permanente Colorado, who heads the CDC’s Vaccine Working Group, referred to Pfizer’s efficacy data: “Uncertainty around it because of some complete transparency to parents. It is appropriate to admit. ” ..
Both vaccines elicited an immune response comparable to that evoked in young adults. This is the main measurement used by the institution to measure effectiveness. Asked to compare them at a press briefing, Dr. Peter Markes, who heads the FDA’s vaccine department, said Modana’s vaccine could provoke an immune response “slightly faster” and Pfizer’s vaccine “third dose.” It will bring a big response later. “
He said parents should feel comfortable with either and recommended choosing the one available. Dr. Robert M. Caliph, FDA Commissioner, said in his statement: And death. “
Asked the reason FDA statement Dr. Marks quoted validity data only for Moderna shots, saying the company’s data are “mature” than Pfizer’s. Another top agency regulator on Wednesday said Pfizer’s estimation of 80% efficacy with three doses was “inaccurate” and subject to change.
Federal agencies are currently investigating whether both vaccines need to be renewed for all age groups to combat the rapidly evolving virus. CDC panelists spent a considerable amount of time on Friday trying to identify how Omicron variants changed the risk to children. They said parents vaccinated their children for many other illnesses and the risk of death was equal or lower.
Dr. Marks urged parents not to wait for the vaccine to be redesigned, saying that current vaccines still provide “excellent basal immunity to a wide range of Covid-19 mutants.” rice field.
“Today is a great relief day for parents and families across the United States,” Biden said in a statement. However, early signs suggest that there may be a large surplus of dose.
So far, Pfizer-BioNTech vaccines have been ordered only 2.5 million times, about half of what the federal government has provided to states, pharmacies and healthcare providers. And a Moderna dose of about 1.3 million, which is about a quarter of what was offered, is claimed.
The distribution can be uneven, depending on the number of vaccines ordered by the state authorities and where they are sent. Florida was initially the only state Do not order a supply of your own shots for next week’s rollout, according to White House officials. Who said the state reversed that position on Friday.. A spokesman for Ron DeSantis, a state Republican governor who rejected the need for vaccines for young children, denied that it was a reversal, but the state “does not recommend vaccination of healthy children. I repeated.
Early Friday morning, Cori J. Darr of Riverside, Missouri, said he would soon look for a vaccine for his five-year-old daughter in November.
“I was starting to think she would mature into the vaccine before anyone bothered to approve the vaccine,” she wrote in an email.
But at the beginning of Friday, she had a hard time figuring out where to go. She said neither her pediatrician’s office nor her local health department planned to provide shots, and the vaccine clinic at her local children’s hospital was closed.
Federal officials say states usually gradually increase orders as vaccination campaigns progress. However, less than 40% of children aged 5 to 11 years have been vaccinated with the coronavirus vaccine at least once. This indicates that many families, including those whose adult members have been enthusiastically vaccinated, may hesitate to inoculate their children.
Pfizer’s vaccine therapy for infants is 3 micrograms each, 3 doses, or 1/10 of adults. The first two doses are given every 3 weeks. The third dose will be given at least 2 months after the second dose. This means that it will take about 3 months to be fully vaccinated.
The Moderna vaccine is given in two doses of 25 micrograms each (a quarter of an adult) at 4-week intervals. Some parents say they prefer a shorter time frame because their child is considered fully vaccinated.
On the other hand, experts say that some parents, pharmacists, and pediatricians feel more comfortable just because Pfizer’s vaccine has been given to children over the age of five for months. ..
Until Friday morning, Moderna’s vaccine was restricted to adults. The FDA has approved it simultaneously for three age groups, from 6 months to 17 years.
The FDA states that both vaccines may require booster immunity. That is, the Pfizer-BioNTech vaccine is given four times and the Moderna vaccine is given three times.
Dr. Erin Rose Medina of Spokane, Washington said she prefers the Moderna vaccine because she believes it may be more effective for her 3-year-old son. “Another reason to use Moderna is to reach a fully vaccinated state sooner,” she wrote in an email, “waiting for Moderna if only Pfizer is available.” No, “he added.
Some pediatric and vaccine experts say it is very difficult to compare the two vaccines.
“I don’t think there is enough compelling data to say that one is better than the other,” said Dr. Christine Moffitt, a doctor at the Boston Children’s Hospital who treated a young Covid-19 patient. “Given the differences between the two research methods, we all need to admit that it is very difficult to make a direct comparison between the two.”
Dr. James Conway, a pediatric infectious disease expert at the University of Wisconsin-Madison, said it was difficult to determine which vaccine could provide how much protection because it was tested against the replaced mutant. Stated. “You are a kind of whac-a-mole,” he said.
The FDA faces criticism that it has not licensed the Moderna vaccine for children under the age of six due to unmet needs. According to Moderna, the company completed applications for all three pediatric age groups on May 9.
However, at a press conference, Dr. Marks argued that regulators would not delay action at Modana’s request. Clearing both vaccines for the youngest children “actually gives people a choice,” he said.
Emily Eldos When Patricia Mattsey Report that contributed.
