COVID-19 Pill

In this article, Evan Tucker writes about the new COVID-19 pill called Paxlovid, which is now under emergency use authorization in the United States.

Paxlovid: An aide in our public health Crisis

By Evan Tucker

On December 22, 2021, the FDA approved Pfizer’s COVID-19 pill called Paxlovid in the United States, under emergency use. This move was made because of the significant number of hospitalizations and increasing cases from the Omicron surge. This drug is now approved to be prescribed by doctors, and sick individuals with mild to moderate Coronavirus symptoms may be able to recover faster, resulting in a decrease in the mortality rate.

Not everyone will have access to this potentially life-saving medication, though. A patient must be COVID-19 positive, 12 years or older (while meeting the weight minimum of 88 pounds), and have a higher chance of developing a severe or fatal case of the disease. Patrizia Cavazzoni M.D, the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration, said, “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.” Unfortunately, Paxlovid will not work as a replacement of the FDA-approved vaccine, and will not prevent people from catching COVID-19. However, a Pfizer study of its drug has shown that it “was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.” This data is groundbreaking. Those who are high risk and vaccine-hesitant now have an alternative option that could potentially save their lives.

Pictured: Patrizia Cavazzoni M.D, FDA

Pictured: Paxlovid

Paxlovid was distributed to 389 patients, resulting in three hospitalizations and no deaths. Meanwhile, of the patients who received the placebo, 27 out of 385 were hospitalized, with seven deaths. In all, 0.8% of the patients who received the treatment were hospitalized, and 7% of those who took the placebo were hospitalized. Consequently, this data resulted in a p<.0001, which means that there is highly convincing evidence that taking Paxlovid is effective for the treatment of COVID-19 positive patients.

While effective, Paxlovid does have some side effects that include: “impaired sense of taste, diarrhea, high blood pressure and muscle aches,” according to the FDA. Although the effects are negative, the FDA has found that they are outweighed by the positive connotations of the drug. “The issuance of an EUA (Emergency Use Authorization) is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of scientific evidence available and carefully balances any known or potential risks with any known or potential benefits of the product.”

Scientists anticipate this drug to lower the death rate of COVID-19. With the innovation of Paxlovid, the future of moving on from the pandemic is looking up.

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