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US allows babies to be vaccinated against COVID-19

On June 17, the US Food and Drug Administration (FDA) approved COVID-19 vaccines for children 6 months of age and older. Writes about it CBS News.

Photo: Shutterstock

The Centers for Disease Control and Prevention (CDC) still needs to sign an authorization before children under the age of 5 can begin vaccinations, which can happen within days.

“Those who are entrusted with the care of children can rest assured that these COVID-19 vaccines are safe and effective, and that the agency has conducted a thorough evaluation of the data,” FDA chief Dr. Robert Kaliff said in a statement.

The FDA's decision came after a unanimous vote at a meeting of the regulator's external advisors, the Advisory Committee on Vaccines and Related Biological Products, which reviewed Moderna's proposals as well as Pfizer's.

FDA approval for emergency use is sufficient to start deliveries across the country to facilities and healthcare providers that have pre-ordered doses for the first wave of shots. They were supposed to be delivered in early June.

However, as with older age groups, federal supply agreements require vaccinators to wait for CDC approval before administering vaccines designed for younger children.

The CDC Advisory Panel vote is scheduled for Saturday, June 18th. When the director of the Centers for Disease Control and Prevention (CDC) formally approves vaccinations after the meeting, federal officials expect many children to be able to start getting vaccinated as early as Tuesday, June 21.

Federal officials said that suppliers in most states, with the exception of Florida, had pre-ordered doses, with 2,5 million vaccine orders received from Pfizer and 1,3 million from Moderna.

The Florida Department of Health says it's taking orders for supplies in the coming weeks.

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Initially, suppliers in some states pre-ordered only one of the brands, although the administration of US President Joe Biden hopes this will even out as supply grows across the country in future shipments.

On June 17, the FDA approved Moderna's vaccine for children ages 6 to 17 after the company's request to vaccinate those children was put on hold for several months over concerns that it carries a greater risk of inflammatory side effects in teens.

If the CDC recommends, Moderna's vaccine will be the first alternative to Pfizer's vaccines, which have been available for older children for several months. CDC advisors are expected to vote on this issue next week.

Smaller doses for children and differences between Moderna and Pfizer

Unlike the largely similar first-round COVID-19 vaccine regimens that were available for adults, the manufacturers of the two mRNA vaccines took different approaches to immunizing young children.

For children aged 6 months to 5 years, Moderna plans to offer two injections one month apart. Their doses will be 25mcg, which is a small fraction of the 100mc adult dose.

The Pfizer vaccine will be given as three shots given over 11 weeks for children aged 6 months to 4 years. These doses are 3 mcg, which is only one tenth of the 30 mcg dose for children 12 years of age and older.

FDA vaccine spokesman Dr. Peter Marks acknowledged that each vaccine has its own "benefits and risks," but urged parents to get the first shots available to them.

Based on the study of antibodies against the virus in blood taken from children during clinical trials, both combinations were strong enough to pass FDA benchmarks for approval.

“If you want your child to start kindergarten or school in September, you must take the Moderna vaccine. You can't do it on a Pfizer schedule. And two doses of Pfizer is not enough,” said Moderna CEO Stefan Bancel.

The FDA review notes that a lower dose in shots is likely to result in fewer side effects.

“We already know that among the elderly, 30% get the vaccine. There can be many reasons for this, but one of them is reactogenicity,” said William Gruber, head of clinical research and vaccine development at Pfizer, referring to short-term side effects such as pain, fever and pain at the injection site.

Two small doses of Moderna also resulted in fewer most types of side effects in children compared to older age groups in the study.

The score for three doses of Pfizer's vaccine is much higher than the score for two doses of Moderna.

But the FDA review cites a wide range of limitations to Pfizer's evaluation, given the few cases of COVID-19 that have been reported in Pfizer's trials and the wide range of dosing intervals. Some trial participants received their third Pfizer shots as early as eight months after their second, the FDA said.

The agency said Pfizer's analysis "was determined to be unreliable due to the small number of cases of COVID-19 reported among study participants."

“I believe the vaccine is effective,” Dr. Amanda Cohn of the CDC told the FDA committee.

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Dr. Peter Marks acknowledged that both vaccines may need to be updated in the coming months, but urged parents to build up a "basic level of immunity" with current versions of vaccines now. The agency has another advisory meeting scheduled to discuss the topic as both vaccine manufacturers rush to ramp up production of their new Omicron vaccine formulations.

“If it turns out that there will be a very major change in strains in the fall, we will adjust and make sure there is an option available for the youngest children and for the entire age range, if necessary,” he assured.

Young children are generally at lower risk of severe COVID-19 than older children and adults. In addition, many asymptomatic cases probably went unreported. No severe cases were reported in the Moderna study, even among children who received placebo.

However, officials and experts have warned the committee that the virus is still taking an unprecedented toll on children. During the omicron wave, hospitalizations and deaths among young children skyrocketed, despite evidence that most children already had some antibodies from a previous infection.

“We have to be careful not to become indifferent to the number of deaths. Every life is important. And we want to try to do something about vaccine-preventable deaths,” said Dr. Peter Marks.

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