Explained: Why WHO's emergency usage listing is important for Bharat Biotech's COVAXIN

Editor's Note: This story was first published on 7 June 2021 and is being republished as Bharat Biotech is set to meet the WHO for its EUL meeting. The story has also been updated to show the new developments.

Indian pharma company Bharat Biotech is still waiting to be added to the World Health Organisation's Emergency Use Listing (EUL). They had begun the process in April and have submitted all the required documents. WHO still needs to analyse the data. A pre-submission meeting has been scheduled on 23 June to evaluate the indigenous COVID-19 vaccine Covaxin. During the meeting, the Hyderabad based company will get an opportunity to submit a summary on the overall quality of the shot.

It is important to note that the Phase 3 clinical trial data of the COVAXIN vaccine is yet to be released to the public. Currently, the company has submitted data from its Phase III trials to the Drugs Controller General of India (DCGI) over the weekend, states government sources.

Interim data of Phase 3 has been shared, and according to the company, the vaccine is 78 percent effective against the vaccine.

PTI reported that the WHO explained the process of the pre-scheduled meeting and said, "The pre-submission meeting does not include a detailed review of data or full study reports. However, an essential aspect of the meeting is the submission (at least two weeks in advance of the pre-submission meeting) of a completed QOS-PD (Quality overall summary product dossiers)."

Bharat Biotech has also begun testing the vaccine on children between the age of 2-18. A petition has been filed against it in the Delhi High Court, however, since the HC hasn't given any stay order, trials will continue as scheduled.

The Centre said that the country is looking forward to WHO's approval for Bharat Biotech's Covaxin.

Recently, during a press briefing, Niti Aayog member (health) VK Paul spoke about the WHO approval. He said, "We are working with both Bharat Biotech and WHO to make it happen. Data sharing is going on. We are very keen that this milestone is achieved as soon as possible."

Recently, the Hyderabad based company appraised the Central Government with its progress. During the discussion, the company's managing director V Krishna Mohan and his colleagues, along with senior officers of the Ministry of Health, Department of Biotechnology and Ministry of External Affairs and Foreign Secretary Harsh Vardhan Shringla were present.

Speaking to PTI, a source said, "BBIL is confident about obtaining WHO's emergency use listing."

Mint reported that Shringla, during his address to the WHO's “South-East Asia Regional Health Partners’ Forum on COVID-19", said, “We are also looking forward to WHO’s approval for India’s indigenous vaccine manufactured by Bharat Biotech."

Bharat Biotech said it hopes to get the approval by the third or fourth quarter of this year. They have submitted 90 percent of the required documents and the remaining documents will be submitted by June.

Raches Ella, head of business development and advocacy at BBIL to TOI, “We’ve started this process with WHO. It’s not an immediate approval that you get. It takes a couple of months. We are quite hopeful that by Q3 or Q4, we will receive our WHO approval."

“Bharat Biotech, in the past, has been approved by WHO for several other vaccines, so we're not new to this process. we are aware of it," he added.

The WHO has given approvals to the Pfizer/BioNTech vaccine for emergency use on 31 December, 2020. The AstraZeneca/Oxford COVID-19 vaccine got its approvals on 15 February, and the COVID-19 vaccine Ad26.COV2.S developed by Janssen (a subsidiary of Johnson & Johnson) was approved on 12 March. Moderna’s COVID-19 vaccine and China’s Sinopharm COVID-19 vaccine have also been approved EUL by the WHO. Recently, a second Chinese vaccine - Sinovac - got approval from WHO.

Why does EUL matter?

With countries slowly opening back to allow foreign travellers, they are most likely to introduce new rules that allow only fully vaccinated people into their countries, in order to stop the spread of the disease.

And while not many countries have instituted a 'vaccine passport', they will create these rules based on the recommendations of their respective health agencies or basis the vaccines approved by the WHO.

This might be one reason why Bharat Biotech is rushing to get this process started - WHO's emergency listing will give it international recognition. The European Union (EU), United Kingdom (UK) and Canada have not included COVAXIN in their approved list of vaccines.

However, according to a Hindustan Times report, the Centre cleared the air and clarified that no country has come up with this rule and a negative RT-PCR report is all it takes for entry into a foreign country.

Brazil approves COVAXIN, Sputnik V

According to PTI Brazil has cleared the proposal to import Bharat Biotech's COVID-19 vaccine Covaxin, into the country, with some conditions. They are expected to receive four million doses of COVAXIN initially.

They will monitor the doses and after using the doses, its drug regulator Brazilian Health Regulatory Agency (Anvisa) will analyse the data in order to assess the next quantities to be imported.

"Anvisa authorised this Friday the exceptional import of the COVAXIN vaccine by the Ministry of Health for distribution and use under controlled conditions. The authorisation defined the amount of 4 million doses, which can be used only under specific conditions. The decision was taken at the 9th Extraordinary Public Meeting of the Collegiate Board," it said in a statement in Portuguese.

Anvisa had earlier denied permission to import COVAXIN after authorities found that the Indian plant in which the jab was being made did not meet the good manufacturing practise (GMP) requirements.

Bharat Biotech presented an adequate action plan and fulfilled all the pending issues related to the certification of GMP request, Anvisa said. They then filed new requests on 25 May.

Anvisa has also approved another proposal to import Russia's Sputnik V vaccine.

Announcing the approval of Sputnik V by Brazil on its official Twitter page, the Russian vaccine-manufacturer said, "#SputnikV will be used in Brazil following ANVISA's approval. Brazil has become the 67th country in the world to authorise Sputnik V. The Sputnik V team fully answered all questions fromANVISA on the vaccine's efficacy & safety."

With inputs from agencies

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