The U.S. Food and Drug Administration is poised to approve Moderna and Pfizer Covid-19 vaccines for children as young as 6 months old. If remaining hurdles are cleared, the vaccines could be rolled out for children early next week. Like vaccines approved for adults, the protection offered is far from perfect, but it’s something.
The FDA advisory committee Wednesday recommended emergency use authorization of the Moderna vaccine for children ages 6 months to 5 years, and the Pfizer vaccine for children 6 months to 4 years. In the coming days, the FDA will make official decisions on whether to approve the EUAs as recommended. The U.S. Centers for Disease Control and Prevention will then undergo a similar advisory panel and authorization process before shots can be administered.
Children are widely considered least susceptible to severe Covid-19 illness, but they are not wholly immune. The original omicron variant that peaked in January brought with it a greater risk of child hospitalizations.
A Coronavirus Disease 19-Associated Hospitalization Surveillance Network study reflected a fourfold increase in child and adolescent hospitalizations between delta and the first omicron variant peaks. The rate increased five times for younger children ages 0 to 4.
Increased hospitalization risk was a driver for the unanimous FDA panel recommendation, despite some disagreement among panelists and concerns over the number of doses required to offer protection, according to Stat News real-time reporting on the FDA panel discussion.
Pfizer’s formula requires a three-dose primary series to achieve 80 percent efficacy – protection was virtually nonexistent with just two doses. Moderna requested approval of a two-dose series given at one-quarter the adult dose, which is estimated to provide 51 percent effectiveness against infection in children between the ages of 0 and 2, and 37 percent for those 2 to 5 years old. But, as noted in Covid-19 adult vaccines, efficacy surges when examined for protection against serious illness and hospitalization.
Omicron subvariants BA.4 and BA.5 are building on the BA.2.12.1 trend in rapid spread and the ability to evade antibodies from prior infection and vaccination, which means there is greater chance of contracting the virus again. No vaccine has provided absolute protection from infection, though people who have received the full series and booster doses are hospitalized far less often than those without any protection.
The medical community is swimming upstream in its attempt to keep the public protected from a rapidly changing virus in an unchecked environment. Most mandates and public health guidelines that pulled us through the past two years have been largely abandoned, giving more contagious variants ample opportunity to run rampant and mutate. Without the ability to predict what’s next in the evolution of Covid-19, the consensus is that some protection against serious illness is better than none at all.
Vaccines currently being considered for Americans as young as 6 months old will not ensure children won’t contract the virus, but the hope is they will keep pediatric hospitalizations to a minimum.