Doctor/Nurse injecting syringe on arm of a Senior Patient.

The Food and Drug Administration is proposing that each year, older adults and others at high risk of severe COVID-19 receive two shots of an updated vaccine to produce protective immunity.

The idea is part of a plan to simplify the country’s COVID-19 vaccine dosing regimen and/or vaccine composition, federal health officials explained in documents released Monday. The FDA’s independent advisory committee is scheduled to weigh in on three elements of the potential plan this Thursday. 

A simplified immunization schedule would “authorize or approve a two-dose series in certain young children, and in older adults and persons with compromised immunity, and only one dose in all other individuals,” the agency stated in a briefing to committee members.  

In addition to a new immunization schedule, FDA advisers will consider the merits of periodically updating vaccine composition to better match changing SARS-CoV-2 variants, and streamlining vaccine composition to single, bivalent vaccine only.

Like flu vaccination 

The process of choosing a new annual vaccine would be similar to that used for seasonal influenza vaccines, the FDA said. Manufacturers would base the formulation of the shot on projections made in June in order to allow for vaccine production by September, the briefing stated.

The FDA also is asking its advisers to consider the potential for transitioning to a single vaccine composition for both the primary series of shots and booster vaccinations. Currently, the primary series consists of two shots and the updated, bivalent booster vaccines are different formulations. With a single vaccine composition, people who need to receive two initial doses plus a booster at least two months later would simply receive the same vaccine for all three shots.

“This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations and potentially increase vaccine compliance,” the FDA briefing stated.

LTC considerations

Clinicians who care for long-term care facility residents have been juggling these complexities while trying to educate residents about the vaccines and when sourcing and administering the shots. Although uptake has gradually increased among nursing home residents, only an average of 50% of nursing home residents nationwide are up-to-date with their vaccinations, according to the Centers for Disease Control and Prevention.

Meanwhile, a recent study revealed some the difficulties in encouraging previously immunized adults to accept a COVID-19 booster shot.

Seniors overestimate immunity

Respondents to a survey of previously vaccinated U.S. adults showed that many overestimated their current immunity to the virus or misunderstood their eligibility status, the agency reported Friday.

Among adults aged 60 years and older, 20% believed they still had strong protection against infection, 17% said they were concerned about side effects and 16% were unsure whether the bivalent booster dose was effective.

Among adults aged 40 years and older who said they believed they were already sufficiently protected against infection or severe disease, 72% had not had a SARS-CoV-2 infection or received a COVID-19 vaccine dose in the prior six months, the CDC reported. And 51% had never been infected.

Protecting older adults

All eligible adults should receive one of the updated mRNA booster vaccines, which are known to prevent severe illness, hospitalization and death, the study’s authors reminded readers.

Healthcare professionals should “use evidence-based strategies to inform persons about booster vaccine recommendations and waning immunity,” they concluded.

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