Johnson & Johnson has released the results of phase three COVID-19 vaccine study and plans to seek emergency use approval from the Food and Drug Administration.
Results showed 85% protection against severe coronavirus disease in adults of all ages and racial groups 28 days after vaccination. The overall effectiveness for preventing moderate to severe diseases was 72% in the US and 66% in all countries studied, the pharmaceutical giant said.
Advantages include that it only requires one dose – unlike those of Moderna and Pfizer vaccinations with two doses – and that it can be kept in a regular refrigerator.
“There is no doubt that this vaccine will be a game-changer,” said Dr. Mathai Mammen, global head of pharmaceutical research and development for Johnson & Johnson, to Dr. Tara Narula from CBS News. “The actual effectiveness of this vaccine is probably very high.”
The Phase 3 clinical studies included approximately 44,000 participants in the US, Latin America and South Africa. A total of 468 people contracted COVID-19 in the study, which looked at protection against both moderate and severe cases. No one who received the vaccine died of the disease.
“What we mean by severe COVID is that you feel particularly sick at home. That’s about 80% of severe cases. Or in some cases being sick enough to seek medical attention,” Mammen explained.
The results also showed protection against multiple emerging virus variants, including the strain recently discovered in South Africa – and has been detected in the US.
Mammen said the numbers were encouraging.
“We had 85% efficacy against the severe COVID disease. And that makes sense because there is one variant in South Africa that is particularly problematic. So that I calm down, ”he said.
The Pfizer and Moderna vaccines use mRNA to carry the code to make the coronavirus spike protein, which allows the virus to enter human cells. The Johnson & Johnson vaccine uses DNA and a modified, attenuated version of a cold virus to access human cells. It then activates an immune response and teaches the body to fight the real coronavirus.
When asked why the Johnson & Johnson vaccine only needed one dose, Mammen explained that they “went through an experimental process and selected the very best that was optimized for neutralizing antibodies, binding antibodies and T cells.”
“So we can get a lot more immune response than a typical single shot,” he said.
Bali Pulendran, an immunologist at Stanford Medicine, believes that a single-dose vaccine alone can help Plan of the administration of Biden to increase availability.
“I would much rather just go in to get my one shot instead of going a month or three weeks later to get my second shot,” he said.
Pulendran said a future single-dose vaccine would have a “huge impact on public health.”
“From a doctor’s perspective, it’s so much easier to administer a single dose of vaccine,” he said,
The U.S. government has pre-ordered about 100 million doses, but Johnson & Johnson expects to have fewer than 10 million doses available by February only.
CBS News asked Dr. Mammen to reports of production delays. He said the company will comply with the US order in June and make a billion doses worldwide this year.
Johnson & Johnson’s data has yet to be reviewed by the FDA.