Fauci: US Still Months Away From COVID-19 Vaccine Approval for Children

Although US health care workers have started receiving the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, vaccines for children won’t be available for “months”, according to Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.

Fauci told NBC's "Meet the Press" that it will take months to test vaccine candidates in phase 1 and 2 trials and then a bridge study—which allows drugs approved in one region of the world to be deployed in another—will be conducted.¹

"You can say okay, now we have safety in the children, we have comparable immunogenicity, namely the same type of immune response—we can get this expeditiously approved for the children before going through a 30,000-person trial that may take a longer period of time," Fauci said.

Before administering the vaccine to children, “you’re going to want to make sure you have a degree of efficacy and safety that is established in an adult population, particularly an adult normal population,” Fauci added.

In late October, Pfizer expanded its trial to include children as young as 12, CNN reported.² Moderna is still looking to expand its trial to include teenagers, but said a vaccine could be ready for children by the middle of next year, according to Business Insider.¹

Pfizer, Moderna, and other COVID-19 vaccine developers will be closely watching the adverse reactions that adults receiving the vaccine experience.

While lauding the rollout of the the Pfizer-BioNTech vaccine, the American Academy of Pediatrics said in a news release that much more safety data is needed for children.³

“Trials in children must keep pace with the tremendous amount of data being generated in adult trials, and this should be initiated safely and as soon as possible so there could be a vaccine authorized for younger children before the next school year begins,” said AAP President Sara “Sally” Goza, MD, FAAP.3

References:

1. Dodge, B. Fauci says ‘it’s going to be months’ before a coronavirus vaccine is approved in children. Business Insider. November 29, 2020. Accessed December 17, 2020. https://www.businessinsider.com/fauci-coronavirus-vaccine-approved-for-children-months-2020-11?amp

2. Fox, M. This 12-year-old is happy to be testing a Covid-19 vaccine. CNN. October 26, 2020. Accessed December 17, 2020. https://www.cnn.com/2020/10/26/health/covid-vaccine-pfizer-trial-kids/index.html

3. AAP: COVID-19 vaccine recommendation a ‘milestone,’ more research needed on vaccines in children. News release. AAP; December 10, 2020. Accessed December 17, 2020. https://www.aappublications.org/news/2020/12/10/vrbpac-pfizer-vaccine-121020