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Yesterday, in FDA Revokes EUA For Evusheld (tm) COVID Pre-Exposure Prophylactic, we looked at the demise of the last monoclonal antibody for COVID, as successive iterations of Omicron over the past 12 months have rendered them ineffective (see FDA Removes Authorization For Two Monoclonal Antibody Therapies Due To Omicron).
While there are still several antiviral treatments (Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) that remain effective, they are not all effective or appropriate for everyone. And nobody can really say when, or even if, they will lose their effectiveness.
Although we were warned about the potential loss of effective therapeutics (and the decline in vaccine effectiveness) 18 months ago (see UK SAGE: Can We Predict the Limits of SARS-CoV-2 Variants and their Phenotypic Consequences?), the rapid decline in our armamentarium over the past year has been sobering.
The good news is, the bivalent COVID booster released last fall appears to provide additional protection (compared to the old vaccine) against newer Omicron variants (see here, here, and here), but relatively few Americans (< 20%) have elected to get boosted.
Faced with a disengaged public, mounting costs, and frankly - limited new options - most governments around the world are moving towards treating COVID as an endemic flu-like illness; at least until a much more virulent variant appears.
Unpopular mask mandates are gone, along with social distancing requirements. COVID testing, self-protection, and self-isolation when sick are now left to the discretion of the individual.
With fewer treatment options available, and increasing evidence that repeated infections put you at risk for severe, often chronic, complications (see Nature: Acute and Postacute Sequelae Associated with SARS-CoV-2 Reinfection), the decisions that people make regarding COVID could be life-changing.
Yesterday the CDC released a `COVID Action Plan' for those who are immunocompromised in their MMWR. While directed primarily towards those who are are immunocompromised, they also include those who are aged ≥50 years or have an underlying health condition as being at higher risk.
First some excerpts from the MMWR report (follow the link to read it in its entirety), then I'll return with more from the CDC on creating a personal COVID plan.
Information for Persons Who Are Immunocompromised Regarding Prevention and Treatment of SARS-CoV-2 Infection in the Context of Currently Circulating Omicron Sublineages — United States, January 2023
Early Release / January 27, 2023 / 72
Pragna Patel, MD1; Evelyn Twentyman, MD1; Emily Koumans, MD1; Hannah Rosenblum, MD1; Shannon Griffin-Blake, PhD1; Brendan Jackson, MD1; Sara Vagi, PhD1 (VIEW AUTHOR AFFILIATIONS)
As of January 20, 2023, >90% of circulating SARS-CoV-2 variants in the United States, specifically Omicron BQ.1, BQ.1.1, XBB, and XBB.1.5 sublineages, are unlikely to be susceptible to the combined monoclonal antibodies, tixagevimab and cilgavimab (Evusheld) used for preexposure prophylaxis against SARS-CoV-2 infection (1). The Food and Drug Administration announced on January 26, 2023, that Evusheld is not currently authorized for preexposure prophylaxis against SARS-CoV-2 infection in the United States (2).It is important that persons who are moderately to severely immunocompromised,* those who might have an inadequate immune response to COVID-19 vaccination, and those with contraindications to receipt of COVID-19 vaccines, exercise caution and recognize the need for additional preventive measures (Box). In addition, persons should have a care plan that includes prompt testing at the onset of COVID-19 symptoms and rapid access to antivirals if SARS-CoV-2 infection is detected.
COVID-19 vaccination remains the most effective way to prevent SARS-CoV-2–associated serious illness, hospitalization, and death. All persons, including those who are immunocompromised and their household members and close contacts, should stay up to date with COVID-19 vaccination, and receive the updated (bivalent) booster dose, when eligible.† Although persons who are moderately to severely immunocompromised might not mount a strong vaccine-mediated immune response, staying up to date with COVID-19 vaccination§ does provide some protection (3,4). A recent CDC study of preliminary data showed that a bivalent booster dose provided additional protection against symptomatic SARS-CoV-2 infection among immunocompetent persons who had previously received 2, 3, or 4 monovalent vaccine doses (4).
Despite evidence of vaccine effectiveness, coverage with the bivalent booster dose across the United States remains low. As of January 18, 2023, 15.3% of persons aged ≥5 years had received a bivalent booster dose (5). CDC recommends that all eligible persons aged ≥6 months receive 1 bivalent booster dose. Persons are eligible for a bivalent booster dose if they are aged 6 months–5 years and have completed a Moderna COVID-19 primary series ≥2 months earlier. Persons aged 6 months–4 years and who received a 2-dose Pfizer COVID-19 primary series ≥8 weeks earlier can receive the bivalent booster as their third dose.
Among persons with immunocompromise and their household members and close contacts, prevention measures¶ including wearing a high-quality and well-fitting mask,** maintaining physical distance from others (≥6 ft [1.8 m]), improving indoor ventilation,†† practicing frequent handwashing, and developing a careCOVID-19 Community Levels. plan,§§ should be considered in addition to receipt of a bivalent booster dose.
It is important to wear a mask and maintain physical distance from others if it is not possible to avoid crowded indoor spaces. In addition, simple interventions should be used to improve ventilation in buildings and decrease SARS-CoV-2 transmission by improving air flow. CDC has developed interactive tools¶¶ to help identify ways to improve ventilation in the home. In-duct ultraviolet germicidal irradiation lights can also be added to home heating ventilation and air conditioning systems to inactivate SARS-CoV-2 as air passes through the system.*** Frequent handwashing with soap and water is the best way to eliminate germs in most situations. If soap and water are not readily available, an alcohol-based hand sanitizer containing ≥60% alcohol is a good alternative. Also, it is important for persons who are immunocompromised to develop a care plan in consultation with their physician, in the event that they develop COVID-19.
Persons with mild to moderate symptoms of COVID-19 who 1) are aged ≥50 years, 2) have an underlying health condition††† (especially moderate to severe immunosuppression), or 3) are unvaccinated are at risk for severe COVID-19–associated outcomes. Irrespective of vaccination status, symptomatic persons who are immunocompromised, their household members, and their close contacts should be tested for SARS-CoV-2 infection as soon as possible and receive treatment within 5–7 days of symptom onset.
Early outpatient treatment of mild to moderate COVID-19 with a recommended first-line therapy, ritonavir-boosted nirmatrelvir (Paxlovid) or remdesivir (Veklury), or the second-line therapy, molnupiravir (Lagevrio), have been shown to reduce the risk for severe COVID-19, including hospitalization and death.§§§ These medications are expected to retain activity against the currently circulating Omicron sublineages (6) and are widely available.¶¶¶ Available COVID-19 treatment does not supplant the need for persons to stay up to date on their COVID-19 vaccinations, which are highly effective at preventing COVID-19–related morbidity and mortality.
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In addition to basic health and hygiene practices, like handwashing, CDC recommends some prevention actions at all COVID-19 Community Levels, which include:
- Staying Up to Date with COVID-19 Vaccines
- Improving Ventilation
- Getting Tested for COVID-19 If Needed
- Following Recommendations for What to Do If You Have Been Exposed
- Staying Home If You Have Suspected or Confirmed COVID-19
- Seeking Treatment If You Have COVID-19 and Are at High Risk of Getting Very Sick
- Avoiding Contact with People Who Have Suspected or Confirmed COVID-19
Build Your Personal COVID-19 Plan
Put together your COVID-19 plan so you have all the information you need on hand if you get sick with COVID-19. Download, edit and save, and share your plan with your family, friends, and healthcare provider.
File Details: 561 KB, 3 pages View PDF
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Prevention Actions to Add as Needed
There are some additional prevention actions that may be done at any level, but CDC especially recommends considering in certain circumstances or at medium or high COVID-19 Community Levels.
Wearing Masks or Respirators
Masks are made to contain droplets and particles that you breathe, cough, or sneeze out. A variety of masks are available. Some masks provide a higher level of protection than others.
Respirators (for example, N95) are made to protect you by fitting closely on the face to filter out particles, including the virus that causes COVID-19. They can also block droplets and particles you breathe, cough, or sneeze out so you do not spread them to others. Respirators (for example, N95) provide higher protection than masks.
When wearing a mask or respirator (for example, N95), it is most important to choose one that you can wear correctly, that fits closely to your face over your mouth and nose, that provides good protection, and that is comfortable for you.
Increasing Space and Distance
Small particles that people breathe out can contain virus particles. The closer you are to a greater number of people, the more likely you are to be exposed to the virus that causes COVID-19. To avoid this possible exposure, you may want to avoid crowded areas, or keep distance between yourself and others. These actions also protect people who are at high risk for getting very sick from COVID-19 in settings where there are multiple risks for exposure.
While the government's emergency response to COVID may be receding, the virus remains very much with us, and its health impacts - including `Long COVID' - continue to exact a heavy toll.
Luckily, there are proactive steps you can take to reduce your risks of infection, or of severe illness. But how willing the public will be to embrace these steps - and for how long - remains to be seen.Since there is no `one-size-fits-all' approach to COVID, going forward each individual will have to make their own risk assessment (which may change from day to day), and act accordingly.
