'Game-changing' new Covid-19 pill 'will be here in weeks', government told

Pfizer, which announced the results of its final analysis of its drug Paxlovid yesterday, has privately told senior Coalition figures it would probably be in a position to supply them to Ireland as early as the end of January or in February, subject to regulatory approval, the Irish Independent understands.

The news will be a welcome boost to the Coalition as it grapples with the looming Omicron wave, with ministers fearing further public health restrictions will be recommended by Nphet tomorrow.

Government leaders were last night warned Ireland could be set to experience similar rates of the Omicron variant to those currently being recorded in England.

Senior Coalition figures believe the development of antiviral pills will be key to avoiding lockdowns or harsh restrictions in 2022.

The pills are already being made in Pfizer’s manufacturing facilities in Ringaskiddy and Newbridge in advance of its market authorisation.

Pfizer announced yesterday that its final analysis of Paxlovid shows that if given within three days of the onset of Covid-19 symptoms, it reduces the risk of hospitalisation and death by 89pc.

The risk is reduced by almost as much – 88pc – if given within five days.

The pharma giant also reported preliminary laboratory studies suggest the pill performs well against the Omicron variant.

The European Medicines Agency (EMA) is already reviewing data on the oral treatment and is due to give a scientific opinion this week that could allow for its limited use in emergency settings.

A wider conditional marketing authorisation would then follow this subject to a further assessment of data.

“If the EMA concludes that the benefits of the medicine outweigh its risks in the treatment of Covid-19 in adults, it will make a recommendation to the European Commission to grant a conditional marketing authorisation,” Ireland’s Health Products Regulatory Authority (HPRA) said in a statement.

“Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU member states, including Ireland.”

The Government is likely to enter an EU-wide agreement with Pfizer through the European Commission. Once the drug is granted authorisation by the EMA, of which the HPRA is a member, the Commission is expected to place orders on behalf of member states, with the pills delivered on a pro rata basis to EU members based on their orders for the first quarter of 2022.

The delivery schedule will be confirmed once orders are placed, the company has told the Government.

Senior Coalition figures believe the development of antiviral pills will be key to avoiding lockdowns or harsh restrictions in 2022.

A spokesperson for Pfizer yesterday said it aimed to deliver the antiviral pills as soon as possible.

“In anticipation of the potential for regulatory authorisation or approval, Pfizer initiated manufacturing of our Covid-19 oral antiviral treatment candidate earlier this year and expects to produce more than 180,000 courses of treatment by the end of 2021, with up to 80 million courses of treatment by the end of 2022. This is an increase from the original forecast of 50 million packs,” they said.

Meanwhile, last night the National Public Health Emergency Team (Nphet) presented modelling to the Taoiseach, Tánaiste and Green Party leader on transmission of the new variant at a meeting in Government Buildings.

The new variant accounts for 20pc of all new cases of the virus in England and 44pc in London.

The Omicron variant currently accounts for around 11pc of all new cases in Ireland.

A source said after the meeting that the outlook for the spread of the new strain in Ireland will be similar to what is being experienced in Britain.

Coalition sources are anticipating that further restrictions will be recommended by the public health team, including curtailing large gatherings, tightening restrictions for the hospitality sector including possible earlier closing times, and further guidance on household visits.

However, chief medical officer Tony Holohan did not outline any plans for restrictions.