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Marathon hearings in US to decide fate of infant COVID shots

Parents who finally want to vaccinate their youngest children against COVID-19, buckle up: a lot is going to happen in the next week.

Both on Wednesday modern and Pfizer must convince what is essentially a court of science — advisers to the Food and Drug Administration — that their shots work well on babies, toddlers, and preschoolers.

The FDA performed its own analysis of Moderna’s vaccine late Friday and found that the shots appear safe and effective for children 6 months and older. A federal review of Pfizer’s vaccine for the youngest children is expected by Monday.

Children under the age of 5 are the only group not yet eligible for a COVID-19 vaccination in the United States. If FDA advisers approve one or both vaccines for them — and the FDA agrees — there’s another hurdle. The Centers for Disease Control and Prevention must recommend whether all young children need to be vaccinated or only those who are at high risk from the virus.

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In addition to complexity, each company offers different dose sizes and number of shots. And the week doesn’t begin with even the slightest child debate: Moderna will first ask FDA advisers to endorse its vaccine for older children.

Only a handful of countries, including China and Cuba, have offered different types of COVID-19 vaccinations to children under the age of 5.

Here’s an introduction to help keep you up to date with all developments.

PFIZER’S PLAN FOR THE YOUNGEST

Pfizer has a pediatric track record — its COVID-19 vaccine is the only type the FDA approves for children of all ages. Two doses plus a booster shot are approved for everyone aged 5 and over. shots for the 5 to 11 year olds contain a third of the dose given to teenagers and adults.

For children under 5, Pfizer and its partner BioNTech have lowered the dose even further, to a tenth of the adult dose. The compromise is the need for three shots, with the first two given three weeks apart and the last at least two months later.

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MODERN PLAN FOR THE YOUNGEST

Moderna is seeking FDA approval for two shots, each one-fourth the adult dose, to be given to children under 6 years of age about four weeks apart. (Moderna tested a slightly different age limit than Pfizer.)

The FDA currently only allows Moderna’s vaccine to be used in adults. However, some countries allow two full-size cans for teens and half-size shots for kids ages 6 to 11 – which Moderna wants to offer in the US too

MAKE YOUR CASE

Pfizer disappointed parents back in December when a study found two shots weren’t powerful enough. Therefore, during the winter tide of the Omicron variant, the researchers tested a third injection in adolescents aged 6 months to 4 years.

Pfizer’s preliminary data showed that after three vaccinations, children developed high levels of virus-fighting antibodies with no safety issues. In addition, the vaccine appeared to be 80% effective in preventing symptomatic COVID-19. However, that calculation was based on just 10 cases diagnosed among study participants through the end of April, and could change if more cases have emerged since then.

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Moderna’s study found that children aged 6 months to 5 years developed high levels of antibodies after two vaccinations. But while there were no severe cases of COVID-19 during the study, the vaccine was only about 40% to 50% effective at preventing milder infections.

In their review, FDA scientists determined that the study was too short to determine how long the vaccine’s effectiveness would last. They also said that based on adult experience, a booster shot would likely be needed.

Moderna recently added a booster dose to the Tot study — and announced in a presentation for Wednesday’s meeting that it also plans to give participants the opportunity to help test an Omicron targeting booster.

WHEN COULD GUNS START?

If the FDA approves one or both injections — a decision expected shortly after its advisory panel meets — all eyes will be on the CDC. This agency recommends how to use vaccines. Which young children should get a COVID-19 vaccination will be a major debate because the coronavirus doesn’t make children as sick as adults, but nearly 500 deaths have been reported in US children under the age of 5.

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CDC vaccine advisors are scheduled to meet next Friday and Saturday, and a final decision from CDC Director Dr. Rochelle Walensky, should be done shortly after her graduation.

If all of these steps are implemented, immunizations could begin on June 21 in many areas.

VACCINATION FACILITIES

Paediatricians, other family doctors and children’s hospitals are expected to vaccinate most of the youngest children. Limited drugstores offer them to at least part of the under 5s group – parents should check local availability for different age groups. The Biden administration says it is also working with a variety of other groups, such as children’s museums, to offer pop-up clinics and reach even more youth.

WHAT IF MY CHILD HAS RECENTLY HAD COVID-19?

Around three quarters of the children of all ages are estimated to have been infected at some point during the pandemic. It’s a question that’s sure to come up as CDC’s advisors make recommendations for the youngest children, so stay tuned.

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For older people, the CDC has recommended vaccination anyway to reduce the chance of reinfection. There is no set guide as to how long to wait. The CDC has said people can wait up to three months.

DEMAND IS UNCLEAR

There are approximately 18 million children under the age of 5, and many parents are keen to get their little ones vaccinated. But it’s unclear how many will eventually become, given disappointing vaccine uptake by older children.

According to the CDC, only 29% of children ages 5 to 11 have received two doses, and about 60% of those ages 12 to 17.

WHAT ABOUT MODERN AND OLDER CHILDREN?

On Tuesday, FDA advisors will consider Moderna shots for older children, ages 6 to 17 — a decision that could ease some parental confusion. The FDA review released Friday also included an analysis of the company’s syringes for this age group.

The FDA withheld Moderna’s juvenile vaccine for months while it investigated a rare side effect, heart inflammation. This is a particular risk for teenagers and young men and can also occur with the Pfizer vaccine. The FDA review said its most recent analysis of reports of myocarditis in both the US and other countries found no conclusive evidence of a difference in risk between Moderna’s and Pfizer’s vaccines.

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https://www.local10.com/health/2022/06/10/marathon-us-hearings-to-decide-fate-of-covid-shots-for-tots/ Marathon hearings in US to decide fate of infant COVID shots

Sarah Y. Kim

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