Moderna Testing COVID Shot on Infants Nationwide

Biotechnology company Moderna Therapeutics has launched a large-scale testing of its COVID jab on infants as young as six months old. The vaccine clinical trial, called KidCOVE, is being carried out at 81 locations across 30 states on some 13,275 healthy children between six months and 12 years old.

The first participants were enrolled in the trial in March 2021 (the same time when Moderna’s competitor Pfizer started the same trials in the same cohort). The study is estimated to be completed in June 2023.

The primary purpose of the study, according to Moderna, is to test the safety and effectiveness of the vaccine mRNA-1273 in protecting children from getting sick if they come into contact with the SARS-CoV-2 virus, which causes COVID-19.

The company plans to conduct the study in two parts, staggering the recruitment of three different age groups: (1) children between the ages of six years to less than 12 years old; (2) children between the ages of two years to less than six years old; (3) children ages six months to less than two years old.

Moderna explains that participation in the KidCOVE Study “lasts approximately 14 months and includes phone calls, telemedicine visits, and up to seven visits to the study site.”

Initially, every young participant will be given “up to 3 dose levels” of the study vaccine or the placebo in the upper arm, about 28 days apart.

Parents or guardians will be asked to use an eDiary app on their smartphones to report any COVID symptoms a child experiences. It is also noted that every child will be closely monitored if any symptoms of COVID are reported at any time throughout their participation.

Moderna specifically underlines an importance of diversity of the study, stressing that recruitment of “children of all ages, genders, races and ethnicities” is critical for “creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.”

Moderna is looking for generally healthy children for its trials, but those with chronic diseases such as asthma, diabetes cystic fibrosis, and human immunodeficiency virus (HIV) infection are also welcome if their conditions are stable. Young girls must not be pregnant or breastfeeding and use proper contraception/ abstinence through the trial.

Excluded from eligibility are children with a “known history” of COVID infection or “close contact” with an infected person within two weeks of the trial, as well as those who have participated in the COVID vaccine trials previously, have an allergy to one of the shot’s components, or have received monoclonal antibodies in the past six months. Read Full Article >

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