People Are Getting Moderna 'Boosters' Anyway

 Several sources have told MedPage Today that they've received a "booster" shot of Moderna, even though the vaccine isn't yet authorized for this indication.

These are people who don't fit the specific criteria for being immunocompromised that would qualify them for a third dose of the vaccine. Some of them are over 65 but didn't get their primary series with Pfizer. The majority got their shots at a pharmacy, not in a doctor's office.

"We both have two Moderna shots and a Moderna booster, figuring that even if the booster isn't approved yet, it can't hurt," said one source who is over 65 but not immunocompromised, speaking of himself and his wife. "Our family doc told us to get one ASAP."

While sources didn't share exactly how they got their Moderna "boosters," the immunocompromised are only required to self-attest to their condition, and don't need to bring a doctor's note to their pharmacies in order to get third doses, according to the CDC.

People have long been pursuing boosters or third shots of COVID vaccines, even before the FDA authorized a third dose of either vaccine for the immunocompromised in August, or Pfizer boosters for certain groups earlier this month.

In early August, for instance, ABC News reported on a leaked CDC memo that found about 1.1 million people had already received an unauthorized third dose of either vaccine -- and acknowledged that number was likely an undercount.

It's possible that number included a large proportion of immunocompromised patients seeking a third dose, but others may have simply been concerned about waning immunity in the face of the Delta variant.

One caution about forging ahead with a Moderna booster is that when the company submitted data to FDA for review, it focused on a 50-mcg shot, rather than the 100-mcg doses given for the first and second shots. It's not clear if the lower dose would carry fewer side effects, as the second Moderna shot garnered a reputation for packing a punch.

In addition to the possible differences in dose with any Moderna booster that's authorized in the future, there are also some differences with the third dose for the immunocompromised. That third shot is authorized at the 100-mcg dose at least 28 days after the initial two-dose series. Any Moderna booster would likely come 6 months after the primary two-dose series.

MedPage Today reached out to CVS and Walgreens to clarify their policies on Moderna boosters and third doses.

A Walgreens spokesperson said it's offering Pfizer boosters to eligible individuals, but Moderna "is not currently available as a booster, and we will continue to follow additional guidance from the FDA and CDC." The spokesperson also acknowledged providing third doses of either mRNA vaccine to immunocompromised individuals.

A CVS spokesperson said the company began administering Pfizer boosters last week, and that "more data on the effectiveness and safety of Moderna and Johnson & Johnson (Janssen) booster shots are expected in the coming weeks."

The CVS spokesperson also noted the availability of Pfizer and Moderna third shots for the immunocompromised, highlighting CDC guidance that "if the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product (Moderna or Pfizer) may be administered."

The back-and-forth on boosters has led to confusion about eligibility. At this point, third doses of both mRNA vaccines are authorized 28 days after the primary series for those with very specific immunocompromising conditions as outlined by CDC's Advisory Committee on Immunization Practices (including solid-organ transplant recipients, those undergoing cancer treatment, and those on immune-suppressing drugs such as alkylating agents, antimetabolites, and tumor necrosis factor blockers). People with chronic conditions like heart disease or diabetes are not considered to be a part of this group.

Those who received a primary two-dose series with Pfizer are eligible for a booster shot (at the same dose as the original shots) at least 6 months after their second dose if they're 65 and older; if they're 18 to 64 and at high risk of having severe COVID; or if they're 18 to 64 and at high risk of contracting COVID-19 due to occupational exposure.

Given the confusion and "booster envy," President Biden has attempted to reassure Americans who are playing by the rules that they'll be okay.

"If you don't qualify for the booster, or you got the Moderna and Johnson & Johnson vaccines: if you're fully vaccinated, you're highly protected from severe illness even if you get COVID-19," Biden tweeted earlier this week.

https://www.medpagetoday.com/special-reports/exclusives/94789