Dr. Gottlieb: CDC’s Booster Decision Like Initial ‘Byzantine’ Rulings on Vaccines

Dr. Gottlieb: CDC's Booster Decision Like Initial 'Byzantine' Rulings on Vaccines (CNBC/"Squwak Box")

By Sandy Fitzgerald | Friday, 24 September 2021 11:35 AM

The decisions from the Centers for Disease Control and Prevention on who is eligible for COVID-19 booster shots are reminiscent of what happened during the initial authorization of the vaccines in December when an "overly byzantine" schedule was released that slowed the shots' distribution, former Food and Drug Administration Commissioner Scott Gottlieb said Friday.

"[That] slowed the actual administration of the vaccines because it was so hard to follow the initial guidance," Gottlieb, a CNBC contributor, said on the network's "Squawk Box."

"We forget that time period when they had these different categories," he added. "They tried to narrowly define discrete populations of patients based on their own prioritization of need. Some governors started to ignore the CDC's recommendations … so by keeping it simple they were able to administer more vaccines."

With the boosters, the CDC "got overly complex" in defining categories and by doing so came up with a plan that was going to be too complex to administer at the pharmacy counter, said Gottlieb.

"It probably would have disadvantaged people who already face obstacles getting access to care," said Gottlieb. "They left some of those provisions in so if you're 18 to 49 and you're not eligible under the occupational exposure provision and you're eligible under the provision by which you have pre-existing medical conditions, they said that you still require consultation with a physician or some assessment of benefit-risk which implies consultation with a physician. So that's going to also leave in some complexity to these guidelines even with the change by the director."

The CDC early Friday backed a booster shot for the Pfizer/BioNTech vaccine for people ages 65 and older, for some people with underlying medical conditions, and other adults in high-risk work situations. The decision came after an agency advisory panel on Thursday didn't recommend the boosters for those in high-risk jobs or living in risky living conditions, but did recommend them for the elderly and for some with underlying medical issues.

Gottlieb, however, said the provision that some people have medical advice before getting the shots will likely mean that people at a pharmacy will have to self-attest. Since that means there will be people who will lie to get their third shots, that could prove dangerous, he added.

"The worst thing that you could do as a public health agency is put out provisions and guidelines that you know are going to be ignored," Gottlieb said. "You want to make them practical so that you know providers and patients can adhere to them and will want to adhere to them."

He said he does think CDC Director Rochelle Walensky did the right thing when overruling the advisory committee.

"Remember it was a close vote as well," said Gottlieb. "I think it was a 9-6 vote so it wasn't like it was a resounding vote that people who are at risk from occupational exposure should be denied the boosters."

He added that there are already a lot of health care workers who were initially vaccinated in December and January who are getting boosters and that there are many people in settings like prisons or in assisted living facilities who might not have the underlying conditions the panel had specified, but who are still in high-risk situations.

Meanwhile, Gottlieb said part of the problem with the initial vaccine distribution was that it was based on a peacetime pediatric childhood immunization system.

"We took that scheme and thought that it would be applicable to a public health crisis when what we should have done is reimagine that process and tried to get the FDA and the CDC in closer alignment maybe in one seamless process while recognizing that if you had discrepancies between the two agencies it was going to create confusion," said Gottlieb. "I don't know why we assumed that processes built for peacetime would be good in a wartime setting of a global pandemic."