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

Pfizer’s oral antiviral pill used against COVID-19, Paxlovid, was rejected by the US but has been approved for use in Spain and the rest of Europe.
The European Medicines Agency (EMA) has just given the green light to Pfizer’s oral antiviral pill, Paxlovid. This is the first antiviral in the European Union set to be used to prevent vulnerable people from becoming severely infected with COVID-19.
The EMA has recommended the use of the pill “in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe”.
This approval comes just after the United States Food and Drug Administration (FDA) withdrew two experimental monoclonal therapies from the list of approved treatments on the market. Tests found that the treatments were not effective against omicron, which led the American experts to recommend their withdrawal. They also rejected the use of Paxlovid for the time being
Ana Luzuriaga, the representative of Pfizer Spain, explained that “the Committee for Medicinal Products for Human Use (CHMP) based its decision on the positive results of the provisional phase-two analysis performed on adults hospitalised with confirmed COVID-19 who were at risk of becoming seriously ill”.
Another Pfizer representative commented that “the data shows a reduction of 89% in the risk of COVID-19-related hospitalisation or death in patients treated with our antiviral in comparison with those who received the placebo”.
The drug has reached Spain and the EMA has approved it, but this does not mean that it will start to be distributed yet. María José Escribano, director of the Official School of Pharmacists, warns that “a mass purchase is anticipated on a European level, which would include Spain”, and “there are still a few steps left to take”.
Escribano also stated that “we will evaluate the reason why they have decided not to put it on the market for the time being and why they have here”.
“It appears to work against omicron, but we would need to see the fact sheet of the medication to see if it is really true,” concluded Escribano.
The FDA has stated that despite removing the pill from the market, it is likely that they will authorise it again if it is shown to be effective against any new variants that arise.
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