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Paxlovid from Pfizer was called a breakthrough in the treatment of COVID-19: where did this drug disappear, which promised to be revolutionary

'18.04.2022'

Nadezhda Verbitskaya

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Pfizer's COVID-19 antiviral Paxlovid has been hailed as a miracle drug against COVID-XNUMX. But he was not heard from during the ensuing omicron wave. And even now it is little discussed and underused, and doses accumulate on the shelves of pharmacies. Has Paxlovid not lived up to the hype caused by the pandemic, or is this yet another effective defense against COVID that has been unfairly rejected by a misinformed public? This question was asked in Intelligencer.

Dr. John Amy, who practices at CareMount Medical in Manhattan, prescribes Paxlovid to his COVID patients. He said he was their fan. “I think it's great medicine. Certainly very effective. Works pretty fast, he said. “Usually within 24 hours, the patient’s condition begins to improve.”

The history of Paxlovid begins back in 2003, when the first outbreak of SARS occurred in Asia. In an effort to develop a drug that could stop its spread, Pfizer began researching certain drugs. Such that could block the action of the viral protease protein, which is necessary for the virus to replicate inside the host cell. One of the advantages of a drug over a vaccine is that it affects the vulnerability of the virus. Because it doesn't mutate the way the spike proteins that vaccines target do. This means that it is likely to be equally effective against all variants.

Pfizer's preliminary research didn't get very far before SARS stopped. But when SARS-CoV-2 arrived, they took the idea back on the fast track, eventually testing more than 600 compounds in test tubes. The most promising ones were then tested on animals before being selected again for human trials.

Pfizer began testing Paxlovid in September 2021, enrolling patients who suffered from mild to moderate symptoms. They had not yet been hospitalized and had a high risk that their symptoms would become severe. Either due to being over 65 years of age or due to comorbidities such as obesity or diabetes. Pfizer expected the study to run until 2022 but was able to complete it ahead of schedule because the results were impressive. The drug cut hospitalizations for those who contracted COVID by 90 percent and eliminated deaths entirely. Among the approximately XNUMX study participants who took the drug, none died, compared with seven people in the control group.

Pfizer applied for an emergency use permit in November and was approved five weeks later. With vaccination rates stalling and omicron infections skyrocketing, it seemed that Paxlovid could prevent the deaths of many Americans. “This anti-covid pill has all the hallmarks of a breakthrough treatment at a time when we need it,” Scripps’ Eric Topol wrote in The Guardian.

But when the wave of Omicron hit in the following weeks, there were very few doses of Paxlovid. And by the time production increased, the number of patients dropped dramatically. Public demand was low.

To help the cause, the Biden administration last month launched a program called Test for Cure. Under the program, patients with COVID symptoms can go to a participating pharmacy, get tested, and receive a five-day course of Paxlovid immediately. The one-stop shop approach is designed to reduce the time between a patient's first symptoms and the first dose, as Paxlovid is intended to be taken within the first five days.

However, judging by the website used to track distribution and consumption of the drug, not many people take advantage of this offer. Of the approximately 50 available pharmacies in Manhattan, about half showed that their stocks were almost intact. Even though the number of cases in the area has risen by about 400 percent since March 1.

According to epidemiologist Saad Omer, director of the Yale Institute for Global Health, there is an obvious reason for the lack of interest: not enough people know about the existence of this program. “We need some health information,” he says. “Any successful treatment testing program depends on accurate, complete and timely information.”

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It will also help if access to the program is expanded. For now, the app only allows prescribing the drug to those at increased risk for severe COVID because they were the ones who took part in the trial. Other trials are currently underway to see if Paxlovid is safe and effective for the rest of the population. Pfizer is also testing Paxlovid in people who have been potentially exposed to COVID but have not yet tested positive. The latest study could yield results within the next few months, says Pfizer spokesman Keith Longley. While the other two "may yield 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 Stanford researchers published a case report of a previously healthy 47-year-old woman who came down with COVID and suffered from symptoms for two days. Then she generally felt better, but continued to feel tired, in pain, and complained of insomnia. These symptoms are consistent with the “Post-Acute Consequences of SARS-CoV-2,” also known as long-term COVID. Six months later, she was exposed to COVID again, developed symptoms, and was put on a course of Paxlovid. Shortly thereafter, “she reported that she was back to her normal pre-COVID health, including full-time work and exercise.”

This is encouraging, but not conducive to action. “We have to be careful not to read too much about individual cases like this. They don't prove anything on their own, but they can suggest avenues for further research, says Linda Gan, professor of medicine at Stanford and lead author. “There are some interesting hypotheses about how Paxlovid might be useful in the long-term treatment of COVID, but we will need further research and clinical trials before drawing any conclusions.” In this regard, two trials of Paxlovid are currently underway, which will include a six-month follow-up of participants.

No matter how widely Paxlovid is distributed and how readily accepted by the public, the most important thing to remember is that the best protection against COVID is a full vaccination and a booster dose.

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