Dr. Scott Gottlieb on Wednesday expressed concern about the smooth delivery of Covid-19 vaccines next year, when injections become available to Americans who are not health professionals or residents of long-term care facilities.
The former Commissioner of the Food and Drug Administration pointed out the challenges that existed reportedly experienced around the administration of antibody drugs to Americans, suggesting that those difficulties could predict similar problems for vaccines.
“The experience with the antibodies 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 will be in the community, it could be a challenge for states to distribute those vaccines if they can’t distribute the antibodies.”
According to CNBC’s Meg Tirrell, only 5% to 20% of antibodies shipped from the US have been used to treat people infected with the coronavirus but not hospitalized. The FDA approved emergency use for Eli Lilly and Regeneron antibody drugs last month. The treatments must be administered via an IV, which is likely a major hurdle contributing to the lack of use.
Gottlieb, a Pfizer board member that makes the only Covid-19 vaccine currently approved by the FDA, said the challenge to the antibody drugs is a last-mile problem for states. In other words, it connects the available range of treatments directly with people in the community who need it. There are examples of where that is done 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 have limited resources on their own, and the federal government could probably do more to stop the states.” He said he believes it could also be a last-mile problem for the vaccines.
Increasing Gottlieb’s concern over whether the available vaccine doses will eventually reach in those candidates for immunization is the fact that each state can take its own approach. Currently, with their initial allocation of vaccines, states are prioritizing health workers and residents of long-term care facilities.
When availability increases – which Gottlieb said he expected at some point next month – the number of people eligible to be vaccinated will increase and may include other essential workers and older Americans who are not living in nursing homes or assisted living.
“I think most states will do a hybrid of both, but then… trying to get into 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’ll see some big differences in accessibility between states, and again, the antibodies are a precursor to that,” he added. “If we completely leave this to 50 states, we can expect there will be a lot of differences between how well this is done and who gets access to it and who doesn’t, and that’s going to be a shame because in an ideal world, you want more see uniformity. “
Disclosure: Scott Gottlieb is a contributor to CNBC and serves on the boards of Pfizer, genetic testing start-up Tempus and biotech company Illumina. Gottlieb is also Co-Chairman of Norwegian Cruise Line Holdings’ and Royal Caribbean’s “Healthy Sail Panel”.