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United States UK medicines regulator approves Pfizer's 'life-saving' Covid pill | Coronavirus | The Guardian
31 Dec 2021
theguardian.com
UK medicines regulator approves Pfizer’s ‘life-saving’ Covid pill
Paxlovid found to be ‘safe and effective’ at reducing hospitalisation and death among vulnerable adults
- Coronavirus – latest updates
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UK regulators have approved Pfizer’s “life-saving” antiviral drug Paxlovid, which boasts nearly 90% success in preventing severe illness among vulnerable adults if taken soon after becoming infected with Covid-19.
The Medicines and Healthcare products Regulatory Agency (MHRA) found the oral treatment “to be safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate Covid-19 infection, who are at an increased risk of developing severe disease”.
The agency said Paxlovid was most effective when taken during the early stages of a Covid infection, and recommended it was used within five days of a patient’s first symptoms. The approval is for patients aged 18 and over with at least one risk factor for developing severe illness, such as obesity or diabetes, or being over 60.
UK regulator approves ‘first of its kind’ Covid antibody treatment
Read more
Dr June Raine, the MHRA’s chief executive, said: “We now have a further antiviral medicine for the treatment of Covid-19 that can be taken by mouth rather than administered intravenously. This means it can be administered outside a hospital setting, before Covid-19 has progressed to a severe stage.
“I hope the announcement gives reassurance to those particularly vulnerable to Covid-19, for whom this treatment has been approved. For these individuals, this treatment could be life-saving.”
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Covid-19 in the UK
Daily cases
-
+-
  vs last week
Daily deaths
-
Total deaths
-
Vaccination rollout
Received 1st dose
-%
Received 2nd dose
-%
Received 3rd dose
-%
Case and death data as of, Vaccinations as % of total population (including under 18s), published.
Weekly change shows difference from 7 days ago.
Source: data.gov.uk.
" frameborder="0" class="dcr-9vd5ud">
Before Christmas Pfizer said the UK government had agreed to purchase 2.5m courses of Paxlovid after an earlier purchase of 250,000 doses, conditional on regulatory approval.
The MHRA noted that Paxlovid was “not a substitute for vaccination”, and said vaccines and boosters remained the best way to avoid being hospitalised because of Covid.
Pfizer has said the drug showed near 90% efficacy in preventing hospitalisations and deaths in high-risk patients, with recent data suggesting the pill was also effective against the Omicron variant.
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UK: coronavirus deaths per day
People who have died within 28 days of their first positive test for coronavirus.
Deaths assigned to the date they are reported. Line shows daily average in a given week.
Data: data.gov.uk, updated
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In a clinical trial involving high-risk adults with Covid, Paxlovid reduced the rate of severe illness by 89% compared with a placebo group. Just three out of 389 patients were hospitalised or died from Covid-19 after taking the drug within three days of symptoms, compared with 27 out of 385 in the placebo group.
Scientists said Paxlovid worked through protease inhibitors, which prevent a virus from replicating. These were similar to those used to treat HIV, making it beneficial for patients with weak immune systems.
The two parts of Paxlovid, nirmatrelvir (PF-07321332) and ritonavir, are taken together, twice a day for five days. PF-07321332 is a new antiviral, while ritonavir – which slows the breakdown of PF-07321332 within the liver to increase its effectiveness – is already used alongside HIV medications.
However, ritonavir can interfere with the functioning of other drugs through the liver, meaning Paxlovid may not be offered if patients cannot pause existing courses of medication.
Prof Munir Pirmohamed, the chair of the MHRA’s commission on human medicines, said its coronavirus expert working group had endorsed the agency’s approval of Paxlovid, calling it “another safe and effective treatment” against Covid-19.
“As it is deployed, we will monitor its effectiveness and safety in the real world, including any drug interactions, as we do with all medicines,” he said.
The MHRA has already approved an antiviral pill, molnupiravir, made by Merck. But its results have been disappointing and it may be only about 30% effective in preventing hospitalisation. There have also been concerns raised over molnupiravir’s potential to lead to further variants.
Topics
- Coronavirus
- Pfizer
- Drugs
- Pharmaceuticals industry
- Health policy
- Infectious diseases
- Medical research
- news
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