risk management

COVID-19 Roundup: Variant Component in Boosters, Damage to Cardiac Muscle, Hypertension Risk

FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Booster Doses1

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee  convened to consider if there was a need to modify the current vaccine strain composition of COVID-19 booster vaccine doses for the upcoming 2022 fall and winter seasons.

After a thorough review and discussion, the majority of the advisory committee voted in support of incorporating a SARS-CoV-2 Omicron BA.4/5 spike protein component to the current vaccine composition to create a bivalent vaccine booster. The modified vaccines can potentially be utilized beginning in early to mid-fall 2022.

Since vaccine manufacturers have already reported data from clinical trials with modified vaccines containing an Omicron BA.1 component, the experts recommended that manufacturers submit this data to the FDA for evaluation prior to any potential authorization of a modified vaccine containing an Omicron BA.4/5 component. Moreover, the manufacturers will also be expected to initiate clinical trials with modified vaccines containing an Omicron BA.4/5 component, as this data will be beneficial as the pandemic further evolves.

No changes are recommended to be made to the vaccine components for the primary series vaccines.

Association Between COVID-19 and Cardiac Damage2,3

Data from preliminary research demonstrated that the spike protein from SARS-CoV-2 may lead to cardiac muscle injury through a specific inflammatory process, leading to cardiac muscle injury. Researchers presented this study at the American Heart Association (AHA) Basic Cardiovascular Scientific Sessions 2022 in Chicago, IL.

Lead study author Zhiqiang Lin, PhD, stated, “It’s known from the clinical side that COVID can induce heart injury; however, what we don’t know is the mechanism for how this occurs. What we suspect is that the spike protein has a likely pathological role.”

Dr Lin further elaborated that the data showed “…for the first time that the spike protein from SARS-CoV-2 causes heart muscle damage.”

The researchers discovered that the SARS-CoV-2 spike protein interacts with a unique inflammatory receptor referred to as Toll-Like Receptor 4 (TLR4) to initiate a natural immune response in cardiac muscle cells, and this is specific to COVID-19 infection as a different spike protein from another coronavirus previously revealed to cause flu symptoms, but cardiac injury did not invoke this response.

Dr Lin concluded that their research findings are key in ascertaining whether the SARS-CoV-2 spike protein affects the cardiac muscle, and the researchers now plan to examine how SARS-CoV-2 spike proteins cause inflammation in the heart. They also noted that there are 2 possible ways. The first is that the spike protein is expressed in the virus-infected heart muscle cells and thus directly activates inflammation. The second way is that the virus spike protein is shed into the bloodstream, and the circulating SARS-CoV-2 spike proteins injure the cardiac muscle.

Hypertension May Augment Risk of Severe COVID-19 Infections4,5

Hypertension may more than double the risk of severe COVID-19 infection and rate of hospitalization from an Omicron-variant COVID-19 infection, even among those who are fully vaccinated and boosted, according to findings from a retrospective cohort study.

Using data from electronic medical records, the researchers identified 912 individuals who were fully vaccinated with an mRNA vaccine, received a booster dose, and were subsequently diagnosed with COVID-19 during the Omicron surge that occurred in Southern California from Dec 1, 2021, through April 20, 2022. Of these individuals, 145 (representing approximately 16%) required hospitalization. The researchers discovered that older age, hypertension, chronic kidney disease, myocardial infarction, heart failure, and the time between the last vaccination and COVID-19 infection were all associated with greater risks of hospitalization. Moreover, those with hypertension were 2.6 times more likely to need hospitalization for severe COVID-19 infection, and among those who were hospitalized, 125 individuals (86.2%) had hypertension.   

Lead author, Dr Joseph E. Ebinger, MD, MS, stated in a press release, “We need to raise awareness and understanding that receiving 3 doses of a vaccine may not prevent severe COVID-19 in everyone, especially among people with high blood pressure. We also need more research to understand why there is this link between high blood pressure and an excess risk for more severe COVID-19 illness.”

The authors concluded that more research is needed to gain a better understanding on measures to diminish the risks for serious COVID-19 infection, whether through more tailored vaccine regimens, new therapeutics, or a combination of measures. Moreover, the biological mechanism underlying the association between hypertension and severe infection also warrants more investigation.

 

— Yvette C. Terrie, BSPharm, RPh

 

References:

  1. Coronavirus (COVID-19) Update: FDA recommends inclusion of omicron BA.4/5 component for COVID-19 vaccine booster doses. News release. U.S. Food and Drug Administration; June 30,2022. Accessed August 15, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster.
  2. MMRI/AHA study finds covid link to heart damage. News Release. Masonic Medical Research Institute. July 26, 2022. Accessed August 15, 2022. https://www.mmri.edu/wp-content/uploads/2022/07/Lin-COVID-Heart-Link-_-MMRI-_-22.07.26v3-2.pdf
  3. American Heart Association. Coronavirus spike protein activated natural immune response, damaged heart muscle cells. News release. American Heart Association Basic Cardiovascular Sciences Meeting – Presentation: P3119. July 25, 2022. Accessed August 15, 2022. https://newsroom.heart.org/news/coronavirus-spike-protein-activated-natural-immune-response-damaged-heart-muscle-cells
  4. Ebinger J, Driver M, Joung S, et al. Hypertension and Excess Risk for Severe COVID-19 Illness Despite Booster Vaccination. Published online July 20, 2022. Hypertension. 2022;101161 HYPERTENSIONAHA12219694. doi:10.1161/HYPERTENSIONAHA.122.19694
  5. American Heart Association. High blood pressure may double the risk of severe COVID, even after full vaccination. News release. Hypertension Journal Report. July 20, 2022. Accessed August 15,2022. https://newsroom.heart.org/news/high-blood-pressure-may-double-the-risk-of-severe-covid-even-after-full-vaccination

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