US FDA clears Johnson & Johnsonís one-dose COVID-19 vaccine
February 27, 2021 08:17 pm
An advisory panel to the United States Food and Drug Administration (FDA) on Friday (February 26) greenlit Johnson & Johnson’s COVID-19 vaccine for emergency use. This brings it one step closer to its rollout in the US.
The FDA will now decide on the emergency use of the vaccine on Saturday. This would be the third vaccine available in the US and it is the only vaccine that requires a single shot.
The outside panel consisting of doctors, infectious disease experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over.
Johnson & Johnson said that it was prepared to supply the vaccine immediately if it received emergency use authorisation (EUA). The company said that it will be able to ship three to four million doses of vaccine next week.
The company expects to have enough supply to vaccinate 20 million people by the end of March.
More than 50 million vaccine shots have been administered nationwide, a milestone highlighted by President Joe Biden on Thursday.
But the emergence of highly contagious new virus variants has heightened the urgency to get hundreds of millions more people inoculated against the coronavirus. COVID-19 has claimed the lives of more than a half a million people in the United States.
The head of the U.S. Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in U.S. COVID-19 cases may be stalling.
In a 44,000-person trial, the J&J vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.
Two-dose vaccines made by Pfizer Inc with BioNTech SE and Moderna Inc were about 95% effective in their pivotal trials. Experts cautioned against drawing too much of a distinction between the vaccines because the trials had somewhat different goals, and importantly, the Pfizer/BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the UK.
J&J’s trial was underway when the new variants were circulating and even prevalent in some countries where it was tested.
Still, its vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.
During the meeting, a J&J vaccine executive said the company was developing a second-generation vaccine that would target the concerning South African variant and will be ready to start Phase I trials by this summer.
The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech and Moderna shots that use messenger RNA technology and are shipped frozen.
J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.