Johnson & Johnson released the results of the third phase Study of COVID-19 vaccine and intends to seek emergency use authorization from the Food and Drug Administration.
The results showed 85% protection against severe coronavirus disease in adults of all ages and racial groups 28 days after vaccination. The overall efficacy rate for preventing moderate to severe disease was 72 percent in the United States and 66 percent in all countries studied, the pharmaceutical giant said.
The benefits include that it requires a single dose – unlike Moderna and Pfizer two-dose vaccinations – and that it can be stored in a regular refrigerator.
“There is no doubt that this vaccine will be a game changer,” Dr. Matara Mammen, global head of pharmaceutical research and development for Johnson & Johnson, told Dr. Tara Narula of CBS News. The actual effectiveness of this vaccine is very good.
Phase 3 clinical trials included approximately 44,000 participants in the United States, Latin America, and South Africa. A total of 468 people contracted COVID-19 in the study, which looked at protection against moderate to severe cases. No one who received the vaccine died of the disease.
“What we mean by severe COVID is that you feel particularly bad at home. This is about 80% of severe cases. Or, in some cases, you are sick enough to go for medical care,” Mammen explained.
The results also showed protection against several emerging virus variants, including the newly discovered strain in South Africa – which was also detected in the US
Mammen said the numbers are encouraging.
“We had an 85% effectiveness against severe COVID disease. And that’s significant because there’s a variant in South Africa this is particularly problematic. So that makes it easier for me to rest, “he said.
Pfizer and Moderna vaccines use mRNA to carry the code to make the coronavirus spike protein, which allows the virus to invade human cells. The Johnson & Johnson vaccine uses DNA and a modified, 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 requires only a single dose, Mammen explained that “they went through an experimental process and chose the best process optimized for neutralizing antibodies, binding antibodies and T cells.”
“So we are able to get a much more immune response than a single typical shot,” he said.
Bali Pulendran, an immunologist at Stanford Medicine, believes a single-dose vaccine can only help Biden administration plan to increase availability.
“I would much rather have to go in to do my one shot than go a month or three weeks later to get the second shot,” he said.
Pulendran said a potential single-dose vaccine would have a “huge impact on public health.”
“From a clinician’s perspective, it’s much easier to give a single-dose vaccine,” he said.
The US government has pre-ordered about 100 million doses, but Johnson & Johnson expects to have less than 10 million doses available by February.
CBS News asked Dr. Mammen about reports of production delays. He said the company will fulfill the US order by June and will make one billion doses globally this year.
Johnson & Johnson data has yet to be reviewed by the FDA.