Pfizer COVID-19 pill first to receive FDA emergency use authorization for adults, children

SILVER SPRING, Md. — A COVID-19 treatment in pill form is now available for both children and adults with mild cases of the illness. The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for Pfizer’s drug combination Paxlovid. The COVID antiviral treatment is a three-pill combination of nirmatrelvir and ritonavir tablets which patients take twice a day.

Clinical trials on the new treatment revealed that Paxlovid reduced the number of COVID patients dying from the virus or needing hospitalization by 88 percent. In comparison to patients taking a placebo, only 0.8 percent of people taking Paxlovid needed hospitalization or died from their infection over the next month. Conversely, six percent of the placebo group developed a severe or fatal case of COVID-19.

“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,” says Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in the Dec. 22 release. “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.”

FDA officials note that Paxlovid is available by prescription only. They recommend starting treatment within five days of the onset of symptoms or after receiving a positive COVID test. The EUA approves the drug’s use for treating mild-to-moderate cases of coronavirus among all adults and children older than 12 who also weigh more than 88 pounds.

What exactly is Paxlovid?

Paxlovid is a five-day treatment for COVID, featuring two tablets of nirmatrelvir and one tablet of ritonavir. A patient takes this combo twice a day, making each prescription a total of 30 pills.

Nirmatrelvir stops the SARS-CoV-2 protein from infecting cells and replicating more of the virus. Ritonavir keeps nirmatrelvir from breaking down in the body too fast, allowing it to remain at a high concentration as it fights off COVID-19.

FDA officials say that their emergency authorization of the drug is strictly for five-day prescriptions and does not allow for longer use. They add that Paxlovid is not meant for use as a preventative measure during the pandemic and people should not take the drug unless they are already sick or test positive for COVID-19.

To increase your odds of not catching COVID-19, the FDA says there is no substitute for getting the COVID-19 vaccine. For vaccinated individuals, officials are now urging people to get a booster shot if they are eligible.

So, is Paxlovid safe for everyone?

The FDA release warns that patients taking Paxlovid for COVID may experience a number of side-effects, including losing their sense of taste, diarrhea, high blood pressure, and muscle aches. For people on other medications, taking the pills at the same time may also cause negative reactions.

Researchers add that ritonavir can cause liver damage, so patients with a history of liver disease or liver inflammation should use the drug with extreme caution. The FDA does not recommend Paxlovid for people with severe kidney or liver disease.

The agency notes their emergency use authorization is not the same thing as receiving FDA approval. When drugs receive an EUA, health officials weigh the risks and benefits of making certain drugs available to the public. In the case of Paxlovid, the FDA looked at the drug’s ability to treat mild and moderate cases of COVID-19 verses the possible side-effects taking the pills may cause.

“There are no adequate, approved and available alternatives to Paxlovid for the treatment of COVID-19,” officials say in the release.

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