FDA approves first COVID-19 shots for infants and preschoolers – Reading Eagle


US regulators on Friday approved the first COVID-19 shots for infants and preschoolers, paving the way for vaccination to begin next week.

The Food and Drug Administration’s actions follow the unanimous recommendations of the Advisory Board for shots from Moderna and Pfizer. In other words, US children under the age of 5 (about 18 million young people) are targeted for shots. The national vaccination campaign began about a year and a half ago with the elderly who were hit hardest by the coronavirus pandemic.

There is one remaining step: the Centers for Disease Control and Prevention recommends vaccine usage. The independent advisor will begin discussions on the two-dose Moderna and three-dose Pfizer vaccines on Friday and make recommendations on Saturday. CDC Director Dr. Rochelle Walensky expects immediate final approval.

At a Senate hearing on Thursday, Warrensky said her staff was working on a federal holiday weekend in June.

She said that child deaths from COVID-19 are higher than commonly seen from influenza each year.

“So I think we really need to not only protect infants, but also vaccines to protect everyone, especially the elderly,” she said.

The FDA has also approved the Moderna vaccine for school-aged children and teens. The CDC review is next week. Pfizer shots were the only choice for these age groups.

For weeks, the Biden administration has been preparing to deploy vaccines for young children, with states, tribes, community health centers, and pharmacies pre-ordering millions of doses. The FDA’s Emergency Use Authorization allows manufacturers to begin shipping vaccines nationwide. Shots are expected to start early next week, but it’s not clear how popular they are.

Some families postponed birthday parties, vacations, and visits with their grandparents without protecting their luggage.

“Today is a great relief day for parents and families across the United States,” President Joe Biden said in a statement.

Toddlers are generally less infected with COVID-19 than older children and adults, but hospitalizations surged during the Omicron wave, and FDA advisers outweigh the minimal risk of vaccination benefits. I decided that there was. Studies by Moderna and Pfizer show that there were few side effects such as fever and fatigue.

“As seen in the elderly, vaccines for young children are expected to provide protection from the most serious consequences of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Caliph said in a statement. It is stated in.

According to the FDA, in tests, the youngest children have developed antibodies that fight high levels of the virus, comparable to those found in young adults. While the Moderna vaccine was about 40% to 50% effective in preventing infection, Pfizer’s study found that there were too few cases to make a reliable and accurate estimate of the effect.

“Both of these vaccines are recognized for their science and safety at the forefront of our hearts,” Dr. Peter Markes, FDA’s Head of Vaccines, said at a press conference.

Marks said parents should be accustomed to both vaccines and should vaccinate their children as soon as possible rather than waiting until the fall when another viral variant may be endemic. rice field. He said vaccine adjustments would be made to explain it.

“Whatever vaccine your healthcare provider or pediatrician has, that’s what I give my child,” Marks said.

The two brands use the same technology, but there are differences.

Pfizer vaccines for children under the age of 5 are one-tenth that of adults. I need 3 shots. The first two are given at 3-week intervals and the last two are given at least 2 months later.

Moderna is given in two injections, each at a dose of one-fourth that of an adult, and children under the age of 6 are given an interval of about 4 weeks. Vulnerable to serious illness.

Both vaccines are for 6-month-old children. Moderna then plans to study the shot for a three-month-old baby. Pfizer has not finalized a plan for a toddler’s shot. Twelve countries, including China, have already vaccinated children under the age of five with other brands.

Shortly after hearing the FDA’s decision, Houston radiologist Dr. Toma Omofoye booked a 4-year-old daughter and a 3-year-old son. Without the shots, she said her family would have missed her family gatherings, indoor concerts, and even trips to grocery stores. During a recent pharmacy stop, Omofoe thanked her for saying her daughter stared like Disneyland and walked around.

“At that moment my heart broke, which is why my heart is so uplifting now,” Omofoye said.

But do other parents aspire to vaccinate their youngest child? According to some estimates, three-quarters of all US children are already infected. And since Pfizer’s shot was opened to them last November, only about 30% of children aged 5 to 11 have been vaccinated.

FDA officials acknowledged these low rates and said the government is working to vaccinate more older children and achieve better success with younger children.

“It’s a real tragedy when there’s a free one with few side effects that prevent death or hospitalization,” Caliph said.

Approximately 440 children under the age of 5 have died of COVID-19, according to federal data.

Dr. Beth Eber of the University of Washington School of Medicine in Seattle said a vaccine of this size would be especially welcomed by parents with children in day care.

“Many people will be happy and many grandparents will be happy because they missed the baby they grew up when you couldn’t see them,” Eber said.


Contributed by AP medical writers Laura Ungar and Carla K. Johnson.


Follow AP Medical Writer Lindsey Tanner: @LindseyTanner


The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.

FDA approves first COVID-19 shots for infants and preschoolers – Reading Eagle

Source link FDA approves first COVID-19 shots for infants and preschoolers – Reading Eagle

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