Why the FDA should quickly clear COVID-19 vaccines for children

As the delta variant takes hold in the United States, millions of parents anxiously await approval of COVID-19 vaccines for children under 12. Parents and experts are concerned that the Food and Drug Administration (FDA) ‘s high level of caution in authorizing these childhood vaccines could delay the start of a vaccination campaign for children. After all, school has already started for many.

People want the safest possible product for their children, but as the FDA seeks extensive safety data for pediatric COVID-19 vaccines, experts and parents also wonder how much data is sufficient, especially in the face of a highly transmissible strain of the coronavirus.

The FDA cited concerns that the Pfizer and Moderna trials of pediatric COVID-19 vaccines were not large enough to detect rare side effects such as myocarditis, an inflammation of the heart. But should the government be paying such attention to a rare disease at the possible expense of faster access to pediatric vaccines at a time when the number of cases in children is soaring? Pull?

Delta variant and the growing need for pediatric COVID19 vaccines. During much of the pandemic, the risk of COVID-19 for children was considered minimal. They did not get sick in the same number as the adults or as sick. It is not known to what extent they contributed to the transmission. Considering these factors, give children Vaccines against covid-19 was not always considered the highest priority.

But the delta variant has made people more suspicious, as reports of pediatric services filling is in the news. It is imperative that the United States protect children who currently cannot get the COVID-19 vaccine, a group including some 48 million children less than 12 years old, the current vaccination threshold. A vaccination campaign of this group is also necessary to build and maintain collective immunity in the USA. In other words, COVID-19 vaccines for children are a matter of public health safety.

How to approve the use of COVID-19 vaccines for childrens. In order to deal with the unprecedented global pandemic caused by the novel coronavirus, the FDA issued the first emergency use authorization for COVID-19 vaccines (Pfizer and Moderna) in December 2020. The regulator subsequently extended the authorization of Pfizer’s vaccine in May 2021 to allow use by adolescents (12 to 15 years old). Moderna also filed for emergency use authorization for adolescents in June and is awaiting the green light from the FDA.

It should be noted that the emergency use authorization process by which the FDA first approved COVID-19 vaccines is fundamentally a homeland security policy, first granted by the Project Bioshield Act of 2004. The process allows the government to authorize unapproved medical countermeasures. or off-label use of approved medical countermeasures to respond in a timely manner to a public health emergency, primarily caused by chemical, biological, radiological and nuclear threats. To meet internal and national security needs, the issuance of an emergency use authorization must therefore meet a basic security principle: The known and potential benefits should outweigh the known and potential risks of vaccines.

The FDA determined that the benefits of COVID-19 vaccines outweigh the risks when it issued the clearances for use in adolescents as well as adults. It wasn’t until August 23 that the FDA finally granted full approval of the Pfizer vaccine for adult use (aged 16 or older). FDA Still Uses Emergency Use Clearance to Approve COVID-19 Vaccines for Adolescents; pediatric vaccines will most likely also be approved under the policy. In other words, COVID-19 vaccines for pediatric use will become available because the FDA has determined that the benefits of vaccinating children under the age of 12 outweigh the risks, a determination some believe – at least for children aged 5 to 11 – the agency can already do that.

Caution is not always better than speed. Careful and cautious approaches to pediatric vaccine development are very important because children may respond to vaccines differently than adults. However, given that the delta variant has caused an increase in pediatric cases of COVID-19, the government’s demand for larger trials and a longer follow-up period means the United States could miss a critical time to protect patients. children of the pandemic.

In July, the FDA asked vaccine manufacturers to include more pediatric participants in the trials. For children under five, The Washington Post reported at the time, the The FDA was expected request six months of safety follow-up rather than the standard two months. At this point, vaccines for children aged 5 to 11 could come later in the fall, according to NPR.

This means several more months during which children are at risk of being exposed to COVID-19 and possibly serious illness.

Since March, major vaccine manufacturers have conducted extensive studies and trials of pediatric vaccines using lower doses and regimens. According to the American Academy of Pediatrics, data already exists to authorize vaccines for children between five and 11 years old. Trials using lower doses of vaccine show promising results that could help avoid unnecessary side effects in young children. However, federal regulators pay special attention to rare side effects such as myocarditis. According to the United States Centers for Disease Control and Prevention, the 9 million adolescents aged 12 to 17 who had received the Pfizer vaccine in mid-July reported over 9,000 side effects. Only 4% of these reports were for myocarditis.

The AAP urges the @US_FDA act quickly to approve a # COVID-19[FEMALE[FEMININE vaccine for young children as the number of cases skyrockets. In @NBCNews: @AAPPres Dr Lee Beers: “The delta variant has created a new and urgent risk for children and adolescents across the country.https://t.co/30yvt4l2xV

– American Academy of Pediatrics (@AmerAcadPeds) August 9, 2021

The pediatrics group wrote a letter to the FDA asking for more urgency in the approval of pediatric vaccines. Referring to the FDA’s request that vaccine manufacturers increase the size of clinical trials, the group wrote, “We urge the FDA to carefully consider the impact of this decision on the timing of a vaccine’s approval for. this age group ”. For children aged five to 11, the group wrote, “The FDA should seriously consider authorizing these vaccines for children aged five to 11 based on data from the initial enrolled cohort. This data, according to the group, is already available.

“In our opinion, the rise of the delta variant is changing the risk-benefit analysis to authorize vaccines in children”, the pediatric group wrote. Emergency Use Authorization is an internal security policy aimed at the timely distribution of medical products in the event of a public health emergency. Raising the vaccine safety bar much higher for childhood vaccines is not the intent of a risk-benefit policy; the United States is missing the chance of a rapid response to the pandemic when it comes to rapidly authorizing pediatric vaccines.