France canceled your order for the antiviral drug COVID-19 from Merck & Co after disappointing trial data and hopes to receive the competing drug from Pfizer before the end of January, the Health Minister said on Wednesday.
France is the first country to say publicly that it has canceled an order for Merck’s treatment after the company released data in late November that suggested its drug was markedly less effective than previously thought, reducing hospitalizations and deaths. in his clinical trial of high-risk people about 30%.
“The latest studies weren’t good,” he said. Olivier veran to BFM TV.
A Merck spokesman said the country’s planned purchase did not take place after the French health authority refused to authorize the pill earlier this month.
The company said it continued to work with the European Medicines Association (EMA) on its regulatory review of the medicine. It has agreements to supply or sell the pill to more than 30 countries and has shipped products to 12.
While vaccines are the main weapons against COVID-19 for governments, there is hope that experimental pills from Merck and Pfizer could change the rules of the game to reduce the chances of death or hospitalization for people at higher risk of disease. serious.
France had pre-ordered 50,000 doses of the drug molnupiravir developed by Merck and Ridgeback Biotherapeutics.
The cancellation will incur no cost, Veran said.
Approval decision in France and other countries
In addition to France in Italy, the office of the special commissioner for the emergency of COVID-19 said on November 18 that it had received a mandate from the Ministry of Health to buy 50,000 courses of the pill of Merck and another 50,000 of that of Pfizer.
“The contract has not yet been finalized, but it is ongoing,” a spokesman for the commissioner told Reuters on Tuesday.
Nicola Magrini, Director of the Italian Drug Regulator Aifa told a Senate committee on December 9 that the two treatments could be available in Italy from the end of January.
However, regardless of the availability of the drugs, there will be evaluations of their use, two top government scientific advisers told Reuters.
“There must and will be an evaluation, regardless of the evaluations of the regulatory bodies,” Walter Ricciardi, chief adviser to Health Minister Roberto Speranza, told Reuters.
Germany has already bought the antiviral treatment from Merck, Health Minister Karl Lauterbach told Reuters on Wednesday.
“This is a binding order,” he said, adding that Berlin It was also in discussions with Pfizer about purchasing its antiviral drug.
The EMA is expected to decide whether to approve the Merck and Pfizer pills in the new year.
Paxlovid Pfizer has been shown to be close to 90% effective in preventing COVID-19 hospitalizations and deaths in high-risk patients.
France had bought that drug instead, Veran said, without saying how many doses it had obtained.
“France is ready to do it before the end of January,” Veran continued. It has not yet been decided whether the drug will be available without a prescription in pharmacies, the minister said.
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