In early 2020, the life-threatening, quickly evolving, and easily transmissible disease COVID-19 (caused by the SARS-CoV-2 virus) had taken the world by storm. Without the proper tools and protocols in place, much of the world was left unequipped to handle a viral outbreak of this magnitude. Because obtaining full U.S. Food and Drug Administration (FDA) approval is a lengthy process, doctors and researchers first turned to medications that already had FDA approval, in hopes to find an overlap in effective treatment strategies. As time went on, new (and more effective) medications were created and granted emergency use approval (EUA) by the FDA. Similar processes for emergency access are in place in the EU, UK and many countries around the world.
Full FDA Approval vs. Emergency Use Approval
Under EUA, the FDA authorizes use of certain medical products when evidence presented at the time of emergency shows reasonable belief the product will be effective. Essentially, EUA is a tool that can expedite the availability of medical products like medications and vaccines during a major health crisis. Although there is no difference in the scientific rigor of trials for full FDA approval compared to EUA, there are a few differences in the process.
The main two differences are that for EUAs, the FDA requires monitoring of at least half of the clinical trial participants for a minimum of two months after vaccination. However, full FDA approval of COVID-19 vaccines and treatments requires at least six months of monitoring. In addition, full FDA approval requires extensive data about the product maker’s processes and facilities. For more information about the difference between full FDA approval and emergency use approval, review this article from Yale Medicine.
Approved Treatments for COVID-19
Since the pandemic began, scientists and researchers around the world have been working hard to create safe and effective medications to treat COVID-19 patients. Thankfully, there has been success in this pursuit, and there are now several medications available for use. As of 3/16/2023, there are two primary types of medications approved for use by the FDA that are effective in treating COVID-19; oral antivirals and IV antivirals.
Antivirals: What Are They and How Do They Work?
Antivirals are medications created to stop viruses from multiplying in the body. They do this by:
- Blocking receptors so viruses are unable to bind to and enter healthy cells
- Boosting the immune system, helping it to fight a viral infection
- Lowering the overall viral load within the body
Receiving antiviral treatment early on in an infection can lessen symptom severity and lower the chances of hospitalization. Antivirals can be prescribed in two forms: oral or IV. Oral antivirals are typically taken in the form of a pill, whereas IV antivirals are administered directly into a patient’s bloodstream over the course of several days.
Less Effective Treatments
Although there are several medications available for use in the treatment of COVID-19, many of those treatments are less effective than originally hoped. Unfortunately, drugs like LAGEVRIO™ (an oral antiviral also known as Molnupiravir), Veklury® (an IV antiviral also known as Remdesivir) and immune modulators like Olumiant (Baricitinib) and Actemra (Tocilizumab) and Dexamethasone have shown to be less effective than the prevailing treatment PAXLOVID™.
- LAGEVRIO™ is an oral antiviral (also known as Molnupiravir) authorized for emergency use on December 23, 2021 to provide an additional treatment option for those 18 and older who were at risk of developing severe symptoms (including hospitalization and/or death). In its first clinical trial, results showed that out of the 709 people who received molnupiravir, 6.8% were either hospitalized or died within a 29-day follow-up period compared to the 9.7% of 699 people who received a placebo. That said, when new COVID-19 variants developed and molnupiravir underwent a second round of trials, researchers found no difference in results for those who were treated with the medication versus those treated with a placebo, indicating molnupiravir may be less effective against newer virus variants.
- Veklury® is an IV antiviral (also known as Remdesivir) originally created in 2009 to help treat hepatitis C and respiratory syncytial virus (RSV). Veklury acts as a nucleotide prodrug that binds to the viral RNA-dependent RNA polymerase and inhibits viral replication by terminating RNA transcription, attempting to stop the viral replication in the body. Due to its long-standing history and prior FDA approval for treating other illnesses, Veklury was the first drug to receive full FDA approval for the treatment of COVID-19. When compared to other treatment options across all other time periods [pre-Delta (35%), Delta (21%), and Omicron (16%)], the prompt administration of Veklury (within two days of hospital admission) was linked with an overall 25% lower risk, according to mortality results at Day 28.
- Immune modulators such as Olumiant (Baricitinib), Actemra (Tocilizumab), and Dexamethasone, all fall under another type of medication that was repurposed for the treatment of COVID-19. Immune modulators are a type of medication that either stimulates or suppresses the immune system, helping restore normal immune function after damage from an infection. The idea to repurpose these already FDA-approved medications came from the fact that COVID-19 attacks the immune system as well as other systems within the body. These medications are typically used to supplement an antiviral COVID-19 treatment.
PAXLOVID™
Pfizer’s PAXLOVID was approved for emergency use on December 22, 2021 and is now the leading treatment for COVID-19.
PAXLOVID has been approved for use in persons 12 years and older (who weigh more than 88 lbs) with an active diagnosis of mild-to-moderate COVID-19 and who are likely to progress to severe COVID-19 (including hospitalization or death). Generally speaking, risk factors for progression to severe COVID-19 include but are not limited to:
- Age 50+
- Being Overweight or Obese
- Being a smoker
- Having health conditions such as heart disease or diabetes
- Having mental health conditions
- Having other physical, mental, or developmental disabilities
How PAXLOVID™ was Created
Although PAXLOVID wasn’t necessarily created from scratch, it was created with the sole intention of treating COVID-19, unlike previously mentioned medications. According to Pfizer’s Chief Scientific Officer Mikael Dolsten, company scientists had begun searching for ways to combat coronavirus during the SARS outbreak of 2003. They were specifically looking at proteins’ crucial role in virus replication. Researchers believed if they could find a compound that would disrupt the process of replication, they could bring the virus to a halt. The knowledge gained during that study was critical to the creation of PAXLOVID.
Prior to its authorization, a clinical trial including over 2,200 participants from around the world was conducted on PAXLOVID to compare how well the medication reduced the risk of developing severe COVID-19 symptoms against a placebo. The results of this trial reported that only 9 out of 1,039 people who started treatment with PAXLOVID within five days of their first COVID-19 symptoms, were hospitalized but none had died. In comparison, 66 out of the 1,046 people who were given a placebo were hospitalized and did pass away (from any cause).
How to Take PAXLOVID™
According to Penn Medicine, PAXLOVID can reduce the risk of hospitalization and death by up to 88% when taken within the first five days of symptoms. For best results, medications should be taken within the first day of showing mild-to-moderate symptoms of COVID-19.
Generally speaking, there are five blister cards with morning and evening doses within each package of PAXLOVID. Each dose contains two types of medicine: nirmatrelvir tablets (pink) and a ritonavir tablet (white to off-white).
Begin taking your first dose in the morning or night (depending on when you get access to the medication). It’s important to take each dose either simultaneously or consecutively and not space them out over time. Note these pills should not be broken, chewed, or crushed, and they are safe to take with or without food. Repeat this process at the same time each day (morning and night) until the course of treatment has been completed.
If you are experiencing side effects, it’s important to discuss these issues with your doctor and continue taking PAXLOVID unless you have been instructed not to. If you miss a dose by less than eight hours, take it as soon as possible. If you miss a dose by more than eight hours, you should skip this dose and resume at your next scheduled dose. You should never take more than one dose in one sitting and should complete your full course of treatment.
For more information about how to use PAXLOVID, visit this information page.
Will There Be Any Additional FDA-Approved COVID-19 Treatments?
The FDA is currently working with additional developers, researchers, and manufacturers, as well as institutions such as the National Institutes of Health (NIH), to provide additional therapeutic medications to COVID-19 patients. To stay up to date on new FDA medication approvals, search the medication name here.
Note that these medications are not meant to be a replacement or substitute for receiving the COVID-19 vaccination. In many cases, COVID-19 treatments are accessible through pharmacies, hospitals, and health clinics. If you have symptoms and tested positive for COVID-19, it’s essential to seek treatment as soon as possible. A healthcare provider will be able to guide you to the appropriate treatment option.
For more information about COVID-19 and Long COVID, consider reviewing: Long Covid: What You Need To Know