Pfiser says its antiviral pill slashes risk of severe COVID-19 by 89pct

06-Nov-2021 Intellasia | Reuters | 10:03 AM Print This Post
Pfiser says its antiviral pill slashes risk of severe COVID-19 by 89pct

Pfiser Inc’s (PFE.N) experimental antiviral pill to treat COVID-19 cut by 89 percent the chance of hospitalisation or death for adults at risk of severe disease, the company said on Friday, as its CEO vowed to make this promising new weapon in the fight against the pandemic available globally as quickly as possible.

The trial’s results suggest that Pfiser’s drug surpasses Merck & Co Inc’s (MRK.N) pill, molnupiravir, which was shown last month to halve the chance of dying or being hospitalised for COVID-19 patients at high risk of serious illness.

Pfiser’s pill, with the brand name Paxlovid, could secure US regulatory approval by the end of the year. Pfiser said it plans to submit interim trial results to the Food and Drug Administration (FDA) before the November 25 US Thanksgiving holiday. The trial was stopped early due to its high success rate.

President Joe Biden said the US government has secured millions of doses of Pfiser’s drug.

“If authorised by the FDA we may soon have pills that treat the virus in those who become infected,” Biden said. “The therapy would be another tool in our toolbox to protect people from the worst outcomes of COVID.”

Shares in Pfiser, which also makes one of the mostly widely used COVID-19 vaccines, rose 11 percent to close at $48.61. Merck’s fell 10 percent to close at $81.61. Shares of vaccine makers took a hit, with Moderna Inc (MRNA.O), Pfiser’s German partner BioNTech SE and Novavax (NVAX.O) all down 11-21%.

Pfiser’s pill is given in combination with an older antiviral called ritonavir. The treatment consists of three pills given twice daily. It has been in development for nearly two years.

The Pfiser and Merck pills are eagerly anticipated, with only limited options currently available for treating people sick with COVID-19. Full trial data is not yet available from either company.

Pfiser is in active discussions with 90 countries over supply contracts for its pill, Chief Executive Officer Albert Bourla said in an interview.

“Our goal is that everyone in the world would be able to have it as quickly as possible,” Bourla said.

Bourla added that for high-income countries Pfiser expects to price its treatment close to where Merck has priced its drug. Merck’s US contract price is around $700 for a five-day course of therapy. For low-income countries, Bourla said Pfiser is considering several options, with the goal of “no barrier for them as well to have access.”

Merck’s pill was approved by British regulators in a world first on Thursday.

Even with the potential offered by the Pfiser and Merck pills, preventing COVID-19 infections through broad use of vaccines remains the best way to control a pandemic that has killed more than 5 million people worldwide, including more than 750,000 in the United States, infectious disease experts said.

“Vaccines are going to be the most effective and reliable tool that we have in this pandemic,” said Dr Grace Lee, professor of pediatrics at Stanford University School of Medicine. “These oral medications are going to augment our ability to really reduce the risk of severe disease, hospitalisation and death, which is huge, but it won’t prevent infection.”

While more than 7 billion vaccine doses have been administered worldwide, that has covered only about half the world’s people. In the United States, 58 percent of all people, including 70 percent of adults, are fully vaccinated.

Mizuho analyst Vamil Divan forecast a “very minor impact” from Pfiser’s drug on vaccination among people who do not want the vaccine or a booster shot as recommended by US health regulators.

“I think there’s a small percentage of people that may decide not to get vaccinated now that there are good treatment options,” Divan said.

MANUFACTURING GOALS

Pfiser said it expects to manufacture 180,000 treatment courses by the end of this year and at least 50 million courses by the end of next year, including 21 million in the first half of 2022. Bourla said that, based on the better-than-expected trial results, Pfiser is considering potentially doubling next year’s manufacturing target.

Antivirals need to be given as early as possible, before an infection takes hold, to be most effective.

The planned analysis of 1,219 patients in Pfiser’s study examined hospitalisations or deaths among people diagnosed with mild to moderate COVID-19 with at least one risk factor for developing severe disease, such as obesity or older age.

Among those given Pfiser’s drug within three days of symptom onset, the pill lowered the chances of hospitalisation or death for adults at risk of developing severe COVID-19 by 89 percent compared to those receiving a placebo. Among these patients, 0.8 percent were hospitalised and none died by 28 days after treatment, compared to a 7 percent hospitalisation rate and seven deaths in the placebo group.

Rates were similar for patients treated within five days of symptoms: 1 percent of the treatment group was hospitalised, compared to 6.7 percent for the placebo group, which included 10 deaths. Pfiser said that represents 85 percent effectiveness at preventing hospitalisation or death.

Two other trials one in people without underlying risk factors and another in people who have been exposed to the virus but are not yet infected are continuing, with those results likely be available in the first quarter of 2022, Bourla said.

Pfiser did not detail side any effects but said adverse events happened in about 20 percent of both treatment and placebo patients. Possible side effects include nausea and diarrhea.

https://www.reuters.com/business/healthcare-pharmaceuticals/pfiser-says-antiviral-pill-cuts-risk-severe-covid-19-by-89-2021-11-05/

 

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