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COVID-19 Treatments: What's FDA Authorized and Approved

Woman receiving IV in hospital during COVID-19
Image: Getty | Design: theSkimm
Jan 7, 2022

Within a 48-hour span in December, the FDA granted emergency use authorization (EUA) for two pills that can help treat COVID-19. And prevent the virus from replicating within the body. Meaning: You can get better faster. Both Pfizer’s Paxlovid and Merck’s molnupiravir (try saying that five times fast) are said to help with mild-to-moderate cases. While COVID-fighting pills sound great — and even superhero-like — what exactly do they do? And what other treatments are out there?

Let’s find out. Below we break down the top FDA-approved and emergency-authorized COVID-19 treatments.

Emergency Use Authorization vs. FDA Approval

In order to get on the market, the FDA has to sign off on treatment options. But getting the agency’s “emergency use authorization” and “approval” aren’t one and the same. Here are the key differences: 

  • FDA emergency use authorization: EUAs are often invoked during a public health emergency (hi, COVID-19). In those instances, the agency will make a product available to the public without all the info required for an FDA approval — since gathering that evidence takes time. Instead, the agency looks at the clinical trial data available. And weighs the potential risks and benefits. EUAs are valid until the emergency declaration ends, and can be altered or taken away at any point.

  • FDA approval: A drug or vaccine is only approved when the agency has found the drug safe and effective for the intended use. The product must also be in line with federal quality standards. This is typically decided through clinical trials and analysis. Unlike EUAs, approvals are permanent. But can be withdrawn or revoked if the product doesn’t stand the test of time.

Now on to what you’ve been waiting for.

FDA-Approved COVID-19 Treatments

Like texts from your dad, the list is short and sweet. Currently, only one COVID treatment has reached full FDA approval: Veklury (aka remdesivir). (No, not the Tom Cruise movie from 2008.)

Quick science lesson: COVID attacks the body by invading cells, taking them over, and making copies of itself. The copies move on to other cells and spread through the body. But antiviral drugs help stop the virus from copying itself. And that’s what Veklury does.

It was approved in October 2020 for patients 12 years and older (weighing at least 88 pounds) who are admitted to a hospital. But it first received emergency use authorization for severe COVID cases in May 2020. And later got emergency use authorization for pediatric COVID-19 patients under 12. That EUA is still in effect.

Veklury is administered in 100 mg doses through an IV infusion — once a day, for up to 10 days. It can be given any time after the onset of symptoms. And research from the manufacturer Gilead (not to be confused with the group from the “Handmaid’s Tale”) found that the drug helped patients recover five days earlier than they would have without the treatment. 

Side note: The cost of all COVID treatments — whether approved or emergency-authorized — vary. Check with your health care professional for more details.

COVID-19 Treatments With Emergency Use Authorization

The list of emergency authorized treatments is a lot longer than the list of those with FDA approval. Antiviral pills and antibody infusions have been the most popular so far — resulting in supply issues, check with your doctor for availability. But here’s what you need to know about each one: 

Antiviral drugs

These drugs work the same way as Veklury: They stop COVID-19 from replicating within the body. The ones that have been given EUA are… 

Merck’s molnupiravir 

  • When it got EUA…December 2021.

  • Who’s eligible…People 18+ with confirmed mild-to-moderate COVID. And only if the patient is at high risk of developing a severe case.

  • How it’s administered…Three tablets, taken by mouth, every 12 hours for five days. Patients should start their dosage either right after their diagnosis or within the first five days of symptoms starting. 

  • Its effectiveness…Merck found that molnupiravir reduced the number of COVID-19 related hospitalizations or deaths by about 30%. 

  • How to get it…Prescription only.

Pfizer’s Paxlovid

  • When it got EUA…December 2021.

  • Who’s eligible…People 12+, weighing at least 88 pounds, with confirmed mild-to-moderate COVID. And only if the patient is at high risk of developing a severe case.

  • How it’s administered…Three tablets, taken by mouth, twice a day for five days. Similar to molnupiravir, patients should start their dosage right after their diagnosis or within the first five days of symptoms starting. 

  • Its effectiveness…Pfizer found that Paxlovid reduced the number of COVID-19-related hospitalizations or deaths by 88%. 

  • How to get it…Prescription only.

Monoclonal Antibodies

These drugs can both treat and prevent COVID-19. And relies on antibodies — which our bodies naturally develop and use to fight off infection. Monoclonal antibodies are basically a dose of lab-produced antibodies. Meant to give your immune system a leg up on the virus. But they’re only accessible through a health care provider. Your physician can help you decide which option is right for you. Here are some key methods currently holding EUAs:

Actemra (Tocilizumab)

  • When it got EUA…June 2021.

  • Who’s eligible…Patients ages two and older who are hospitalized with COVID-19. It must be used in conjunction with other routine COVID treatments. 

  • How it’s administered…Through an IV infusion. Dosage is either eight or 12 mg depending on the patient’s weight

  • Its effectiveness…After a 28-day follow up, Actemra — paired with corticosteroid therapy — reduced the risk of COVID-related death. It also lowered the amount of time patients were hospitalized. And decreased the risk of being placed on a ventilator.

Sotrovimab

  • When it got EUA…May 2021. 

  • Who’s eligible…People 12 years+, weighing at least 88 pounds — with mild-to-moderate COVID-19. And who are at risk for developing severe cases.

  • How it’s administered…A 500-mg infusion given through an IV. 

  • Its effectiveness…Not totally clear. The FDA has only said that clinical trials found Sotrovimab "may be effective" in treating certain cases.

Bamlanivimab and etesevimab

  • When it got EUA…February 2021. 

  • Who’s eligible…People 12 years+ weighing at least 88 pounds — with mild-to-moderate COVID-19. And who are at risk for developing severe cases. In September, the FDA expanded its order to cover those who are exposed to the virus and fall under the same age and weight specs.

  • How it’s administered…A mix of two monoclonal antibodies dispensed together via an IV infusion.

  • Its effectiveness…Also not clear. The FDA has only said that clinical trials found bamlanivimab and etesevimab "may be effective" in treating certain cases and preventing infection.

REGEN-COV

  • When it got EUA…November 2020. 

  • Who’s eligible…People 12+ weighing at least 88 pounds — with mild-to-moderate COVID-19. And who are at risk for developing severe cases. In July, the FDA expanded the authorization for this treatment to include those exposed to COVID.

  • How it’s administered…Similar to the treatment above. A mix of two monoclonal antibodies discharged together via IV infusion. Or by subcutaneous injection (aka small needle that goes just under the skin).

  • Its effectiveness…The FDA said these monoclonal antibodies “were shown to reduce” COVID-related hospitalization in clinical trials. Additional data showed an 81% reduced risk of symptomatic infections in those exposed to the virus.

theSkimm

With vaccines, we have the ability to prevent many severe COVID-19 cases. And treatment options like the ones above can help people avoid a worst-case scenario with the virus. Be sure to do your research. And talk to a medical professional, before exploring any treatment options.

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