India’s Drug Regulator Gives Greenlight for Oxford Vaccine & Covaxin for Emergency Pandemic Use: Some Worry Not Enough Transparency

India’s Drug Regulator Gives Greenlight for Oxford Vaccine & Covaxin for Emergency Pandemic Use Some Worry Not Enough Transparency

The Drugs Controller General of India (DCGI) issued emergency authorization for two vaccines, including ‘COVISHIELD’, produced by the Serum Institute of India (SII), which is actually licensed from  AstraZeneca as well as the locally developed vaccine produced by Bharat Biotech known as ‘Covaxis.’   The AstraZeneca product, known as AZD1222, was originally developed by the University of Oxford and called ChAdOx1 nCoV-19. The regulatory authority also approved the commencement of a Phase 3 clinical trial led by vaccine sponsor Cadila Healthcare Limited.  The ‘Subject Expert Committee’ (SEC) of the Central Drugs Standard Control Organization (CDSCO) met on New Years’ Day and Jan. 2, found sufficient positive data associated with immunogenicity and safety to recommend the greenlight for restricted use in this emergency while clinical trials will continue. There was considerable pressure to award the greenlight, given India’s number of COVID-19 cases and the fact that the UK’s regulatory authority recently also issued an emergency use authorization for AZD1222 (again the same vaccine as COVISHIELD).

Serum Institute of India (SII), the world’s biggest vaccine producer by volume, partnered with AstraZeneca and the University of Oxford to conduct clinical trials in the world’s second most populated nation testing the recombinant chimpanzee adenovirus vector vaccine encoding the SARS-CoV-2 spike (S) glycoprotein.

Meanwhile, the authorities declared that the locally developed vaccine known as Covaxin, produced by Bharat Biotech, was “safe and provides a robust immune response,” according to the head of DCGI.

India Vaccination Plan

The nation plans on inoculating up to 300 million people on a prioritized list this year. With the second highest number of infections in the world next to America, over 150,000 have died in India. The country held drills this past Saturday preparing over 90,000 health care workers to administer the now emergency authorized vaccines across the nation with 1.3 billion people in total.

Allegations of Lack of Transparency

Although, DGGI has declared there was sufficient data from both drug producers for them to issue the emergency edict with confidence, many in that country are concerned about the lack of transparency. TrialSite reported about a lawsuit filed from a volunteer who experienced serious neurological issues about 10 days after receiving the vaccine. The trial site diagnosed the injury and determined  that there was no connection to the study yet there hasn’t been any evidence produced, not at least publicly. Moreover, the sponsor, SII, threatened to counter sue for about $13 million U.S..

As reported recently by TrialSite, a consumer advocacy group calling itself ‘All India Drug Action Network’ submitted a letter to leading authority representatives expressing their concerns about lack of transparency in the process.

A Mumbai infectious diseases researcher, Dr. Swapneil Parikh, shared with the BBC that the need for speed toward emergency authorization was understood, “However…[governments and regulators] have a duty to be transparent about the data they have reviewed and the process involved in making the decision to authorize a vaccine because if they don’t do this, it can affect the public’s faith in the process.”

The BBC suggested that the local vaccine known as Covaxis was approved “despite the absence of data on how efficient it can be.”

Transparency vs. Expediency in Emergency

The DCGI’s V.G. Somani was on the record that ultimately, given the emergency pandemic conditions, the approvals were “in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in the case of infection by mutant strains.”

The expectations in the United States and Europe drove the biotech firms to share far more information, disclosing their protocols, for example. In India, it would appear that the authorities there require less transparency, at least for now.