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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
MRNA,
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 booster 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 booster shot of the Moderna vaccine or the Pfizer
PFE,
/BioNTech
BNTX,
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 booster shots can restore the vaccine’s effectiveness six months after a second dose, a group of independent advisers for the FDA voted against recommending Pfizer booster shots for people above 16 years old on Friday.
The committee did, however, recommend the FDA authorize boosters 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.
‘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,’ said Dylan Morrongiello, pictured.
Photo courtesy of Dylan Morrongiello
“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.
The data showed “a favorable safety profile and strong immune responses,” according to Kathrin Jansen, senior vice president and head of vaccine research & development at Pfizer.
The findings “and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters 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 booster dose for a broader population,” he added.
Dr. Fauci’s comments on boosters
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 boosters 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.
“‘I don’t think a booster dose is going to significantly contribute to controlling the pandemic’”
Fauci also acknowledged that some people are getting boosters 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 booster 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 booster 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 booster 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
FB,
mention they were also able to get third shots without having questions asked.”
“That definitely empowered me a little,” he added.
“‘We reserve the right to cancel appointments if it’s determined that information provided for establishing eligibility is not truthful’”
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 booster shots.
“This will help prevent barriers to access for this vulnerable population receiving a needed additional dose,” the agency added.
Some 955,000 people have received a booster shot since mid-August, the Wall Street Journal reported, citing CDC data.
How pharmacies screen for booster eligibility
But receiving a booster shot isn’t always as simple as just walking into a pharmacy and asking for one.
Pharmacy chain CVS
CVS,
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
WBA,
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 booster 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.
Health vs. ethical considerations
Though Pfizer has said everyone age 16 and up should get a booster shot, not everyone is convinced yet.
While there’s agreement that a booster 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.
“‘Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated’”
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 booster 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.”
