WHO Done It! Bharat Biotech's Covaxin gets the go-ahead for global emergency use listing
Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V
The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-19 vaccine Covaxin.
The WHO tweeted:
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. pic.twitter.com/dp2A1knGtT
— World Health Organization (WHO) (@WHO) November 3, 2021
This comes after Prime Minister Narendra Modi had pushed for Covaxin approval at G20 with WHO director-general Dr Tedros Adhanom Ghebreyesus, sources told News18.
Emergency Use Listing (EUL) is a procedure to streamline the process by which new or unlicensed products can be used during public health emergencies, according to WHO guidelines. The approval for the made-in-India vaccine was much awaited, especially by students, medical tourists, business travellers and people, who have international travel plans.
Bharat Biotech had submitted all the necessary documents required for the EUL on 9 July. The Emergency Use Listing nod to Bharat Biotech’s Covaxin, which was found to have 78% efficacy against COVID-19 of any severity, expands the availability of vaccines - the most effective medical tools to end the pandemic, a top World Health Organisation official said on Wednesday.
On Wednesday, WHO issued an emergency use listing (EUL) for Covaxin, adding to a growing portfolio of vaccines validated by the UN health agency for the prevention of COVID-19 caused by SARS-CoV-2. "This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.
"But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory."
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. WHO Director-General Tedros Adhanom Ghebreyesus said that he is “glad” to see Covaxin get the Emergency Use Listing approval, as he underlined that the more products the world has to fight the coronavirus pandemic, the better it is.
"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 said in a tweet.
Following the EUL approval for Covaxin, manufactured by Bharat Biotech, WHO Chief Scientist Soumya Swaminathan said in a tweet "One more vaccine gets @WHO emergency use listing. Congratulations India @BharatBiotech @ICMRDELHI @MoHFW_INDIA for successful development of indigenous vaccine #Covaxin as well as for a massive vaccination program!.”
"Congratulations India for Emergency Use Listing of its indigenously produced #COVID19 vaccine COVAXIN,” WHO South East Asia Regional Director Poonam Khetrapal Singh said in a tweet. Union minister Mansukh Mandaviya, reacting to the development, tweeted:
यह समर्थ नेतृत्व की निशानी है, यह मोदी जी के संकल्प की कहानी है, यह देशवासियों के विश्वास की ज़ुबानी है, यह आत्मनिर्भर भारत की दिवाली है। Thanking @WHO for granting emergency use listing ( EUL) to Made-in-India #Covaxin — Dr Mansukh Mandaviya (@mansukhmandviya) November 3, 2021
Speaking to India Today, vaccine panel chief VK Paul said, ""Yes, it is very apt that we have a gift from WHO."
The TAG on 26 October had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
"The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin," a source told PTI. The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a COVID-19 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. 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.
This comes on the same day that Covaxin was granted an extension of shelf life for up to 12 months from the date of manufacture, as per a statement from Bharat Biotech. The approval of extension of shelf life by the Central Drugs Standard Control Organisation (CDSCO) was based on the "additional stability data", Bharat Biotech said in a tweet.
The shelf life extension has been communicated to "our stakeholders," it added. The development comes after several Indians complained of travel difficulties due to Covaxin not being recognised for international travel by several countries.
Recently at the G-20 Summit in Rome, Prime Minister Narendra Modi said India will be able to produce over 5 billion vaccine doses next year to help the world in the fight against the pandemic. Earlier this year, Bharat Biotech had written to the Drugs Controller General of India (DCGI) seeking extension of the shelf life of the indigenously developed vaccine from six to 24 months.
Covaxin is one of the six vaccines that have received emergency use authorisation from India's drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.
The WHO in October had said it "cannot cut corners” before recommending a vaccine for emergency use and emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
With inputs from PTI
“After dodging COVID-19 for two years, in the 3rd year of 2022 the stubborn Omicron variant has finally infiltrated my immune system. I tested positive last night. Please be safe and take care of yourselves diligently. This is a very contagious one. #Willfightthis,” Sussanne Khan, who is the ex-wife of actor Hrithik Roshan, wrote.
WHO chief Tedros Adhanom Ghebreyesus said the record numbers of people catching the new variant meant hospitals were being overwhelmed.
But WHO senior emergencies officer Catherine Smallwood sounded an ominous note of caution, telling AFP that the soaring infection rates could have the opposite effect.