SUMMARY:
WHO grant of EUL will ease international travel for those vaccinated with the Bharat Biotech`s Covaxin and the WHO clearance is a significant step in Covaxin being accepted by foreign governments.
WHO grants Most-awaited emergency use listing to Bharat Biotech’s Covaxin
Bharat Biotech’s Covaxin has obtained the much anticipated Emergency Use Listing (EUL) from the World Health Organisation (WHO) in a development that comes as a relief for students, medical tourists, business travelers, and people who have international travel plans.
The WHO granted a EUL to Covaxin on November 3, after a risk-benefit assessment for global use of the company’s Covaxin vaccine. The WHO said in a tweet: “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’s approval is critical for citizens who wish to take up international travel in the near future. The delay has been a concern especially for students and business travelers.
So far, the WHO has recognized the Pfizer-BioNTech, AstraZeneca, Johnson & Johnson-Janssen, Moderna and Sinophram vaccines for emergency use. (See table: Vaccines with WHO EULs)
Covaxin demonstrated 77.8 per cent efficacy against symptomatic Covid-19 infection and a 93.4 per cent efficacy against severe symptomatic Covid19 infection.
WHO’s Technical Advisory Group (TAG), which met on October 26, sought additional clarifications from Bharat Biotech. Rolling data submission for Covaxin to the WHO began on July 6, and the company has been providing additional data as and when sought by the WHO.
TAG is an independent advisory group that provides recommendations to WHO on whether a Covid19 vaccine can be listed for emergency use under the EUL procedure.
On Monday Australia recognized Covaxin for the purpose of establishing a traveler’s vaccination status. Apart from Australia several other countries including Oman, Philippines, Mexico, Botswana, Cameroon, Guatemala, Guyana, Honduras, Iran, Mauritius, Myanmar, Nepal, Nicaragua, Paraguay, Zimbabwe, Oman, Iran, Nepal, Sri Lanka, UAE have allowed travelers inoculated with Covaxin.
Last week, the US Centres for Disease Control and Prevention had also recently put Covaxin on the list of qualifying Covid-19 vaccine candidates, under the category of “Participants in certain Covid-19 vaccination.”
Bharat Biotech said: “With validation from the WHO, countries can now expedite their regulatory approval processes to import and administer Covaxin. Furthermore, UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility, will be able to procure Covaxin for distribution to countries worldwide.”
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “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.”
India had thrown its weight behind locally manufactured Covid19 vaccines getting global recognition. Prime Minister Narendra Modi at a G-20 summit session in Rome on Saturday said that it was necessary that the WHO approves Indian vaccines “at the earliest”.
The EUL process is centred on determining if a manufactured product is quality-assured, safe and effective. The WHO Strategic Advisory Group of Experts on Immunization (SAGE) is centred on issuing evidence-based policy recommendations for the best use of vaccines against COVID-19.
Last month, in the SAGE review meeting, the Hyderabad-based vaccine maker made a 25-minute presentation before the SAGE working group on clinical data on Covaxin from phase-1, 2, 3 and post marketing studies on safety, immunogenicity, efficacy and effectiveness.
The presentation by Raches Ella, project lead, Covid19 vaccines, Bharat Biotech gave an outline of ongoing and planned studies on safety and effectiveness.
“Such product-specific recommendations are issued once a vaccine is authorized through a regulatory process, including the assessment of safety and efficacy from phase III clinical trials,” the spokesperson of WHO has said.
The EUL was long anticipated.
In May Bharat Biotech had said that it expects the EUL from WHO between July and September. The firm had submitted all the necessary documents for the EUL on July 9.
Later that month, Suchitra Ella, the company’s co-founder and joint managing director, had said that approval from WHO is not expected to be a “long-drawn process”.
“We are working closely with the World Health Organisation for the inclusion of Covaxin in its Emergency Use Listing. Approval from WHO is not expected to be a long-drawn process as the cell line and majority of our facilities have already been audited and approved by WHO for our other vaccines in the past,” Suchitra Ella had said in a tweet.
A source in India’s vaccine industry said, “Pfizer and Moderna got WHO EULs within six to nine weeks or so after they published their phase 3 clinical trial results. Bharat Biotech declared the results around July, and it’s been over 12 weeks or so. An inadequately drafted application can be a reason behind the back and forth between the company and the WHO.”
The person quoted above who is a senior executive at a vaccine maker also added that ‘back and forth’ with queries is part of the normal process of approval though. “In some cases it takes longer than usual. It is not a matter of concern,” he added.
| VACCINES WITH WHO EULs | ||
| Covid19 vaccine | Company | WHO EULs |
| BNT162b2/COMIRNATY Tozinameran | Pfizer-BioNTech | December 31, 2020 |
| AZD1222 Vaxzevria | AstraZeneca | February 15, 2021 * |
| Covishield (ChAdOx1_nCoV-19) | Serum Institute of India | February 15, 2021 |
| Ad26.
COV2. S |
Janssen | March 12, 2021 |
| mRNA-1273 | Moderna | April 30, 2021 |
| SARS-CoV-2 Vaccine (Vero Cell), Inactivated (lnCoV) | Sinopharm (1) | May 7, 2021 |
| COVID-19 Vaccine (Vero Cell), Inactivated/ CoronavacTM | Sinovac | June 1, 2021 |
WHAT IS COVAXIN?
Covaxin is an indigenous vaccine developed by Hyderabad-based Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune (NIV).
Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. Bharat Biotech’s Covaxin and Serum Institute’s Covishield are the two widely used vaccines in India.
About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Prequalifications. Located in Genome Valley in Hyderabad, India, a hub for global biotech research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer.