FDA Approves Omicron-targeted Children’s Vaccines

21.12.2022 - The US Food and Drug Administration (FDA) has issued Emergency Use Authorizations (EUAs) for the updated Covid-19 vaccines of both Pfizer/BioNTech and Moderna in children aged six months to five years.

The approvals come at a time when US uptake of vaccines for Covid shots or any disease is slipping, and parent’s rights groups are increasingly critical of immunization mandates for children.

Under the FDA-approved rules, children in the appropriate age group who received two doses of the original (monovalent) Covid vaccines are now eligible to receive a single booster of the updated (bivalent) vaccines two months after completing a primary series with the monovalent vaccine.

The bivalent shots, targeting the coronavirus Omicron subvariants BA.4 and BA.5 are already available to Americans five years of age and older, in a different dosage.

In Europe, the European Medicines Agency (EMA) and UK Medicines and Health Regulatory Agency (MHRA) have also approved Omicron-adapted vaccines for young children, but their makeup differs from those offered in the US.

US vaccine uptake slowing

In interviews conducted immediately prior to the new FDA authorization, agency researchers said they saw “disappointing” uptake rates for the new Omicron-targeted Covid booster in adults, which was rolled out in September.

Only four in 10 said they had received the updated booster or intended to. Among those 65 and older, one in four said they had been too busy to get it or hadn’t found the time, even if half were apprehensive about rising infection rates.

Right wing media spread misinformation

A growing problem for vaccine uptake in the US is misinformation distributed by right wing news outlets, commentators say. However, the FDA stresses that the resistance to Covid vaccines is not greater than to vaccine mandates for schoolchildren generally.

Many states mandate vaccination against common childhood diseases such as polio, measles or rubella but only California and Washington DC require Covid shots.

“The talking point circulated is the concept of taking away parents’ rights,” Sean O’Leary, chairman of the American Academy of Pediatrics’ committee on infectious diseases, told the New York Times. But what about the right to have your children be safe in school from vaccine-preventable diseases?”

O’Leary said he wasn’t worried that school vaccine mandates would be lifted but that the growing embrace of parents’ rights might further slow compliance with state-required immunization schedules.

During the administration of former president Donald Trump, vaccine skeptics were welcome in the White House. The hospitality signs came down when Joe Biden took office in January 2021 but now a new presidential aspirant is stirring the waters again.

New White House aspirant stirs the waters

Ultraconservative Florida governor Ron De Santis, thought likely to challenge Trump for the 2024 Republican presidential nomination, has evidently decided that opposition to Covid vaccines is a good issue to run on.

The governor recently called for a grand jury investigation into alleged “crimes and wrongdoing” against Floridians related to Covid vaccines and said he would establish a Public Health Integrity Committee in the state because he doesn’t trust the national Centers for Disease Control (CDC).

In a TV discussion with people identified as physicians, researchers and “victims of adverse events from mRNA vaccines” as well as in his petition to establish the grand jury, DeSantis said the federal government, medical associations and “other experts” suggest that getting vaccinated is an ethical or civic duty when in reality “they simply create these perceptions for financial gain.”

Fauci points to “life-saving “vaccines

Reacting to the DeSantis pronouncements, outgoing White House medical adviser Anthony Fauci, who also served and suffered under Trump, said he didn’t know what the governor hoped the grand jury would accomplish.

Fauci cited research by the Commonwealth Fund that found Covid vaccines from Pfizer, Moderna and Johnson & Johnson to have collectively saved over 3.2 million American lives and averted more than 18.5 million hospitalizations in two years of the pandemic.

With a majority of Americans vaccinated, hospitalizations and deaths from Covid have plateaued. However, the Biden administration is urging Americans to get the new booster shots as immunity wanes.

Author: Dede Williams, Freelance Journalist