Johnson & Johnson released the results of its phase three COVID-19 vaccine trial and plans to seek emergency use authorization by the Food and Drug Administration.
The results demonstrated 85% protection against severe coronavirus disease in adults of all ages and racial groups 28 days after vaccination. The overall effectiveness rate for preventing moderate to severe illness was 72% in the United States and 66% in all countries studied, said the pharmaceutical giant.
Benefits include that it requires only one dose – unlike Moderna and Pfizer two-dose inoculations – and that can be stored in a regular refrigerator.
“There is no doubt that this vaccine will change the game,” said Dr. Mathai Mammen, global head of pharmaceutical research and development at Johnson & Johnson, to Dr. Tara Narula of CBS News. “The effectiveness of this vaccine in the real world tends to be very high.”
Phase 3 clinical trials included about 44,000 participants in the United States, Latin America and South Africa. In all, 468 people contracted COVID-19 in the study, which sought protection against moderate and severe cases. No one who received the vaccine died of the disease.
“What we mean by severe COVID is to feel particularly sick at home. That is about 80% of serious cases. Or, in some cases, to be sick enough to seek medical attention,” explained Mammen.
The results also showed protection against multiple variants of emerging viruses, including the strain recently discovered in South Africa – which was also detected in the USA
Mammen said the numbers were encouraging.
“We were 85% effective against severe COVID disease. And this is significant because there is a variant in south africa this is particularly problematic. It makes me more relaxed, “he said.
The Pfizer and Moderna vaccines use mRNA to carry the code to make the peak protein from the coronavirus, which allows the virus to invade human cells. The Johnson & Johnson vaccine uses DNA and a modified and weakened version of a cold virus to enter human cells. It then triggers an immune response and teaches the body to fight the real coronavirus.
Asked why the Johnson & Johnson vaccine needed only one dose, Mammen explained that he “went through an experimental process and chose the best one that was optimized to neutralize antibodies, binding antibodies and T cells.”
“So we are able to get a lot more immune response than a single typical injection,” he said.
Bali Pulendran, an immunologist at Stanford Medicine, believes that a single dose vaccine can only help Biden administration plan to increase availability.
“I would much rather have to go in to get my one chance, rather than having to go a month or three weeks later to get my second chance,” he said.
Pulendran said that a possible single-dose vaccine would have a “huge impact on public health.”
“From the clinician’s point of view, it is much easier to administer a single dose vaccine,” he said,
The U.S. government has ordered about 100 million doses, but Johnson & Johnson expects to have less than 10 million doses available for February.
CBS News asked Dr. Mammen about reports of production delays. He said the company will fulfill the order from the United States by June and will make one billion doses this year worldwide.
Johnson & Johnson data still needs to be reviewed by the FDA.