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Recently, the FDA has authorized several other medications for emergency use for COVID-19 in addition to the drug Veklury (remdesivir)
Until recently, there was only one FDA-approved drug for COVID-19, a type of antiviral medication called Veklury (remdesivir). The FDA approved Veklury on October 22, 2020 for use in adults and certain pediatric patients ages 12 and older, weighing at least 88 pounds, with COVID-19.
Veklury can only be given to patients who are ill enough to require hospitalization, and the use of this drug is restricted to hospital or other health care settings where patient care is comparable to hospital care. Veklury is available as a lyophilized powder that is administered intravenously.
The FDA has continued the Emergency Use Authorization (EUA) of Veklury for use by licensed health care providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients.
Besides Veklury, the FDA has also authorized several other medications for emergency use against COVID-19, including some antiviral drugs and monoclonal antibodies. Recently, the FDA issued an EUA for Pfizer’s drug Paxlovid, which is a combination of two drugs—nirmatrelvir and ritonavir—given as oral tablets. This drug may be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients ages 12 and older, weighing at least 88 pounds, in the following cases:
- Confirmed positive results of direct SARS-CoV-2 test
- High risk for progression to severe COVID-19 including hospitalization or death.
Paxlovid is available only by prescription. It should be initiated as soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
What are the side effects of Veklury (remdesivir)?
The side effects of Veklury generally include allergic (hypersensitivity) reactions that may range from mild to severe (anaphylaxis). Veklury may cause liver injury manifesting as increased liver enzymes on blood tests.
Hypersensitivity may manifest as:
- Skin rash
- Shivering
- Sweating
- Changes in blood pressure and heart rate
- Shortness of breath
- Wheezing
- Decreased blood oxygen levels
- Nausea
- Swelling over the lips and around the eyes
Does Veklury (remdesivir) prevent COVID-19?
There is no data so far regarding the role of remdesivir in preventing COVID-19. Hence, the drug is not approved or authorized for the prevention of COVID-19. The only available strategies for preventing COVID-19 are vaccination, social distancing, wearing masks, and practicing hand and respiratory hygiene.
Currently, the monoclonal antibodies tixagevimab and Evusheld (cilgavimab) have been given authorization by the FDA for the prevention of COVID-19 in certain groups of immunocompromised individuals or those with a history of severe reactions to a COVD-19 vaccine.
What is emergency use authorization (EUA)?
EUA refers to the authorization issued by the FDA for emergency use of an unapproved product or unapproved uses of an approved product. In order to issue an EUA, the FDA assesses several aspects of the products and their use, such as their effectiveness in the prevention, diagnosis, or treatment of a life-threatening or serious health condition.
An EUA is issued after the FDA has determined that the known and potential benefits outweigh the known and potential risks for the product. Also, the FDA ensures that there are no adequate, approved, and available alternatives for use in the health condition.
Several drugs have received EUA for the treatment of COVID-19, such as certain antiviral medications (Paxlovid) and monoclonal antibodies such as bamlanivimab, baricitinib, bamlanivimab and etesevimab, and Casirivimab and Imdevimab.
