Experts today claimed that Britain should accelerate the approval of Pfizer’s at-home Covid tablet. This is in spite of Omicron’s hopes that it will still be effective.
Yesterday’s announcement by the pharmaceutical giant was of the’stunning final results’ for its antiviral drug Paxlovid.
This reduced the likelihood of elderly people dying in hospital by nearly 90%. Laboratory tests showed that the two-a-day pill was a superior alternative to the ultra-transmissible version.
Britain already has ordered over 250,000 doses of this drug. The drug’s safety and efficacy are being assessed by Watchdogs, with a final decision due in the next weeks.
The NHS doesn’t expect Paxlovid stocks to be distributed to thousands of patients with serious health issues until January.
Experts recommend that the process be expedited based upon Pfizer’s 2200 trial participants who were at high risk.
MailOnline spoke with Professor Ian Jones from Reading University about how speeding up approvals will help reduce hospital congestion and save lives.
After yesterday’s record-breaking 59,610 positive test results, the UK has now reached its highest level of infection in almost one year.
Omicron triggered another 633 infections according to Sequencing. However, health officials have estimated that around 200,000 people contracted the strain since Monday.
Covid antivirals were not used to turbo-charge the boost campaign in order to reduce the impact of the coming wave. They are being given as trials to 10,000 Britons who are at risk.
Antiviral molnupiravir has been approved by the Medicines and Healthcare Products Regulatory Agency. It is sold by Merck and marketed as Lagevrio.
This month, the drug company revealed that it is only 30% effective in reducing hospitalisations and deaths among vulnerable patients. It is lower than the initial estimates.
Pfizer tested 2,200 adult patients and found that people who started taking Paxlovid after experiencing Covid symptoms for a short time were 99% less likely to require hospital care or death. It is evident that 0.7% of patients who took the drug received hospital treatment, and 6.5% who did not were admitted to the hospital or died. Paxlovid was not associated with any deaths.
Pfizer claimed that the Covid pill called Paxlovid (pictured) is as effective at preventing deaths and hospitalisations than any other medication. It can be taken in just a few days after Covid symptoms appear.
Paxlovid works as a protease inhibitor by inhibiting an enzyme used by the coronavirus to create copies of itself within human cells.
The company stated that protease inhibitors are effective in treating viral diseases such as HIV/hepatitis C and other viruses, either alone or with antivirals.
It would be administered to the patient at the first signs of Covid infection if approved. This is in the interest of decreasing the chance of developing serious illnesses.
Professor Jones stated that both Merck and Pfizer antiviral drugs ‘are significant new additions’ to existing treatments for Covid.
He stated that neither virus can stop infection, but each one limits disease growth by stopping it from growing. Less virus means less disease.’
Professor Jones explained that infected persons must receive the medication as soon after they have caught the virus.
He stated that it was possible to reduce hospital congestion and even save lives by speeding up the licensing process.
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’.
But he stated that it wouldn’t be distributed to everybody, but only those who are most susceptible to serious 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 declared: “The inacceptably 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.’
Dr Griffin explained that these patients need to be given’rescue therapy’ in the event they are bitten by Covid.
He added that “These valuable medicines should be preserved for those who are most in immediate need” and they must not be used in any way to replace vaccines over the long term.
The Pfizer Paxlovid trial enrolled 2,246 at risk adults. Half of them were administered the drug within five days after their first Covid symptoms. Phase two and three trials involved the placebo group.
Participants based more than 40% in America, the remainder in Europe, Africa or 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.
The drug cut the chance of dying or being hospitalized by 88% when taken 5 days after the onset of symptoms.
Five Paxlovid patients were admitted to hospital within the 3-day period, while 44 of those who received the placebo drug had been admitted. There were no fatalities among patients who received Paxlovid within this period, as opposed to the nine in the placebo group.
There were 8 hospitalisations, no deaths, and the first Covid symptoms occurred five days later. This compares to 6 hospitalisations, and 12 deaths, in the placebo-treated group.
The drug proved to be most efficient in older patients, cutting the chance of death or hospitalisation by 94% among those over 65.
Pfizer tested the drug for Covid symptoms on both 673 healthy adults and vaccinated individuals with one or more risk factors.
Although the participants did not experience any symptoms, the likelihood of them being infected was 75% lower. No deaths occurred.
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.
The pill has been tested in laboratory and is believed to be effective against Omicron. It doesn’t attack the spike protein that contains the majority of Omicron’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.’
According to the company, it submitted its data to the FDA as part of an emergency submission.
FDA expected to rule soon on Pfizer’s drug and Merck’s competing product. The FDA submitted the pills several weeks ago and saw a reduction in hospitalizations and deaths of 30% among high-risk individuals.
These pills could be granted if they are approved.