WHO recognizes India’s indigenously developed vaccine COVAXIN
COVAXIN has been found to have 78 percent efficacy against COVID19 of any severity
The World Health Organization on Wednesday granted Bharat Biotech made COVAXIN, an emergency use listing (EUL), thereby giving a shot in the arm of Indian scientists who manufactured the first indigenously developed vaccine.
“WHO has granted emergency use listing (EUL) to #COVAXIN® (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of #COVID19,” the WHO tweeted.
This means made-in-India vaccine will be recognized by foreign countries and Indians who have received COVAXIN shot will not undergo self-quarantine or face restrictions while travelling abroad.
As per the WHO, the emergency use listing (EUL) is done by a Technical Advisory Group, which is an independent advisory group that provides a recommendation to the United Nations health agency whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions.
The Technical Advisory Group-EUL, as per WHO, will have following functions: To review the assessment reports prepared by the WHO Product Evaluation Group (PEG) as part of the EUL assessment process, including the initial evaluation and any updates based on additional information received by the WHO.
The UN health body further said that additional information may be requested from the WHO for consideration to conduct a risk-benefit assessment of these Covid-19 vaccines’ potential use in response to the Covid-19 pandemic; to provide a recommendation to WHO if the assessed vaccine should be listed for emergency use under the EUL procedure, and under what conditions; to advise on formulating conditions for the listing should the decision be positive. Conditions will include a detailed list of post-listing commitments from the manufacturer; to consider any emergency program needs as applicable.
“COVAXIN was found to have 78 percent efficacy against COVID19 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,” the WHO said in another tweet.
The UN health body also said that the Covexin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.
However, the WHO said available data on vaccination of pregnant women with the Covaxin 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’s EUL procedure assesses the quality, safety and efficacy of COVID19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines,” the UN health body said.