Dr. Scott Gottlieb told CNBC on Wednesday that it is unlikely there will be widespread deployment of a coronavirus vaccine this year.
“I think we’ll have to have one more cycle of this virus in the fall, heading into the winter, before we get to a vaccine,” Gottlieb said on “Squawk Box.” “I really think a vaccine is probably a 2021 event, in terms of having wide availability of a vaccine for the general population.”
The former commissioner of the Food and Drug Administration reiterated his belief that a vaccine could be available in an emergency-use situation this fall, if a large-scale Covid-19 outbreak were to materialize in a particular city.
By the end of 2020, vaccine manufacturers will be able to produce the sizable quantities needed to reach tens of millions of people, Gottlieb predicted.
However, he said the issue with widely distributing the potential vaccine this year will be having sufficient data. “You’re going to have to test these probably in 30,000-patient clinical trials to have a reasonable data set to tell both safety and effectiveness.” He added, “With a virus where 20 to 40% of people develop asymptomatic disease, you have to vaccinate a lot of people to be able to discern whether or not it’s working.”
“Look, the more effective the vaccine is, the earlier we’re going to get a reading on whether or not it’s working,” stressed Gottlieb, a CNBC contributor who sits on the boards of Pfizer and biotech company Illumina. Pfizer has a Covid-19 vaccine under development, as do a host of other pharmaceutical and biotech companies such as Moderna, AstraZeneca and Johnson & Johnson.
President Donald Trump recently launched “Operation Warp Speed,” a public-private effort designed to fast-track development of a vaccine to prevent Covid-19. Some U.S. health officials are hopeful a vaccine could be ready in early 2021.
“It’s reasonable to have confidence that we’re going to get a vaccine for this in the foreseeable future,” Gottlieb said, noting some of the positive signs from early trials and that “all the major pharmaceutical companies that can develop vaccines are now in this race.”
However, Gottlieb said there may be challenges this summer in expanding into the later stages of human trials, which would ultimately make it difficult to have a vaccine ready by year’s end. According to Gottlieb, the main question is: Where do companies conduct the large-scale trials?
“You have to really guess right now what city you’re going to have outbreaks in, because if you start doing a trial in Dallas and there’s an outbreak in Houston in the fall, or you do a city like Boise, which has been largely unexposed, and it ends up being outbreaks in Little Rock, you haven’t deployed the vaccines in the settings where you’re going to get an early answer,” Gottlieb explained.
He argued it may be “more prudent” to wait to enroll the large-scale until there is more information available about where Covid-19 is likely to be spreading this fall.
Gottlieb, who has argued the U.S. may be able to “take a breather” from the virus this summer, said that information will not be available in July, when some want to begin phase three trials. “But by July, we might not have a sense on where the outbreaks are going to be.”
Published at Wed, 27 May 2020 13:49:47 +0000