FDA Unanimously Recommends Pfizer-BioNTech and Moderna COVID-19 Vaccines for Infants and Toddlers

Compiled by | Li Tom

On June 15, the US FDA Vaccines and Related Biological Products Advisory Committee voted unanimously, with all 21 members agreeing to recommend the Pfizer/BioNTech and Moderna COVID-19 vaccines for use in infants older than 6 months.

Specifically, the Pfizer/BioNTech COVID-19 vaccine has been approved for injection in children aged 6 months to 4 years. A total of three doses are required: the first two doses need to be spaced three weeks apart, and the third dose needs to be administered eight weeks after the second dose is completed. The Moderna COVID-19 vaccine requires a total of two doses and is suitable for children aged 6 months to 5 years.

However, the market has some doubts about the protective efficacy of the Pfizer/BioNTech COVID-19 vaccine. It remains unknown what kind of protection this vaccine can provide to young children.

Consultation Panel Experts Ultimately Unanimously Deem Vaccine Efficacy and Safety Data Reliable; Foreign Media Analysis Suggests U.S. FDA May Have Considered Urgent Need for COVID-19 Vaccination in This Age Group of American Children.

▶Pfizer/BioNTech COVID-19 Vaccine

As early as May this year, Pfizer and BioNTech jointly announced that the U.S. FDA had revised the Emergency Use Authorization (EUA) for their COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, trade name: Comirnaty). The revision approved a booster dose of the vaccine for children aged 5-11 who had completed two doses of the vaccine, to be administered at least five months after the second dose. (For details, click on "For Use in Children Ages 5 to 11! U.S. FDA Expands Emergency Use Authorization for Pfizer’s COVID-19 Vaccine Booster")

Now, the Pfizer/BioNTech COVID-19 vaccine has once again expanded its eligible population, targeting children aged 6 months to 4 years.

In addition, Pfizer announced on June 15 that the European Medicines Agency (EMA) had initiated a rolling review of the COVID-19 variant vaccine. It plans to submit data on the variant vaccine to the U.S. Food and Drug Administration (FDA) within a few weeks.

▶Moderna COVID-19 Vaccine

Before Moderna's COVID-19 vaccine received FDA recommendation this time, the same FDA advisory committee also made a similar agreement decision on Tuesday this week. At that time, the expert panel members unanimously voted to recommend issuing an Emergency Use Authorization (EUA) for Moderna's COVID-19 vaccine for children aged 6 to 17 years. The agency’s next steps may include deciding whether to modify the existing EUA to include the age range for younger children.

If the U.S. FDA ultimately chooses the aforementioned approach, an advisory committee under the U.S. Centers for Disease Control and Prevention (CDC) will further decide whether to make a recommendation regarding this decision. The specific voting process is scheduled to take place on Friday or Saturday of this week.

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Children's Urgent Need for COVID-19 Vaccine Injections

According to data from the U.S. Centers for Disease Control and Prevention (CDC), during the Omicron period, the hospitalization rate for children aged "6 months to 5 years and under" was particularly concerning. Since January 2020, COVID-19 has led to the deaths of 202 children aged 6 months to 5 years.

Although younger children are less likely to contract COVID-19 and develop severe symptoms compared to adults, the risks of multisystem inflammation and even death still exist. Especially with the current new Omicron variant and its subvariants, which have proven to be more contagious and prone to immune escape, this significantly amplifies the infection risks for infants and toddlers who have never received a COVID-19 vaccine.

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Effectiveness of Pfizer/BioNTech COVID-19 Vaccine in Young Children Questioned

Despite the urgent demand, the market has doubts about the efficacy of the Pfizer/BioNTech COVID-19 vaccine. It remains unknown what kind of protection the vaccine can offer to young children. The expert panel of the U.S. FDA also frankly stated that it is difficult to answer this question with the existing data at present. The clinical data of the Pfizer/BioNTech vaccine is only preliminary, and the true efficacy of the vaccine is still not entirely clear.

However, Pfizer and BioNTech have claimed that the level of neutralizing antibodies in young children after receiving their COVID-19 vaccine is sufficient to protect them, thereby justifying the vaccine's EUA authorization. The two companies believe this is also why the U.S. FDA recommends the vaccine for the youngest age group to receive three doses.

In the study by Pfizer and BioNTech, the two companies claimed that three doses of the vaccine showed 80% effectiveness in preventing the Omicron variant among children aged 6 months to 4 years. The recommended dose for children is three micrograms, one-tenth of the adult dose. However, regrettably, seven days after the second dose, the vaccine's protection against the coronavirus in young children dropped to a mere 14.5%.

For the dismal result that the protection efficacy nearly becomes ineffective after the second dose, Pfizer and BioNTech’s solution is that a third shot must be administered again. However, even the protection efficacy number for the first dose of this vaccine is hardly convincing. The claimed high efficacy of 80% actually comes from an ultra-small-scale study, including only 7 cases in the placebo group and 3 children in the vaccine group.

Shockingly, despite the unconvincing vaccine efficacy data and the extremely small sample size, the expert panel ultimately reached a unanimous decision that the vaccine's efficacy and safety data were reliable. Foreign media analysis suggests that the U.S. FDA may have primarily considered the urgent need for COVID-19 vaccination among children in this age group in the United States.

Dr. Jay Portnoy, a pediatric professor at Children's Mercy Hospital in Kansas City, Missouri, told The New York Times that the mortality rate of young children caused by COVID-19 may not be high, but for parents, every child’s illness is a terrifying nightmare. With so many parents in the U.S. eager for their children to receive this vaccine, he believes the FDA should provide them with this option.

Reference Source:

FDA Panel Unanimously Recommends Pfizer-BioNTech and Moderna Vaccines for Young Kids

Original Title: Unanimously Approved! FDA Recommends Pfizer/BioNTech and Moderna COVID-19 Vaccines for Infants and Toddlers