Pfizer Says Its Vaccine Is Very Effective In Children 5-11 Years Old

Pfizer released data on Friday showing that its coronavirus vaccine had a 90.7% effectiveness rate in preventing symptomatic Covid-19 in...

Pfizer released data on Friday showing that its coronavirus vaccine had a 90.7% effectiveness rate in preventing symptomatic Covid-19 in a clinical trial in children aged 5 to 11.

The company and its partner BioNTech submitted the information to the Food and Drug Administration, which was due to release its own analysis of the data later today.

Children participating in the trial were given a dose of 10 micrograms, or one-third of the adult dose. The researchers said the dosage was safe and the trial participants saw only mild side effects.

Of 2,268 children participating in the trial, twice as many received the vaccine as a placebo. Sixteen children who received the placebo contracted Covid-19, compared to three who received the vaccine.

There were no cases of serious illness. All of the cases occurred in July or later, around a time when the highly transmissible Delta variant was spreading in the United States and around the world, Pfizer said.

After the second injection, children had neutralizing antibody levels at least equal to those of volunteers aged 16 to 25 in another Pfizer-BioNTech trial. Although antibody levels are only one measure of the immune system’s response, experts said such a finding would indicate that a third of strength is the correct dosage for young children.

Pfizer also reported that there had been no cases of heart disease from myocarditis, which is inflammation of the heart muscle, or pericarditis, which is inflammation of the lining around the heart, in volunteers about three months afterward. have received the second dose. The two conditions have been linked to adult vaccine recipients, especially young men. Because the conditions are rare, it’s unlikely that any of them would have occurred in a study as small as Pfizer’s.

Studies have also shown that the risk of heart problems after Covid-19 is higher than after vaccination.

The FDA released the data ahead of a meeting on Tuesday where the agency’s expert advisers will decide whether or not to recommend the agency to authorize the vaccine for children in this age group. Federal regulators have already made the vaccine available for ages 12 and older.

The Biden administration has enthusiastically promoted the prospect of protection for the 28 million children aged 5 to 11, promising that tens of thousands of pediatric or primary care offices, pharmacies and school clinics and rural people will be ready to administer injections if regulators grant permission. . With the school year well underway, many parents are eagerly awaiting development.

If the FDA grants clearance, distribution of doses will still depend on approval from the Centers for Disease Control and Prevention, which sets vaccine policy. The CDC has scheduled a two-day meeting of its own advisory committee on November 2-3. Federal officials said they intended Immediately ship 15 million doses to states if regulatory and health authorities authorize relocation.

About 17 million adolescents aged 12 to 15 became eligible for the Pfizer-BioNTech vaccine in May. A month ago, Pfizer and BioNTech said their vaccine was also safe and effective for young children but has not published detailed clinical trial data.

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Newsrust - US Top News: Pfizer Says Its Vaccine Is Very Effective In Children 5-11 Years Old
Pfizer Says Its Vaccine Is Very Effective In Children 5-11 Years Old
Newsrust - US Top News
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