UK is urged to speed up approval of Pfizer's 'stunning' Covid pill

UK is urged to speed up approval of Pfizer’s ‘stunning’ at-home Covid pill as doctors say drug could save lives and ease pressure on hospitals in face of Omicron

  • Pfizer’s at-home Covid pill cuts risk of severe outcomes by 89% for at-risk adults
  • Experts today called for the drugs to be rolled out in the UK as soon as possible
  • Britain has ordered 250,000 courses of drug, which is being assessed by MHRA

Britain should speed up the approval of Pfizer’s at-home Covid pill, experts claimed today amid hopes it should still work against Omicron.

The pharmaceutical giant yesterday unveiled ‘stunning’ final results of its anti-viral drug Paxlovid. 

It was found to cut the risk of vulnerable adults being hospitalised or dying by up to 90 per cent. And laboratory tests suggested the twice-a-day pill offered a ‘robust’ response to the ultra-transmissible variant.

Britain has already ordered 250,000 courses of the drug. Watchdogs are currently assessing its safety and efficacy with a decision expected in the coming weeks.

The NHS isn’t expecting stocks of Paxlovid to dish out to thousands of people with underlying health conditions until January at the least.

But experts have called for the process to be fast-tracked, based on findings from Pfizer’s trial of 2,200 at-risk adults.

Professor Ian Jones, a virologist at Reading University, told MailOnline speeding up the approval will ‘directly reduce hospital crowding and ultimately save lives’.     

It comes after the UK yesterday recorded its highest daily number of infections in almost a year, with 59,610 positive tests. 

Sequencing of positive samples revealed another 633 infections were triggered by Omicron but health chiefs estimate 200,000 people caught the strain on Monday alone. 

Despite turbo-charging the booster campaign to limit the impact of the incoming wave, Covid antivirals are only being used in trials and given to 10,000 vulnerable Britons as part of a national study.

The Medicines and Healthcare Products Regulatory Agency has already approved antiviral molnupiravir, sold by Merck and branded as Lagevrio.

The drug firm this month revealed it was just 30 per cent effective at reducing the risk of hospitalisation and death among the vulnerable, lower than early estimates. 

Findings from Pfizer’s trial of 2,200 adults showed those most at-risk from the virus who took Paxlovid within a few days of Covid symptoms were 89 per cent less likely to need hospital treatment or die. The graph shows that 0.7 per cent of patients who received the drug were hospitalised, compared to 6.5 per cent of of those who did not receive the pill being hospitalised or dying. No deaths were recorded among those who took Paxlovid

Pfizer said that its Covid pill, called Paxlovid (pictured), is up to 89 per cent effective at preventing hospitalisations and deaths when taken within the first few days of Covid symptoms 

Paxlovid is a protease inhibitor, which works by inhibiting an enzyme the coronavirus uses to make copies of itself inside human cells. 

Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.

If approved, it would be given to patients at the first sign of Covid infection with the aim of reducing the risk of serious illness. 

HOW DOES PFIZER’S PILL WORK?

What is it? 

Pfizer’s drug is part of a class known as protease inhibitors.

It is designed to block an enzyme the coronavirus needs in order to multiply. 

Like protease inhibitors used to treat HIV, it is given in combination with other antivirals.  

How effective is it?  

A recent trial of the pill in more than 2,200 adults found that it cut hospitalisation and death rates by 89 per cent in people at high risk of a severe illness from Covid. 

It also cut the risk of being admitted to hospital and dying by 70 per cent among healthy unvaccinated people and vaccinated adults with one or more underlying illnesses. 

It should be given as soon as possible after catching Covid, ideally within three to five days.

How much has the UK ordered?  

250,000 courses  

Professor Jones said both the Pfizer and Merck antiviral medications ‘are important new additions to the treatments available for Covid’. 

He said: ‘Neither stops infection but they each limits the disease by stopping the virus growing. Less virus means less disease.’

The pills must be given to infected people as soon as possible after catching the virus, ‘which means in practice that they need to be prescribed immediately after a positive Covid test, particularly to vulnerable people’, Professor Jones said. 

He added: ‘Anything that can be done to speed up licensing and availability to ensure this is possible will therefore directly reduce hospital crowding and ultimately save lives.’

Professor Paul Hunter, a public health expert at the University of East Anglia, told MailOnline Pfizer’s data suggests Paxlovid ‘will find a valuable role in reducing the severity of illness and keeping people out of hospital’. 

However, he said ‘it probably would not be given to everyone but would be targeted at people most at risk of severe disease’.  

Professor Penny Ward, an expert in pharmaceutical medicine at King’s College London, said Pfizer’s findings suggest Paxlovid ‘could be helpful in a highly vaccinated population and reduce the strain of additional admissions within an overloaded health service’.

Dr Stephen Griffin, a viral oncologist at the University of Leeds, told MailOnline Paxlovid should be swiftly approved and rolled out, but only to vulnerable adults and children and under clinical supervision. 

He said: ‘The unacceptably high prevalence [of Covid] we’ve seen in this country since July poses a huge risk to clinically vulnerable individuals who may not be able to either respond well, or indeed receive vaccines.’

These patients require a ‘rescue therapy’ if they catch Covid, Dr Griffin said.  

‘These precious medicines need to be preserved for those most in need and certainly must not be used to replace vaccines for the long term in any way, shape, or form,’ he added.

 

Pfizer trial of Paxlovid enroled 2,246 at-risk adults by November 4, half of whom were given the pill within five days of their first Covid symptoms as part of phase two and three trials, while the remaining group received a placebo pill.

More than 40 per cent of participants were based in the US, while the rest were in Europe, Africa and Asia. 

They found the drug, which is taken orally every 12 hours for five days, ‘significantly reduced’ the risk of hospitalisation or death by 89 per cent when taken within three days of symptoms, compared to the placebo group.

Omicron-hotspot London is seeing Covid cases rise quicker now than since very first wave

Cases in London are rising faster than at any point since the first wave, according to Professor Tim Spector, who runs the UK’s largest coronavirus symptom-tracking study.

He claimed the capital’s outbreak was ‘really accelerating’, after it emerged that the super-mutant variant has already become dominant despite only being spotted a fortnight ago.

Professor Spector also warned that his team’s data — which is given to ministers — suggests anyone battling a cold in London probably has Covid, saying the illness now causes a headache, sore throat and runny nose for the vast majority who get infected.

His comments came as other scientists advising the Government ramped up the pressure for ministers to impose tighter Covid curbs.

Dr Jenny Harries, head of the UK Health Security Agency — which replaced the now-defunct Public Health England — warned Omicron posed the ‘biggest threat’ yet and that the NHS was ‘in peril’.

SAGE modeller Professor Graham Medley said he feared the super-strain could trigger a ‘very large’ wave of hospitalisations because it is so transmissible, while jabs adviser Professor Adam Finn called for action to halt the ‘alarming’ spread of the virus.

 

And the drug still cut the risk of being hospitalised or dying by 88 per cent when it was taken five days after symptom onset.

Five patients who took Paxlovid within the three-day window were hospitalised, compared to 44 among the placebo group. And no deaths were recorded among those who took its drug in this timeframe, compared to nine fatalities in the other group.

Meanwhile, there were eight hospitalisations and no deaths among those who took the drug five days after their first Covid symptoms, compared to six hospitalisations and 12 deaths among the placebo group.

And the drug was the most effective among older groups, slashing the risk of hospitalisation or death by 94 per cent among the over-65s. 

Pfizer also trialled the drug on 673 healthy unvaccinated adults, as well as vaccinated adults who had one or more risk factors, with the aim of alleviating all Covid symptoms for four days.

The pill did not prevent participants from feeling unwell, but the chance of being hospitalised from the virus was 70 per cent lower among the group and no deaths were recorded. 

Paxlovid also slashed the viral load — the amount of virus detected in an infected individual’s nose or throat swab — 10-fold compared to the amount of virus detected in those who didn’t take the drug. 

And laboratory tests suggest the pill is expected to work against Omicron, because it doesn’t target the virus’s spike protein, which contains most of the new variant’s mutations. 

Dr Bourla, Pfizer’s chair and chief executive officer, said the results provide further evidence that its pill ‘could have a meaningful impact on the lives of many’ if it is approved in the fight against the virus.

Emerging variants of concern, such as Omicron, have ‘exacerbated the need for accessible treatment options for those who contract the virus’ and Pfizer is confident the pill could be a ‘critical tool to help quell the pandemic’, he said.

Dr Bourla added: ‘The data further supports the efficacy of Paxlovid in reducing hospitalisation and death and show a substantial decrease in viral load.

‘This underscores the treatment candidate’s potential to save the lives of patients around the world.’

The company said it shared its data with the US Food and Drug Administration (FDA) as part of a rolling submission for emergency authorisation.   

The FDA is expected to soon rule on whether to authorise Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier and reduced hospitalisations and deaths by 30 per cent among at-risk adults. 

If granted, the pills would be the first Covid treatments that Americans could pickup at a pharmacy and take at home.

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