Dr. Scott Gottlieb on Wednesday expressed concern about the smooth administration of Covid-19 vaccines next year, when shots are available for Americans who are not health workers or residents of health care centers. long-term care.
The former commissioner of the Food and Drug Administration noted the challenges according to reports, experienced around administering antibody drugs to Americans, suggesting that these difficulties could portend similar difficulties for vaccines.
“The experience with antibody drugs is not a good omen,” Gottlieb told CNBC’s “Squawk Box”. “As we enter the next stretch of people to be vaccinated, which will be in the community, it can be a challenge for states to distribute these vaccines if they cannot distribute antibody drugs.”
Only between 5% and 20% of antibody drugs shipped to the United States have been used to treat people infected with coronavirus but who are not hospitalized, according to CNBC’s Meg Tirrell. Last month, the FDA granted an emergency use authorization for antibodies to Eli Lilly and Regeneron’s antibodies. Treatments should be administered using an IV, which is probably a major hurdle that contributes to lack of use.
Gottlieb, a board member of Pfizer, which manufactures the only Covid-19 vaccine currently authorized by the FDA, said the challenge of antibody drugs is a last-mile problem for states. In other words, it connects the available supply of treatments directly with the people in the community who need it. There are examples of where it’s going well, like Maryland, which has created dedicated infusion sites, Gottlieb said.
But for the most part, he said, “I think states have limited resources on their own and there will probably be more things the federal government could do to support states.” He said he believes it could also be a last-mile problem for vaccines.
Adding to Gottlieb’s concerns about whether the available doses of vaccine will eventually reach those who are eligible for vaccination is the fact that each state can take its own approach. Right now, with their initial vaccine allocation, states are giving priority to health care workers and long-term care center residents.
As availability increases (which Gottlieb said he expects sometime next month), the range of people who would be eligible to get vaccinated will expand to potentially include other essential workers and elderly Americans who do not reside in residences for the elderly or in facilities for assisted living.
“I think most states will make a hybrid of both, but then … trying to get out into the community to administer the vaccines, as they do, you’ll see a huge heterogeneity,” said Gottlieb, who led the FDA to the Trump administration from 2017 to 2019.
“I think you’ll see some drastic differences in accessibility between states, and again, antibody drugs are a harbinger of that,” he added. “If we leave all this up to 50 states, we can expect to see a lot of differences between how well it works and who gets it and who doesn’t, and that will be unfortunate because in an ideal world, you want to see more uniformity.”
Outreach: Scott Gottlieb is a CNBC contributor and a member of Pfizer’s boards of directors, the start of Tempus genetic testing, and the biotech company Illumina. Gottlieb is also co-chair of Norwegian Cruise Line Holdings and the Royal Caribbean Healthy Sail Panel.