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Pfizer expecting authorisation to market its oral Covid medicine in Europe

By Chris King • Published: 10 Jan 2022 • 19:55

Paxlovid: the COVID antiviral pill rejected in the US and approved in Spain

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Authorisation to market their new antiviral Covid medicine in Europe is expected shortly by Pfizer

The European Medicines Agency (EMA) announced this Monday, January 10, that it is evaluating a request from Pfizer for conditional marketing authorisation for their oral antiviral medicine ‘Paxlovid’.
Their new product has been developed for the treatment of adult and adolescent patients who are displaying mild to moderate Covid-19 symptoms. It is suitable for anybody from 12 years of age, with a minimum weight of 40 kilos, who presents a high risk of progression to a serious condition with the virus.
Pfizer is hoping that the EMA will assess the benefits and risks of ‘Paxlovid’ in a short period of time. Approval could then be given “in a matter of weeks”, depending on “whether the data presented is sufficiently robust, and whether more information is needed to support the assessment”.
This accelerated schedule is possible because the EMA’s Committee for Medicinal Products for Human Use (CHMP) has already initiated a review of data on the medicine during an ongoing review. The review included data from laboratory studies, animals, and clinical, as well as data on the quality of the medicine.
Interim results were also evaluated by the CHMP of the main study on the use of ‘Paxlovid’ in non-hospitalised, unvaccinated patients, affected by Covid-19. These were patients who had symptomatic disease and at least one underlying condition that put them at risk of having a serious illness.
‘Paxlovid’ is an oral antiviral medication that reduces the ability of SARS-CoV-2 to multiply in the body. The active principle PF-07321332 blocks the activity of an enzyme necessary for the virus to multiply.
Paxlovid also provides a low dose of ritonavir, which slows down the breakdown of PF-07321332, allowing it to stay in the body for longer at levels that affect the virus. The forecast is that ‘Paxlovid’ will reduce the need for hospitalisation of patients with coronavirus.
Pedro Sanchez, the President of the Government, already mentioned this Monday, January 10, in an interview on Cadena SER, that Spain will buy 344,000 doses of this antiviral that Pfizer is manufacturing in January, that, as he explained, “reduces the possibility of hospitalisation of vulnerable patients by 88 percent”, as reported by mallorcadiario.com.

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Written by

Chris King

Originally from Wales, Chris spent years on the Costa del Sol before moving to the Algarve where he is a web reporter for The Euro Weekly News covering international and Spanish national news. Got a news story you want to share? Then get in touch at editorial@euroweeklynews.com

Comments

    • Naimah Yianni

      11 January 2022 • 08:52

      Something that could have been done by the use of ivermectin for the last 2 years, but of course, that is an old, cheap drug…..say no more

    • Naimah Yianni

      11 January 2022 • 08:52

      Something that could have been done by the use of ivermectin for the last 2 years, but of course, that is an old, cheap drug…..say no more

    • M

      11 January 2022 • 13:58

      Antiviral drugs have always been available, however politics muscled in to suppress the medical use of these. however now is the time to embrace ALL antivirals Medication, to put an end to the madness of covid passports which have clearly shown they they DON’T work, and have virus bleed through problems as the covid virus mutates further leading to passing on the virus anyway with reduced (down to 10%) protection.

    • M

      11 January 2022 • 13:58

      Antiviral drugs have always been available, however politics muscled in to suppress the medical use of these. however now is the time to embrace ALL antivirals Medication, to put an end to the madness of covid passports which have clearly shown they they DON’T work, and have virus bleed through problems as the covid virus mutates further leading to passing on the virus anyway with reduced (down to 10%) protection.

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