The use of the Zifivax vaccine from the Chinese pharmaceutical Chongqing Zhifei Biological Products was also given way.
The agency that regulates the use of medicines in Colombia authorized this Friday the use of molnupiravir, a pill to treat the coronavirus, developed by the pharmaceutical company Merck Sharp & Dohme.
The National Institute for Food and Drug Surveillance (Invima) said in a statement that it approved “the request for the Emergency Use Health Authorization (Asue) of the drug molnupiravir” to treat “patients with mild to moderate covid-19 disease.”
The Specialized Chamber, Invima’s expert advisory body, explained that the approval came after evaluating “scientific data, finding an acceptable risk-benefit balance at the current time of the pandemic, so it is approved with some special characteristics for its indication”.
The drug will only be supplied under medical prescription to older people with mild to moderate disease and who have not been vaccinated. In addition, the contagion must have been confirmed by a PCR or antigen test.
Likewise, these people cannot have previously presented the disease and must have at least one risk factor for developing severe covid-19 such as obesity, being over 60 years of age, chronic kidney disease, chronic obstructive disease or active cancer.
Chinese vaccine approved
Likewise, Invima yesterday authorized the use of the Zifivax vaccine against the coronavirus from the Chinese pharmaceutical company Chongqing Zhifei Biological Products, which does not have the approval of either the World Health Organization (WHO) or the European Medicines Agency (EMA). ).
According to Invima, ongoing phase III clinical studies, which include 28,500 volunteers, confirmed that the vaccine is 81.76% effective within two weeks of applying three doses of it.
Other results indicated that there were no major problems in relation to adverse events with respect to the group that received the vaccine, according to Invima.
The complete schedule for this vaccine would be three doses. After the first, the second should be placed the following month. These biologicals may only be applied to people over 18 years of age. (I)
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