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Pharmaceutical and medical device giant Johnson & Johnson, Inc. (J&J) announced on February 28, 2021 its intention to test its investigational vaccine Ad26.COV2.S for COVID-19 in infants (including newborns), pregnant women and people with immune systems.
J&J did not include infants, pregnant women, or immunocompromised people in the U.S. population in clinical trials of the investigational COVID-19 vaccine last year.1,2,3 A recent New York Magazine article noted:4
“The initial clinical trials of COVID-19 vaccines did not include children, which is standard practice; now trials for young children are conducted in descending order of age, calibrating the best dosage for each cohort. “
J&J’s announcement came the day after the United States Food and Drug Administration (FDA) granted J&J subsidiary Janssen Biotech Inc. Emergency Use Clearance (EUA) to distribute the vaccine to United States for use by persons 18 years of age and over. At this time, the single dose Ad26.COV2.S vaccine cannot be given to anyone in the United States under the age of 18.5,6,7,8,9
According to a spokesperson for Janssen, which manufactures Ad26.COV2.S, the single-dose vaccine will first be tested on children between 12 and 18 years old. J&J will then quickly test the vaccine on infants, pregnant women and people with compromised immune systems.ten
FDA reviewed J&J plans to test COVID-19 vaccine on babies
J&J’s decision to test its COVID-19 vaccine on very young children, as well as pregnant women and people with compromised immune systems, was expected. Plans to conduct these clinical trials would have been included in J&J’s FDA application for EUA and were discussed by members of the FDA advisory committee that reviewed J&J’s data on Ad26.COV2.S.11,12
“They (J&J) didn’t go into a lot of detail on this, but made it clear that they would be pursuing studies on pediatric and maternal coronavirus vaccination,” said Dr Ofer Levy, member of the advisory committee of FDA, Ph.D., director of the Precision Vaccine Program at Boston Children’s Hospital at Harvard University.13
Other companies are testing COVID-19 vaccines on older children
Clinical trials of the COVID-19 vaccine planned by J&J will be the first to include infants. AstraZeneca plc, which produced the experimental vaccine AZD1222 for COVID-19 in partnership with the University of Oxford, has conducted clinical trials in children as young as 6, while Moderna Inc. and Pfizer Inc. ( in partnership with BioNTech SE) are currently testing their experimental mRNA-1273 and BNT162b2 COVID-19 vaccines on children from the age of 12.14,15
J&J began shipping 4 million doses of Ad26.COV2.S on March 1, 2021. The company has committed to having 20 million doses of the vaccine ready for distribution by the end of March and 100 million doses by this summer.16
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