(This May 31st story rectifies the difference between third and second Pfizer Shot in paragraphs 5 to 2 months, not 3 months

By Manas Mishra

(Reuters) – The U.S. Food and Drug Administration’s advisory committee will meet in June to discuss whether or not to authorize. Moderna (NASDAQ:) Inc’s vaccine to children under 6 years of age, as well as Pfizer Inc (NYSE) and BioNTech Se (NASDAQ:) COVID-19 vaccines for children younger than 5 years.

This is an overview of some factors that will be taken into consideration in the decision regarding the age group not covered by the previous U.S. regulations for COVID-19 vaccinations.

WHAT TYPES OF DOSES DO YOU NEED?

Moderna applied to the FDA for authorization of a Spikevax vaccine in a two-dose dose. This is for children six months through six years. Although Pfizer is yet to file its FDA authorization, its clinical trial showed that a three-dose vaccine was safe for children aged 6 months to 5 years.

Moderna plans to use a 25 micrograms dose in that age group, lower than the 100 micrograms used in the first two doses in adults and the 50 micrograms used as a booster dose for non-immunocompromised adults. Moderna gave the doses at 28-day intervals during its clinical trial.

Pfizer and BioNTech developed the vaccine Comirnaty. The 3 microgram formula was used to test it in children younger than 5 years. It is different from the 10 microgram form used in children 5-11 years. A 30 microgram dose was used for adults 12 and up. Children were given two doses of the vaccine, the first dose being three weeks apart. A third dose was administered two to three months later.

The side effects from vaccines will be lessened by lower-dose variants.

HOW EFFECTIVE IS THE VACCINE?

In a clinical study involving approximately 6,700 children, Moderna’s efficacy at preventing symptoms in children aged 6 to 2 years was 43.7% and 37.5% respectively for those 2-6 years.

The final efficacy figures cannot be determined because there are not enough COVID-19 cases in children enrolled in the Pfizer BioNTech study. Based on 10 cases of COVID-19 symptoms, a preliminary analysis suggested that the vaccine had an 80.3% efficacy in children under 5. Pfizer will be updating those numbers after 21 patients in the trial are diagnosed with COVID-19.

ARE VACCINES SAFE TO CHILDREN?

Pfizer trial data which included 1678 children showed side effects that were comparable to those seen in adults. Pfizer claimed that the low-dose, 3-microgram vaccine was chosen because it had a better safety profile. It did not provide any specific safety data but stated that the vaccine was about the same as the placebo.

Moderna found that most side effects had mild or moderate severity, and the fever was similar to what children experienced with vaccines. In 0.2% of the children aged 2-6 and 2 to 3 years, fevers greater than 104°F were observed.

Moderna stated that there was no evidence of myocarditis and pericarditis. These are rare forms of inflammation of the heart, which have been associated with mRNA vaccinations.

According to data from Pfizer’s vaccine, the U.S. Centers for Diseases Control and Prevention (CDCP) has found that heart inflammation rates are lower among boys between 5 and 11 years than they were in teenagers and young men.

WHY VACCINATE YOUNG CHILDS?

The shots will be approved for use in the following age groups. Parents must decide whether their children should get vaccinated. They might be unsure if it’s worth the effort, given how many children became infected by Omicron. Experts believe that natural immunity diminishes with time. The data shows that COVID-19 protection is less effective in adults than in children, as well as in older people, who are infected and have received booster shots. Dr. Matthew Harris, Northwell Health’s pediatric emergency medicine doctor, said that this has been proven to be true in both adult and child patients.

Harris stated that vaccines can also prevent hospitalizations or deaths. Harris cited these as important reasons parents should consider vaccinations for their children.

FDA has established June 15th as the review date for the Moderna and BioNTech vaccines.