US FDA rejects emergency use authorisation for Bharat Biotech’s COVID-19 jab Covaxin; all you need to know

Bharat Biotech’s coronavirus jab, Covaxin, which has been mired in controversy since its release in India, hit another roadblock Thursday as its US rollout plans were shelved temporarily.

A media report, citing the Hyderabad-based company’s US partner Occugen, has said that the US Food and Drug Administration (FDA) has refused an emergency use authorization (EUA) to Covaxin on the basis of inadequate data from clinical trials. Bharat Biotech, however, pointed out that no Indian vaccine manufactured or developed in India has ever achieved the feat; thus the approval, when it comes, “will be a great leap forward for vaccines innovation and manufacturing from India.”

The Hyderabad-based company had tied up with Occugen Inc, a biopharmaceutical company headquartered in Pennsylvania, US with an eye on the US and Canadian market. It announced the agreement on 2 February 2021.

Under the terms of the agreement, Occugen will have the US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval including Emergency Use Authorisation and commercialization for the US market.

Earlier, Astrazeneca’s shot had also faced a similar predicament as the company struggled to compile additional data sought by the US FDA before it gave the EUA, even though the vaccine is one of several authorised by the World Health Organization for use within COVAX global vaccine alliance. Reports said that the company is now in favour of pursuing the more time-intensive application for a full-fledged license to sell the shot.

Why did US FDA refuse to grant EUA to Covaxin?

According to the Livemint report cited earlier, the US FDA has asked the company to launch an additional trial and file for a Biologics Licence Application (BLA), which is a full approval. The move can also apparently be attributed to US FDA’s decision last month to no longer grant emergency authorization to new applications. The decision was taken as the US has immunised a large section of its adult population and is on the way to inoculate children as well against the coronavirus.

Bharat Biotech, in a statement issued Friday, also reiterated the same, stating: “USFDA had earlier communicated that no new EUA’s will be approved for covid vaccines. All applications have to follow the biological license application process, with is the standard process for vaccines.”

However, Occugen told its investors on 26 May it was still eligible to submit its EUA in June since it had been engaged with the US FDA for approvals since last year and the US FDA decision made last concerns new applicants.

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for Covaxin as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA,” the company’s statement from 26 May said.

But another aspect is that the company filed key information and data including preclinical studies, chemistry, manufacturing, and controls (CMC), and clinical studies as a Master File for FDA review only in late May. And even then, Occugen was still awaiting additional data from Bharat Biotech from the ongoing Phase 3 clinical trial, as per a PTI report

“We are currently waiting for additional data from Bharat Biotech from the ongoing Phase 3 clinical trial for a EUA submission. Due to the current surge in COVID-19 cases in India, this process is taking longer than anticipated. We are continuing to monitor the situation and intend to file the EUA submission as soon as practicable. Any significant delays could adversely affect our business, results of operations, or financial condition,” Ocugen had said on 25 May.

Pending clinical research data impedes Covaxin’s global plans yet again 

Covaxin had earlier suffered a similar impediment in securing World Health Organisation approvals after the world body said it needed more research data before it can grant the EUL.

The latest guidance document issued by the WHO on the status of approval of vaccines under evaluation for emergency use listing showed that Bharat Biotech had submitted an Expression of Interest, or EOI, on 19 April. The health body’s document, released on 18 May, said that “more information [was] required” for the EOI and a pre-submission meeting was scheduled for May-June.

On its part, the vaccine maker has said that it has submitted “90 percent of the documents” required for WHO’s approval. Although it is not clear yet what documents are missing, the company’s case surely complicates by the fact that it has not yet concluded the phase 3 trials and hasn’t published its efficacy data in a peer-reviewed scientific journal. The company said on Wednesday that it expects the results in two to four months.

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

Bharat Biotech has already said it hopes to get the WHO 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 said, “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.

How the USFDA decision impacts the vaccine maker?

The primary and the most immediate impact will be that this will likely delay plans to roll out the vaccine in the US markets. Data from an additional and much more extensive clinical trial will be required to support the application for a full licence for Covaxin.

However, a more nuanced read on the impact of this decision indicates that it will have deeper financial implications for Occugen, which has also acquired rights for selling the vaccine in Canada.

Occugen in a regulatory filing said it has agreed to pay $15 million to Bharat Biotech upfront for transfer of technology and extending the vaccine rights for sale, marketing and manufacturing in Canada as well. The company also agreed to pay another $10 million to Bharat Biotech within a month from the commercial launch of Covaxin in the North American country.

On profit-sharing agreement, Bharat Biotech had said similar to the US arrangement, Ocugen will retain 45 percent of the profit from sales of Covaxin in Canada.

Under the terms of the agreement, Occugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval including Emergency Use Authorisation and commercialisation for the US market.

Another factor to consider is the timeline of rollout and the market demand at that point in time. US has already managed to fully vaccinate 42 percent of its population while another 9.5 percent have received at least one shot. A delay of six months or more may mean that the number expands further. And vaccine acceptance and marketing will be other factors to consider.

Furthermore, the Indian government’s temporary suspension of the export of COVID-19 vaccines may require Bharat Biotech to focus its resources, including Covaxin supply, on domestic requirements and thereby prevent it from shipping supply of the vaccines abroad, including to the United States, the American company said in the risk factors.

The initial US supply will be done by Bharat Biotech upon receiving authorisation from the FDA and also there will be technology transfer to US facilities.

“Due to the current surge in COVID-19 cases in India, this process is taking longer than anticipated. We are continuing to monitor the situation and intend to file the EUA submission as soon as practicable. Any significant delays could adversely affect our business, results of operations, or financial condition,” Ocugen had said.

How the USFDA decision impacts COVAXIN beneficiaries?

It will have direct implications on people who have taken COVAXIN doses and plan to travel abroad, especially to the US, as countries do not recognise immunity imparted by COVAXIN shots. In the absence of a WHO approval as well, many countries are likely to treat people vaccinated with COVAXIN as unvaccinated.

Vaccine passports, though still not mandatory entirely, aren’t a distant reality either.

A vaccine passport is proof that a traveller has been vaccinated; usually in the form of a certificate, a stamp on the passport on an app on the smartphone. The idea behind these vaccination passports has emanated from governments around the globe trying to protect citizens from another outbreak while balancing the need for connectivity and commerce.

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