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Moderna accepts FDA COVID-19Vax for Kids Under 6: What Parents S

Moderna accepts FDA COVID-19Vax for Kids Under 6: What Parents S

 


  • Moderna will submit an application to the Food and Drug Administration for emergency use of the COVID-19 vaccine for infants.
  • Given the low effectiveness of the two doses for infection, a third dose may also be needed for younger children.
  • The clinical data for these trials have not yet been peer-reviewed.

modern announcement On Wednesday, we will submit an application to the Food and Drug Administration for emergency use of the COVID-19 vaccine for children aged 6 months to under 6 years.

The COVID-19 vaccine is not licensed for this age group in the United States.

The company also released interim results from two Phase 2/3 clinical trials in children aged 6 months to <2 years and children aged 2 to 6 years.

These showed that the double dose pediatric vaccine produced a similar immune response in infants, as seen in the double dose series given to 18-25 years old.

The dose given to younger children was one-fourth of the dose given to adults.

“Given the need for a vaccine against COVID-19 in infants, we are working with the US FDA and regulatory agencies around the world to submit these data as soon as possible,” said Moderna CEO. Stéphane Bancel said in a statement.

The clinical data for these trials have not yet been peer-reviewed.

In children aged 6 months to 2 years, two doses of the Moderna vaccine were 43.7% effective against symptomatic treatment. Children between the ages of 2 and 6 had a 37.5% effect on infection.

This is far less effective against infection than was seen in the original clinical trials of the adult mRNA vaccine.

However, these early studies were done before the emergence of Omicrons with mutations that allowed them to circumvent some of the immune protection provided by vaccines and previous infections.

According to the company, clinical trials in modern infants were conducted when Omicron was the predominant mutant.

Real world research In adults, two doses of the mRNA COVID-19 vaccine have been shown to be less protective against infection by Omicron than the original coronavirus strain.

However, two doses are still offered Protection against severe illness and hospitalization.. Booster doses enhance that protection.

In Moderna’s clinical trials in young children, there were no serious cases, hospitalizations, or deaths, and the company cannot estimate how much protection the vaccine will provide against these results.

According to the company, the vaccine’s side effect profile was good, similar to that found in older children, adolescents, and adults.

Most side effects in infants were mild or moderate and were more frequent after the second dose. According to the company, the fever rate was similar to that found in other pediatric vaccines.

After vaccination, no child had inflammation of the heart or tissues around the heart (myocarditis or pericarditis).

In addition, there have been no reports of cases of multisystem inflammatory syndrome (MIS-C) that can occur in children after coronavirus infection.

Given the low effectiveness of the two doses for infection, a third dose may also be needed for younger children.

Several Pediatric vaccine Two or more doses including diphtheria, tetanus, cell-free whooping cough (DTaP), hepatitis B, and poliovirus are required.

December, Pfizer and BioNTech announcement The COVID-19 vaccine trial in children aged 6 months to under 5 years should also be tested for a third dose in this age group.

This occurred after intermediate data showed that two doses in this age group were less protective against coronavirus infection.

Moderna announced on Wednesday that it is preparing to study booster doses for all children and adolescents. This includes testing booster doses for the Omicron variant.

“No one should consider this trial a failure, especially given that the published data is based on a two-dose schedule instead of three,” said Dr. Christina Johns, a pediatrician and senior medical adviser. I am saying. PM Pediatrics..

Also, “In many seasons of the flu, it should be noted that the flu is successful. [vaccine] Efficacy is believed to be similar to these percentages, “she added.

Parents of young children have long waited for the COVID-19 vaccine through most of the delta and omicron waves. They are still waiting as many of the countries withdraw COVID-19 mitigation measures.

“announcement [that] Moderna is seeking an emergency use authorization for the COVID-19 vaccine for children under the age of six. This is welcome news for millions of parents waiting to vaccinate their young children. ” Dr. Diego R. HihanoAn infectious disease specialist at St. Jude Children’s Research Hospital said in an email statement.

“Parents should not delay any further if their children are vaccinated against this life-threatening illness after being licensed,” he added.

By the time the FDA reviews Moderna’s data, the surge caused by the Omicron BA.1 sublineage may be over.

But Johns said there are other potential signs of a surge in the United States. This is caused by the BA.2 omicron subline.

“We have no way of predicting future rises and surges, so it’s an important initiative to protect people of as many ages as we can,” she said.

Modana also said Wednesday that it had begun filing an FDA seeking an emergency vaccine permit for children aged 6 to 12 years.

Moderna vaccines are approved for this age group in Canada, Europe and Australia.

Sources

1/ https://Google.com/

2/ https://www.healthline.com/health-news/moderna-to-ask-fda-to-ok-covid-19-vax-for-kids-under-6-what-parents-should-know

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