Johnson & Johnson, the company that received emergency use authorization for the first one-shot COVID-19 vaccine in the United States, reportedly plans to conduct clinical trials that extend beyond adults, including to younger teenagers and then infants.
According to The New York Times, Food and Drug Administration officials who reviewed the emergency authorization material at a meeting Saturday discussed Johnson & Johnson’s future trial plans. Those plans include conducting trials for healthy children between 12 and 18 years old, and then all children up to 18 years old, including newborns, to analyze safety and immune responses to the COVID-19 vaccine.
In trials beyond that, Johnson & Johnson also plans to test its one-shot COVID-19 vaccine in pregnant women, and then later, in another clinical study, in immunocompromised individuals, according to FDA advisory committee documents. A spokesperson for Johnson & Johnson told the Times that the company is planning to include children in future trials.
Although Johnson & Johnson is the third vaccine to be authorized for emergency use by the FDA, it’s the first vaccine to rely on a more widely tested vaccine technology — using a disabled adenovirus — instead of the newer mRNA technology utilized by Moderna and Pfizer. Dr. Ofer Levy, director of the Precision Vaccines Program at Harvard’s Boston Children’s Hospital and a member of the FDA advisory committee, told the Times that adenovirus vaccines have been used more than 200,000 times without any serious safety concerns.
Currently, no COVID-19 vaccines have been authorized for use in children, with the exception of the Pfizer vaccine, which has been authorized for individuals 16 years or older.
On Saturday, the FDA announced that Johnson & Johnson’s COVID-19 vaccine was “85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination” in trials that spanned several countries and that included nearly 40,000 participants, roughly half of whom received a placebo. A Centers for Disease Control and Prevention committee has since voted in favor of recommending the company’s one-shot COVID-19 vaccine to adults.
“In the midst of this tragedy we do have some reason for optimism,” said Dr. Matthew Daley, a member of the CDC committee and senior investigator at the Institute for Health Research with Kaiser Permanente Colorado, reports The Wall Street Journal. “How very grateful I am that we now have three safe and highly effective vaccines.”
Johnson & Johnson plans to have enough vaccines to inoculate 20 million Americans by the end of March, and enough to inoculate an additional 80 million by the end of June. According to The New York Times, Pfizer and Moderna plan to have a total of 600 million vaccines — enough for 300 million Americans to receive the full two-dose regimen — delivered by the end of July 2021.
“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” Alex Gorsky, CEO of Johnson & Johnson, said in a statement. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
According to The New York Times, 75 million COVID-19 vaccines have been administered in the United States, and 15% of people in the U.S. have been vaccinated at least partially against COVID-19. Furthermore, 7.5% of people in the United States have been fully vaccinated against COVID-19.
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