What Serum Institute's persistence on Oxford vaccine trials means for India

The company is going ahead regardless of AsraZeneca pausing trials in UK after an adverse impact was reported

On Tuesday AstraZeneca voluntarily suspended clinical trials in the UK for the University of Oxford-developed vaccine candidate after an event of potential adverse side effect came to notice. The Indian arm of the trials continues its process. A lot is riding on what is dubbed as one of the frontrunners for Covid-19 vaccine. A look at what it means for India and Serum Institute: 

Why was the AstraZeneca-Oxford University trial paused?

British-Swedish drug major AstraZeneca on Tuesday decided to halt clinical trials of AZD1222, a vaccine candidate developed by the University of Oxford, after a participant fell sick with an unexplained illness. The UK arm of the clinical trials, which is now in phase 3, fell sick with what may be called a suspected case of serious adverse reaction and needed hospitalisation. The drug maker voluntarily put the trial on hold and said that it was working to review the event. As such, side effects are never ruled out in any vaccine trial. Why this event became important is because the sickness is not only serious but also unexplained as of now. The company, however, is trying to ensure at the same time that the event does not result in a significant delay to the study. 

What does this mean for the India arm of the clinical trials?

Serum Institute of India (SII), the partner of AstraZeneca-Oxford vaccine candidate in India, said that the Indian trials continue as the Indian arm has not faced any issues. It did not wish to comment on the UK trials which have been paused for further review and hoped that it restarted soon. 

Is there any safety concern about continuing clinical trials on Indian volunteers?

The lead investigator of one of the clinical trial sites in western India felt that ideally the trials here should also be paused as it is the same vaccine that is getting administered to volunteers. The person added that they were waiting to hear from the Indian Council of Medical Research (ICMR) and SII on this. There would also be a meeting of the Data and Safety Monitoring Committee (DSMC) to review the situation, the person told Business Standard. 

What do experts say?

Virologists point out that events of unexplained sickness are not very uncommon in vaccine trials as such. It can also be someone who has received a placebo shot and that would be unravelled when the DSMC sits down to review and analyse the event, said senior virologist Jacob John, former professor at the Christian Medical College, Vellore. He felt that in case it was a placebo receiving individual, the trials would be back on track soon. John also explained that the Indian arm of the clinical trial need not halt its process here because it is an independent arm. If India would have taken a decision based on data from UK trials alone, then there was no need to conduct a clinical trial on our population here, he felt. 

Was there any impact on AstraZeneca stock prices due to the news?

The Oxford-AstraZeneca vaccine candidate has been recently dubbed by the World Health Organisation (WHO) as probably the world's leading candidate that is in advanced stages of investigation or trials. More than a billion doses of this vaccine have been booked by countries even as the candidate is under investigation.  All eyes were pinned on this vaccine and the stock prices reacted negatively to the news - the Indian arm of the British drug major saw its shares tank by 12 per cent on Wednesday, recovering by the end of the day. It ended the day's trade on the BSE at Rs 4070 apiece, down 3.8 per cent. In London the news triggered a 2 per cent fall in the stock prices. 

Is the suspected serious adverse reaction bad news for the development of the vaccine?

Scientists feel that in large scale trials such as this one (the UK arm is conducting a trial on 10,000 volunteers) some incidents of illness beyond the usual known side effects like fever and muscle cramps is not really uncommon. They feel that the reason to have large scale trials is to see how different sections of the population with different health preconditions react to the vaccine administration. Virologists like John say that it is, in fact, a good thing that science has systems in place to pick up such events even amidst the mad global rush to fast-track vaccine development. This only implies that the checks and balances are in place, he felt

Can the trials restart soon?

According to international agencies, the final decision to restart the trial will be taken by the British medical regulator MHRA soon. It depends on what is the outcome of the investigation. 

What does this mean for Serum Institute?

Large-scale, late-stage clinical trials are on in different parts of the globe on AZD1222 - it aims to enroll 50,000 across the world in US, South Africa, Brazil, India, Japan etc. Several countries, including the US and UK, have booked millions of doses of this vaccine already. SII is conducting phase-2 and 3 trials in India to have data on the Indian demographics. The Drug Controller General of India (DCGI) gave nod to SII to conduct phase-2 and 3 trials here in the first week of August. SII CEO Adar Poonawalla has said that he would start manufacturing the vaccine at his 'personal risk', even before the results of trials are out. SII is adding capacities to make vaccines at Pune--expanding it from 1.5 billion doses per annum to 1.9 billion doses and would be delivering one billion doses to AstraZeneca. This would require the company to sacrifice manufacturing capacity for some of its existing vaccines.