Health

Indian COVID-19 vaccine approved by WHO |

COVAXIN, manufactured by the Indian company Bharat Biotech, has received WHO Emergency Use List (EUL) meaning it will soon be available to millions of people around the world.

The EUL process evaluates the quality, safety and efficacy of vaccines and is a prerequisite for their inclusion in the global solidarity initiative. COVAX

‘Maintain the pressure’

It also allows countries to expedite import and dose administration approvals from regulatory authorities.

“This list of emergency uses expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simau, WHO Assistant Director-General for Access to Medicines and Health Products.

“But we must continue to put pressure to meet the needs of all populations, giving priority to those at risk who are still waiting for their first dose before we can declare victory.”

COVAXIN has already been introduced in India, where authorities have approved its use since January, although, according to media reports, the third phase of clinical trials is still ongoing. Bharat Biotech later released data showing that the vaccine was about 78 percent effective.

Compliance with WHO standards

A WHO advisory group evaluated COVAXIN in accordance with the EUL procedure based on analysis of data on quality, safety, efficacy, risk management plan and programmatic suitability.

The vaccine has been determined to meet WHO standards for protection against COVID-19and received the green light for worldwide distribution.

Last month, COVAXIN was also reviewed by the WHO Strategic Advisory Group of Experts on Immunization (SAGE), which formulates specific vaccine policies and recommendations for their use.

SAGE recommends the use of COVAXIN in two doses four weeks apart for all age groups over 18 years of age.

Simple storage requirements

The vaccine was found to be 78 percent effective against COVID-19 of any severity 14 days or more after the second dose. It is also extremely suitable for low- and middle-income countries due to its ease of storage.

WHO stated that the available data on vaccination of pregnant women is insufficient to assess its safety or effectiveness in this population, although studies are planned.

Nearly 247 million cases of COVID-19 and more than five million deaths have been reported worldwide, according to the latest WHO data available.

The agency said there were more than three million new infections last week, a slight upward trend. Epidemiological news COVID-19, published on Tuesday.

The increase was driven by a six percent increase in weekly new cases in Europe, as all other regions reported declines or steady trends.




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