What are the prevailing recommendations for annual vaccines like COVID and flu?

Respiratory viruses such as influenza and COVID-19 often evolve considerably over time for various intriguing reasons. Consequently, vaccines must be routinely updated to remain effective against the viral variants that are currently anticipated to be most prevalent. The Centers for Disease Control and Prevention (CDC) continues to advise that almost everyone aged 6 months and older should receive an influenza vaccine annually in September or October. Some individuals have medical exemptions preventing them from getting the vaccine, but such exceptions are uncommon.

For COVID-19, the Food and Drug Administration recently sanctioned new vaccines for this virus season, but the approval is restricted to adults over 65 and those adults/children over 5 years who present at least one high-risk health issue. For children under 5 years old with one serious health condition, the Moderna vaccine will be the sole available option due to the new guidelines.

The outcome of this is that vaccines will be more challenging to obtain for individuals under 65 who lack one of the specified high-risk factors. Pharmacies may still administer vaccines to people who fulfill the criteria. For those who do not qualify, a physician’s prescription will likely be necessary.

Physicians can prescribe medications to individuals for issues outside of FDA regulations, which means they can provide vaccines for patients who do not meet the criteria, although pharmacists might be unable to administer these vaccines. Depending on pharmacy reactions to these changes, that could introduce yet another limitation to vaccine accessibility.

Finally, it remains uncertain whether insurance providers will cover vaccines administered off-label. Due to the requirement of a physician’s prescription, the challenges confronting pharmacists in administering “off-label” vaccines, and the ambiguity surrounding insurance coverage, the alterations in the FDA’s approvals for COVID-19 vaccines pose a significant obstacle for patients under 65 without a serious health condition to receive a vaccine.

How might these adjustments affect pharmaceutical companies’ profits and future vaccine development investments?

Pinpointing the exact number of individuals vaccinated against COVID is challenging, but it is acknowledged that Pfizer’s initial revenues from COVID vaccines have diminished in recent years. Nonetheless, COVID vaccines have still notably contributed to the company’s profitability. In light of the new FDA regulations, it is sensible to presume that fewer individuals will be vaccinated, which could adversely affect earnings. While Pfizer’s diverse portfolio may shield them from severe impacts, Moderna’s near-total commitment to COVID vaccines suggests it may experience a more pronounced overall effect.

The pandemic instigated substantial investments in vaccine creation from various pharmaceutical firms. The recent actions by the government underscore some of the uncertainties manufacturers may encounter, especially when developing vaccines requiring regular approval for new variants. Considering that optimal business function occurs in stable environments, it is reasonable to assume that this will prompt companies to exercise greater caution regarding investments in vaccine production.

From the pharmaceutical perspective, do you foresee any additional challenges due to the administration’s initiatives?

I find no reason to believe that these regulations will affect vaccine efficacy; however, I suspect that manufacturers will considerably reduce ongoing vaccine production in anticipation of decreased demand. This could pose supply chain challenges, particularly given the unpredictability in a physician’s willingness to prescribe and a pharmacist’s ability to administer vaccines to individuals not meeting the approved criteria.

How might these changes affect pharmacies?

Although major pharmacy chains do not dissect their revenue in sufficient detail to ascertain the specific impact of vaccines on overall earnings, the obstacles confronting the retail pharmacy sector indicate that any decline in revenue is problematic. Vaccines generally yield higher margins compared to other prescriptions due to differing price negotiations and the inclusion of an administration fee not associated with other products. Any reduction in high-margin activities raises concerns among pharmacy leaders.

Under the current regulations, will consumers have the option to receive vaccines?

Consumers will likely require prescriptions to access vaccinations under the new guidelines unless they meet the FDA’s eligibility standards. Even with those prescriptions, pharmacists may face barriers in administering the vaccines due to distinct regulations regarding their practice scope. This will consequently limit the access some patients have to COVID vaccines. Additionally, insurance companies may or may not reimburse for COVID vaccines administered to patients not meeting the criteria, further inflating costs and limiting access for those unable to afford them.

How may this influence hospitals and healthcare systems?

Data regarding vaccine efficacy clearly indicates that recipients have a reduced likelihood of severe illness, although this data is primarily reliable for patients for whom the FDA has approved vaccines.

For others, there is less clarity regarding the effect that a decline in vaccination rates will have on hospitals and healthcare systems. While forecasting the precise impact is challenging, if a considerable segment of the population remains unvaccinated, hospitals may witness an increase in respiratory illnesses, intensifying overcrowding and complicating access for patients who require hospital care for differing reasons.