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Saturday, May 28, 2022

Costa Rica Authorizes sale of Paxlovid as treatment for COVID-19

The Costa Rican Ministry of Health authorized the emergency use of Pfizer’s Paxlovid 150/100 mg capsules.

Paxlovid is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who have a high likelihood of developing severe COVID-19. The recommended dose in adult patients is 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet), taken simultaneously by mouth twice daily for 5 days with or without food.

It should also be administered as soon as possible after a positive direct viral test for SARS-CoV-2 and within 5 days of the appearance of symptoms.

On November 5th 2021, Pfizer issued a statement regarding the study on Paxlovid: “today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations.”

In December 2021, the FDA issued an emergency use authorization for Pfizer’s Paxlovid. The entity clarified it was not approved for the prevention of COVID-19 and it was not a substitute for vaccination.

The World Health Organization (WHO) also endorsed the use of Pfizer’s antiviral treatment in high-risk patients and insisted on vaccination.

“These therapeutics do not replace vaccination. They just give us another treatment option for those patients that do get infected that are at higher risk,” said Janet Diaz, WHO lead on clinical management.

According to the Ministry of Health, the entity is not involved in the importation period of the medication and is not responsible of establishing the price of the treatment in the country.

In addition to this treatment, Molnupiravir 200 mg capsules from Merck Sharp & Dohme Corp. were authorized on February 23rd, 2022 by resolution MS-DRPIS-AUE-M-01-2022.

As part of the authorization, Pfizer Free Trade Zone S.A. must ensure records of drug distribution (i.e., lot numbers, quantity, date and destination), as well as submit monthly reports of possible adverse or safety events.

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