Indian lab files for clearance in Brazil of covid-19 vax
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- 02 May 2022
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Brazil's National Health Surveillance Agency (Anvisa) has announced it had received this week the request for registration of a COVID-19 vaccine that uses recombinant protein technology.
The application has been submitted by Zalika Farmacêutica Ltda., the local representatives in Brazil of India's Serum Institute, the developers of the Covovax drug, which is intended for people over 18 years of age.
”The protocol was received on Wednesday (April 27) and is already being evaluated by the technical areas involved. The deadline for the Agency's analysis is 60 days,” Anvisa said Friday in a statement.
According to Oswaldo Cruz Foundation (FioCruz) sources quoted by Agencia Brasil, recombinant vaccines use the technology of a non-replicating viral vector of chimpanzee adenovirus. The genome is genetically manipulated so that it can no longer replicate and then they insert the SARS-CoV-2 spike protein gene. Once obtained, the adenoviruses are amplified in large numbers using modified cells to allow amplification of the adenovirus and production of the vaccine in disposable bioreactors. These adenoviruses are purified, concentrated, and stabilized to make up the final vaccine. The vaccine goes through rigorous quality control before being sent to health clinics.
According to Friday's issue of Fiocruz's Covid-19 Observatory Bulletin, the pandemic is not over and the risks are still present. The publication carries data from April 10 to 23, during which period an average of 14,000 daily cases were registered nationwide, a 36% decrease compared to the previous fortnight.
There were also about 100 deaths per day, close to the number at the beginning of the first epidemic wave in April 2020, a 43% drop from the previous two weeks.
The Fiocruz researchers advocate short-, medium-, and long-term planning, which includes training epidemiology teams, introducing surveillance strategies for Severe Acute Respiratory Syndromes (SARS) associated with COVID-19, and strengthening monitoring to detect and characterize new variants. Read More...
