COVID-19 updates, actions, and advice from the FDA

Despite progress with COVID-19 vaccine development and distribution, the COVID-19 virus and its variants continue to plague the US. According to the New York Times​, on December 13, 2020, the US had 184,219 new cases of the virus; one year later, on December 13, 2021, the country had 201,930 reported new cases.

To help keep COVID-19 at bay, the US Food and Drug Administration (FDA) continues to strive to keep on top of the situation, issuing advice and working with life-science industry professionals to come up with solutions.

Fighting the omicron variant

Acting US Food and Drug Administration (FDA) commissioner Janet Woodcock Coronavirus (COVID-19) offered an update on the agency’s efforts to wrangle with the omicron variant, as well as anticipate what future variants might bring.

“As we have with previous emerging COVID-19 variants, the U.S. Food and Drug Administration is actively working with our federal partners, international regulators, and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic​,” she commented. “The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics, and vaccines; we are closely monitoring the situation and are committed to communicating with the public as we learn more​."

Woodcock explained work to obtain genetic information and patient samples for variants, then perform testing is a time-consuming prospect. However, she related, the agency expects this work to be completed in the coming weeks.

“The FDA is committed to continuing to use every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts, to arm ourselves with the best available diagnostics, and life-saving therapeutics and vaccines to fight this virus​,” Woodcock commented.

Expanded antibody EUA

The FDA has tweaked the emergency use authorization (EUA) of bamlanivimab and etesevimab--previously authorized for pediatric patients 12 years of age and older weighing at least 40 kg (88 lbs)—to also authorize the administration of the two drugs in combination for treating mild to moderate COVID-19 in all younger pediatric patients (including newborns) who have a positive COVID-19 test and are at high risk for progression to severe COVID-19. Additionally, the revised authorization also gives the nod for the combo treatment to be administered for post-exposure prophylaxis for preventing COVID-19 in all pediatric patients including newborns who may be at high risk of progression to severe COVID-19, including hospitalization or death.

“Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention​,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER). “Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population​.”

“While today’s authorization includes post-exposure prevention of COVID-19 in children, this therapeutic option is not a substitute for vaccination​,” Cavazzoni added. “Vaccines remain our best tool in the fight against the virus and there is a COVID-19 vaccine authorized for children 5 years of age and above.​”

Booster for teens

The FDA has expanded eligibility for the Pfizer/BioNTech booster to 16-  and 17-year-old patients. According to the agency, such patients are good to go at least six months after their primary vaccination with that vaccine.

“The Pfizer-BioNTech COVID-19 Vaccine has been available to individuals 16 years of age and older for nearly a year, and its benefits have been shown to clearly outweigh potential risks,​” said Peter Marks, CDER director. “Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group; a single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups​.”