Shares of Ocugen, the NASDAQ-listed company and Bharat Biotech's US partner for its COVID-19 vaccine Covaxin in the US, dropped 28 percent to $6.69 on bourses on June 10, after the company's announcement that it had to change its application from an Emergency Use Authorisation (EUA) to a full Biologics License Applications (BLA) approval, based on the recommendation of USFDA.
USFDA has requested additional information beyond what was submitted by Ocugen. Bharat Biotech said that data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
Bharat Biotech didn't clarify the nature of the additional clinical trials - whether this will be a local bridging trial or a full Phase-3 trial data. The EUA is based on clinical trial data from India.
The new clinical trial would mean a stretch of timelines, and possibly delay by several months. USFDA can take about six to 10 months to approve a Biologic Licensing Application (BLA).
Is it a setback?
Experts say that this is a temporary setback to Bharat Biotech's aspiration for US emergency approval. An emergency approval in the US would have fast-tracked Covaxin's approval globally including in other highly regulated markets.
"US emergency approval could have been a coup of sorts for Covaxin, as global regulators take a cue from USFDA actions," said Arun Bhatt, Independent research and ethics consultant.
"I don't think there is something wrong with Covaxin; it is an approach that USFDA took," he pointed out.
Bhatt says that Bharat Biotech's partner Ocugen will now have to submit full data on pre-clinical, clinical trial and manufacturing data to convince USFDA for approval, and if needed have to submit new additional clinical trials.
According to Bharat Biotech, Covaxin has received EUA's from 14 countries with more than 50 countries in the process.
"No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. When approved, it will be a great leap forward for vaccine innovation and manufacturing from India," Bharat Biotech said.
An EUA request for a COVID-19 vaccine can be submitted to FDA based on a final analysis of phase-3 clinical efficacy trial or an interim analysis of such trial. Bharat Biotech said its vaccine has an efficacy of 78 percent as per its interim analysis. The company said it will submit the final efficacy data in July.
What led USFDA to change its mind on EUA
According to USFDA, the EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies such as the current COVID-19 pandemic.
Under an EUA, USFDA may allow the use of unapproved medical products in an emergency when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the USFDA, manufacturers decide whether and when to submit an EUA request to FDA. Once submitted, USFDA will evaluate the EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.
Bharat Biotech said USFDA didn't reject its partner Ocugen's application for EUA but recommended changing the application to a full BLA approval under changed circumstances.
"The USFDA had earlier communicated that no new EUAs will be approved for COVID vaccines," Bharat Biotech said in a statement.
"All applications have to follow the biological licence application process, which is the standard process for vaccines," the company said.
"They already have two good vaccines, Pfizer and Moderna, and a third single dose one from Johnson & Johnson, with enough supplies. Two other vaccines, AstraZeneca and Novavax, have been waiting; they don't seem to be in an emergency situation. In case new variants emerge and become a problem, and if Ocugen and Bharat Biotech clinically demonstrate that Covaxin is working well against these variants, they might consider giving EUA," Bhatt added.