The World Health Organisation has approved the Bharat Biotech COVAXIN. The Biotech COVAXIN on Tuesday was approved as an Emergency Use Listing.
The approval of this vaccine is an addition to the number of vaccines approved for the prevention of COVID-19.
The WHO’s EUL procedure assesses the quality, safety and efficacy of the COVID-19 vaccines. This is a standard prerequisite for COVAX vaccine supply.
Also, this enables countries to expedite their own regulatory approval. The approval is to import and administer COVID-19 vaccines.
Speaking with the press, the WHO Assistant-Director General for Access to Medicines and Health Products, Dr Mariangela Simao spoke about the vaccines.
His words, “this emergency use listing expands the availability of vaccines, the most effective medical tools we have.
“But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”
The Technical Advisory Group determines what vaccine meets the standard. This group convened by the WHO is made up of regulatory experts around the world.
The vaccines must meet the WHO standards for protection against COVID-19. The benefits of the vaccine must also outweigh the risks and they can be used globally.
The vaccine is derived from an inactivated SARS-CoV-2 antigen. and is presented in single-dose vials and multidose vials of 5, 10, and 20 doses.
“COVAXIN was also reviewed on October 5 by WHO’s Strategic Advisory Group of Experts on Immunisation, which formulates vaccine-specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).
“The SAGE recommended the use of the vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above. COVAXIN® was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.
“Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,” WHO noted in a press statement.
Source: PUNCH HealthWise.