Hamilton Journal News

J&J’s planned vaccine trials to include infants

- ©2021 The New York Times

Gina Kolata

Johnson & Johnson plans to test its coronaviru­s vaccine in infants and even in newborns, as well as in pregnant women and in people who have compromise­d immune systems.

The bold plan for expanded clinical trials met with the approval of Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the Food and Drug Administra­tion advisory committee that reviewed the company’s vaccine data.

When Levy saw the outlines of the planned trials, “they turned my head,” he said. They were reported as part of the company’s applicatio­n to the FDA for emergency use approval and discussed at the FDA meeting.

“They did not get into a lot of detail about it but did make it clear they will be pursuing pediatric and maternal coronaviru­s immunizati­on studies,” Levy said. They referred committee members to their briefing materials where, on page 34, the company mentioned the planned studies.

A spokespers­on for Janssen Biotech, the Johnson & Johnson subsidiary that is manufactur­ing the vaccine, confirmed that the company planned to extend clinical trials to children.

PfizerBioN­Tech and Moderna, whose coronaviru­s vaccines are now being given to adults, plan to gradually test them in younger and younger age groups. Those vaccines are now being tested in children 12 and older.

Johnson & Johnson will first test its vaccine in children older than 12 and under 18, but plans to immediatel­y after begin a study that includes newborns and adolescent­s. The company then will test its vaccine in pregnant women, and finally in immunocomp­romised people. Like the other companies, Johnson & Johnson will analyze safety and immune responses.

Unlike the COVID-19 vaccines currently in use, which use a new technology involving messenger RNA, the Johnson & Johnson vaccine utilizes a method that has been widely tested for years. It relies on a disabled adenovirus, similar to viruses that cause the common cold, to deliver instructio­ns to cells to briefly make copies of the virus’s spike protein. The recipient’s immune system then makes antibodies against the spike protein. The coronaviru­s needs its spike proteins to infect cells, so the antibodies can block a COVID infection before it starts.

 ?? MARK HUMPHREY / AP ?? A National Guard soldier directing drivers is reflected in the mirror of a car waiting in a vaccinatio­n line in Shelbyvill­e, Tenn. Tennessee has continued to divvy up doses based on how many people live in each county.
MARK HUMPHREY / AP A National Guard soldier directing drivers is reflected in the mirror of a car waiting in a vaccinatio­n line in Shelbyvill­e, Tenn. Tennessee has continued to divvy up doses based on how many people live in each county.

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