Paxlovid: FDA Grants Full Approval as a Game-Changing Treatment for Covid-19

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The COVID-19 tablet Paxlovid, manufactured by Pfizer, obtained final approval on May 25, 2023. This medication has long been the standard of care for coronaviruses.

PBS News Hour Reported that Since the Food and Drug Administration approved emergency use of Paxlovid in late 2021, more than 11 million prescriptions for the medication have been written. Early studies served as the foundation for the emergency status, which was only meant to last while additional study was conducted.

Adults with COVID-19 who run a high risk of developing a serious illness that can result in hospitalization or death have received complete approval from the FDA.

U.S. Food and Drug Administration approved the use of the oral antiviral Paxlovid (nirmatrelvir and ritonavir pills packed together for oral administration) in the management of mild-to-moderate COVID-19 in people who are at a high risk of developing severe COVID-19, which could result in hospitalization or death. As the fourth medication to treat COVID-19 in adults.

As per U.S. Food and Drug Administration report, Paxlovid will continue to be manufactured and shipped through the U.S. Department of Health and Human Services under the emergency use authorization (EUA), ensuring continued access for adults and the treatment of eligible children ages 12 to 18 who are not covered by today’s approval. As a prior-exposure or post-exposure prophylactic for preventing COVID-19, Paxlovid is neither approved nor authorized for use.

According to the Federal Food, Drug, and Cosmetic Act, approving a novel drug is contingent on, among other things, strong proof of its efficacy and a demonstration of its safety when used as intended. The Food and Drug Administration conducts a benefit-risk analysis based on exacting scientific standards before deciding whether to approve a drug to ensure its advantages outweigh its disadvantages for the target market.

The EPIC-HR clinical trial’s final results provided the most evidence for Paxlovid’s efficacy. Paxlovid was studied in the randomized, double-blind, placebo-controlled clinical trial known as EPIC-HR for treating symptomatic, non-hospitalized people with a confirmed diagnosis of SARS-CoV-2 infection.

Patients were to be above 60, independent of pre-established chronic medical issues, and had to be adults 18 years of age or older with a pre-defined risk factor for progression to severe disease. None of the patients had ever been exposed to COVID-19 or received a COVID-19 vaccination.

Paxlovid significantly decreased the proportion of patients treated within five days of symptom onset who did not receive COVID-19 therapeutic monoclonal antibody treatment and who experienced hospitalization or death from any reason through 28 days of follow-up by 86% compared to placebo. In this investigation, 989 patients received placebos, and 977 patients received Paxlovid.

Of these patients, 0.9% of those who received Paxlovid required hospitalization for COVID-19 or passed away during the 28-day follow-up period, compared to 6.5% of those who received the placebo.



Patients who have already developed immunity to the viral infection that causes COVID-19 benefited from Paxlovid. The incidence of COVID-19-related hospitalization or mortality from any reason during the 28th day of follow-up was 0.2% of the 490 patients who received Paxlovid compared to 1.7% of the 479 patients getting placebo among EPIC-HR patients who were antibodies positive at trial enrollment.

Another clinical trial, EPIC-SR, included individuals who had received the vaccine and had at least a single risk factor for developing severe COVID-19. Although not statistically noteworthy, there was a decreased incidence of COVID-19-related hospitalization or death for any reason among these vaccine recipients.

The randomized controlled trials EPIC-HR and EPIC-SR shed light on COVID-19 rebound. Data from these two trials revealed that a subset of patients saw a resurgence in SARS-CoV-2 (RNA or virus) shedding or COVID-19 symptoms, which occurred in both the Paxlovid- and placebo-treated patients. According to the evidence that the FDA currently has, there isn’t a definite link between Paxlovid medication and COVID-19 rebound.

The approved label and authorized Fact Sheets for healthcare professionals for the Paxlovid EUA include a boxed warning with recommendations for prescribers due to the significance of lowering the risk of serious drug-drug interactions with Paxlovid.  To check for potential drug interactions and establish whether any other medications the patient may be taking need a dose change, interruption, and additional monitoring, prescribers should review all the drugs the patient takes.

The effectiveness of Paxlovid treatment in lowering hospitalization and mortality should be considered by prescribers, as well as if the danger of potential drug-drug interactions for a specific patient can be effectively handled. In connection with the drug’s clearance, the FDA distributes crucial information to all prescribers, including dosage guidelines, possible adverse effects, and details on medications that can interact negatively with Paxlovid.

The most frequent adverse effects of using Paxlovid include diarrhea and taste impairment. If they think Paxlovid is the proper medication for them, patients should discuss this with their doctor. The FDA, a division of the U.S. Department of Health and Human Services, safeguards the public’s health by ensuring the efficacy, security, and safety of pharmaceuticals for use in humans and animals, medical devices, and vaccines.

The organization also oversees the security and safety of our country’s food supply, cosmetics, nutritional supplements, and items that emit electronic radiation.

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