Dr. Scott Gottlieb on Friday cheered the results of Johnson & Johnson’s Covid vaccine trial, telling CNBC he believes they bode well for the U.S. fight against the pandemic.
J&J said earlier in the day its vaccine demonstrated 66% effectiveness overall in preventing the disease, although the level of protection varied by region. In the U.S., for example, it was 72%, compared with 66% in Latin America and 57% in South Africa after four weeks.
Across all geographies, the vaccine was 85% effective in preventing severe cases of Covid-19 after four weeks, according to J&J. Protection improved over time, the company said, with zero participants reporting a severe case after 49 days. Additionally, J&J said the vaccine provided complete protection against Covid-related hospitalizations after four weeks.
“This is a very good result,” Gottlieb said on “Closing Bell,” while seeking to downplay comparisons with the vaccines made by Moderna and Pfizer–BioNTech. Those vaccines, which have been granted emergency use authorization by the U.S. Food and Drug Administration, were more than 94% effective in preventing Covid-19 in clinical trials.
“I don’t think you can make apples-to-apples comparisons across the clinical trials. They were run a little bit different,” said Gottlieb, a former FDA commissioner who sits on the board of Pfizer.
For example, he noted a majority of J&J’s trial participants were in Latin America and South Africa, where different variants of the coronavirus are circulating. Vaccines from all manufacturers are probably going to be less effective against those variants, he said.
Johnson & Johnson’s vaccine also offers advantages over the ones Americans are currently receiving, said Gottlieb, who led the FDA from 2017 to 2019 in the Trump administration. J&J’s vaccine requires just one dose, whereas Moderna and Pfizer-BioNTech’s vaccines both require two shots a few weeks apart.
“The immune protection that it affords seems to be pretty durable,” Gottlieb said of J&J’s vaccine. “If you look at the clinical trial data from the phase two study and also this study, based on what we know, the immune cells that the vaccine was generating continued to increase for the duration of the time they were looking at these patients.”
New Jersey-based Johnson & Johnson said it intends to apply for emergency use authorization with the FDA in early February. Gottlieb said he expects the regulatory agency to grant that limited clearance, which would pave the way for its distribution and administration across the U.S. “It’s a great addition to the market,” he said.
The U.S., after a slower-than-expected start, has administered initial vaccine doses to nearly 23 million people, according to data from the Centers for Disease Control and Prevention. An additional 4.8 million people have received their second dose, as of Friday morning.
While Johnson & Johnson’s clinical data suggests its vaccine is less effective against virus variants such as the one originating in South Africa, Gottlieb emphasized there had been expectation that mutations could be problematic for the vaccines.
Indeed, Novavax announced Thursday its vaccine was more than 89% effective in protecting against Covid-19 in a phase three trial conducted in the U.K. However, the vaccine had a lower efficacy rate of 49.4% in the company’s phase two trial in South Africa, where 90% of the cases involve the troubling new variant.
“I think the good news is that they are still effective against those variants — 50%, 60% effectiveness is pretty good,” Gottlieb said, noting the FDA indicated in July it would grant emergency use authorization to any Covid vaccine that proved safe and at least 50% effective.
For comparison, the seasonal flu vaccine generally reduces a person’s risk of contracting influenza by 40% to 60% compared with those who do not receive the shot, according to the CDC.
Eventually, Gottlieb said there will be a need to update the Covid vaccines to better protect against new mutations and develop booster shots. “We have time to do that,” he said.
“In the meantime, these vaccines are still going to be effective against these new variants,” he said. “They are still a backstop against the spread of these variants into the United States, and we just have to get people vaccinated.”