Brazil’s sanitary regulator Anvisa granted the temporary request for the emergency use of the vaccine developed by pharmaceutical firm Janssen, a subsidiary of Johnson and Johnson. The government has purchased 38 million doses of the inoculation.
Most directors based their votes on reports that benefits outweigh risks.
The vaccine may be administered to people aged 18 and older, with or without comorbidities. The inoculation’s reported general efficiency was 66.9 percent. Considering severe cases alone, the efficiency was 76.7 percent after 14 days, 85,4 percent after 28 days.
Unlike vaccines by other manufacturers, Janssen’s works with a single dose. This is the fifth vaccine approved by Anvisa, including both vaccines registered and those authorized for emergency use.
Anvisa’s Manager-General for Medications and Biological Products Gustavo Mendes said the studies and documents perused confirmed the efficiency and the adequate conditions for use in the combat against COVID-19.
The vaccine lasts up to three months if stored between 2ºC and 8ºC. After packages are removed from thermal storage, they have up to six hours to be used with the vaccine’s efficiency intact.
As part of the assessment of the vaccine’s production chain, the different locations where the inoculation or some of the supplies were developed were also evaluated.
Ana Carolina Araújo, manager-general for Inspection and Sanitary Surveillance, said that the data gathered cover eight locations within the jab’s production chain. “Plants’ physical structure as well as the activities and quality systems have proved satisfactory,” she stated.
Anvisa’s officials have also examined issues surrounding adverse risks, and possibilities were not detected beyond normal responses to the vaccination.
Manager Mendes mentioned that some of the items with less information are referred to as “uncertainties.” “Data must be generated to subsidize large-scale production. Not all manufacturing locations have their large-scale manufacture capacity well defined,” he noted.
Nonetheless, both Anvisa’s technical representatives and directors stated that benefits surpass risks.
The clinical trials did not gauge the jab’s efficiency against the new variants of the coronavirus. Therefore, demonstration in new clinical tests is still absent.
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