Why the FDA should promptly approve the COVID-19 vaccine for children

As the Delta variant becomes established in the United States, millions of parents are worried that the COVID-19 vaccine will be approved for children under the age of 12. Parents and professionals alike are worried about the high levels of the Food and Drug Administration (FDA). Paying attention to the approval of these pediatric vaccines can delay the start of vaccination campaigns for children. After all, school has already started for many.

People want the safest product possible for their children, but because the FDA wants to expand the safety data for the pediatric COVID-19 vaccine. Expert When parents Similarly, we are asking how much data is sufficient, especially in the face of highly contagious strains of coronavirus.

FDA quoted concern The Pfizer and Modana trials of the pediatric COVID-19 vaccine were not large enough to detect rare side effects such as myocarditis and heart inflammation.However, the government needs to pay such close attention to rare conditions at the expense of faster access to pediatric vaccines when the number of cases in children is high. Shoot up??

Increasing need for delta mutants and pediatric COVID19 vaccine. In many pandemics, the risk of COVID-19 to children was considered minimal. They did not get the same number or illness as adults. It was unclear how much they contributed to the transmission.Given these factors, give to children COVID-19 vaccine It is not always considered a top priority.

However Delta variant Reported that made people more vigilant Pediatrics ward It will be news when it is full. Protecting children who are currently unable to receive the COVID-19 vaccine is essential for the United States. 48 million children Under 12 years old, current cutoff for vaccination.Campaigns to vaccinate this group are also needed to build and maintain Herd immunity In the United States. In other words, the COVID-19 vaccine for children is a public health safety issue.

How to approve the use of COVID-19 vaccine for childrenNS. To address the unprecedented global pandemic caused by the new coronavirus, the FDA issued the first emergency use authorization for the COVID-19 vaccine (Pfizer and Moderna) in December 2020. Regulators then extended Pfizer’s vaccine license in May 2021. Adolescent use (12 to 15 years old). Moderna also filed an emergency use authorization application for adolescent use in June, awaiting the FDA’s green light.

The FDA’s first approved emergency use authorization process for the COVID-19 vaccine is essentially the first national security policy granted by the Project Bioshield Act of 2004. This process allows the government to approve unapproved medical measures. Or, unlabeled use of approved medical measures to respond in a timely manner to public health emergencies primarily caused by chemical, biological, radiological, and nuclear threats. Therefore, in order to meet the needs of national and national security, the issuance of an emergency use authorization must meet basic security principles. Known potential benefits should outweigh the known potential risks of vaccines..

The FDA has determined that the benefits of the COVID-19 vaccine outweigh the risks when issuing approvals for adolescent and adult use. The FDA finally approved full approval of the Pfizer vaccine for adults (aged 16+) on August 23. The FDA is still using an emergency use authorization to approve the COVID-19 vaccine for adolescent use. Pediatric vaccines are also most likely to be approved under this policy. In other words, the COVID-19 vaccine for children is available because the FDA has determined that the benefits of vaccination of children under the age of 12 outweigh the risks. ..

Carefulness is not always better than timeliness.. A careful and careful approach to pediatric vaccine development is very important, as children can react differently to vaccines than adults. However, as the delta variant caused a surge in pediatric COVID-19 cases, government demands for larger trials and longer follow-up periods could miss an important time for the United States to protect children from pandemics. It means that there is sex.

In July, the FDA asked vaccine manufacturers to include more pediatric participants in the trial. For children under 5 years old, Washington post Reported at that time, FDA was expected Require 6 months of safety follow-up instead of the standard 2 months.At this point, vaccines for children aged 5 to 11 may come Late autumn, according to NPR..

This means that children will be exposed to COVID-19 and will probably be at risk of serious illness for a few more months.

Since then march, Major vaccine manufacturers have conducted detailed studies and trials on pediatric vaccines, using lower doses and regimens. According to the American Academy of Pediatrics, data are already available to license vaccines for children aged 5 to 11 years.Studies with low-dose vaccines show promising results that may help Avoid unnecessary side effects For young children. However, federal regulators pay special attention to rare side effects such as myocarditis.9 million teenagers aged 12 to 17 years vaccinated with Pfizer vaccine by mid-July, according to the US Centers for Disease Control and Prevention report Over 9,000 side effects. Only 4% of these reports were myocarditis.

AAP is @US_FDA Move quickly and approve # COVID-19 (New Coronavirus Infection) Vaccines for younger children as the number of cases soars.of @NBCNews: @AAPPres Dr. Lee Beers: “Delta variants have created new and imminent risks to children and adolescents throughout the country.”https://t.co/30yvt4l2xV

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

Pediatrics group wrote letter To the FDA for more urgency in approving pediatric vaccines. In reference to the FDA’s request for vaccine manufacturers to scale up clinical trials, the group “requests the FDA to carefully consider the impact of this decision on the timeline for licensing vaccines in this age group.” I wrote. For the ages of 5-11, the group said, “The FDA should strongly consider authorizing these vaccines for children aged 5-11, based on data from the first enrolled cohort.” I am writing. According to the group, that data is already available.

“In our view, the rise of the delta variant will change the analysis of the risks and benefits of licensing a child to a vaccine.” Pediatrics group I have written. Emergency Use Authorization is a homeland security policy for the timely distribution of medical products in the event of a public health emergency. Much higher vaccine safety standards for children’s vaccines do not correspond to policy intent based on risk and benefit analysis. The United States is missing out on a timely pandemic response to the rapid approval of pediatric vaccines.