The World Health Organization (WHO) recommended this Wednesday (3) the emergency use of the vaccine against Covid-19 Covaxin, developed by the Indian laboratory Bharat Biotech. The immunizing agent is eighth on the list of Covid-19 vaccines that the WHO authorizes emergency use since the start of the coronavirus pandemic in March 2020.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single-dose vials and 5-, 10-, and 20-dose multidose vials.
Covaxin has been shown to have 78% efficacy against Covid-19 of any severity 14 or more days after the second dose, and, according to WHO, “it is extremely suitable for low- and middle-income countries due to easy storage requirements.”
The WHO recommended the use of the vaccine in two doses, with an interval between doses of four weeks, in all age groups above 18 years, as determined by the WHO Strategic Advisory Group of Immunization Specialists (SAGE, its acronym in English) .
Available data on the vaccination of pregnant women with the vaccine were insufficient to assess the safety or efficacy of the vaccine in pregnancy. But studies are being planned in pregnant women, said the WHO.
Approval Steps
The WHO procedure assesses the quality, safety and efficacy of Covid-19 vaccines and is a prerequisite for the supply of the vaccine in the Covax Consortium, which distributes vaccines to poor and developing countries. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
The Technical Advisory Group (TAG), convened by WHO and comprised of regulatory experts from around the world, has determined that Covaxin meets WHO standards for protection against Covid-19, saying that the benefit of the vaccine far outweighs the risks , indicating that the vaccine can be used globally.
Covaxin was also reviewed on October 5 by SAGE, which formulates specific policies and recommendations for the use of vaccines in populations, ie, recommended age groups, intervals between doses, specific groups such as pregnant and nursing women.
“This emergency use list expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariângela Simão, WHO Deputy Director General for Access to Medicines and Health Products.
“But we must keep up the pressure to meet the needs of all populations, giving priority to groups at risk that are still waiting for their first dose, before we start declaring victory”, he stressed.
Reference: CNN Brasil
