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'An extraordinary effect': Pfizer says its COVID-19 pill reduced the risk of hospitalization and death by 89% in high-risk patients

Andrew Dunn   

'An extraordinary effect': Pfizer says its COVID-19 pill reduced the risk of hospitalization and death by 89% in high-risk patients
  • Pfizer's experimental COVID-19 pill decreased the risk of hospitalization and death, a study found.
  • "Our ability to stop living in fear is now within reach," Pfizer's Mikael Dolsten told Insider.

Pfizer's experimental coronavirus pill slashed the risk of hospitalization and death by 89% among high-risk people recently infected with COVID-19, the New York drugmaker said on Friday.

The landmark result raises the possibility that multiple COVID-19 pills could soon be available for patients, as the drugmaker Merck also recently announced positive results for its antiviral pill molnupiravir.

The treatments appear poised to play a major role in addressing the pandemic, supplementing vaccinations by lowering the risk of severe disease for people who are infected.

"Our ability to stop living in fear is now within reach," Mikael Dolsten, Pfizer's chief scientific officer, told Insider.

"This should really break the fear, reduce the tremendous burden on hospitals - and the risk that if you get infected you'll end up in a hospital and die is statistically becoming smaller and smaller and almost nonexistent," he added. "It's a huge medical advance for humanity."

Pfizer expects to produce more than 180,000 treatment courses by the end of 2021 and at least 50 million more courses in 2022. A spokesperson said Pfizer was expanding capacity and planned to update these numbers in the coming weeks.

Pfizer touts 'extraordinary' efficacy result combined with good safety profile

Pfizer's antiviral, which the company plans to name Paxlovid, is a protease inhibitor designed to block an enzyme that plays a key role in the virus' copying process. The drug is given with a low dose of another antiviral, ritonavir, to help Paxlovid last longer in the body.

The study had volunteers take three pills - two containing Pfizer's antiviral and one with ritonavir - every 12 hours for five days.

An early look at the study's results included data from 774 adults who enrolled, were at high risk of severe COVID-19, and were recently infected. Volunteers were randomly assigned to get Pfizer's antiviral or a placebo. Among those taking Pfizer's drug, less than 1% were hospitalized, and none died. In the placebo group, about 7% of people were hospitalized, and 10 died.

Overall, the impact was an 89% reduction in hospitalization or death for patients who took Pfizer's drug within three days of symptom onset. For those who took the drug within five days of symptom onset, the benefit was 85%, Dolsten said.

The results were described in a Friday-morning press release. They have not been published in a peer-reviewed medical journal.

"I would say this is as close as you can come with an antiviral to short-term cure-like outcomes," Dolsten said, adding that he was expecting a good antiviral to show efficacy of 70% or more. "It's an extraordinary effect."

Pfizer said that it was stopping its study early because of the strong results and that it was planning to apply for emergency authorization with US and global health regulators as soon as possible.

The safety data also appears promising. Most reported side effects were mild, and the placebo group had higher rates of serious side effects, Pfizer said.

The 89% risk reduction that Pfizer found is greater than what Merck found with molnupiravir in a similar study focused on high-risk COVID-19 patients, in which molnupiravir reduced the risk of hospitalization or death by about 50%. The Food and Drug Administration is now reviewing molnupiravir. The UK this week became the first country to approve the treatment.

Questions remain on resistance and benefit for vaccinated

Despite the promising results, there are still some unanswered questions.

Pfizer and Merck both excluded people who'd received a COVID-19 vaccine from their studies, making it unclear whether vaccinated people could meaningfully benefit from taking the pills if they got COVID-19.

Pfizer is running additional studies that include vaccinated people. Dolsten said he was optimistic that it would have positive results early next year. The company is also studying whether the pill could be used to prevent infections and illness in the first place as a prophylactic.

Some scientists are also concerned about whether COVID-19's ability to mutate could make antivirals weaker over time. Widespread use of the pills could lead to the virus developing resistance to the treatments.

But Dolsten said he wasn't worried about the risk of resistance anytime soon.

"I don't expect for the next many years - five, seven years - there will be resistance problems," he said, adding that Pfizer was looking out for that possibility further down the line.

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