👍🦠💊 FDA Done Give Da Green Light to Paxlovid for Fighting Covid in High-risk Kupuna and Braddahs

FDA wen first make da Paxlovid available undah one kine emergency use authorization, yeah? But now, get plenny data showing dat dis pill, stay safe and powaful kine 💪📊.

On da Thursday, da Food and Drug Administration, da FDA, wen say “aloha” to Pfizer’s Covid antiviral pill, Paxlovid, fo’ da adults who stay high risk of getting real sick with da virus 🦠👴.

Dis Paxlovid, specifically made fo’ da treatment of da ‘small kine’ to ‘middle kine’ Covid in adults who older than 50 and da peeps who get certain medical conditions. Dese conditions make ’em mo’ likely fo’ end up in da hospital or worse, dying from Covid 😷🏥.

Dese conditions include da ones who get diabetes, heart conditions, cancer or one weak immune system 💔🩸. As many as three-quarters of adults in da U.S. stay at high risk of da bad kine Covid.

Da FDA first wen make dis Paxlovid available in December 2021, undah emergency use authorization, fo’ high-risk peeps ages 12 and up 🚑⏳. Da FDA quickly wen’ give the green light fo’ da treatment based on top first trial data.

But da FDA’s latest decision mean get choke kine clinical data showing dat Paxlovid stay safe and effective, fo’ real 📚💊.

Da treatment get two medications inside: nirmatrelvir, which k’o da enzyme dat da Covid virus need fo’ multiply, and ritonavir, which boost da first medication’s powa fo’ fight da infection 💣🦠.

Both Pfizer and da FDA think dis treatment stay one important tool to go along with vaccination. Can help da high-risk Americans manage their Covid infections and even save lives, brah 🎯💉.

Da big brains at FDA wen’ estimate, dat if we go by da Covid rates in January, dat Paxlovid could save 1,500 lives and prevent 13,000 hospital trips each week in da U.S. 🏥⚠️.

But, stay unclear what uptake going look like lata dis year. Da U.S. get 1.1 million courses of dis treatment available fo’ free. Once dat runs out, da government going shift da distribution of Paxlovid to da business market 💸🔄.

Dat means Pfizer going sell Paxlovid directly to healthcare providers at one price da company neva yet talk about. Right now, Paxlovid stay priced at about $530 per course 📈💰.

Pfizer, which wen’ see Paxlovid sales jump to nearly $19 billion in 2022, tinks da money from da drug going drop 58% in 2023.

In March, one independent group of advisors to da FDA recommended da treatment. Dey based dis on three of Pfizer’s clinical trials 📋👍.

One trial wen’ check da high-risk adults who neva’ get vaccinated and had no prior Covid infection. Dat trial wen’ find dat Paxlovid reduced da risk of hospitalization or death by 86% in adults treated within five days of their first symptoms, and 89% in those treated within three days, according to an FDA review of da company’s data. No major safety concerns were found in da trial, da review wen’ say 👏💯.

But some doctors worry about Paxlovid “rebound cases.” Dat’s when patients who take da treatment see their Covid symptoms come back or test positive shortly after they thought they were pau 🔄😨.

Reports of dese cases popped up not too long after Paxlovid first hit da market. Even President Joe Biden and his former chief medical advisor Dr. Anthony Fauci wen’ recover from Covid aftah taking da antiviral mix, but then tested positive again soon after recovering 🇺🇸👨‍⚕️.

An FDA review of Pfizer’s clinical trials found overall rates of rebound ranged from 10% to 16%, “with no evidence of a higher rate of symptom rebound or moderate symptom rebound” in patients who got Paxlovid compared with those who got a placebo. Those results also stayed the same no matter the patients’ risk of bad disease, or whether the omicron variant or an earlier version of the virus was more, according to da FDA review 📝🔄.

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NOW IN ENGLISH

😷🎉 ‘Help’ Pill Paxlovid Gets FDA’s Full Approval for Treating High-Risk Adults and Elderly with Covid 🧑‍⚕️👵

The FDA initially made Paxlovid available under a type of emergency use authorization, yes? But now, there’s a lot of data showing that this pill is safe and effective 💪📊.

On Thursday, the Food and Drug Administration (FDA) officially said “hello” to Pfizer’s Covid antiviral pill, Paxlovid, for adults who are at high risk of becoming seriously ill with the virus 🦠👴.

This Paxlovid is specifically designed for the treatment of ‘mild’ to ‘moderate’ Covid in adults over the age of 50 and people who have certain medical conditions. These conditions make them more likely to end up in the hospital or even worse, dying from Covid 😷🏥.

These conditions include those who have diabetes, heart conditions, cancer, or a weak immune system 💔🩸. As many as three-quarters of adults in the U.S. are at high risk of severe Covid.

The FDA first made this Paxlovid available in December 2021, under emergency use authorization, for high-risk individuals ages 12 and up 🚑⏳. The FDA quickly gave the green light for the treatment based on preliminary clinical trial data.

But the FDA’s latest decision means there’s a ton of clinical data showing that Paxlovid is safe and effective 📚💊.

The treatment contains two medications: nirmatrelvir, which destroys the enzyme that the Covid virus needs to multiply, and ritonavir, which enhances the first medication’s power to fight the infection 💣🦠.

Both Pfizer and the FDA see this treatment as an important tool alongside vaccination. It can help high-risk Americans manage their Covid infections and even save lives 🎯💉.

The brains at the FDA estimated that if we go by the Covid rates in January, Paxlovid could save 1,500 lives and prevent 13,000 hospitalizations each week in the U.S. 🏥⚠️.

However, it’s unclear what uptake will look like later this year. The U.S. has 1.1 million courses of this treatment available for free. Once that runs out, the government will shift the distribution of Paxlovid to the commercial market 💸🔄.

That means Pfizer will sell Paxlovid directly to healthcare providers at a price the company has not yet discussed. Right now, Paxlovid is priced at about $530 per course 📈💰.

Pfizer, which saw Paxlovid sales jump to nearly $19 billion in 2022, expects revenue from the drug to drop 58% in 2023.

In March, an independent group of advisors to the FDA recommended the treatment. They based this on three of Pfizer’s clinical trials 📋👍.

One trial examined high-risk adults who were not vaccinated and had no previous Covid infection. That trial found that Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of their first symptoms, and 89% in those treated within three days, according to an FDA review of the company’s data. No major safety concerns were identified in the trial, the review said 👏💯.

But some doctors are worried about Paxlovid “rebound cases.” That’s when patients who take the treatment see their Covid symptoms return or test positive shortly after they thought they were over it 🔄😨.

Reports of these cases cropped up not long after Paxlovid first entered the market. Even President Joe Biden and his former chief medical advisor Dr. Anthony Fauci seemingly recovered from Covid after taking the antiviral cocktail, but tested positive again soon after recovering 🇺🇸👨‍⚕️.

An FDA review of Pfizer’s clinical trials found overall rates of rebound ranged from 10% to 16%, “with no evidence of a higher rate of symptom rebound or moderate symptom rebound” in patients who received Paxlovid compared to those who received a placebo. Those results also remained the same regardless of the patients’ risk of severe disease, or whether the omicron variant or an earlier strain of the virus was dominant, according to the FDA review 📝🔄.