What happened to the Paxlovid, COVID-19 wonder drug?
What happened to the Paxlovid, COVID-19 wonder drug?

What happened to the Paxlovid, COVID-19 wonder drug?

Photo Illustration: Intelligences

Paxlovid, the COVID antiviral developed by Pfizer, was hailed as one miracle cure for COVID-19 when it was approved for use by the FDA in December. But it was nowhere to be found during Omicron wave which followed and is now little discussed and underutilized, with doses reportedly piles up on the pharmacy shelves. Have Paxlovid did not live up to the hype as a pandemic game changer, or is it another effective defense against COVID that has been unfairly rejected by a misinformed public?

To get a front-line view, I turned to my brother-in-law, John Emy, a physician in internal medicine who practices at CareMount Medical in Manhattan and has prescribed Paxlovid to his patients with COVID. He said he’s a fan – with qualifications. “I think it’s a great drug. It’s definitely very effective. It’s starting to work pretty quickly,” he told me over the phone while he was going to work. “Usually within 24 hours the symptoms start to get better.” wondered, though, how hard it really was necessary. “It’s probably wasted on the mildly ill,” he said. “Before we got Paxlovid, a lot of people who had mild symptoms would get over it, and they were fine. . “

Five hours later he wrote to me that he had thought of another argument for taking Paxlovid. “By reducing viral load quickly, it could reduce contagion,” he wrote, before dropping the sound: “I woke up and did not feel great, but so much worse in the subway after talking to you. I have COVID.”

He was on the fence about taking Paxlovid. His symptoms were mild. He felt feverish and mentally cloudy, but his temperature was normal. As an extremely healthy marathon runner who is fully vigilant, he was not particularly worried about getting seriously ill. On the other hand, he has asthma, which is a risk factor for severe COVID. In the end, talking to a colleague helped push him toward a decision. “I think I would do without an antiviral drug,” he wrote, “but I will take it with the hope of getting back to work faster.”

The story of Paxlovid starts back in 2003, when the first SARS outbreak took place in Asia. Looking to develop a drug that could stop its spread, Pfizer began researching drugs that could block the action of a viral protein called a protease, which is necessary for the virus to replicate itself inside the host cell. An advantage of a drug like this compared to a vaccine is that it attacks a vulnerability of the virus that does not mutate in the same way as the tip proteins that vaccines are targeted at. This means that it is likely to be equally effective against all variants.

Pfizer’s preliminary research did not go too far before SARS disappeared. But when SARS-CoV-2 emerged, they put the idea back on track and eventually tested more than 600 candidate compounds in test tubes. The most promising ones were then tested on animals before being pulled down again for human trials.

Pfizer started testing Paxlovid in September 2021, enrolling patients suffering from mild to moderate symptoms – meaning they had not been hospitalized yet – and at high risk of having their symptoms severe, either due to being over the age of 65 or have comorbidities such as obesity or diabetes. Pfizer expected the study to last into 2022, but was able to end the trial early because the results were so spectacular. It reduced hospital admissions among those who caught COVID by 90 percent and completely eliminated deaths. Among the thousands or so trial participants who took the drug, no one died, against seven people in the control group.

Pfizer applied for emergency use permit in November and was approved five weeks later. At a time when vaccination rates had stalled and Omicron infections were soaring, it seemed that Paxlovid could prevent the deaths of a lot of Americans. “This anti-COVID pill has all the features of a groundbreaking intervention at a time when we absolutely need it,” wrote Scripps’ Eric Topol in The Guardian.

But when the Omicron wave hit in the weeks that followed, there was a lot few doses of Paxlovid are available, and as production increased enough to produce significant quantities, the case volumes had dropped dramatically. Public demand was low.

To help things get under way, the Biden administration last month launched a program called “Test to Treat” where patients with COVID symptoms can go to a participating pharmacy, get a test, and immediately receive a five-day course in Paxlovid. The one-stop-shopping approach is designed to cut down on the time between the patient’s first symptoms and the time they take their first dose because Paxlovid is intended to be taken within the first five days.

Judging by one website is used to track the distribution and uptake of the drug, but not many people take advantage of the offer. Of the approximately 50 available sites listed in Manhattan, about half showed that their shares are apparently pristine – although case rates in the borough have risen about 400 percent since March 1st.

There is an obvious reason for the lack of interest, says epidemiologist Saad Omer, director of the Yale Institute for Global Health: Not enough people know the program exists. “We need to have some public health information on meat and potatoes,” he says. “Any successful test-to-treat program relies on accurate, complete and timely information.”

It will also help if access to the program is extended. So far, the application for emergency use only allows prescribing the drug to those with an increased risk of severe COVID because it was they who participated in the trial. Other trials are currently underway to see if Paxlovid is safe and effective for children and for patients with a standard risk of severe symptoms – that is, the rest of the public. Pfizer is also testing Paxlovid on individuals who have potentially been exposed to COVID but have not yet tested positive. The latter study could yield results within the next few months, Pfizer spokesman Kit Longley said, while the other two “could have results by the end of the year.”

Another burning question is whether Paxlovid can be effective against long-term COVID. Last month, a team of researchers at Stanford published one pre-print reporting the case of a previously healthy, double-dose 47-year-old woman who came down with COVID and suffered from symptoms for two days, after which it mostly felt better, but continued to feel tired and sore, with insomnia and cognitive difficulty – consistency of symptoms with “Post-Acute Sequelae of SARS-CoV-2”, aka long COVID. Six months later, she was potentially exposed to COVID again, began to experience symptoms and was put on a Paxlovid regimen. Shortly after, “she reported that she was back to her normal health status and function before COVID-19, including working full-time and exercising rigorously.”

It is encouraging, but not dispositive. “We have to be careful not to read too much into individual cases like this – they can not in themselves prove anything, but they can suggest opportunities for further research,” says Linda Geng, professor of medicine at Stanford and the paper’s lead author. . “There are some interesting hypotheses about how Paxlovid may be useful in the treatment of long-term COVID, but we need further studies and clinical trials before we can draw any conclusions.” To that, two Paxlovid trials is currently underway, which will include a six-month follow-up of the participants.

No matter how broadly Paxlovid is rolled out and how eagerly it is taken up by the public, the most important thing to keep in mind is that the best defense against COVID is to be fully grown and boosted.

My brother-in-law for his part, after deciding to take Paxlovid, got much better the next morning. However, he gives most of the credit for it to the mRNA plugs he had been given. “Thank God for the vaccines,” he wrote. “I probably would have been much sicker if I had not been vaccinated.”

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