The Public Health Service Act’s COVID-19 public health emergency (PHE), which was announced by the Department of Health and Human Services, is anticipated to end on May 11, 2023. The COVID-19 pandemic remains a top focus for the Center for Drug Evaluation and Research even though the PHE will expire (CDER). CDER will continue to take part in a variety of initiatives to safeguard and advance public health.
The authority of CDER to approve medications for use in emergencies will not be impacted by the conclusion of the COVID-19 PHE. Current emergency use authorizations (EUAs) for items will continue to be valid, and if the circumstance fits the requirements, the agency may continue to issue new EUAs.
For the treatment of COVID-19 in hospitalized individuals receiving systemic corticosteroids who need additional oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, Actemra (Tocilizumab) is authorized (ECMO).
Veklury (Remdesivir) is approved for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3 kilogrammes), who have positive direct SARS-CoV-2 viral testing results, are hospitalised or not hospitalised, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalisation or death.
Adults hospitalised with COVID-19 who require supplementary oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation may be treated with olumiant (baricitinib) (ECMO).
All therapeutic items that are currently approved under an EUA are listed on the CDER’s EUA page, along with any updated product Fact Sheets and other details for patients and healthcare professionals.
The FDA and HHS/ASPR have stated that several EUA products now have longer shelf lives. The FDA’s Expiration Dating Extension website has these revisions.
Antiviral medications are prescribed treatments (pills, liquid, powder for inhalation, or intravenous solution) that combat viruses in your body.
Veklury (remdesivir), as mentioned above, is approved for the treatment of COVID-19 in adults and paediatric patients (28 days of age and older and weighing at least 3 kilogrammes) with positive results of direct SARS-CoV-2 viral testing who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Drugs known as immune modulators assist to stimulate, enhance, or decrease immunological activity. The immune system may become overactive in the event of COVID-19 infection, which might aggravate the condition. Immune regulators can aid in reducing this inflammation.
- For the treatment of COVID-19 in hospitalised adults with pneumonia who need supplemental oxygen (low- or high-flow oxygen), are at risk of developing severe respiratory failure, and are also likely to have elevated plasma soluble urokinase plasminogen activator receptor levels, Kineret (anakinra) is approved (suPAR).
- Olumiant (baricitinib) is approved for the treatment of COVID-19 in children 2 to under 18 years of age who require extracorporeal membrane oxygenation, invasive mechanical ventilation, or supplemental oxygen (ECMO).
- For the treatment of COVID-19 in hospitalised paediatric patients aged 2 to less than 18 who are taking systemic corticosteroids and need additional oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, Actemra (tocilizumab) is approved (ECMO).
As mentioned before, the same indication for adult hospitalised patients is approved for Olumiant (baricitinib).
SARS-COV-2-targeting Monoclonal Antibodies
Monoclonal antibodies (mAbs) that specifically target SARS-COV-2 can support the immune system’s fight on the virus. Similar to other contagious organisms, SARS-CoV-2 can evolve over time, leading to genetic heterogeneity in the population of circulating viral strains. These mAbs inhibit entrance into human cells, neutralising the virus. Some variations have the potential to result in resistance to one or more of the mAb treatments approved to treat COVID-19.
The following products are not currently approved in any U.S. region until further notice by the FDA and may not be administered for the pre-exposure prophylaxis for prevention or the treatment of COVID-19 under the EUA due to the high frequency of variants circulating within the United States that are not susceptible to the following mAbs:
- REGEN-COV (casirivimab and imdevimab)
- Bamlanivimab and Etesevimab
- Evusheld (tixagevimab co-packaged with cilgavimab)
Sedatives are medications that keep patients who are intubated and need mechanical breathing in an intensive care unit (ICU) environment sedated, often by continuous intravenous infusion. Sedatives like the ones listed below may be used in an emergency:
Renal Replacement Therapies
When a patient’s kidneys are impaired or destroyed, continuous renal replacement therapy (CRRT), a kind of “dialysis,” is used to filter and purify the patient’s blood. In acute care settings, CRRT is utilised for patients with renal damage.
The prevalence of severe illnesses and multiple organ failure, particularly acute renal damage, rose as a result of SARS-CoV-2, boosting the demand for CRRT. Also, there wasn’t enough of a supply of substitute medications to fulfil the urgent need for CRRT in critically sick patients.