Late Friday, federal health regulators stated that child-sized doses of Pfizer’s Covid-19 vaccine are highly effective in preventing symptoms in elementary schoolchildren. There were no safety concerns as Pfizer weighs starting vaccinations for children.

Pfizer data analysis was posted by the Food and Drug Administration ahead of the public meeting next week. The purpose of the meeting is to discuss whether vaccines are available for all of the country’s approximately 28 million children aged 5-11 years. A panel of vaccine experts from outside will vote for the agency on this question.

FDA scientists determined that the benefits of vaccine for Covid-19 in preventing death and hospitalizations would be greater than any potential side effects for children in nearly every case. However, agency reviewers did not recommend that Pfizer be given the shot.

This question will be put to the panel of independent advisers by the agency next Tuesday. The agency will then evaluate their recommendations before it makes its decision.

The FDA will authorize the shots. If not, the Centers for Disease Control and Prevention (CDC) will issue additional recommendations about who should get them in the first week. It is possible that children could get their vaccinations in the early part of next month, with all those who are eligible fully protected by Christmas.

Pfizer full-strength shots are already recommended for those 12 and older. However, many parents and pediatricians are eagerly waiting for protection for their children as they face the additional-contagious delta variant.

FDA approved Pfizer’s early-day results showing that the two-dose shot is nearly 91% effective in preventing symptoms in young children. This figure was calculated using data from 16 Covid-19-infected children given dummy shots and three cases for vaccinated ones. The youngsters did not suffer from any severe diseases, although the symptoms were milder in the vaccinated children than the unvaccinated.

The majority of study data was collected during the August/September period in the U.S., when the Delta variant became the predominant COVID-19 strain.

FDA reviewed the side effects and found that they were not unexpected. Most of them consisted in sore arms, fever, or achiness, as teens often experience.

FDA scientists acknowledged that they were unable to detect rare side effects like myocarditis. This is a condition that occurs when there are two doses of the drug.

It used statistical modeling and mathematical modelling to determine how many deaths or hospitalizations COVID-19 vaccine could prevent, as well as the potential side effects to the heart. Four scenarios were used to illustrate the effects of COVID-19. The vaccine was able to prevent more hospitalizations that would have been expected due the heart side effect.

Only in very rare cases of virus, would more people be hospitalized by the vaccine than they would have prevented. However, the regulators agreed that the vaccine’s “clearly outweighs” its potential risks.

The CDC reports that Covid-19 has claimed the lives of more than 630 Americans aged 18 and younger, despite their lower mortality rate than people older than them. The American Academy of Pediatrics reports that nearly 6.2 million children were infected by the coronavirus. This is more than the 1.1 million who contracted it in six weeks, as the number of cases of the delta virus exploded.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. Millions of vaccine doses, as well as kid-sized needles, will be shipped out to the nation if the vaccine has been cleared.

Over 25,000 primary care and pediatricians have already signed up for the vaccines.