Pfizer Reports Promising Results for Anti-COVID Pill PaxPAXLOVID, Plans to Submit Data for FDA Emergency Use Clearance

NEW YORK – A series of pills developed by Pfizer may reduce the risk of being hospitalized or dying from COVID-19 by 89% if taken within three days of developing symptoms, according to results released by the company on Friday pharmaceutical.

In a study of more than 1,200 COVID-19 patients at higher risk of developing serious illness, people who took Pfizer pills were much less likely to end up in hospital compared to people who have received placebo pills.

None of the people who received the real pills died, but 10 people who received the placebo pills died, according to the results summarized in a press release from Pfizer.

Pfizer CEO Albert Bourla said in prepared remarks that the data suggests that the pill-based treatment, if allowed, could “eliminate up to nine out of ten hospitalizations.”

Infectious disease experts have warned that these findings are preliminary – described only in a press release, not in a peer-reviewed medical journal – but they represent another promising development in the search for effective and easy-to-use COVID-19 pills. administer.

Currently, the only authorized treatments are administered by intravenous infusion.

“Having oral therapy is critically important,” said Dr. Carlos Del Rio, executive associate dean and global health expert at the Emory School of Medicine.

“If we can get patients to start treatment early before they progress to serious illness and sadly death, everyone wins in the fight against COVID,” said Dr. Simone Wildes, medical specialist in the field of COVID. infectious diseases certified by South Shore Health and ABC News. donor.

Infectious disease specialists have stressed that these pills are not a substitute for a vaccine – by far the safest and most effective way to reduce the risk of being hospitalized with COVID-19.

But they can make a big difference if given to people quickly after contracting COVID-19, especially those who are immunocompromised, or in places where a vaccine is not available.

Pfizer’s pill-based treatment “would be a good drug for patients with COVID and at high risk of progression, vaccinated or not,” said Del Rio, “although the vaccinated were not included in this study. “.

Another company, Merck, is ahead of Pfizer on develop COVID pill treatment, having already filed an authorization request with the Food and Drug Administration. Emergency use authorization for Merck processing could arrive before the end of the year.

Merck’s treatment reduced the risk of hospitalizations and death by 50%. This could indicate that Pfizer’s treatment has an advantage over efficacy, but experts cautioned against directly comparing studies because they were designed in different ways and measured different so-called ‘primary endpoints’.

“We have to be careful comparing studies,” said Dr Todd Ellerin, director of infectious diseases at South Shore Health and medical collaborator at ABC News. But, said Ellerin, it’s “great that there is another oral polymerase inhibitor that appears to be very effective in high-risk symptomatic ambulatory patients.”

The FDA analyzes safety and efficacy before authorizing any drug.

The FDA advisory committee is due to review Merck’s request on November 30. Merck’s CEO told CNBC in late October that the company was ready to distribute 10 million treatments by the end of the year.

Pfizer, meanwhile, plans to start sharing the data with the FDA “as soon as possible.”

This Pfizer data comes from one of three clinical trials conducted by the company. The results of the other two trials are expected by the end of the year. Pfizer then plans to submit all data and seek authorization at that time, meaning the new drug could be available in early 2022.

Using lessons learned from other infectious diseases, experts said it may one day prove beneficial to combine different antiviral treatments.

“Pfizer’s oral drug is an investigational SARS-COV-2 protease inhibitor antiviral therapy,” said Wildes. “We have used protease inhibitor drugs in our HIV patients and they have worked well.”

“Overall, it’s similar to HIV and [hepatitis C] where we have different antivirals, ”Ellerin added. “There might be an opportunity for combination therapy in the future. ”

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