FDA Advisors Weigh Expanding COVID-19 Vaccines for Younger Children – CBS Detroit

(CNN) — Months after older children became eligible to be vaccinated against COVID-19, the United States may be just days away from offering vaccines to children under the age of 5.

The independent Vaccines and Related Biological Products Advisory Committee of the US Food and Drug Administration meets Tuesday and Wednesday to discuss changing the emergency use authorization (EUA) of Moderna and Pfizer/BioNTech’s COVID-19 vaccines for younger ages .

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Children under the age of 5 – about 18 million people – are the only age group in the US not eligible for a COVID-19 vaccine.

The Moderna vaccine is approved for use in adults, but on Tuesday the advisers will discuss including children ages 6 to 17; on Wednesday they will consider extending the authorization to infants and children aged 6 months to 5 years.

The Pfizer/BioNTech vaccine is approved for people ages 16 and older and is approved for use in children ages 5 and older. At Wednesday’s meeting, advisers will discuss how to amend the EUA to include doses of the pediatric vaccine for infants and children as young as 6 years old. months to 4.

According to FDA briefing documents posted Sunday, an agency review found that data supports the effectiveness of the Pfizer/BioNTech COVID-19 vaccine, given as a series of three doses, in preventing the disease in children aged 6. months to 4 years old. According to another paper, an FDA review found that Moderna’s COVID-19 vaccine is also safe and effective in younger children.

In their meetings Tuesday and Wednesday, VRBPAC members will vote on whether the benefits of the Moderna and Pfizer/BioNTech vaccines outweigh the risks to younger children.

What’s the next step after vaccine advisors meet?

After the FDA vaccine advisors vote, the agency will consider their decision and consider whether to approve the vaccines.

However, shots cannot be given until the U.S. Centers for Disease Control and Prevention’s vaccine advisers vote on whether or not to recommend it and CDC director Dr. Rochelle Walensky has signed the recommendation.

The White House has said vaccines for the youngest children could begin next week.

The rollout of vaccines for this group could mirror that for older children, as pediatricians’ offices will play a major role in getting the guns fired up.

Some pharmacies are also preparing to administer more vaccines.

“We plan to provide COVID-19 vaccinations to children ages 18 months through four years in our national network of 1,100 MinuteClinic locations once the FDA and CDC provide guidance and inventory is received,” said CVS- spokesman Matt Blanchette in an emailed statement Monday. †

“Our MinuteClinic clinicians, made up of certified family nurses, physician assistants and nurses, have significant experience in providing vaccinations to a younger population and in private examination rooms, which will make the process easier for children, parents and guardians,” says the explanation.

Children under 5 tend to have lower rates of COVID-19 than other age groups. But in the first week of June, hospital admissions in these children were slightly higher than in adults under 50 and four times higher than in other children.

At least 481 American children under the age of 5 have died from COVID-19, according to the CDC.

Data from Pfizer

People 5 years and older are already eligible for the COVID-19 vaccine with two doses of Pfizer/BioNTech and a booster dose – but at Wednesday’s meeting, VRBPAC members will discuss whether younger children should be added to the authorization for use in case of emergency.

According to a briefing paper, Pfizer’s three-dose COVID-19 vaccine appears to be safe for children under the age of 5 and elicits an immune response similar to that seen in older people in studies.

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One trial involved more than 4,500 children ages 6 to 23 months and 2 to 4 years. Some received three injections of 3 micrograms, with the second injection three weeks after the first and the third at least eight weeks after the second. The rest received a placebo.

The FDA briefing paper says that for this age group, the Pfizer vaccine caused reactions similar to those seen in 16- to 25-year-olds. There were not enough COVID-19 cases to establish the vaccine’s efficacy in the study, but the FDA noted that this vaccine is known to be less protective against the Omicron variant.

A preliminary analysis put the vaccine’s efficacy for children under 5 years old at 80.4%, with three COVID-19 cases in the vaccine group and seven in the placebo group. All cases happened while the Omicron variant was dominant in the United States.

“Given the uncertainty of the COVID-19 pandemic and the likelihood of continued transmission of SARS-CoV-2 during subsequent months, the deployment of the vaccine for use in children 6 months to 4 years of age is likely to have a beneficial effect have COVID-19 associated morbidity and mortality in this age group,” the FDA said in its analysis.

There were no cases of anaphylaxis. There were also no cases of myocarditis or pericarditis — inflammation of the heart muscle and inflammation of tissue around the heart — reported in more than 3,000 vaccine recipients in the study, but it wasn’t a large enough group to rule out the risk.

The most common adverse reactions in children aged 6 to 23 months were irritability, somnolence, loss of appetite and tenderness at the injection site. In children aged 2 to 4 years, the most common side effects were pain or redness at the injection site and fatigue.

It’s not clear how long the vaccine will be effective; the agency noted that the evaluation period was limited and that protection is known to decrease over time with old age. The agency also said it is “likely to require a booster dose in addition to the primary three-dose series to increase the robustness, breadth and duration of protection.”

Modern data

The immune response and safety profile of Moderna’s COVID-19 vaccine also appear favorable for the youngest children, according to FDA briefing documents.

VRBPAC members will discuss Moderna’s vaccine on Tuesday and Wednesday and evaluate whether it should be approved for younger ages.

In studies evaluating more than 6,000 children aged 6 months to less than 6 years, Moderna scientists found that two doses of 25 micrograms of vaccine given 28 days apart produced a similar immune response to the two-dose vaccine series in adults. from 18 to 25 years. †

For children and teens ages 6 to 17, Moderna found that two doses of the vaccine produced a similar immune response as two doses in adults.

The vaccine was also found to be safe in all age groups, with side effects described as “usually mild to moderate in severity, generally short-lived,” and more frequent after the second dose than the first, according to the document. Injection site pain was the most commonly reported adverse reaction. As for serious adverse events, the document described them as rare and raised no concern. No deaths were reported.

While there have been no known cases of vaccine-related myocarditis or pedicarditis, it is recognized as one of the known risks and has been reported primarily in males ages 18 to 24.

The FDA did not require vaccine manufacturers to submit vaccine efficacy data for emergency use authorization for young children, but Moderna’s vaccine is estimated to be 93.3% effective against symptomatic COVID-19 in teens ages 12 to 17 when the original coronavirus and the Alpha variant were dominant.

The vaccine was estimated to be 76.8% effective against symptomatic COVID-19 for children ages 6-11 when the Delta variant predominated. However, the FDA also noted that for children in that age group, the “efficacy of the vaccine could not be reliably determined due to the small number of COVID-19 cases contracted during the study.”

The vaccine was tested at a time when the Omicron variant was dominant. It was estimated to be 36.8% effective against symptomatic COVID-19 for children aged 2 to 5 years and 50.6% protective for children aged 6 months to 23 months.

Estimates of vaccine efficacy “were generally consistent” with what has been seen in adults, according to the FDA briefing document.

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