Johnson & Johnson’s Covid-19 vaccine was approved on Friday by a group of experts advising the Food and Drug Administration and cleared the final hurdle before formal approval expected on Saturday, according to two people familiar with the agency’s plans are. The nation’s first shipments will run out in the days thereafter.
It will be the third shot made available to the United States in the year since the first wave of coronavirus cases washed across the country, and it will be the first vaccine to require just one dose instead of two.
The Johnson & Johnson formulation worked well in clinical trials, especially against serious illness and hospitalization, although it did not match the sky-high efficacy rates of the first two vaccines from Pfizer-BioNTech and Moderna.
The panel, made up of independent infectious disease experts, statisticians and epidemiologists, voted unanimously to approve the vaccine.
“We are dealing with a pandemic right now,” said Dr. Jay Portnoy, an allergist at Children’s Mercy Hospital in Kansas City, MO, and a board member. “It’s great that we have this vaccine.”
During Johnson & Johnson’s presentation to the panel, Dr. Gregory Poland, a virologist at Mayo Clinic and the company’s paid external consultant, noted the vaccine’s effectiveness, ease of use and low side effect rate. It “checks almost all the boxes,” he said. “It is clear to me that the known benefits far outweigh the known risks.”
The vaccine had an overall effectiveness rate of 72 percent in the US and 64 percent in South Africa, where a worrying variant emerged in the fall. The shot showed an effectiveness of 86 percent against severe forms of Covid-19 in the US and 82 percent against serious illnesses in South Africa.
These are strong numbers, but they are below the efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate, and severe cases of Covid of around 95 percent.
The Johnson & Johnson vaccine is a single dose and uses a different technology from the approved vaccines. The scope and size of the Johnson & Johnson trial was huge, spanning eight countries, three continents, and nearly 45,000 participants.
Although the vaccine works with one shot, studies are currently being carried out to see if a second dose would increase the level of protection.
Dr. Paul Offit, a pediatrician at Philadelphia Children’s Hospital and one of the panellists, pointed out Friday that Johnson & Johnson found in early clinical trials that took place over the summer that a second dose resulted in levels of coronavirus antibodies that were almost three times higher than those produced by one dose alone.
The results of the Johnson & Johnson late-stage two-dose clinical trial are not expected until July at the earliest. If these results are found to be better than a single dose, Dr. Offit: “Will this be a two-dose vaccine?”
Dr. Johan Van Hoof, the global director of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, said the company decided to pursue the one-shot strategy after its studies on monkeys last spring showed that a single dose was sufficient to provide strong protection against the disease.
“It is clear that in a situation of an outbreak, in a raging epidemic, the big challenge is getting the epidemic under control,” he said. “The regime is very well positioned to be used in outbreak situations.”
Dr. However, Van Hoof also noted that it will be important to track volunteers who have received a single dose to see if their immunity changes over the coming months. Firing a booster shot may be required for long-term protection. “The big question mark is still how long does the protection last?” he said.
Following the vote, the FDA told Johnson & Johnson that it “will work quickly towards completion and emergency clearance,” a statement said. The FDA also said it had notified other government agencies “so they can implement their plans for timely vaccine distribution”.
Sharon LaFraniere contributed to the coverage.