Johnson & Johnson Will Take a look at its Vaccine in Infants
Johnson & Johnson plans to test its coronavirus vaccine in infants and even newborns, as well as in pregnant women and people with compromised immune systems.
The bold plan for expanded clinical trials was promoted by Dr. Ofer Levy, director of the Precision Vaccine Program at Harvard Children’s Hospital and a member of the Food and Drug Administration Advisory Committee that reviewed the company’s vaccine records, approved.
When Dr. When Levy saw the outline of the planned trials, “they turned my head,” he said. They were reported as part of the company’s filing with the FDA for emergency approval and discussed at the FDA meeting.
“They haven’t gone into great detail, but have made it clear that they will be doing studies on immunizing coronaviruses in children and mothers,” said Dr. Levy. They referred the committee members to their informational materials in which the company mentioned the planned studies on page 34.
A spokesman for Janssen Biotech, the subsidiary of Johnson & Johnson that makes the vaccine, confirmed that the company plans to expand clinical trials to include children.
PfizerBioNTech and Moderna, whose coronavirus vaccines are now being given to adults, plan to gradually test them in increasingly younger age groups. These vaccines are currently being tested in children 12 years and older.
Johnson & Johnson will initially test its vaccine in children over 12 years of age and under 18 years of age, but plans to begin immediately after a study begins in newborns and adolescents. The company will then test its vaccine in pregnant women, and eventually 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 uses a method that has been extensively tested for years. It relies on a disabled adenovirus, much like viruses that cause colds, to instruct cells to make brief copies of the virus’ spike protein. The recipient’s immune system then makes antibodies against the spike protein. The coronavirus needs its spike proteins to infect cells so that the antibodies can block a Covid infection before it starts.
Existing adenovirus vaccines include one for Ebola, safely given to babies aged 1 year old, and another for respiratory syncytial virus, safely given to newborns. Almost 200,000 people have received adenovirus vaccines with no serious safety issues, said Dr. Levy. He said Johnson & Johnson mentioned this safety record at the FDA meeting.
Most of the global vaccine market consists of pediatric vaccines.
Dr. Levy added that he believes children do not need to be vaccinated in order for schools to open. But many parents are afraid of sending their children to school without a vaccine. And he noted that vaccinating children will help the country achieve herd immunity.