Fiocruz signs cooperation agreement with MSD for the production of the first antiviral against Covid-19 | Health

The Oswaldo Cruz Foundation (Fiocruz) announced this Thursday (5) that it has signed a cooperation agreement with the pharmaceutical company MSD for the production of a first oral antiviral against Covid-19 — see below who can take and which are the limitations.

The drug in question is Molnupiravir, approved for emergency use this Wednesday (4) by the National Health Surveillance Agency (Anvisa). The regulator had received the order to use the antiviral manufactured by Merck/MSD in November 2021.

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Fiocruz will be responsible for storing, administering, labeling, packaging, testing, releasing, importing and supplying the drug to the Unified Health System (SUS).

“The agreement also provides for the conduction of clinical trials, in partnership with the pharmaceutical company, for possible use in the prophylaxis of Covid-19, and the beginning of experimental studies to analyze the activity of the drug in other viruses also endemic in Brazil, such as dengue and chikungunya,” the foundation said on Thursday.

Molnupiravir has also received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK, the European Regulatory Agency (EMA) and the FDA (Food and Drug Administration), the US regulator. The drug is in use in 17 countries, according to Fiocruz.

According to Hugo Nisenbom, president of MSD in Brazil, the company had been “talking” with Fiocruz since the beginning of 2021 about a possible partnership.

“We are happy to take this first step to guarantee the Brazilian population access to an efficient drug that significantly reduces hospitalizations and 89% reduction in mortality”, he said. of Health as soon as possible”.

Undated image shows Merck’s molnupiravir tablet — Photo: Merck & Co.via AP

How does it work and who can take it?

According to Anvisa, the drug is indicated for adults who do not require supplemental oxygen and who are at increased risk of disease progression to severe cases and whose alternative treatment options approved or authorized by Anvisa are not accessible or clinically appropriate.

Molnupiravir, internationally known by the trade name Lagevrio, is an antiviral; It works by preventing the replication of the coronavirus.

The drug is for adult use, sold under medical prescription.

Its use is not recommended during pregnancy, breastfeeding and in women who may become pregnant and who are not using effective contraceptives. According to Anvisa, this is because laboratory studies in animals have shown that high doses of the drug can affect the growth and development of the fetus.

The Agency also clarifies that the drug is contraindicated for use for more than five days, for initiation of treatment in patients who require hospitalization due to Covid-19 and as a form of pre-exposure or post-exposure prophylaxis to SARS-CoV- two.

Also according to the regulatory entity, the drug must be used after medical evaluation and prescription and it does not replace vaccines against Covid.

“This is a very specific application drug, which will require constant monitoring and which, therefore, is not a panacea of ​​wide and unrestricted use in the case of the Covid-19 pandemic, where the vaccine is imposed as a flagship”, said the director-president of the Agency, Antônio Barra Torres.

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