COVID treatment pill not substitute for vaccination
FDA: Paxlovid benefits outweigh the risks
NASSAU, BAHAMAS — The United States Food and Drug Administration (FDA) yesterday issued an emergency use authorization (EUA) for Pfizer’s Paxlovid oral tablets for the treatment of mild-to-moderate COVID-19 in adults and children 12 years or older, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The FDA further advised that Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Director of the FDA’s Center for Drug Evaluation and Research Dr Patrizia Cavazzoni, MD, said: “Today’s (yesterday) authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic.
“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.”
The drug will be administered as three tablets taken together orally twice a day for five days, for a total of 30 tablets.
It is not authorized for use for longer than five consecutive days.
The FDA noted that the Paxlovid drug is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19.
It is also not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.
Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic.
– Dr Patrizia Cavazzoni, FDA
The agency has also determined through its review of the scientific evidence available about the drug that the known and potential benefits of Paxlovid outweigh its known and potential risks.
Additionally, there are no adequate, approved and available alternatives to Paxlovid for the treatment of COVID-19.
Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches, according to the FDA.
The drug is further not recommended for patients with severe kidney or liver impairment, while a reduced Paxlovid dose is needed for patients with moderate renal impairment.
Last month, Pfizer announced that its pill to treat COVID-19 had been found in a clinical trial to be “highly effective” at preventing severe illness among at-risk people when the drug was taken shortly after they exhibited severe symptoms.
According to studies, the pill could reduce the chance of a patient needing hospitalization in these cases by as much as 89 percent.
At the time of the revelation, Director of the National HIV/AIDS and Infectious Disease Programme Dr Nikkiah Forbes said the COVID antiviral pills being approved for use and made available for the “global public health good” is “wonderful news” in the fight against the ongoing pandemic.
The Bahamas is exploring these medicines and is expected to acquire the pill before the end of the year, according to government officials.
