Pfizer’s COVID Pill Now Cleared By FDA: It Won’t ‘Cure’ Omicron, But Here’s What It Does


The manufacture of Paxlovid is already underway and is ready to ship.


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the FDA Granted Emergency Use Clearance for Pfizer’s Paxlovid Wednesday for the treatment of COVID-19. It is the first oral antiviral treatment authorized to fight against the coronavirus.

Last week, Pfizer announced that Paxlovid reduced the risk of hospitalization or death by 89% if given within three days of symptoms. The data also suggests that the pill will be effective against the new variant of omicron. If given within five days, the pill still reduced the risk of a serious reaction by 88%, compared to an 85% effectiveness rate reported in an interim review in November.

The “Pfizer pill” is actually a combination of two drugs: the existing antiviral ritonavir with the newer drug nirmatrelvir (or PF-07321332). The two antivirals work together as a protease inhibitor to disrupt COVID-19 replication in infected patients.

Many doctors and scientists hope the Pfizer pill will change the course of the COVID-19 pandemic and save significant numbers of lives. However, the pill will not stop the transmission of COVID-19, and some fear that a new pill may actually hamper COVID-19 vaccination and mitigation efforts. Doctors note that no therapeutic pill should replace vaccines as the first line of defense against COVID-19.

While COVID-19 vaccines are very effective – including against newer ones omicron variant – millions of Americans are still not vaccinated. According to a September CDC report, unvaccinated people are more than 10 times more likely to be hospitalized or die from the virus than those who are fully vaccinated.

Paxlovid “could have a significant impact on the lives of many people,” Pfizer CEO Albert Bourla said in a statement last week. “Emerging variants of concern, such as omicron, have exacerbated the need for accessible treatment options for those who contract the virus… We are convinced that, if authorized or approved, this potential treatment could be an essential tool for help quell the pandemic. “

The Paxlovid protocol requires you to take two nirmatrelvir tablets and one ritonavir tablet, twice a day for five days. It promises to reduce the most severe symptoms of COVID-19 and will now be a new tool in the fight against the pandemic, with approval Covid vaccines from Modern, Pfizer and Johnson & johnson.

“We have a lot more tools to fight this virus than we had just a year ago,” said Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, in a briefing at the White House last week.

Merck also has an antiviral drug recently FDA cleared, although it is nowhere near as effective as Paxlovid appears to be.

Here is what we know about Pfizer’s antiviral pill. We’ll update this story as more details emerge. To learn more about COVID-19, check out the latest news at vaccination warrants, by keeping your vaccination record close at hand and this year’s flu season.

What is Pfizer’s antiviral drug COVID-19?

In the United States, all three approved COVID vaccines can prevent infection. But for people already infected, antiviral drugs could reduce the risk of severe symptoms, hospitalization and death.

Nirmatrelvir, marketed under the brand name Paxlovid, is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. In clinical trials, taken in combination with ritonavir, a medicine used to treat HIV, Paxlovid reduced the risk of hospitalization or death by 89% when taken within three days of symptoms, Pfizer said. . (Ritonavir allows the drug to stay active in the body for longer at higher concentrations.)

If Paxlovid is approved, two 150 mg tablets would be given at the first sign of symptoms or a positive COVID-19 test result and continued for five days of treatment.

The pill has been shown to be effective against worrying variants of COVID-19, including delta and the new strain omicron, Pfizer said.

In clinical trials, the side effects reported between those taking Paxlovid and those taking a placebo were about the same, according to the drug company.

When will Pfizer’s COVID-19 pill be available?

In November, Pfizer applied to the FDA for emergency use authorization for its antiviral drug, and Bourla said it expected the FDA to make a decision by the end of 2021. If it is is approved, Paxlovid is ready to go: “We have already shipped the product to the United States. , said Bourla, then [it] will be available this month if approved. “

How does Paxlovid compare to molnupiravir, Merck’s COVID-19 pill?

Merck applied for emergency use authorization for its antiviral pill it developed with Ridgeback in mid-October and received authorization in November.

Merck said its pill can reduce the risk of hospitalization and death by 30% if taken within five days of symptom onset for people who test positive and have a higher risk of disease. serious.

The drug has already been given to patients in the UK in an ongoing national study, the BBC reports.

Ahead of clearance in the United States, Merck said it plans to produce 10 million cycles of molnupiravir by the end of 2021, with at least 20 million in 2022.

Will Pfizer’s medicine be free?

President Joe Biden said Pfizer’s antiviral treatments would be “readily available and free” thanks to his administration’s purchase of 10 million treatments. In addition, the government purchases 1.7 million antiviral treatments from Merck, molnupiravir, to be administered if and when approved by the FDA.

To learn more about COVID-19, here are the latest on COVID-19 vaccines for children, what there is to know mix and match vaccines and what is going on with booster injections.

Will drug approval lead to lower vaccination rates?

“This [89% efficacy rate] equates to protection from the vaccine – it’s so good, ”Dr. Monica Gandhi, an infectious disease expert at the University of California, San Francisco, told CNET. “But during this pandemic, we have done everything in our power to get people to get vaccinated – we instigated, cajoled, mandated. At this point, a year after the announcement of the first vaccine, I don’t think we’re going to change our mind. “

Could COVID-19 Drugs Lead to Drug Resistant Strains?

The abuse of certain antibiotics has led to strains of drug-resistant diseases like MRSA, pneumonia, tuberculosis and gonorrhea, according to the World Health Organization. But Gandhi said it was unlikely to happen with Paxlovid because the treatment is so short – only five days.

“It will not exert selective pressure on the virus to evolve,” she said. “Plus, there will be real limits to who it’s prescribed: it won’t be dispensed like crazy – you will need to have a positive COVID test and it will likely only be given to unvaccinated patients. “

The information in this article is for educational and informational purposes only and is not intended for health or medical advice. Always consult a physician or other qualified healthcare professional with any questions you may have about a health problem or health goals.


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