What are the recommendations for using mSpikevax (Spikevax) in individuals with severe conditions, such as immunocompromised state, heart failure, or chronic obstructive pulmonary disease (COPD)?

mSpikevax (Spikevax/Moderna mRNA-1273) in Severe Conditions

Individuals with severe conditions including immunocompromised states, heart failure, and COPD should receive mSpikevax vaccination, as these populations are at substantially higher risk for severe COVID-19 outcomes and mortality, and the vaccine demonstrates high efficacy with acceptable safety profiles in these groups. 1, 2, 3

Immunocompromised Patients

mRNA COVID-19 vaccines including mSpikevax are strongly recommended for immunocompromised individuals, though they require additional doses to achieve adequate protection. 1, 2

• Immunocompromised patients demonstrate decreased vaccine effectiveness with correspondingly high rates of breakthrough infections, making vaccination even more critical in this population 4
• A booster dose is necessary for immunocompromised patients to produce an optimal antibody response, as they typically achieve a less robust and less durable antibody response to vaccination 2
• High-certainty evidence demonstrates that mRNA-1273 reduces confirmed symptomatic COVID-19 by 93.20% (95% CI 91.06% to 94.83%) and severe/critical disease by 98.20% (95% CI 92.80% to 99.60%) in the general population 5
• Immunocompromised individuals should receive their primary series plus additional booster doses as recommended by current CDC guidelines 1, 6

Important Caveat for Immunocompromised Patients

• Adherence to booster dose recommendations among immunocompromised individuals has been documented as low (only 41% received a fourth dose), despite their increased vulnerability 6
• Negative or low-positive results on SARS-CoV-2 antibody tests may help identify immunocompromised persons at increased risk for breakthrough infection who may benefit from additional protective measures 4

Heart Failure and Cardiovascular Disease

COVID-19 vaccination with mSpikevax is indicated in all patients with heart failure, including those with advanced disease, congestive heart failure, and those who are immunocompromised (such as post-heart transplant patients receiving immunosuppressive therapy). 3, 2

• Patients with heart failure who contract SARS-CoV-2 infection are at higher risk of both cardiovascular and non-cardiovascular morbidity and mortality 3
• The American College of Cardiology recommends prompt vaccination with proactive addressing of any barriers or hesitancy for patients with cardiovascular conditions, particularly those with poorly controlled or advanced disease 2
• It is preferable to vaccinate heart failure patients in an optimal clinical state (clinical stability, adequate hydration and nutrition, optimized HF treatment), but corrective measures should not delay vaccination 3
• Patients with chronic cardiovascular disease (including heart failure, coronary artery disease, or congenital heart disease) are recognized as high-risk for severe respiratory viral infections 1

Chronic Obstructive Pulmonary Disease (COPD)

Individuals with COPD should be prioritized for COVID-19 vaccination regardless of age and frailty, as they face increased likelihood of contracting SARS-CoV-2 and greater disease severity. 1

• Current and former smokers with COPD have higher mortality rates from coronavirus infections, with increased ICU admission rates, need for mechanical ventilation, and mortality compared to non-smokers 1
• Chronic lung or respiratory disease (including COPD, emphysema, asthma, interstitial lung disease) is recognized as a major risk factor for severe respiratory viral disease 1
• Cumulative exposure to cigarette smoke is an independent risk factor for increased hospital admission and death from COVID-19 1

Safety Profile in High-Risk Populations

mRNA-1273 (mSpikevax) probably results in little or no difference in serious adverse events compared to placebo (RR 0.92,95% CI 0.78 to 1.08), with fewer than 5 serious adverse events per 1000 participants 5

• The most common adverse events are injection site pain, fatigue, and headache, with most being mild to moderate in severity 7
• Only 1.2% of participants required hospitalization or emergency room visits for adverse events 7
• Women and participants aged 18-55 years experience greater reactogenicity, and those with prior COVID-19 infection have more systemic events after the first dose 7
• Participants with chronic diseases other than hypertension reported fewer systemic adverse events following the second dose 7

Practical Implementation Algorithm

1. Identify the severe condition: immunocompromised state, heart failure, COPD, or other high-risk comorbidity 1, 2, 3

2. Recommend vaccination immediately - do not delay for optimization of underlying conditions unless patient is acutely decompensated 3

3. For immunocompromised patients: Plan for primary series plus additional booster doses; consider antibody testing to assess response 2, 4, 6

4. For heart failure patients: Optimize clinical state when possible (hydration, nutrition, HF medications) but do not delay vaccination 3

5. For COPD patients: Prioritize vaccination regardless of age, smoking status, or frailty 1

6. Address barriers proactively: Counsel patients on the substantially higher risk of severe COVID-19 outcomes versus minimal vaccine-related risks 2, 3

7. Ensure continued precautions: Vaccinated high-risk patients should continue using facemasks, hand hygiene, and social distancing 3

Critical Pitfall to Avoid

Do not delay vaccination while attempting to optimize chronic conditions or waiting for "better timing" - the risk of COVID-19 infection and severe outcomes in these populations far outweighs any theoretical benefit of delaying vaccination. 2, 3 The only exception is acute clinical decompensation requiring immediate stabilization.