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FDA Grants Emergency Use Of Pfizer COVID Pill Paxlovid

FDA Grants Emergency Use Of Pfizer COVID Pill Paxlovid

On Friday (March 11), the Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Pfizer COVID pill Paxlovid, according to the officer-in-charge Oscar Gutierrez. At the moment, the country has now two oral antiviral treatments against COVID-19 — Paxlovid and Molnupipiravir.

Announcement of EUA for Pfizer COVID Pill

At the Laging Handa briefing, it is with delight that Gutierrez announced the good news to everyone.

“We are glad to inform you that we approved Paxlovid yesterday. That’s for EUA,” he said in the vernacular. We already have two oral antiviral treatments against COVID-19 – Paxlovid and Molnupiravir.”

He also highlighted that Bangladesh is the manufacturing country of molnupiravir with the brand name Molenzavir. On the other hand, FDA already granted a compassionate use permit for a generic version of the Pfizer COVID pill called Bexovid.

What is an Emergency Use Authorization?

According to the Department of Health (DOH), emergency use authorization is a remark utilized to unlicensed (under development) vaccines and therapeutics that are evaluated using a risk-based approach. Officials normally use this label during international public health emergencies such as a pandemic.

The decision to grant of EUAs is meant to ensure quick access to drugs and vaccines by shortening the approval processes, which usually take six months, to around a month.

The goal is to make resources available for people as soon as possible, with quality, safety, and efficacy in mind

While an EUA allows the public to use vaccines and medicines, it is not the same as a certificate of product registration or authorization to market the product.

More About Pfizer COVID Pill Paxlovid

On December 22, 2021, the US FDA granted an EUA for the Pfizer COVID pill Paxlovid. Based on preliminary results from approximately 1,200 people, the US drugmaker stated in November 2021 that oral medicine was approximately 89% more effective in preventing hospitalizations or deaths than a placebo.

It consists of nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use for the treatment of mild-to-moderate COVID-19.

Nirmatrelvir works to hinder the SARS-CoV-2 protein from replicating. Whereas, ritonavir, is the one responsible for slowing down the nirmatrelvir’s breakdown. This, in turn, provides some time allowance to stay in the body for longer at higher concentrations.

The Pfizer COVID pill comes in the form of three tablets (two nirmatrelvir tablets and one ritonavir tablet). Oral treatment should take place as soon as there is COVID-19 diagnosis. Additionally, it should also be within five days of the appearance of symptoms.

People should not use it before or after COVID-19 exposure, or for the initiation of treatment in those who require medical attention due to severe or critical COVID-19. Moreover, it is not a substitute for vaccination in people who need COVID-19 vaccination and a booster dose.

Paxlovid will only be available by prescription to those who:

  • Have tested positive for COVID-19 but have yet to be admitted to the hospital
  • Are at high risk of contracting severe COVID-19 and
  • Are 12 years old or older (and at least 40 kilograms)

Worried About COVID-19? Take Our Risk Screener Here:

Side Effects After Pfizer COVID Pill Administration

Just like any other medication, the Pfizer COVID pill may also have its side effects which are as follows:

  • Dysgeusia (taste disturbance)
  • Diarrhea
  • Headache and vomiting
  • High blood pressure
  • Muscle pain

People with severe kidney or liver impairment should not take Paxlovid as it may also interact with other drugs and have an impact on other health conditions. This is why it is best to consult your doctor before getting yourself one.

Molnupiravir was the first one to receive FDA approval for an EUA in December of last year. Since then, the FDA has approved six more brands of the anti-COVID pill.

Check out other Health News here.

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Sources

FDA grants EUA to Pfizer’s anti – COVID pill Paxlovid, https://newsinfo.inquirer.net/1566824/fwd-fda-grants-eua-to-pfizers-covid-19-pill-paxlovid Accessed March 12, 2022

FAQs: Emergency Use Authorization, https://doh.gov.ph/faqs/emergency-use-authorization Accessed March 12, 2022

Philippines grants emergency use of Pfizer COVID-19 pill, https://www.rappler.com/nation/philippines-grants-emergency-use-pfizer-covid-19-pill/ Accessed March 12, 2022

How Do COVID-19 Antiviral Pills Work & Who Is Eligible to Receive Them?, https://www.houstonmethodist.org/blog/articles/2021/dec/how-do-covid-19-antiviral-pills-work-who-is-eligible-to-receive-them/ Accessed March 12, 2022

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19 Accessed March 11, 2022

Paxlovid, https://www.ema.europa.eu/en/medicines/human/EPAR/paxlovid Accessed March 11, 2022

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Written by Fiel Tugade Updated Apr 15
Medically reviewed by Dexter Macalintal, MD