The Food and Drug Administration published its analysis of Pfizer data ahead of a meeting next week to discuss whether vaccines are available for nearly 28 million children between 5 and 11. A panel of vaccine experts from outside will vote on the question.
FDA scientists concluded that the vaccine's potential side effects for children would be outweighed by its benefit in preventing hospitalizations and deaths from COVID-19. However, agency reviewers did not recommend that Pfizer be given the shot.
Next Tuesday, the agency will ask its independent advisors this question and then weigh their opinions before taking its final decision.
If the FDA approves shots, the Centers for Disease Control and Prevention (CDC) will make recommendations about who should get them in the first week. The first children to be fully protected by Christmas could start their vaccinations as early as next month.
Pfizer full-strength shots are recommended for all children 12 and older. However, pediatricians and parents anxiously await protection for their younger children to prevent infection from the more contagious delta variant.
FDA reviewed Pfizer's earlier-in-the-day results that showed the two dose shot was almost 91% effective in preventing symptoms in children under the age of three. The researchers calculated this figure using 16 COVID-19 cases from children who received dummy shots, compared to three in the vaccinated group. None of the children suffered from severe illness, but the vaccinated had milder symptoms than the unvaccinated.
The majority of the study data was collected in America during August and September when the Delta variant had become dominant COVID-19 strain.
FDA reviewed the FDA and found no unexpected or new side effects. The side effects that did occur were mostly sore arms, fever and achiness.
FDA scientists pointed out that there wasn't enough data to detect rare side effects such as myocarditis (a form of inflammation in the heart that can occur after the second dose).
To predict the amount of deaths and hospitalizations from COVID-19, the agency used statistical modeling. The vaccine prevented four types of pandemics. The vaccine could only cause more hospitalizations if the virus incidences were very low. Overall, however, regulators determined that the vaccine's benefits outweighed its risks.
According to the CDC, children are at lower risk of serious illness and death than those who are older than them. However, COVID-19 has claimed the lives of more than 630 Americans aged 18 or under. The American Academy of Pediatrics reports that nearly 6.2 million children have been infected by the coronavirus. This is more than 1.1million in just six weeks, as the delta variant surged.
Biden's administration purchased enough doses in kid-sized quantities -- in specially orange-capped vials to differentiate them from the adult vaccine -- to supply all children aged 5 to 11. Millions of doses, as well as kid-size needles, will be shipped out to the nation if the vaccine is approved.
Already, more than 25,000 primary care providers and pediatricians have signed up for the shot.