Dr. Scott Gottlieb expressed concerns Wednesday about the smooth administration of Covid-19 vaccines next year, when shots become available for Americans who are not health-care workers or residents of long-term care facilities.
The former Food and Drug Administration commissioner pointed to the challenges that have been reportedly experienced around administering antibody drugs to Americans, suggesting those difficulties could portend similar difficulties for vaccines.
“The experience with the antibody drugs is not a good harbinger,” Gottlieb said on CNBC’s “Squawk Box.” “As we get into the next tranche of people to be vaccinated, which is going to be in the community, it might be challenging for states to distribute those vaccines if they can’t distribute the antibody drugs.”
Only 5% to 20% of antibody drugs that have been shipped across the U.S. have been used to treat people who are infected with the coronavirus but are not hospitalized, according to CNBC’s Meg Tirrell. The FDA granted emergency use authorization last month for the antibody drugs from Eli Lilly and Regeneron. The treatments need to be administered through an IV, which is likely a major hurdle that is contributing to the lack of use.
Gottlieb, a board member of Pfizer, which makes the only Covid-19 vaccine currently authorized by the FDA, said the challenge for the antibody drugs is a last-mile problem for states. In other words, it’s connecting the available supply of the treatments directly with people in the community who need it. There are examples of where that is happening well, such as in Maryland which has set up dedicated infusion sites, Gottlieb said.
But for the most part, he said, “I think the states are resource constrained on their own and there’s probably more that the federal government could do to be backstopping the states.” He said he believes it may also be a last-mile problem for the vaccines.
Adding to Gottlieb’s concerns about whether available vaccine doses will ultimately make it to those who are eligible to be immunized is the fact each state may adopt its own approach. Right now, with their initial vaccine allocation, states are giving priority to health-care workers and long-term care facility residents.
When availability increases — which Gottlieb said he expects at some point next month — the range of people who would be eligible to be vaccinated will widen to potentially include other essential workers and elderly Americans who do not reside in nursing homes or assisted-living facilities.
“I think most states will do a hybrid of both but then … trying to go out in the community to actually deliver the vaccines, how they do that, you’re going to see a tremendous amount of heterogeneity,” said Gottlieb, who led the FDA in the Trump administration from 2017 to 2019.
“I think you’re going to see some stark differences in accessibility across the states, and again, the antibody drugs is a harbinger of that,” he added. “If we are leaving this fully up to 50 states, we can expect to see a lot of differences between how well this is run and who gets access to it and who doesn’t, and that’s going to be unfortunate because in an ideal world, you want to see more uniformity.”
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic testing start-up Tempus and biotech company Illumina. Gottlieb also serves as co-chair of Norwegian Cruise Line Holdings′ and Royal Caribbean’s “Healthy Sail Panel.”