Despite not being approved yet, European Union countries could already be acquiring Paxlovid, Pfizer’s drug against Covid for patients who are at risk of progressing to a severe stage of the disease, after the European Agency for Medication (EMA) will guarantee its emergency use. However, the community patients are not yet accessing this drug, unlike those in the United States, or the United Kingdom in the case of molnupiravir (MSD’s anticovid pill). Why?
As EL ESPAÑOL-Invertia has learned from sources close to the negotiation between the company and the EU countries, there would not be enough stock of the drug to supply these territories until January.
Consulted by this means, Pfizer does not confirm this information, although it does not deny it either. Of course, the company claims to be taking measures to supply in the coming months.
“In anticipation of possible regulatory clearance or approval, Pfizer began manufacturing Paxlovid earlier this year and expects to produce more than 180,000 treatment cycles by the end of 2021, and up to 80 million treatment cycles by end 2022 for global supply“They indicate from the multinational.
It should be remembered that despite the fact that the drug does not have the full approval of the EMA, the member countries they could already turn to him Through the processes enabled for the acquisition of medicines not authorized (yet) by the Agency.
As this media has learned, this would be the procedure that Spain would resort to to acquire Paxlovid. In fact, the Spanish Agency for Medicines and Health Products (Aemps) would be prepared to turn to him as soon as a public body requests it (which would be the one that would pay the cost of the drugs, which would have to be negotiated with the company as it does not have an approved price in Spain)… and Pfizer has the capacity to supply this antiviral.
By the time there is supply, the European Commission is negotiating with member countries the possibility of drive a new centralized purchase, but it will be different from that of vaccines against Covid. In the case of antigens, purchases were anticipated. In this case, it will wait for the EMA to give its approval before closing them.
The new antivirals in the US and the UK
The U.S. Food and Drug Administration (FDA) emergency authorized the purchase and distribution of the new antivirals, Paxlovid from Pfizer and Molnupiravir from Merck & Co and Ridgeback Biotherapeutics, in the days leading up to Christmas. Batches of medications are already being distributed by clinics across the country.
The main argument in favor of granting conditional permits was that the monoclonal antibody therapy, so far recommended in severe COVID-19 patients or at risk of hospitalization, was showing lower efficiency compared to cases caused by omicron. A week later, the World Health Organization (WHO) confirmed the resistance of the disease caused by the new variant to these treatments.
The United States expects to receive doses for 265,000 treatment cycles through January, and is counting on receiving en the next six months a total of ten million doses. Each cycle of treatment will be priced at $ 530, half the cost of therapy with monoclonal antibodies according Thomson Reuters.
If to this is added the treatment with remdesivir, the only antiviral authorized to date in the US and popularized by former President Donald Trump, the combined cost of both drugs has risen to as high as $ 5,000 for private insurance users. Paxlovid is only licensed on prescription at this time, although Pfizer has already announced that it will seek full regulatory approval throughout 2022.
It can be prescribed to adult patients and children from the age of 12 who are in the first stages of the disease but run the risk of developing unfavorably. They should be taken as soon as possible after the positive diagnosis or in the first five days after the presentation of symptoms, with a schedule of one pill every 12 hours for fivedays.
Pxlovid is really a combination of drugs: the new antiviral PF-07321332 and ritonavir, an antiretroviral used for HIV. The latter is contraindicated in some circumstances, such as kidney disease, but Pfizer has suggested that these patients could reduce incompatible medication during treatment justifiably, taking into account the percentage of reduction in the risk of hospitalization for severe Covid – 90% – that the trials demonstrated.
The contract with Merck for Molnupiravir, on the other hand, is for 5 million treatments at a price of $ 700 per unit. The United Kingdom was the first country to approve its emergency use in early November and purchased half a million doses before learning that its effectiveness was reduced from 50% to 30%. Like Paxlovid, it should be taken during five days from symptom onset and it is being given as an experimental treatment to people with conditioning risk factors for severe Covid, such as asthma or diabetes.