J&J Plans to Expand Vaccine Trials Targeting Children and Newborns

FDA Approves Related Plan... Vaccination Currently Authorized Only for Adults in the US

[Image source=Yonhap News]

[Asia Economy Reporter Eunmo Koo] Johnson & Johnson (J&J) plans to conduct clinical trials of its COVID-19 vaccine on infants, including newborns, young children, and pregnant women, the New York Times (NYT) reported on the 28th of last month (local time).

J&J recently submitted an emergency use authorization application for its vaccine to the Food and Drug Administration (FDA), along with this plan to expand clinical trials. The plan was approved by Ofer Levy, a member of the FDA advisory committee, the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

Levy explained, "J&J did not provide many specific details about the clinical expansion plan, but it clearly stated that it will conduct COVID-19 immunity-related research on children and pregnant women."

Janssen Biotech, a subsidiary producing the J&J vaccine, also confirmed to the NYT that it will expand clinical trials to include children. The FDA and the U.S. Centers for Disease Control and Prevention (CDC) have authorized the use of the J&J vaccine for adults aged 18 and older.

According to the plan submitted by J&J to the FDA, the vaccine efficacy will first be tested on children and adolescents aged 12 to 18, then the trial subjects will be expanded to all under 18. Subsequently, clinical trials will be conducted on pregnant women, newborns, and then immunocompromised individuals.

Before J&J, Pfizer-BioNTech and Moderna, which have received vaccine use authorization for adults in the U.S., are also currently conducting clinical trials on children and adolescents aged 12 and older, the NYT reported.

Unlike the Pfizer and Moderna vaccines, which are manufactured using messenger RNA (mRNA) technology, J&J's vaccine was developed using an adenovirus, a common cold virus.

The NYT explained that the Ebola vaccine, which is also an adenovirus vaccine, is currently safely administered to infants as young as one year old, and another adenovirus vaccine for respiratory syncytial virus (RSV) has been safely given to newborns.

Levy stated that about 200,000 people have received adenovirus vaccines so far without serious safety issues, and this history was mentioned during the FDA advisory committee meeting.