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The FDA Approves Pfizer’s COVID Pill for Emergency Use—What Here’s You Need to Know About Paxlovid

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Medicine pills are seen with Pfizer logo displayed on a screen in the background in this illustration photo taken in Krakow, Poland on April 27, 2021. (Photo Illustration by Jakub Porzycki/NurPhoto via Getty Images)

The approval comes after studies have shown that antiviral therapy can help people avoid hospitalization and death. This is how it works with the pill.

The US Food and Drug Administration (FDA) has granted Paxlovid, Pfizer’s first oral antiviral for the treatment of mild-to-moderate COVID-19, an emergency use authorization (EUA).

According to the FDA’s December 22 release, the tablets can be taken by adults (as well as adolescents 12 years and older who weigh at least 88 pounds) who test positive for COVID and are at high risk of progressing to severe COVID-19 (eg, hospitalization or death).

After evidence revealed Paxlovid was successful at avoiding severe COVID-19 among individuals who had the antiviral medication within days of symptom start, the FDA granted the approval.

“Today’s approval brings the first COVID-19 medication in the form of an orally administered pill—a significant step forward in the battle against this worldwide epidemic,” said Patrizia Cavazzoni, MD, head of the FDA’s Center for Drug Evaluation and Research, in a statement. “At a critical point in the pandemic, as new variations develop, this authorization gives a new weapon to battle COVID-19, and it promises to make antiviral therapy more accessible to patients who are at high risk of progressing to severe COVID-19.”

When persons with a mild to moderate COVID infection who were at high risk of developing a severe infection received Paxlovid within three days of symptom start, there was an 89 percent lower chance of hospitalization or death when compared to a placebo. When the tablet was administered within five days of symptom start, there was an 88 percent decreased chance of hospitalization or death.

Paxlovid, according to experts, might be a game-changer in the fight against COVID-19. But, given the newness of the treatment option, it’s normal if you have concerns about how the tablet works and what it means for you. Here’s everything you need to know.

What precisely is Paxlovid?

According to Thomas Russo, MD, professor and chief of infectious disease at the University of Buffalo in New York, a COVID tablet is an antiviral medicine that can help reduce the chance of severe COVID-19 in persons who contract the virus. Pfizer’s tablets include a combination of nirmatrelvir, a novel antiviral drug, and ritonavir, an antiretroviral drug presently used to treat HIV/AIDS.

Dr. Russo compares Paxlovid to Tamiflu, an antiviral medicine used to help individuals who have the flu from becoming really ill. However, infectious disease specialist Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore, believes it may be much better. “This isn’t simply a Tamiflu knockoff,” explains Health. “For influenza, it’s a lot better than Tamiflu.”

What is Paxlovid’s mechanism of action?

Paxlovid is only available with a prescription. According to the FDA authorization notice, you should begin therapy as soon as feasible after being diagnosed with COVID-19 and within five days of symptom onset.

Paxlovid is given as a combination of three pills (two nirmatrelvir tablets and one ritonavir tablet) taken orally twice daily for five days. That implies you’d be taking 30 pills in total.

When it comes to how the therapy works, there are two options. According to Pfizer, nirmatrelvir inhibits the action of SARS-CoV-2-3CL protease, which the virus requires to proliferate. Dr. Russo claims that if a virus can’t proliferate, it can’t make you ill. Meanwhile, a modest dosage of ritonavir slows nirmatrelvir’s breakdown in the body, allowing it to be active for extended periods of time at greater concentrations to combat the virus.

Paxlovid’s efficacy is debatable.

The findings in the lab are encouraging. The research that served as the foundation for the approval looked at 2,246 unvaccinated persons who are at a high risk of having serious consequences from the infection. The COVID tablet was shown to be 88 percent to 89 percent effective at preventing hospitalization or mortality in this cohort, according to the research.

Paxlovid may also prevent a COVID infection of the Omicron form from progressing to a severe illness, according to laboratory data.

Pfizer is also testing the tablet in patients who are at “standard risk” for problems, and so far, they’ve discovered a 70% reduction in hospitalization and no fatalities in this group.

Who can benefit from Paxlovid?

Pfizer’s medicines have been approved for use in patients who are at a high risk of developing severe types of COVID-19 as of right now. That means you won’t be able to acquire it until you have specific risk factors for severe COVID, such as obesity, certain lung problems, or diabetes, if and when it’s allowed or approved for usage.

You’ll also need a prescription, so responding immediately at the first indication of a symptom is critical to receiving the help you need. “People are prone to denial early on,” adds Dr. Russo. “It might be close to that five-day window by the time they go to their doctor, get tested, receive the findings, and get their prescription filled.” He also points out that not everyone has access to a doctor, which might make the procedure more difficult because taking the prescription sooner rather than later is preferable.

“Paxlovid is not permitted for the pre-exposure or post-exposure prevention of COVID-19, or for the commencement of therapy in patients needing hospitalization due to severe or critical COVID-19,” according to the CDC.

Is Paxlovid a viable alternative to the COVID vaccine?

Doctors are adamantly opposed. “Vaccination is a form of prevention is always preferable to therapy,” says Dr. Adalja. “However, it’s fantastic that an efficient oral antiviral will be accessible.”

Dr. Schaffner is in agreement. “Vaccination is the only way to protect yourself,” he explains. “You don’t want to become infected if you don’t have to, and even if it works extremely quickly and everything is done precisely as intended as it was in these research trials, it’s not 100 percent.”

Are there any more COVID tablets in the pipeline?

Merck also makes molnupiravir, a COVID pill with less spectacular evidence than Pfizer’s COVID tablet. Early evidence claimed that the pill reduced hospitalizations and fatalities by 50%, while later evidence found that it was only 30% effective. There are also fears that the Merck tablet might damage a growing baby if used by pregnant women. Merck has submitted its data to the FDA, but it appears that the process has come to a halt.

For the time being, there’s the Pfizer COVID tablet, and the company claims that the 10 million treatment courses it promised the US government would be delivered by 2022.

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