FDA Expands Approval of COVID-19 Treatment, Remdesivir

May 04, 2022 - FDA recently expanded the approval for COVID-19 treatment, Veklury (remdesivir), to include pediatric patients 28 days of age and older weighing at least seven pounds. 

The agency's decision makes remdesivir the first approved COVID-19 treatment for children under 12 years of age. FDA also revoked the emergency use authorization for remdesivir that previously covered this pediatric population.  

"As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population," Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, said in the announcement.  

"Today's approval of the first COVID-19 therapeutic for this population demonstrates the agency's commitment to that need," Cavazzoni continued.  

FDA based its expanded approval on efficacy results from Phase 3 clinical trials in adults and from a Phase 2/3 single-arm, open-label clinical study of 53 pediatric patients with confirmed SARS-CoV-2 infection and mild, moderate, or severe COVID-19. 

Patients in the pediatric Phase 2/3 trial received remdesivir for 10 days. Notably, the safety and pharmacokinetic results were similar to those in adults.  

FDA emphasized that remdesivir is not a substitute for vaccination in individuals for whom COVID-19 vaccination and booster doses are recommended and urges the public to get vaccinated and receive a booster when eligible.  

Modera Submits EUA Request for COVID-19 Vaccine  

Moderna recently submitted a request for emergency use authorization (EUA) for its COVID-19 vaccine, mRNA-1273, in children six months to under two years and two to under six years of age. 

The company based its request on interim results from the Phase 2/3 KidCOVE study, which showed a robust neutralizing antibody response and a favorable safety profile in both age groups after completing a two-dose primary series.  

The antibody titers in the pre-specified six months to under two years and two years to under six years age sub-groups met the statistical criteria for similarity to the adults in the COVE study.  

Moderna will complete its EUA submission for these age groups next week and is also currently studying booster doses for all pediatric cohorts. 

"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," Stéphane Bancel, CEO of Moderna, said in the announcement.  

"We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers," Bancel continued.  

Novavax Administers First Booster Dose of COVID-19 Vaccine 

Novavax recently initiated the administration of the first booster dose of its COVID-19 vaccine, NVX-CoV2373, in the pediatric expansion of the PREVENT-19 pivotal Phase 2 clinical trial.

The trial will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12–17. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen and may be administered at least five months after receiving an active vaccine. 

Post-booster objectives include the assessment of the humoral immune response 28 days after the booster dose administration, a Novavax spokesperson explained. The initial results are expected during the second half of 2022.  

"We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19," Gregory M. Glenn, MD, president, research and development at Novavax, said in the announcement.  

"The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population," Glenn continued.