FDA Approves Pfizer, Moderna Covid-19 Vaccines for Infants and Toddlers

“Many parents, caregivers and clinicians are waiting for the vaccine for young children, and this action will help protect children under 6 months of age,” said FDA Commissioner Robert Calif. The statement reads. “As we have seen with respect to older age groups, we expect younger children to be vaccinated against the most severe consequences of COVID-19, such as hospitalization and death.”

In addition to authorizing mRNA vaccines for younger children, the FDA has approved Moderna’s Covid-19 vaccine for children 6 to 17 years of age. For all ages, the FDA has determined that a third dose of the Moderna vaccine should be given to children with certain types of compromises. Immune system at least one month after receiving the second vaccine. The Pfizer-BioNTech vaccine has already been authorized for children under 5 years of age.

The CDC panel of expert advisors will consider the recommendation of the firing administration at its Friday and Saturday meetings. As soon as CDC Director Rochelle Valensky signs the recommendation, the children are expected to start recruiting on Tuesday.

Children under 6 years of age receiving the Moderna vaccine will receive two doses of 25 micrograms at four-week intervals. The Pfizer vaccine is two 3-microgram doses at three-week intervals, followed by a third dose at least eight weeks later.

Some members of the FDA Advisory Panel have expressed concern that parents may be confused by different dosing regimens of the products – especially since the Pfizer-BioNTech vaccine does not offer great protection after two doses, while Moderna’s primary series is full of two doses.

“I’m very sad that many of these children will not be able to get a third dose,” said Janet Ian Lee, a professor of biostatistics at the University of Arkansas School of Medicine, on the Pfizer vaccine. “This is a struggle to split people in two,” he added, noting that the intake of amplifiers for older populations is also low.

In the real world, efficacy for the Omicron variant in the Moderna vaccine ranged from 36 percent to 51 percent in the 6-month to 5-year-old age group, and efficacy assessments were “generally consistent” with the rates seen in adult observational studies. During the waves of the same variant, the FDA said.

Preliminary analysis of the Pfizer vaccine showed 80 percent efficacy against the disease in children under 5 years of age, although only 10 Covid cases were reported among study participants before the cessation date in April, which limits confidence in this figure.

Some FDA advisors have expressed concern that parents will compare the efficiency percentages presented by companies and determine which product to choose based on these figures alone. Asked at a news conference, Commissioner Caliph said speed should be a decision-maker for parents. “I am a grandparent and I have two who are in the age category we are discussing,” Calif told a news conference. “They all get the first thing that is available.”

To date, states, territories, pharmacies, and other federal partners have ordered approximately 2.5 million doses of Pfizer vaccine – half of the vaccine offered so far – and 1.3 million doses of Moderna, or about a quarter, available for pre-use. The order, said HHS Assistant Secretary of State for Readiness and Response Dawn O’Connell on Thursday.

Michael Nelson, head of the Asthma, Allergy and Immunology Division at UVA Health, called on manufacturers to quickly collect data on the prospect of vaccination of these children while they receive other routine childhood immunizations.

“If we do not get a quick response to the co-administration question, it will be a barrier to completing a three-dose series. [the Pfizer] “The vaccine and, most likely, the Moderna vaccine,” he said. “Being isolated will be a big challenge for families and children here in the United States.”

“Today is a day of great relief for parents and families across America,” President Joe Biden said in a statement. “As early as next week, in anticipation of the recommendations of the Centers for Disease Control and Prevention, parents will finally be able to protect their young children from the safe and effective Covid-19 vaccine.

The Biden administration is trying to persuade parents to vaccinate young children quickly. Summer vacations – and young children attending different levels of school up to the age of 5 – along with misinformation about vaccines can inhibit early activity. Many young children also become infected with Covid while taking omicron, which may persuade parents to stop their immunizations until they are free from natural infections.

Administration Faced criticism At the time it took to authorize these vaccines. Modern Asked the FDA for authorization In April, well before Pfizer-BioNTech Asked the FDA to authorize their vaccine Earlier this month. Moderna footage was expected to be ready to be transferred to the hands and hips by mid-May.

“I will not call it a delay,” said Peter Marx, director of the Center for Biological Assessment and Research. “The full submission was from 6 months to 17 years. Admission was very important [the data review] That’s right and we did. ”

“It so happens that towards the end, we are nearing the end of Pfizer’s updated release,” he added. “We believe that their unification with American society … actually gives people a choice.”

The latest poll by the Kaiser Family Foundation It is estimated that about 20 percent of parents want their children under 5 to be vaccinated as soon as they are eligible, while almost 40 percent plan to “wait and see” how the vaccine works, while the remaining 40 percent do not want immunization at all.

Only 29 percent of children between the ages of 5 and 11 in the United States are fully vaccinated, almost 56 percent of children between the ages of 12 and 15, and 67 percent of 16- and 17-year-olds, according to the CDC, which ended April 30. .

FDA Approves Pfizer, Moderna Covid-19 Vaccines for Infants and Toddlers

Source link FDA Approves Pfizer, Moderna Covid-19 Vaccines for Infants and Toddlers

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