In another promising development for vaccine science, Johnson & Johnson says its vaccine – a single shot tested against a complex barrier of newly emerging COVID-19 variants – is 66% effective in preventing symptomatic diseases and 85% effective in preventing prevention of serious diseases.
A team of scientists at the company was “elated” and “happy” when they saw the results, Dr. Mathai Mammen, MD, Ph.D., global head of Janssen Research & Development, told ABC News.
“We are a single shot … And now we produce data that says our vaccine is highly effective, 85% effective against severe COVID, 100% effective against hospitalization or death,” said Mammen.
“We had the objective of producing a vaccine for the world, which is easy to use, easy to distribute and works against the prevention of the form of COVID-19 that worries people so much,” said Mammen, referring to a disease that can cause seriously ill at home and lead to hospitalization or death.
In a press release, Johnson & Johnson said the vaccine is also safe. The volunteers experienced mild reactions after the injection, with less than 10% experiencing fever.
The complete data package will be made available to the public and evaluated by the FDA advisory committee in mid-February.
The Food and Drug Administration (FDA) has said it will consider a vaccine more than 50% effective, and the Johnson & Johnson vaccine exceeds that limit. An emergency use permit can be granted and people can start receiving vaccines before the end of February.
With its single dose administration and more convenient transportation and storage requirements, Mammen calls it a “workhorse vaccine”.
“We are very pleased to see that this vaccine is very effective against mild diseases [and] excellent effectiveness against serious diseases … [in] all geographic regions studied, “said Dr. Dan Barouch, from Beth Israel Deaconess Medical Center, who collaborated with Johnson & Johnson on the development of the vaccine.
While existing PDA / BioNTech and Moderna vaccines authorized by the FDA have approximately 95% efficacy rates against symptomatic diseases and almost perfect protection against serious illnesses, they also have disadvantages, as both must be administered in two doses and have more complex storage requirements.
In addition, they were tested in the summer, before the emergence of the newly discovered COVID-19 variants.
“They applied the vaccine at a time that was simpler,” said Mammen. “These variants are particularly complicated, as they can be more virulent [and] a little harder to protect. “
The Johnson & Johnson trial, launched in September, was conducted in the United States, South Africa and Latin America. Although unforeseen at the time, this massive clinical trial of more than 44,000 volunteers was carried out in countries where new variants of COVID-19 emerged soon after, often taking control of previous versions of the virus.
South Africa, in particular, is home to a variant that appears not only more communicable, but is also capable of mitigating the effect of other existing vaccines. Latin America, in turn, is home to a more transmissible Brazilian variant that shares some of the same mutations.
“It’s a much more complex pandemic now than it was months ago,” said Barouch.
Divided by region, the Johnson & Johnson vaccine, in the test, was 72% effective in the United States, 66% in Latin America and 57% in South Africa.
Mamment said the company is “very lucky” to have chosen South Africa as one of the homes for its test, because it gave them the opportunity to show that their vaccine works even against a variant that may one day become dominant.
So now, Mamment said, “I am not thinking so much about the South African strain, but about other mutations that may arise.”
He is particularly encouraged by the fact that all the volunteers saw a significant benefit in getting a vaccine that eliminates the possibility of being hospitalized or dying from COVID-19.
In the trial, the Johnson & Johnson vaccine proved to be approximately 66% effective in preventing a person from developing COVID-19 with symptoms. But it was 85% effective in preventing serious illnesses that could send a person to the hospital.
“So this is probably the most exciting result in our entire clinical study that we have 85% protection against severe COVID, regardless of where in the world you are talking and what kind of variants you are talking about,” Mamment said.
“From the point of view of making a vaccine for this pandemic, your goal is to keep people out of the hospital and the morgue,” said Dr. Paul Offit, member of the FDA advisory committee, director of the Vaccine Education Center and professor of pediatrics in the Infectious Diseases Division of Children’s Hospital of Philadelphia.
“Obviously it’s not fun to have a mild illness,” said Offit. “But the real question is, how effective was it in keeping people out of the hospital?”
The development takes place while the world is waiting for a more convenient, single-dose vaccine against coronavirus – and preferably one that does not need to be frozen for long-term transport and storage, as Pfizer and Moderna do.
Mamment said his company’s vaccine checks these boxes.
“We know that it is a magnificent advantage to have a single shot,” he said. “I believe that everyone benefits from this vaccine.”
They are now planning studies on children and pregnant women to ensure that the vaccine is also safe and effective for these groups.
If authorized, the Johnson & Johnson vaccine would help facilitate the supply of strained vaccine.
The company said it could deliver 100 million doses to the United States by June, if the FDA goes green.