Tuesday’s recommendation by a crucial advisory group of Food and Drug Administration officials was for a lower intake Pfizer and BioNTech‘s Covid-19 vaccine for children ages 5 to 11, a critical step in getting some 28 million more kids in the U.S. protected against the virus as the delta variant spreads.

The endorsement by the agency’s Vaccines Related Biological Products Advisory Committee will now be considered by the FDA, which could issue a final decision within days. It was almost unanimous, with 17 voting in favor and one abstention.

While the agency does not always follow the recommendations of its independent committees, they often do. The Centers for Disease Control and Prevention’s vaccine advisory committee is set to issue its recommendations next week. Shots for children as young as five years old could be started immediately if it endorses and Dr. Rochelle Walensky is a signatory.

Biden’s administration stated it plans to distribute the dosesOnce it is approved by FDA/CDC. It should be available in mid-January. According to the administration, enough vaccine has been purchased to cover all 28, million children aged 5 to 11, and that it will be distributed in lower doses and with smaller needles so it is easier for pharmacists and pediatricians to give to children.

Many parents are anxiously anticipating the authorization of the vaccine with schools opening across the U.S.A and the new delta variant driving an increase in cases among children.

According to Tuesday’s FDA data, approximately 9% of reported Covid cases in America are children aged 5-11 years old. American Academy of Pediatrics reports that the American Academy of Pediatrics has added more than 1.1million cases of Covid to their database in just six weeks.

However, advocacy groups and parents still believe Covid vaccinations are not necessary for children. There are studies that show that even though adults get the disease at a similar rate as kids, they are more likely to develop symptoms.

Some members of the committee stated Tuesday that vaccinations for younger people would be beneficial in the United States’ transition to Covid’s “endemic phase”. This is where the virus circulates but is at lower levels than now. Some others noted that there were still many unknowns such as the incidence of myocarditis among young children, but they still believed the vaccines had benefits outweighing the risks. Another member asked if they should only make a recommendation for high-risk children.

Amanda Cohn, member of the ICU said that she didn’t wish for children to die from Covid.

Prior to voting, FDA’s chief vaccine regulator Dr. Peter Marks asked members of the committee for civility in the discussion, saying that strong feelings existed on both sides.

Marks declared at the start of the meeting, “To clarify, today’s conversation is going to concern the scientific data which have been presented and not vaccine mandates that were left outside FDA.” To have productive discussions, I request that our discussion today be kept civil. We should instead focus on the scientific aspects of these issues.

Pfizer asked FDA for authorization to its vaccine to be approved by children ages 5 to 11. Oct. 7 The company published data that showed a two-dose regimen of 10 micrograms — a third of the dosage used for teens and adults – is safe and generates a strong immune response in a clinical trial of young children. According to the study, shots are well tolerated. They produce an immune reaction and have side effects similar to those observed in studies of adults aged 16-25.

As the deputy director for the FDA’s vaccines division, Dr. Doran Fink said Tuesday that a small army of FDA employees worked round the clock in the past month to make sure the data they presented today on children was accurate.

The staff of the FDA published an analysis late Friday, saying a smaller dosage of the Pfizer vaccine appears to be safe and highly effective in young kids. The FDA staff noted an increased risk for myocarditis or pericarditis, but stated that the vaccine’s benefits, such as preventing death from severe illness, outweigh any risk.

As of October 6, there were 1,640 myocarditis cases among people aged 30 and under who had received Moderna’s Covid or Pfizer vaccines. Dr. Mathew Oster, a CDC official told FDA’s vaccine committee. Only 877 people met myocarditis’ case definition by the CDC. The agency had not seen an increase in the incidence of myocarditis among children between 12 and 17.

This is an ongoing story. Stay tuned for new updates.