Jan. 19, 2021 -- Johnson & Johnson’s single-dose coronavirus vaccine proved safe and generated a promising immune response in volunteers in phases I and II of clinical trials, according to trial data published in the New England Journal of Medicine.
If phase III clinical trials are successful, the company says it plans to seek FDA authorization for the vaccine soon. The Johnson & Johnson vaccine would have logistical advantages over the two-dose Pfizer and Moderna vaccines currently in use because it only needs one shot and doesn’t have to be shipped in extremely cold temperatures.
About 800 volunteers in two age groups, 18-55 and 65 and older, received the Johnson & Johnson vaccine or a placebo.
Antibodies against COVID-19 were found after 29 days in 90% of volunteers who got the vaccine and 100% of volunteers in the 18-55 age group after 57 days. These antibodies remained stable after 71 days in the younger group of volunteers. Johnson & Johnson said it will release more information about “durability of immune responses” in the older age group soon.
Some volunteers in the 18-55 age group also received two doses of vaccine 56 days apart. That produced “more than a two-fold increase in antibodies against COVID-19,” Johnson and Johnson said in a statement.
The NEJM said the side effects were predictable -- fever, fatigue, headache, and muscle aches at the injection site.
“The safety and immunogenicity profiles of (the vaccine) support further development of this vaccine candidate,” the NEJM concluded.
One flaw in the clinical trials was lack of representation of minority groups, the NEJM said.
“This finding is a point of focus in our clinical-development program to ensure the availability of data with respect to groups that seem to be affected most by the COVID-19 pandemic,” the NEJM said.
The company hopes to release results in late January from phase III clinical trials involving around 45,000 volunteers. That phase would show whether the vaccine is effective in protecting people against infection or symptoms of COVID-19.
“If the single-dose vaccine is shown to be safe and effective, the company expects to submit an application for emergency use authorization with the U.S. Food and Drug Administration shortly afterwards, with other regulatory applications around the world to be made subsequently,” Johnson & Johnson said in a statement.
The New York Times said Johnson & Johnson signed a contract with the U.S. government to deliver 12 million doses of the vaccine by the end of February.
But the Times, citing people familiar with the situation, reported that the company has fallen behind in production and might not be able to catch up until April.
An Operation Warp Speed official, Carlo de Notaristefani, confirmed the delay but said the company might be able to catch up with initial production goals by March, the Times said.
Johnson & Johnson paused clinical trials in the fall because a participant developed an “unexplained illness.” Trials were restarted 2 weeks later.