Geneva [Switzerland], November 3 (ANI): The World Health Organisation (WHO), has granted approval for Emergency Use Listing (EUL) for Hyderabad-based Bharat Biotech’s COVID-19 vaccine, Covaxin.
Earlier, the WHO panel had sought additional clarifications from the manufacturer of Covaxin, in order to conduct a final EUL risk-benefit assessment for global use of the vaccine.
The approval was done on the recommendation of the Technical Advisory Group (TAG) for Emergency Use Listing (TAG-EUL), an independent advisory panel that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.
Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent protection against the new Delta variant. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech’s Covaxin and AstraZeneca and Serum Institute’s Covishield are the two widely used vaccines in India.
Hyderabad-based Bharat Biotech‘s COVID-19 vaccine Covaxin has received an extension of shelf life for up to 12 months from the date of manufacturing on Wednesday by India’s pharmaceuticals and medical regulatory body. “The Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of COVAXIN up to 12 months, from the date of manufacture,” said Bharat Biotech in a statement posted by the biotechnology company on its official Twitter handle.
The company said, “Extension is based on the availability of additional stability data, which was submitted to CDSCO. The extension has been communicated to our stakeholders.”
WHO chief ‘glad’ to see Covaxin get WHO approval for emergency use
Geneva [Switzerland], November 3 (ANI): Director-General of the World Health Organisation Tedros Adhanom Ghebreyesus on Wednesday said that he was glad to see Hyderabad-based Bharat Biotech’s COVID-19 vaccine, Covaxin, get WHO approval for Emergency Use Listing (EUL).
“Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver #VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose,” Ghebreyesus tweeted.
The WHO granted emergency use listing for India’s indigenous vaccine Covaxin, adding to a growing portfolio of vaccines validated by the world health body for the prevention of COVID-19.
The WHO said in a tweet that the Technical Advisory Group, convened by World Health Organisation (WHO), has determined that the Hyderabad-based Bharat Biotech’s COVID-19 vaccine meets WHO standards for protection against COVID-19.
“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,” WHO said in a tweet.
“The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks and the vaccine can be used,” it added.
The global health body said that the Covaxin vaccine was also reviewed by WHO‘s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended the use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above.
“Available data on vaccination of pregnant women with the Covaxin vaccine is 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 said.
WHO approval will expedite Covaxin regulatory approval in other countries: Bharat Biotech
The approval of the World Health Organisation (WHO) for emergency use listing of Covid-19 vaccine COVAXIN, will lead to the expedition of regulatory approval of India’s indigenously made vaccine all across the world, said the vaccine manufacturer Bharat Biotech.
“The WHO‘s Emergency Use Listing (EUL) for COVAXIN facilitates countries to expedite their regulatory approval processes to introduce and administer India’s indigenously made COVID-19 vaccine developed and manufactured by Bharat Biotech,” said the press note released by Bharat Biotech.
The World Health Organisation (WHO) on Wednesday granted approval for Emergency Use Listing (EUL) for Covaxin.
“The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies, with the objective of providing rapid access to medicines, vaccines and diagnostics, while adhering to stringent criteria of safety, efficacy and quality,” reads the release.
Further, Dr Krishna Ella, Chairman and MD of Bharat Biotech said that “The validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious COVAXIN.”
“As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. The EUL authorisation for COVAXIN will enable us to contribute to accelerating the equitable access of the Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency,” added Dr Krishna Ella.
As per the official statement, the phase 3 trial data for COVAXIN was available during June 2021. The World Health Organisation (WHO) Emergency Use Listing (EUL) process commenced on July 6, 2021, with rolling data submission. The WHO‘s Strategic Advisory Group of Experts on Immunization (SAGE) had reviewed COVAXIN data on October 5 and granted EUL for the vaccine on November 3.
“Manufacturing capacity expansion was started during Q1 2021, as the first phase 3 efficacy readouts were available. Within a short period of nine months, the capacity was scaled up to 50-55 million doses per month, as of October 2021.
Bharat Biotech has established COVAXIN manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are also in progress to companies in India, the United States, and other countries,” added the official statement.
Meanwhile, India’s cumulative vaccination coverage crossed 107 crore. The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson – Janssen, Moderna, and Sinopharm for emergency use. (ANI)
