(LONDON) Press Release MHRA Statement Report: Oral #COVID19 antiviral, Paxlovid, approved by UK regulator #AceHealthDesk report

#CoronavirusNewsDesk says this new combination treatment is for people with mild to moderate #COVID19 who are at high risk of developing severe #COVID19 This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines according to

Developed by Pfizer, Paxlovid is an antiviral medicine with a combination of active ingredients, PF-07321332 and ritonavir, that works by inhibiting a protease required for virus replication. This prevents it from multiplying, keeping virus levels low and helping the body to overcome the viral infection. Ritonavir slows the breakdown of the second ingredient PF-07321332 in the body, thereby increasing its effectiveness.

The two active substances of Paxlovid come as separate tablets that are packaged together and taken together, twice a day by mouth for 5 days. PF-07321332 is a new antiviral, meaning that it has not been approved for use before. However, ritonavir has been used alongside some HIV medicines for many years to ‘boost’ their activity, which is similar to what it is doing for PF-07321332.

In a clinical trial in high-risk adults with symptomatic COVID-19 infection, a five day treatment course of Paxlovid reduced the risk of COVID-19 related hospitalisation and death within 28 days by 89% when compared to a placebo group when treatment was started within 3 days of the onset of COVID-19 symptoms. The number of hospitalisations and deaths were 0.8% (3 out of 389) in the Paxlovid group compared with 7% (27 out of 385) in the placebo group. Similar favourable results were seen in patients when treatment was started within 5 days of the start of symptoms.

Based on the clinical trial data, Paxlovid is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of the start of symptoms. It has been authorised for use in people aged 18 and above who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

It is too early to know whether the omicron variant has any impact on Paxlovid’s effectiveness but the MHRA is proactively working with the company to establish this.

Dr June Raine, MHRA Chief Executive, said:

“Today we have given our regulatory approval for Paxlovid, a COVID-19 treatment found to cut COVID-19 related hospitalisations and deaths by 89% when taken within three days of the start of symptoms.

“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 today 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.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Paxlovid.

“Based on this data, it is clear Paxlovid is another safe and effective treatment to help us in our fight 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. Any side effects should be reported to the MHRA using the Yellow Card scheme.”

Health and Social Care Secretary Sajid Javid, said:

“The UK has been a world leader at finding and rolling out COVID-19 treatments to patients. This is further proved by the MHRA being one of the first in the world to approve this life-saving antiviral.

“We are also leading the whole of Europe in the number of antivirals we’ve bought per person – with over 2.75 million courses of this antiviral secured for NHS patients by the Antivirals Taskforce.

“The booster campaign, testing and antiviral defences ensure our country is in the strongest possible position to deal with the threat posed by Omicron as we head into the new year.”

Paxlovid may interact with certain other medications. Before it is prescribed, the MHRA is therefore advising that patients’ current medications should be carefully reviewed, and appropriate advice given on adjustments that may be needed to their current medications. Additional tests may also be needed for its safe use. More information is provided in the patient information leaflet.

Paxlovid is not a substitute for vaccination against COVID-19. Vaccination and having a booster after the first course remains the best way to avoid hospitalisation due to COVID-19 for most people. The government and the NHS will confirm how this COVID-19 treatment will be given to patients in due course.

Additional Notes:

  • The Medicines and Healthcare products Regulatory Agencyis responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes theNational Institute for Biological Standards and Control (NIBSC)and theClinical Practice Research Datalink (CPRD). MHRA is an executive agency of theDepartment of Health and Social Care.
  • TheCommission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
  • The MHRA’s Conditional Marketing Authorisation for Paxlovid is valid in Great Britain only. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorisations were made on the basis of the same rigorous evaluation.
  • More information can be found in the product information

#AceHealthDesk report …………Published: Jan.01: 2022:

Editor says …Sterling Publishing & Media Service Agency is not responsible for the content of external site or from any reports, posts or links, and can also be found here on Telegram: https://t.me/acenewsdaily all of our posts fromTwitter can be found here: https://acetwitternews.wordpress.com/ and all wordpress and live posts and links here: https://acenewsroom.wordpress.com/and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#govuk, #london, #mhra

(LONDON) GOVUK Press Release Statement Report: MHRA approves Xevudy (sotrovimab), a #COVID19 treatment found to cut hospitalisation and death by 79% #AceHealthDesk report

#AceHealthReport – Dec.03: Another #COVID19 treatment, Xevudy (sotrovimab), has today been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found 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.

#CoronavirusNewsDesk says this monoclonal antibody – the second to be authorised by the Medicines and Healthcare products Regulatory Agency – is for people with mild to moderate #COVID19 who are at high risk of developing severe disease according to

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the second monoclonal antibody therapeutic to be approved following Ronapreve.

Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody. The drug works by binding to the spike protein on the outside of the COVID-19 virus. This in turn prevents the virus from attaching to and entering human cells, so that it cannot replicate in the body.

In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalisation and death by 79% in high-risk adults with symptomatic COVID-19 infection.

Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible and within five days of symptom onset.

Like molnupiravir, it has been authorised for use in people who have mild to moderate COVID-19 infection and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>55 years), diabetes mellitus, or heart disease.

Unlike molnupiravir, sotrovimab is administered by intravenous infusion over 30 minutes. It is approved for individuals aged 12 and above who weigh more than 40kg.

It is too early to know whether the omicron variant has any impact on sotrovimab’s effectiveness but the MHRA will work with the company to establish this.

Dr June Raine, MHRA Chief Executive said:

“I am pleased to say that we now have another safe and effective COVID-19 treatment, Xevudy (sotrovimab), for those at risk of developing severe illness.

“This is yet another therapeutic that has been shown to be effective at protecting those most vulnerable to COVID-19, and signals another significant step forward in our fight against this devastating disease.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA have conducted a robust and thorough assessment of all the available data.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and agrees with the MHRA’s regulatory approval of Xevudy (sotrovimab).

“When administered in the early stages of infection, sotrovimab was found to be effective at reducing the risk of hospitalisation and death in high-risk individuals with symptomatic COVID-19. Based on the data reviewed by the Commission and its expert group, it is clear sotrovimab is another safe and effective treatment to help us in our fight against COVID-19.”

Sotrovimab is not intended to be used as a substitute for vaccination against COVID-19.

The government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course.

Additional Notes:

  • The Medicines and Healthcare products Regulatory Agencyis responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes theNational Institute for Biological Standards and Control (NIBSC)and theClinical Practice Research Datalink (CPRD). MHRA is an executive agency of theDepartment of Health and Social Care.
  • TheCommission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
  • The MHRA’s Conditional Marketing Authorisation for sotrovimab is valid in Great Britain only. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorisations were made on the basis of the same rigorous evaluation.
  • More information can be found in the product information

#AceHealthDesk report …………..Published: Dec.03: 2021:

Editor says …Sterling Publishing & Media Service Agency is not responsible for the content of external site or from any reports, posts or links, and can also be found here on Telegram: https://t.me/acenewsdaily all of our posts fromTwitter can be found here: https://acetwitternews.wordpress.com/ and all wordpress and live posts and links here: https://acenewsroom.wordpress.com/and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#govuk, #health, #london, #mhra

(LONDON) MHRA Press Release Statement Report: First oral antiviral for #COVID19, Lagevrio (molnupiravir), approved in tablet form #AceHealthDesk report

#AceHealthReport – Nov.04: The antiviral Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate #COVID19 who are at increased risk of developing severe disease, the Medicines and Healthcare products Regulatory Agency (MHRA) announced today.

#CoronavirusNewsDesk reports that MHRA The antiviral was found to be safe and effective following a stringent review of the available evidence……

This follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines, making it the first oral antiviral for the treatment of COVID-19 to be approved.

Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.

Based on the clinical trial data, Lagevrio is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptoms onset

Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

Health and Social Care Secretary Sajid Javid said:

“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment.

“The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments, and my thanks goes to the expert teams at the MHRA and MSD for this triumph, as well as the Antivirals Taskforce who have procured the treatment.

“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible

“This antiviral will be an excellent addition to our armoury against COVID-19, and it remains vital everyone comes forward for their life-saving COVID-19 vaccine – particularly those eligible for a booster – to ensure as many people as possible are protected over the coming months.”

Dr June Raine, MHRA Chief Executive, said:

“Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

“Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:

“The Commission on Human Medicines and its COVID-19 Therapeutics Expert Working Group has independently reviewed the data and endorses the MHRA’s regulatory approval of Lagevrio.

“In clinical trials, Lagevrio was found to be effective in reducing the risk of hospitalisation or death for at-risk non-hospitalised adults with mild to moderate COVID-19 by 50%.

“Based on this and other data that has been carefully reviewed by the Commission and its expert group, it is clear Lagevrio is another safe and effective treatment to help us in our fight against COVID-19.”

Lagevrio is not intended to be used as a substitute for vaccination against COVID-19.

The government and the NHS will confirm how this COVID-19 treatment will be deployed to patients in due course.

Additional Health Notes:

  • The Medicines and Healthcare products Regulatory Agencyis responsible for protecting and improving the health of millions of people every day through the effective regulation of all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  • The MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes theNational Institute for Biological Standards and Control (NIBSC)and theClinical Practice Research Datalink (CPRD). MHRA is an executive agency of theDepartment of Health and Social Care.
  • TheCommission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
  • The MHRA’s Conditional Marketing Authorisation for Lagevrio is valid in Great Britain only. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorisations were made on the basis of the same rigorous evaluation.

#AceHealthDesk report ……………Published: Nov.04: 2021:

Editor says …Sterling Publishing & Media Service Agency is not responsible for the content of external site or from any reports, posts or links, and can also be found here on Telegram: https://t.me/acenewsdaily all of our posts fromTwitter can be found here: https://acetwitternews.wordpress.com/ and all wordpress and live posts and links here: https://acenewsroom.wordpress.com/and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#health, #london, #mhra

(LONDON) Press Release MHRA Statement Report: On #COVID19 booster vaccines for Winter 2021 – 2022 #AceHealthDesk report

#AceHealthReport – Sept.15: We are committed to getting safe and effective COVID-19 vaccines to the UK public. This means ensuring that existing COVID-19 vaccines can continue to be used in the most effective way possible…..

#CoronavirusNewsDesk reports on Regulatory updates by the MHRA today on the #COVID19 booster vaccine programme for winter 2021 to 2022…..

Dr June Raine, MHRA Chief Executive said:

We confirmed on 9 September 2021 that the COVID-19 vaccines made by Pfizer and AstraZeneca can be used as safe and effective booster doses. This is an important regulatory change as it gives further options for the vaccination deployment programme which has saved tens of thousands of lives.

The regulatory decision followed a careful review of available data on safety and effectiveness of booster or supplementary vaccine doses by the MHRA and the independent Commission on Human Medicines(CHM, which advises the government.

We have also now looked at data for the Moderna vaccine to be used as a booster, and this has also been reviewed by the CHM experts who concluded that the Moderna vaccine can be used as a safe and effective booster dose, including in a half dose, which also gives an effective boost to antibodies.

The CHM took into account data on waning vaccine effectiveness after the second dose, providing important insights into potentially waning immunity.

The data reviewed showed that giving the booster jabs with flu vaccines at the same time is safe and does not affect an individual’s immune response to either vaccine. Therefore COVID-19 booster doses may be given at the same time as flu vaccines.

We have in place a comprehensive safety surveillance strategy for monitoring the safety of all COVID-19 vaccines and this surveillance includes booster jabs.

As with first and second doses, if anyone has a suspected side effect, please report it to us using our Yellow Card scheme.

#AceHealthDesk report ……Published: Sept.15: 2021:

Editor says …Sterling Publishing & Media Service Agency is not responsible for the content of external site or from any reports, posts or links, and can also be found here on Telegram: https://t.me/acenewsdaily all of our posts fromTwitter can be found here: https://acetwitternews.wordpress.com/ and all wordpress and live posts and links here: https://acenewsroom.wordpress.com/and thanks for following as always appreciate every like, reblog or retweet and free help and guidance tips on your PC software or need help & guidance from our experts AcePCHelp.WordPress.Com

#health, #london, #mhra, #vaccine