Sept. 30, 2021 -- Many people are confused – patients and healthcare providers alike – in the wake of the FDA and CDC announcements about who is authorized to get a third or “booster” shot of the Pfizer/BioNTech COVID-19 vaccine and who is not.
The official word on boosters from the CDC in the early morning hours of September 24 sparked a jump in people calling or coming in for a third shot, vaccine providers report. At the same time, the uncertainty from changing federal messages about boosters is causing some chaos, especially in the form of vaccine misinformation.
The confusion started, in part, with the Aug. 13, 2021 announcement that immunocompromised Americans were eligible for a booster shot. Next came the initial Biden administration intention to provide most U.S. adults with a third shot starting September 20 – an announcement later rolled back – followed by the FDA and CDC limiting boosters to select groups last week.
"It was only 3% of the population that was going to be getting a third dose, then it was back to everyone being able to get the booster, and then it's back to a select crew," Louito Edje, MD, a family physician in private practice in Cincinnati told Medscape Medical News.
This kind of mixed messaging is generating more questions than answers.
"Even though that is following the science, translating the science into policy – it's really fraught with confusion for patients, especially," continued Edje, professor educator in the Departments of Medical Education and Family and Community Medicine at UC Health and a fellow of the American Academy of Family Physicians.
When asked if he's seeing more uncertainty about boosters, community pharmacist Brian Caswell, RPh, said, "I'm going to have to say yes because I've been confused myself at times."
"Yes, there is a lot of confusion," said Caswell, owner or co-owner of four pharmacies in Kansas and Missouri and president of the National Community Pharmacists Association.
"Unfortunately, confusion leads to an acceleration of misinformation," Caswell said.
Edje shared an example. "The folks who have been hesitant to even get the first vaccine – appear now a little less likely to want to go ahead and get vaccinated."
These patients point to breakthrough COVID-19 cases with the Delta variant, which "reinforces that they don't need to get vaccinated in the first place," Edje said.
"That's unfortunate because it's a complete fallacy."
Clearer communication from the federal government could help alleviate confusion, Caswell said.
"I would like to see an official CDC chart that states who is eligible as of a certain date. Something that is accessible through their webpage or a social media source that can be updated. That would help all of us."
"For myself, I've got patients from Kansas, Oklahoma, and Missouri that might be operating under different guidelines. That makes it even more confusing," he said.
More clarity is need for individuals seeking boosters as well.
"It would help to be very clear with the general public, who are becoming very knowledgeable within this vaccine realm," Caswell said.
'Gaming the System'
Although most people seeking a booster shot at one of Caswell's pharmacies are following official recommendations, there are some who remain ineligible but nonetheless come in for an additional vaccine.
"Even before this announcement last Friday, in the latter part of August when the CDC talked about a booster for immunocompromised, we had interest from people who did not meet the criteria," Caswell said.
To the ineligible, he and his staff explain the approval process, why certain decisions are made, and point out that the number of eligible Americans is likely to expand in the future.
"The vast majority of them are understanding," Caswell said. "But we've had some people who really didn't want to accept the information, and I don't know what they've done."
"Some people are gaming the system to get their booster or second shot of J&J," he said.
For example, Caswell had a patient who crossed over state lines from Missouri seeking a vaccine booster at Wolkar Drug, a pharmacy in Baxter Springs, Kansas.
"We found out later he had a J&J shot at a facility or provider in Missouri. He came over to Kansas, signed up for it and got a booster with Moderna. We called and asked him if he was aware of it. He said 'yes.' When we questioned him more about it, he hung up."
Edje is likewise seeing interest from some ineligible patients, she said.
Crossing a Liability Line?
Caswell has asked for advice from lawyers and the State Board of Pharmacy on potential liability if pharmacists give a booster to a patient not eligible under the official FDA and CDC guidance.
"We ask patients direct questions about whether they've had the COVID vaccine, COVID, and a whole litany of questions they must answer. And we're assuming they are going to be honest and forthright," he said. "The pharmacist needs to make sure they make every effort to get that information from the patient."
Normally, healthcare providers like Caswell report each COVID-19 vaccination to the state registry after administration.
"We have not gone through a police action and checked the registry first," he said.
But, if people continue to try “gaming the system,” he said, he might have to start checking the state registry before giving someone a booster.
The American Academy of Family Physicians offers advice from the CDC about legal protections for providers.
"As outlined by CDC, any off-label use of the COMIRNATY/Pfizer-BioNTech COVID-19 Vaccine is not authorized at this time and may not be covered under the PREP Act or the PREP Act declaration. This means that clinicians providing the vaccine outside of the authorized/approved use may not have immunity from claims," the AAFP website states.
"Per CDC, Individuals who receive a third dose may not be eligible for compensation after a possible adverse event. Such use would be in violation of the CDC COVID-19 Vaccination Program provider agreement and therefore may not be reimbursable and may impact the ability of a provider to remain in the CDC Program, in addition to other potential sanctions. Administration fees for off-label doses may not be reimbursed by payers.”
Despite Confusion, Demand Is Up
Even amid all the uncertainty, there appears to be a jump in enthusiasm for the booster shots.
"The requests have gone up quite a bit. We've seen a number of requests from people in person and over the phone looking to get a booster," Caswell said. "Since the discussion at the federal level …there has been a lot of interest in the third shot booster itself, as well as about a booster for J&J."
"There is a quite a bit of excitement out there," he said.
Edje agreed. "I take care of a fair number of folks …including the elderly and health care professionals. They are already asking for the booster."
Interestingly, Edje would like to get a booster herself but is not eligible for the Pfizer third shot. She is a participant in a Moderna vaccine trial and can only receive additional immunization as part of the study.
'Walk, Don't Run'
To quell any potential early rush to get a third shot, U.S. health officials are reminding booster-ineligible people that they still carry some protection against COVID-19.
"If you're a person who ultimately might get a booster that will make you optimally protected, you don't necessarily need to get it tomorrow," Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases told CNN.
CDC Director Rochelle Walensky, MD, also weighed in. She told ABC that boosters for people who got a Moderna or Johnson & Johnson vaccine will be addressed with urgency.
"I want to reiterate that this is a very slow wane. There is no urgency here to go and get your booster immediately. You know, walk don't run to your booster appointment," she said.
"We will come and look at the data for Moderna and J&J in very short order."