Finally, WHO includes Covaxin in its emergency use list for COVID-19 vaccines – The New Indian Express
Express news service
NEW DELHI: The World Health Organization on Wednesday granted an emergency use list for Bharat Biotech’s COVID-19 vaccine, Covaxin, after months of detailed review of data from its clinical trials and process for vaccine development.
This brings good news to millions of vaccinated, with international travel plans for many in limbo as the WHO’s non-approval meant most countries did not recognize them as having been “vaccinated.” Against COVID-19.
The WHO EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for the procurement of COVAX vaccines, allowing countries to expedite their own regulatory approval to import and administer vaccines.
“WHO has granted an Emergency Use List (EUL) to Covaxin (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19,” said the agency said in a statement.
He added that the technical advisory group, convened by WHO and composed of regulatory experts from around the world, determined that Covaxin meets WHO standards for protection against COVID, that the vaccine benefits it. far outweigh the risks and can be used around the world.
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“This emergency use list expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariângela Simão, WHO Assistant Director-General for Access to Medicines. drugs and health products.
“But we must keep up the pressure to meet the needs of all populations, prioritizing at-risk groups who are still waiting for their first dose, before we can start claiming victory.”
Covaxin, formulated from inactivated SARS-CoV-2 antigen and presented in single dose vials and multidose vials of 5, 10 and 20 doses, has been evaluated according to the WHO EUL procedure based on review of data on quality, safety, efficacy, risk management plan and programmatic adequacy.
The vaccine was also reviewed on October 5 by the WHO Strategic Advisory Group of Experts on Immunization, which formulates vaccine-specific policies and recommendations for vaccine use in populations with details such as recommended age groups, intervals between doses, specific groups such as pregnant and lactating women.
SAGE has recommended the use of the vaccine in two doses, with an interval of four weeks, in all age groups 18 years and older.
This vaccine has been shown to be 78% effective against COVID-19 of any severity, 14 days or more after the second dose, and is extremely suitable for low- and middle-income countries due to the easy storage requirements, a said the United Nations health agency.
He added, however, that the data available on immunizing pregnant women with the vaccine is insufficient to assess the safety or effectiveness of the vaccine during pregnancy; studies in pregnant women are planned, including a pregnancy substudy and a pregnancy registry.
The WHO EUL procedure assesses the suitability of new health products during public health emergencies. “The objective is to make drugs, vaccines and diagnostics available as quickly as possible to deal with the emergency while respecting strict criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefits that would arise from using the product against the potential risks.
The EUL path involves a rigorous evaluation of data from late phase II and phase III clinical trials, as well as substantial additional data on safety, efficacy, quality and a risk management plan.
As part of the EUL process, the company producing the vaccine must commit to continuing to generate data to enable full approval and WHO prequalification of the vaccine.
Incidentally, WHO’s recognition of Covaxin comes on a day when India’s drug regulator approved its request to extend the shelf life from six months to 1 year, which will go a long way to helping private hospitals drain their stockpiles of. vaccine.
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