WHO updates COVID vaccine and clinical care guidelines

Regulatory NewsRegulatory News | 26 January 2021 |  By 

The World Health Organization (WHO) has released recommendations that include the use of low-dose anticoagulants for hospitalized patients with COVID-19 to reduce the risk of venous thromboembolism. That recommendation accompanies four other updates to the agency’s “living guidance” document for clinical management of patients with COVID-19.
For inpatients, the specific anticoagulation regimen recommended is thromboprophylaxis-level dosing rather than intermediate or therapeutic dosing for inpatients with COVID-19, barring indications for higher levels of anticoagulation medications.
For the subset of symptomatic COVID-19 patients at home who are at risk for progression to severe disease, the document recommends pulse oximetry monitoring “as part of a package of care” that includes education and follow-up.
Inpatients with severe COVID-19 who are receiving supplemental oxygen or non-invasive monitoring may be placed in the prone position while awake, according to another recommendation.
Broader care management recommendations included in the 26 January updates include a preference for clinical judgment over prediction models to guide admission and ICU transfer decisions for patients with COVID-19. Factors such as patient values and preferences and both local and national policy should play into clinical decisionmaking, according to the guidance document.
Existing care bundles – “three or more evidence-informed practices delivered together and consistently to improve care” – can be used for critically ill COVID-19 patients. These bundles may be formulated by the hospital or be ICU-specific, but they can be “adapted as necessary for local circumstances.”
All of the updated recommendations are conditional, and carry an evidentiary weighting of low, or very low, certainty.
In a separate announcement, WHO’s Strategic Advisory Group of Experts (SAGE) that focuses on immunizations detailed interim recommendations for the COVID-19 vaccine jointly developed by Moderna and the US National Institutes of Health.
The vaccine is indicated for us in adults aged 18 years and up, and priority should be given to high-risk health workers and older individuals, with other groups included as more vaccine doses are available. Equity considerations should factor into prioritization, according to SAGE.
The advisory group reiterated that the vaccine is safe and effective, even in patients with known comorbidities. Those who are immunocompromised can also be vaccinated but should be counseled about risk, as should those living with HIV.
Breast feeding women who are in a priority group eligible for vaccination should be offered the vaccine, and need not discontinue breastfeeding.
In a break from recommendations of some other regulators including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), SAGE currently recommends against vaccination of pregnant women who are not at high exposure risk. Both FDA and EMA recommend that pregnant women make a decision about vaccination in consultation with a health care professional after weighing benefits against potential risks.
The interim guidance document from SAGE also details a dosing regimen of two doses 28 days apart, but notes that “if necessary,” that interval can be stretched to 42 days. This maximum acceptable interval mirrors the scheme delinated by the US Centers for Disease Control and Prevention in a 21 January update to its website.
SAGE interim guidance
COVID-19 Clinical management: living guidance


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