CDSCO has approved the extension of shelf life of Covaxin up to 12 months from the date of manufacture
New Delhi: The World Health Organisation (WHO) on Wednesday granted emergency use approval for Bharat Biotech's COVID-19 vaccine Covaxin, in a move that the pharma major said is a "significant" step towards ensuring wider global access to the indigenously developed jab.
The announcement by the WHO came after the Technical Advisory Group (TAG), an independent advisory committee of the world body recommended Emergency Use Listing (EUL) status for Covaxin, and days after the TAG sought "additional clarifications" from Bharat Biotech on October 26 to conduct a final "risk-benefit assessment" of the vaccine for global use.
Bharat Biotech, meanwhile, said 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. It was initially given permission for the sale and distribution of Covaxin with a shelf life of six months, which was later extended to nine months, a company spokesperson told PTI.
Thanking the WHO for granting the licence to Covaxin, Union Health Minister Mansukh Mandaviya said the achievement is a "sign of capable leadership and Modi ji's resolve, a tale of people's trust and this is Diwali of self-reliant India".
"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 COVID-19," the global health body said in a tweet.
The WHO said the TAG convened by it and made up of regulatory experts from around the world determined that Covaxin meets its standards for protection against COVID-19, and that the benefit of the vaccine far outweighs risks and thus can be used.
In another tweet, it said Covaxin 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.
Dr Poonam Khetarpal Singh, Regional Director of WHO South East Asia, in a tweet, said, "Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine Covaxin."
Bharat Biotech said that with the validation from the WHO countries can now expedite their regulatory approval processes to import and administer Covaxin.
United Nations Children's Fund (UNICEF), Pan-American Health Organisation (PAHO) and GAVI COVAX facility will also be able to procure Covaxin for distribution to countries worldwide, Bharat Biotech said.
"Validation by WHO is a very significant step towards ensuring global access to India's widely administered, safe, and efficacious Covaxin," Bharat Biotech Chairman and Managing Director Krishna Ella said.
As an organisation, Bharat Biotech has focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO and as a result many of its vaccines have received WHO prequalification, he added.
"The EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency," Ella said.
Covaxin has been specifically designed to meet the needs of global distribution chains, the requirements for which are more critical in low and middle-income countries, Bharat Biotech said.
The vaccine has been formulated to enable shipping and long-term storage at 2-8 degrees Celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike, the company added.
"The WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level," Bharat Biotech Joint Managing Director Suchitra Ella said.
The global health body, however, said that available data on vaccination of pregnant women with the Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy.
"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," the WHO said in a series of tweets.
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, it said.
"Covaxin EUL expands the availability of Syringe, the most effective medical tools we have to end #COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income countries," it stated.
WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 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 EUL procedure assesses the suitability of novel health products during public health emergencies. The aim is to make medicines, vaccines & diagnostics available as rapidly as possible while adhering to stringent criteria of safety, efficacy & quality.
"The Technical Advisory Group for Emergency Use Listing is an independent advisory group that provides a recommendation to WHO whether an unlicensed vaccine can be recommended for emergency use under the EUL procedure, and if so, under what conditions," the WHO said.
Before the WHO announcement, a source told PTI: "The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin."
Prime Minister Narendra Modi had met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit in Rome recently.
Besides demonstrating 77.8 per cent effectiveness against symptomatic COVID-19, Covaxin has shown 65.2 per cent protection against the new Delta variant.
In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.