After AstraZeneca's decision to temporarily halt ongoing Phase III clinical trials of its Covid-19 vaccine candidate, the spotlight is now clearly on India's Serum Institute which is not just developing the same Oxford vaccine for 130 crore Indians but also has rights for 91 other countries around the world.
Serum Institute CEO Adar Poonawalla told BusinessToday.In: "Indian trials have not been stopped yet...there's nothing to worry about. It's related to some unrelated issue that happened... neurological issue with a patient in the UK and we have to wait for AstraZeneca to explain what is happened there but this is not vaccine-related. So, nothing to really worry about...India trials are also going on, and that has not been stopped".
AstraZeneca halted-not cancelled-the trials after a patient in UK developed adverse reaction. The company did not explain the nature of the illness. The company said it's "routine" to halt trials and review the candidate through an expert committee before continuing. A New York Times report attributed a person familiar with trials saying that one UK participant had 'transverse myelitis', an inflammation of the spinal cord which is normally caused by viral infections. It's not clear yet if this was in direct response to the vaccine.
Serum Institute of India(SII), which licensed the same vaccine from the developers AstraZeneca and the University of Oxford, has been conducting final trials since the last week of August among 1,600 volunteers at 17 centres in India, each with about 100 volunteers. Serum has also started manufacturing the vaccine, targeting to use in India and 92 other countries upon completion of trials and regulatory clearances. The vaccine was permitted by the drug controller general of India (DCGI) and related regulatory bodies for conducting advanced trials in India, after reviewing data of research and trial results in the pre-clinical and initial phase stage human trials done in the UK.
The AstraZeneca-University of Oxford Covid-19 vaccine is the frontrunner among vaccines under development against Covid-19. More than 50,000 patients have been enrolled to undergo final phase trials with AZD1222 COVID-19 vaccine, including about 30,000 in the US, India, Brazil and the UK. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities, AstraZeneca had said earlier.
Meanwhile, in an official response Serum said "we can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all". In a tweet yesterday, Adar Poonawala, CEO of SII, had said 'Proud and excited for the next few months and looking forward to the vaccine', while sharing pictures with Professor Adrian Hill of the Jenner Institute at the University of Oxford, UK.
Sources say the central government had indicated to SII that it would directly procure the vaccines for immunising Indians, if the vaccine is found successful. Centre has sought 68 crore doses for 130 crore Indian citizens from Serum Institute by June, next year, a source had said. For the rest, it is likely to place orders with 'Covaxin' being developed by ICMR and Bharat Biotech and Zydus Cadila's 'ZyCoV-D', if their trials proceed successfully. Both these companies are also yet to divulge details of final phase of clinical trials and vaccine development.
Meanwhile, experts say unless similar adverse drug reactions (ADR)s are reported from other trial sites, the progress of the vaccine is not under question. "One off such incident and reaction need not be interpreted as the vaccine has some issues, because it went through extensive pre-clinical studies before getting into the trial stage and while the vaccine is being tested in thousands of people in the final phase. It is upto the experts of that trial to clarify and we need not jump into conclusions", said a medical director of a leading Indian drug company. In July 2020, interim results from the ongoing Phase I/II trials were published in The Lancet and had not showed any major adverse drug reactions (ADR)s. Normally, during vaccine trials or vaccinations, fever, nausea, dizziness etc do happen and normally these subside after a day or two. AstraZeneca is yet to divulge details of the nature of ADR for the trial subject, he noted.