Immunocompromised Have Less COVID Protection, Despite Multiple Boosters

Multiple COVID-19 vaccines and boosters provide limited protection for patients with immunocompromising conditions but nearly as much as healthy adults accrue, according to a new study. Find out how well the mRNA vaccines work among the immunocompromised and what can be done to keep them from getting potentially-dangerous infections.

INDIANAPOLIS, IN – One of the greatest challenges during the COVID-19 pandemic, even with the development of effective vaccines, has been how to provide adequate protection to immunocompromised patients.

That conundrum is underscored in a new study from the national Centers for Disease Control and Prevention’s VISION Network, including Regenstrief Institute and the Indiana University School of Medicine, both in Indianapolis, and other researchers.

The first real-world data on mRNA COVID vaccine effectiveness during Omicron BA.4 and BA.5 predominance for immunocompromised adults was concerning, according to a report in the CDC's Morbidity & Mortality Weekly Report.

The authors report that their large, geographically diverse study confirms that overall protection provided by vaccination for immunocompromised patients was lower than for other adults. And that was the case even with one, or later two, boosters.

The study advises that vaccine effectiveness was lowest for patients with solid organ or stem cell transplants or hematologic malignancies such as leukemia, lymphoma, or multiple myeloma

Those findings were based on a review of the medical records of 30,000 immunocompromised adults. Protection against COVID-19-associated hospitalizations was found to be 34% after two vaccine doses, increasing to 71% during days 7 to 89 after a third dose, then declining to 41% 90 days or more after that dose.

"This study confirms that even with boosters, immunocompromised adults, because of their weakened immune systems, are still at high risk of moderate to severe COVID," said study co-author Brian Dixon, PhD, MPA, of the Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health. "While vaccines in the general adult population have been found to be 70 to 90 percent effective, for the immunocompromised we’re looking at a much lower range -- 34 to 71 percent effective,"

The authors call for greater use of interventions such as masks, prophylactic antibody treatment, and anti-viral treatment after the acquisition of the virus. "This higher-risk group has been taking precautions and should continue to work with their providers to access needed tools to protect themselves. Immunocompromised individuals should consult their physician with any questions regarding remaining up-to-date with COVID vaccinations to optimize their protection," said Shaun Grannis, MD, MS, of the Regenstrief Institute and Indiana University School of Medicine. "Adults with immunocompromising conditions and other populations have specific questions about the pandemic and vaccine effectiveness. Our findings in this study are a step forward in helping to answer these questions."

The study sought to determent the effectiveness of monovalent 2-, 3-, and 4-dose mRNA vaccines against COVID-19–related hospitalization in immunocompromised adult inpatients. During the study period of Dec. 16, 2021–Aug. 20, 2022, among SARS-CoV-2 test-positive case-patients, 1,815 (36.3%), 1,387 (27.7%), 1,552 (31.0%), and 251 (5.0%) received 0, 2, 3, and 4 mRNA COVID-19 vaccine doses, respectively. Among test-negative control-patients during this period, 6,928 (23.7%), 7,411 (25.4%), 12,734 (43.6%), and 2,142 (7.3%) received these respective doses.

"Protection offered by vaccination among persons with immunocompromising conditions during Omicron predominance was moderate even after a 3-dose monovalent primary series or booster dose," the authors point out. "Given the incomplete protection against hospitalization afforded by monovalent COVID-19 vaccines, persons with immunocompromising conditions might benefit from updated bivalent vaccine booster doses that target recently circulating Omicron sublineages, in line with ACIP recommendations."

The study suggests protection likely was even lower during BA.2/BA.2.12.1 and BA.4/BA.5 sublineage predominance periods.

Statins Appear to Reduce Severity of COVID-19 Immune Overreaction

Millions of Americans might be increasing their protection against severe COVID-19 by popping their statin each morning. A large retrospective study found that the cholesterol-lowering drugs “cool the process” by which the SARS-C0V-2 virus sometimes causes an overwhelming immune system overreaction. Here are more details.

ORLANDO, FL – The risk of death and severity of COVID-19 appears to be mitigated somewhat by the use of statins, according to a presentation at the ANESTHESIOLOGY® 2022 annual meeting.

The retrospective study involved more than 38,000 patients who had been hospitalized because of infection with SARS-CoV-2.

“While there is no ‘magic bullet’ to help patients who are very ill with COVID-19, statins decrease inflammation, which may help reduce the severity of the disease,” said lead author Ettore Crimi, MD., MBA, professor of anesthesiology and critical care medicine at the University of Central Florida, Orlando. “Results of our study clearly showed regular statin use is associated with reduced risk of death and improved outcomes in hospitalized COVID-19 patients.”

For the study, researchers analyzed the electronic medical records of 38,875 patients hospitalized for COVID-19 at 185 hospitals in the United States between Jan. 1, 2020, and Sept. 30, 2020. About 30% of those patients regularly used statins to treat high cholesterol.

Results indicate that statin users had a 37% lower risk of dying from COVID-19 than those who didn’t use statins. The authors also point out that regular statin users were significantly less likely to be discharged to hospice, be admitted to the intensive care unit (ICU) or develop blood clots. The patients on cholesterol-lowering drugs also had shorter hospital stays and spent less time on a ventilator.

Crimi suggests in a press release that the anti-inflammatory actions of statins “cool the process” by which COVID-19 can cause an extreme inflammatory reaction.

The study is significant because the use of statins is so widespread. Background information in the article notes that about a fourth of Americans over 40 are prescribed statins.

“This research illustrates the importance of evaluating medications that could be repurposed to help patients in ways other than their intended use,” Crimi said. “Our results suggest statins could be an additional cost-effective solution against COVID-19 disease severity and should be studied further.”

Specifically, preexisting statin use lowered rates of the study’s outcomes of interest, including all-cause mortality (OR, 0.69 [95% CI 0.64-0.75]; P <.001), mortality from COVID-19 (OR, 0.63 [95% CI 0.58-0.69]; P <.001), discharge to hospice (OR, 0.79 [95% CI 0.68-0.88]; P <.001), ICU admission (OR, 0.69 [95% CI 0.66-0.74]; P <.001), severe ARDS with COVID-19 (OR, 0.72 [95% CI, 0.66-0.79]; P <.001), critical ARDS with COVID-19 (OR, 0.57 [95% CI, 0.52-0.61]; P <.001), mechanical ventilation (OR, 0.6 [95% CI 0.56-0.65]; P <.001), severe sepsis with septic shock (OR, 0.66 [95% CI, 0.57-0.76]; P <.001) and thrombosis (OR, 0.46 [95% CI 0.30-0.72]; P <.001).

COVID-19 Pandemic Changes Public Perspective on Pharmacists’ Practice

Adults in the United States, many of whom visited retail pharmacies to get their COVID-19 vaccines, expressed great confidence in the ability of pharmacists to provide more of their healthcare. That’s according to a new survey that identified strong consumer preference and demand for an expanded role for pharmacists. Here is more information.

WOONSOCKET, RI – A new survey provides more evidence that pharmacists’ roles during COVID-19 changed the public’s view of the profession and what level of healthcare it can provide.

A CVS Health/Morning Consult survey finds that 61% of adults would like to get a greater range of health services from their local pharmacy

CVS Health recently released The Rx Report: A New Day in Retail Pharmacy,which is based on the results of a CVS Health/Morning Consult survey. That survey identified strong consumer preference and demand for an expanded role of pharmacists. “Released during American Pharmacists Month, the report examines the history and evolution of community pharmacy in America, as well as specific opportunities to expand pharmacists' ability to provide access to affordable, high-quality health care,” according to a CVS press release. “Built on lessons learned and the role pharmacy has played during the COVID-19 pandemic, this includes unlocking capacity for more pharmacy-based services that further align the role of the pharmacist with their clinical abilities.”

Prem Shah, PharmD, Executive Vice President, CVS Health and President and Chief Pharmacy Officer at CVS Pharmacy, added, "Throughout the pandemic, pharmacists and pharmacy technicians played a critical role in the nation's response by helping to ensure widespread access to testing and vaccination in local communities. Consumers have become accustomed to receiving expanded care at their local pharmacies and it's imperative that lawmakers and regulators take action to ensure continued access to critical services."

Key findings of the survey indicate that respondents:

  • Trust their local pharmacist/pharmacy team and agree pharmacists should provide health care services when primary care is unavailable (74%).

  • Would like to be able to get a greater range of health services from their local pharmacy (61%).

  • Believe pharmacist services should be covered by insurance like other provider services (69%).

"To continue evolving the role of the pharmacist and the industry, we must first make retail pharmacy a better and preferred place to stay and grow a career. This will require innovative approaches that challenge long-standing ways of working and create important capacity for patient care and new pharmacist services," Shah said.

On the positive side, the survey found that most U.S. adults (79% are aware that pharmacists can provide immunizations, and 50% of the respondents said they had received a vaccine at a pharmacy. The survey also indicates that most adults are aware that pharmacists can offer tips for:

  • prescription cost savings (72%);

  • counseling about medications (69%) such as potential side effects and medication interactions with other drugs, food or supplements; and

  • education on conditions (65%).

Less well-known, however, is that pharmacists now can provide more comprehensive services such as prescribing certain medications, including hormonal contraceptives (69% unaware) in certain states or delivering smoking cessation counseling (59%).

The changing view of pharmacists is directly related to the COVID-19 pandemic, according to the report. As of September 2022, the authors note, retail pharmacies have administered more than 266.5 million doses of COVID-19 vaccines through the Federal Retail Pharmacy Program. “In addition, as a result of an amendment to the emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), pharmacists may prescribe the oral anti-viral Paxlovid for the treatment of COVID-19,” they add, pointing out, “This first-of-its-kind nationwide initiative underscores the important role of the pharmacist in local communities by granting them authority to prescribe a medication, helping to increase convenient access for patients.”

The Morning Consult poll was conducted between August 16-17, 2022, among a national sample of 2,210 adults. The interviews were conducted online, and the data were weighted to approximate a target sample of adults based on age, gender, educational attainment, race, and region. Results from the full survey have a margin of error of plus or minus two percentage points.

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