By Elisabeth Buchwald and Andrew Keshner
Dylan Morrongiello, 27, has a list of health conditions including Type 1 Diabetes and pulmonary hypertension that make him more vulnerable to contracting COVID-19, but he isn’t officially considered immunocompromised.
Yet Morrongiello, who lives in Indialantic, Fla., was able to get a third Moderna /zigman2/quotes/205619834/composite MRNA -2.31% COVID-19 vaccine shot at a local supermarket pharmacy two weeks ago. He received his first dose at the end of December and his second a month later.
He’s among a set of people who sought out a third shot, even though he wasn’t technically eligible for one. But those considering this route may want to weigh a few different factors before proceeding, experts say.
The FDA’s current position
Around mid-August, the Food and Drug Administration said certain people with weakened immune systems were eligible for a third shot of the Moderna vaccine or the Pfizer /zigman2/quotes/202877789/composite PFE -0.43% /BioNTech /zigman2/quotes/214419716/composite BNTX -1.06% vaccine. Certain organ transplant recipients and people with similarly compromised immune systems were eligible, the FDA said — but the agency emphasized the announcement did not apply to everyone else.
Despite Pfizer data from Israel that suggests third shots can restore the vaccine’s effectiveness six months after a second dose, a group of independent advisers for the FDA voted against recommending third shots of Pfizer for people above 16 years old on Friday.
The committee did, however, recommend the FDA authorize third shots for people with health conditions putting them at a higher risk for severe disease, and for people who are age 65 and above. Morrongiello would likely fall into the former category.
“Scientific debate goes on constantly, and this is a very reasonable resolution,” Dr. William Schaffner, a professor at Vanderbilt University Medical Center’s Infectious Diseases Division, said after the FDA committee votes.
Type 1 Diabetes would count as “high risk,” according to Schaffner, along with conditions like heart disease and lung disease.
Pfizer says a third shot is ‘a critical tool’
The Pfizer data on the third shots showed “a favorable safety profile and strong immune responses,” said Kathrin Jansen, senior vice president and head of vaccine research & development at Pfizer, after Friday’s decision.
The findings “and the larger body of scientific evidence presented at the meeting, underscore our belief that third shots will be a critical tool in the ongoing effort to control the spread of this virus,” Jansen said.
“We thank the committee for their thoughtful review of the data and will work with the FDA following today’s meeting to address the committee’s questions, as we continue to believe in the benefits of a third dose for a broader population,” she added.
‘We shouldn’t be cavalier’
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, was “not surprised” by the decision, he said in a CNBC interview on Friday.
But given initial data from Israel where third shots are being offered to anyone above 12 who received a second dose at least five months ago, Fauci said that he’s “in favor of boosters,” but declined to comment on what age groups he’d recommend it for.
Fauci also acknowledged that some people are getting third shots who aren’t immunocompromised, but said that “it is not advised to do that until you get the approval from our regulatory authorities.”
Schaffner falls in the Fauci camp. For anyone who’s healthy and getting a third shot, “they would be functioning outside of the current recommendations. That ought to give them pause,” he said.
It’s likely that at some point in the future, everyone will need a third shot, Schaffner said. But what happens at that future point, when someone who’s already had a third shot is now being advised to get a third shot?
Any side effects from a fourth shot are not known. “We shouldn’t be cavalier,” he said.
Morrongiello did not want to wait
“Considering my conditions, as well as the fact I’ll be traveling for work for almost a year in a few weeks, I decided I’d jump the gun a little bit just to make sure I was as protected as possible,” Morrongiello, a professional opera singer, told MarketWatch.
The pharmacy he went to didn’t ask questions regarding eligibility, which didn’t surprise him given that he saw “two other people on Facebook /zigman2/quotes/205064656/composite FB -1.15% mention they were also able to get third shots without having questions asked.”
“That definitely empowered me a little,” he added.
The U.S. Centers for Disease Control and Prevention is urging vaccinators not to deny “COVID-19 vaccination to a person due to lack of documentation,” the agency said in an online post addressing frequently asked questions relating to third shots.
“This will help prevent barriers to access for this vulnerable population receiving a needed additional dose,” the agency added.
Some 2.16 million Americans have received a third shot since mid-August, according to CDC data .
How pharmacies screen for eligibility
But receiving a third shot isn’t always as simple as just walking into a pharmacy and asking for one.
Pharmacy chain CVS /zigman2/quotes/209664499/composite CVS +1.51% said it’s asking people to “attest that all information provided, including health status, is truthful and accurate while scheduling a vaccination appointment,” said Matthew Blanchette, a spokesman for the company.
“We reserve the right to cancel appointments if it’s determined that information provided for establishing eligibility is not truthful,” he added.
Walgreens /zigman2/quotes/203410933/composite WBA -3.64% said that patients seeking a third dose will be asked to “complete, sign and date an attestation form confirming they meet all eligibility requirements for the additional vaccine upon arriving at our stores,” a spokeswoman told MarketWatch.
Similarly, independent pharmacies “are not obligated” to administer third shots to everyone who asks, said Kurt Proctor, senior vice president of strategic initiatives at the National Community Pharmacists Association, a trade group that represents more than 21,000 independent pharmacies.
Will insurance cover the cost of a third shot if you don’t qualify?
“At the moment, a member who received a third shot would not have that claim denied,” said Michelle Vanstory, vice president of external communications at Anthem /zigman2/quotes/203808743/composite ANTM +0.60% . “But it would be misleading to state that as a policy because it could change pending the guidance,” she added. “This is an evolving situation.”
A spokesman for Aetna, however, stressed that “the additional dose is available at no cost to any eligible patient either through insurance or a federal program for the uninsured,” said Ethan Slavin, a spokesman for the company.
Slavin did not clarify whether Aetna members who are ineligible for a third dose would be charged.
Jeff Zients, the White House COVID-19 response coordinator, said last month that “boosters will be free, regardless of immigration or health insurance status. No ID or insurance required.”
But Zients was not speaking directly about what occurs when an ineligible person gets an additional dose. Rather, he seemed to be referring to what Americans could expect if the FDA greenlighted boosters for the general population.
Health vs. ethical considerations
Though Pfizer has said everyone age 16 and up should get a third shot, not everyone is convinced yet.
While there’s agreement that a third shot is a good idea for people with weakened immune systems, some scientists say the data still isn’t there that supports it for the general population.
“Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated,” according to a group of scientists who signed on to an opinion piece published Monday in The Lancet, a prominent medical journal.
It may be difficult to disentangle any rising case counts due to waning vaccine efficacy from rising cases due to changed behavior as more people get vaccinated, they noted.
During Friday’s meeting, Dr. Cody Meissner, director of pediatric infectious disease at Tufts Medical Center and a committee member, sounded wary of expecting too much from a third shot.
“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” he said.
The World Health Organization has called on rich countries to pause their third efforts while people in many parts of the globe are still waiting for their first jab — a point the Lancet opinion piece emphasizes.
Even though many countries are struggling to get first doses of vaccines, Morrongiello said considering his health conditions, he doesn’t have “any regrets.”
But he acknowledged that “it could be a potential issue if too many people get booster shots too soon.”