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Paxlovid, the flop of the anti-Covid super drug

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Paxlovid, the flop of the anti-Covid super drug

Announced as a miracle weapon to fight Covid if the vaccine failed, the aniviral was purchased in 600,000 doses in Italy alone at huge costs. But only 20% used it also because in the meantime they learned to treat with anti-inflammatories. And Pfizer is now taking remedial measures by “correcting” the leaflet on expiration and conservation.

It was announced a year ago as the “magic pill”, the drug that would give the final blow to Covid: it is the Paxlovid, the antiviral released from Pfizer factories. Of course it shouldn’t have been an alternative to the vaccine, but to complete its work. In fact, if despite the various doses of mRNA serum a patient had still contracted Covid (a possibility which actually occurred in hundreds of thousands of cases) the super drug that would have defeated the virus would have been ready.

Albert Bourla, president and chief executive officer of Pfizer“We designed the clinical development program for Paxlovid to be comprehensive and ambitious with the goal of being able to help combat COVID-19 in a very large patient population,” he said. The drug was approved and licensed for conditional or emergency use in more than 60 countries worldwide for the treatment of patients at high risk of developing serious disease. From the outset, however, it was clear that it was a drug that had not already given particularly significant results in tests prior to its marketing and that it presented important side effects, especially precisely in the most fragile categories (such as, for example, heart patients) for which it should have been specifically intended.

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Therefore, one year after its introduction in therapeutic use, disconcerting data emerge.

Data from the monitoring activated by the Italian Medicines Agency (Aifa) on the use of the drug Paxlovid, of which the Italian Government purchased 600,000 doses last year, as of March 7, approximately 120,000 patients have been treated with this therapy. Equal to 20% of the entire huge game purchased by Draghi, Speranza and partners.

The Government had decided that the drug should cost nothing to the patient, and was then distributed to pharmacies and nursing homes. The cost was totally borne by the State, and it was not indifferent: a cure for 5 days was equivalent to 700 euros. Why was this drug – which had been widely advertised – and about which doctors had been adequately sensitized through webinars, meetings, information material, so little used?

For different reasons. Dr. Pierluigi Bartoletti, deputy secretary of the Italian Federation of General Practitioners (Fimmg) in an interview stated that the problem was the lack of familiarity in identifying and classifying subjects at risk of serious illness, those for whom this medicine is indicated . Therefore, the blame is placed on the managers – technicians and politicians – of the pandemic, who should have provided more detailed protocols. A rather weak justification.

But criticisms of the current top health officials also come from Fimmg: there is a lack of clarity – it is said – in the political indications on whether or not to consider Covid still as a priority and an emergency. One could reply to colleagues who express these complaints, that it is certainly not the politicians, in the first place, who have to decide on the matter, but it is from the doctors, from the clinical data, from the epidemiological data that the decisions to be taken are evaluated.

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In recent days, for example the Lombardy Region declared that the Intensive Care Units are empty of Covid patients. Evidently the epidemic conditions have changed a lot, and those who are general practitioners should have realized this, as well as the therapeutic opportunities (which, moreover, were there from the beginning) to effectively treat Covid. But perhaps this concept is still not clear enough.

Bartoletti in fact, hoping for a greater use of Paxlovidargues that «it has remained the only weapon against Covid-19, after the Molnupiravir it was suspended from use due to lack of efficacy, and monoclonal antibodies were equally poorly effective». A very significant public admission, that on monoclonal antibodies and other antivirals. In the meantime, however, several studies have come out on the efficacy of other simple drugs such as anti-inflammatories, thus without having to resort to Paxlovid whose real efficacy and safety is yet to be verified.

But there’s one last worrying aspect to this huge one surplus of the drug unexpectedly purchased in an abnormal quantity: the expiry date. But once again an at least nonchalant solution is being proposed: the arbitrary lengthening of expiry times. Pfizer was able to extend the expiration date of the lots of the antiviral for use in Italy by 6 months. In a communication sent to prescribers last February, we read: «We would like to inform you that the pack of Paxlovid that has been delivered to you has an outdated expiry date on the pack. Therefore, if the expiry date has passed to date, this does not mean that the product is to be considered expired. In fact, on 24 January 2023 the European Medicines Agency (EMA) approved a new shelf life for Paxlovid extending it from 18 months to 2 years. This means that packages with an expiry date between November 2022 and November 2023 on the box and blister remain valid for a longer period than the printed expiry date. This extended shelf life applies to medicine manufactured after the approval date of the current change, as well as retrospectively to all batches of Paxlovid manufactured before the approval date of January 24, 2023».

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Another interesting element is that with the approval of the new validity period, the storage conditions have also been changed. The statement “Do not store above 25°C. Do not refrigerate or freeze” was changed to: “This medicinal product does not require any special storage conditions”.

Just a stroke of the pen and everything is resolved. So now for another six months you can prescribe great. Assuming that there are still cases to do so. Assuming all of this is correct.

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