Covid: Paxlovid receives definitive registration from Anvisa – 01/06/2024 – Health

Pfizer’s Covid drug, Paxlovid, received definitive registration from Anvisa (National Health Surveillance Agency) on December 29th. Previously, its use had been approved on an emergency basis, in March 2022, during the most critical phase of Covid-19.

In the same year, the medicine had already been incorporated into the SUS (Unified Health System) through Conitec (National Commission for the Incorporation of Technologies into the SUS), linked to the Ministry of Health. Its sale in pharmacies has also been authorized since 2022.

According to the agency, emergency registration is granted for medicines and vaccines with restricted use in the population, generally for well-defined risk groups. There is also the possibility of incorporating new recommendations for emergency use based on scientific studies still in progress.

Now, with definitive registration, the medicine can be used by the entire population and no longer has its criteria in the leaflet changed.

The pill, composed of two antivirals (nirmaltrevir + ritonavir), works by blocking the replication of Sars-CoV-2 in cells. Its effectiveness has been proven in clinical studies with an 89% reduction in the risk of hospitalization and around 44% in the risk of death in vaccinated people over 50 years of age.

Paxlovid administration consists of one tablet, 400 mg each, twice a day, for five days. According to Anvisa, use should not be longer than five days and is also not recommended for pregnant women or patients with severe kidney failure.

Studies carried out abroad indicate the effectiveness of Paxlovid in protecting people at higher risk of severe illness, such as immunocompromised people, and at risk of death or hospitalization up to 28 days after infection.

In individuals with a lower risk, such as those aged 70 or over who were not vaccinated, there was no significant reduction in the risk of hospitalization and death.

Last Thursday (4), a study published in the Journal of Medical Virology showed that the use of Paxlovid in the first days of infection in vaccinated individuals without the need for hospitalization reduced the risk of developing long Covid in the 90 days after Covid.