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game-changer Cork company behind new ground-breaking Pfizer antiviral Covid-19 treatment

New drug can potentially cut the chances of death from the disease by 89%


New antiviral drug can potentially cut the chances of hospitalisation and death for adults at risk of of severe disease from Covid-19

New antiviral drug can potentially cut the chances of hospitalisation and death for adults at risk of of severe disease from Covid-19

New antiviral drug can potentially cut the chances of hospitalisation and death for adults at risk of of severe disease from Covid-19

Irish pharmaceutical staff in Cork are involved in making a gamechanger Pfizer antiviral drug which can potentially cut the chances of hospitalisation and death for adults at risk of severe disease from Covid-19 by 89pc, it emerged today.

The results appear to surpass those seen with the Merck (MSD) pill, molnupiravir, which was shown last month to halve the likelihood of dying or being hospitalised for Covid-19 patients also at high risk of serious illness.

The Merck drug has now been given the green light in the UK and is still being reviewed by the European Medicines Agency before being released in Ireland.

A spokeswoman for Pfizer said today :"We are pleased to confirm that Pfizer’s manufacturing facility in Ringaskiddy, Cork, will support the global manufacturing and supply of our investigational Covid-19 oral antiviral candidate, should it be approved.

"Pfizer has begun investing – prior to regulatory authorisation and solely at our own risk and expense – in the manufacture of our potential Covid-19 oral antiviral candidate to help bring this potential treatment to patients as soon as possible.

It is understood Ireland has not submitted any pre-orders for either drug unlike other countries such as the UK, France and the United States despite the extreme ongoing risk to vulnerable people from Covid-19 and their increased chance of hospitalisation.

Pfizer said it planned to submit interim trial results for its pill, which is given in combination with an older antiviral called Ritonavir, to the US Food and Drug Administration (FDA) as part of the emergency use application it opened in October.

That filing is expected to be submitted before the US Thanksgiving holiday on November 25, Pfizer Chief Executive Albert Bourla said .

The combination treatment, which will have the brand name Paxlovid, consists of three pills given twice daily.

The planned analysis of 1,219 patients in Pfizer's study looked at hospitalizations 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.

It found that 0.8pc of those given Pfizer's drug within three days of symptom onset were hospitalised and none had died by 28 days after treatment.

That compared with a hospitalization rate of 7pc for placebo patients. There were also seven deaths in the placebo group.

Rates were similar for patients treated within five days of symptoms - 1pc of the treatment group was hospitalised, compared with 6.7pc for the placebo group, which included 10 deaths. Bourla said that works out to being 85pc effective.

The data compared favourably to Merck's oral antiviral in a similar patient population, Cantor Fitzgerald analyst Louise Chen said in a note, but added that Merck was in the lead with the launch of its pill and expects an FDA decision before the end of the year.

A panel of outside experts to the FDA is scheduled to meet November 30 to discuss Merck's pill, which was approved by British regulators in a world first on Thursday. read more

With Covid-19 still circulating widely and current therapeutic options requiring access to a healthcare facility, antiviral treatments that can be taken at home to keep people out of the hospital are critically needed, Chen said.

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Antivirals need to be given as early as possible, before an infection takes hold in order to be most effective. Merck tested its drug within five days of symptom onset.

"This means that we have time to treat people and really provide a benefit from a public health perspective," Annaliesa Anderson, head of the Pfizer program, told Reuters.

The company did not detail side effects of the treatment, but said adverse events happened in about 20pc of both treatment and placebo patients. Ritonavir's possible side effects include nausea and diarrhoea.

White House Chief of Staff Ronald Klain said the prospect of an antiviral this effective along with rollout of vaccines for children between the age of 5 and 11 underway could be a turning point week in fight against COVID-19.

Klain cautioned that the pill still needed to be reviewed by the FDA.

"These data suggest that our oral antiviral candidate, if approved by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations," Bourla said in a statement.

Pfizer said it was currently expecting to produce more than 180,000 packs by the end of 2021 and at least 50 million packs by the end of 2022, of which 21 million would be produced in the first half.

Infectious disease experts stress that preventing COVID-19 through wide use of vaccines remains the best way to control the pandemic, but only 58pc of Americans are fully vaccinated and access in many parts of the world is limited.

Pfizer's drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs to multiply.

Merck's molnupiravir has a different mechanism of action designed to introduce errors into the genetic code of the virus. Merck has already sold millions of courses of the treatment to the United States, Britain and others.

Pfizer is also studying whether its pill could be used by people without risk factors for serious Covid-19 as well as to prevent coronavirus infection in people exposed to the virus.

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