Image: T. Narayan/Bloomberg
Even as India is now almost reaching the point of recording 100,000 daily Covid-19 cases, the much publicised Oxford Covid vaccine trials have been paused, as the test patient developed complications. The Serum Institute of India has been issued a notice after vaccine trials were paused. According to multiple news reports, the Drugs Regulator General of India has questioned why the Serum Institute of India “even progressed with the trials and why it has not sent a detailed report about the patient in the United States.”
While a vaccine was not expected anytime soon the big announcements made by the Union government, and the Serum Institute that it was being developed in India had boosted morale. However, the pause in the trial and the questioning of the company developing the vaccine could have dimmed the light at the end of the Covid-19 tunnel.
By Thursday, September 10, it has become clear that India is inching towards the 100,000 daily Covid-19 case mark. According to NDTC the numbers of total cases are around 4.46 million, and around 1,152 deaths were reported over the past 24 hours. This has taken the death toll to 75,062, and now India has the second highest number of Covid-19 infections in the world, after the United States, which has around 6.5 million cases.
While the government states that the rise in numbers is due to the rise in testing, it remains a cause of worry. The Serum Institute of India, owned and run by Chairman and Managing Director Dr. Cyrus S. Poonawalla, and his son Adar C. Poonawalla who is the CEO, is manufacturing the Oxford University’s Covishield vaccine and was expected to start phase 3 clinical trials in India from next week will now have to answer the show cause notice by the Drug Controller General of India (DGCI) first. The NDTV report states that “trials for the vaccine were stopped in four nations as a precautionary measure after one of the recipients in the UK showed some adverse symptoms, which are yet to be linked to the vaccine.”
Now the Drugs Regulator General of India has questioned why the Serum Institute is progressing with the trials and why it has not sent a detailed report about the patient in the UK. The Serum Institute is still stated to be “enrolling volunteers for the phase 3 trial of the Covishield, which is being developed jointly by the Oxford University and pharma giant AstraZeneca,” reported NDTV, adding that the vaccine trials were expected to be conducted on “around 1,600 participants across 17 sites.”
On Wednesday evening, the NDTV reported Serum Institute’s response as: “We are going by DCGI’s direction and so far were not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.” The Pune-based vaccine manufacturer said the Indian trials have not “faced no issues at all”, adding that they “can’t comment much on the UK trials, but they have been paused for further review”.
The company, AstraZeneca, is stated to be a “British-Swedish pharma giant that’s developing the vaccine jointly with Oxford University,” and had said that the volunteer undergoing the trial, had developed “an unexplained illness” however, it added that “such pauses in drug trials are “routine”.” This was widely reported by those covering the Covid-19 beat.
According to NDTV, an AstraZeneca spokesperson had said it is too early to determine the sick participant’s specific diagnosis. It cited a New York Times report that a volunteer in the UK trials was diagnosed with transverse myelitis, an inflammation of the spinal cord generally caused by infections, citing a person close to the situation that it didn’t name. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” spokeswoman Michele Meixell said in a statement.
According to a report in Hindustan Times, the country added 95,950 cases of Covid-19 on Wednesday itself. India is also third in the fatality rate. The worst hit state in terms of infection continues to be Maharashtra, with around 23,577 on Wednesday, and climbing, it recorded 380 deaths as well. Andhra Pradesh had around 10,418 cases. However, it was Karnataka that recorded the second highest number of fatalities at 128.
Meanwhile, the government continued to share rising testing numbers.
— ICMR (@ICMRDELHI) September 10, 2020
In another morale damper, the Indian Council of Medical Research (ICMR) recently shared a study that indicates that the much celebrated Plasma therapy may not reduce mortality in Covid-19 cases. According to reports, even though the use of “convalescent plasma as a treatment modality for Covid-19 has received authorisation for off-label use in India,” the ICMR’s PLACID trial was aimed at investigating its effectiveness for treatment of Covid-19 infections. Convalescent plasma therapy uses blood plasma donations from those who have recovered from an illness, in this case Covid-19. Now, as reported by the Indian Express, “Convalescent Plasma was not associated with reduction in mortality or progression to severe Covid-19, suggests a study by Indian Council of Medical Research published in MedRxiv, a preprint server for health sciences”. However, the ICMR officials told The Indian Express that the study, published on September 8, has not been peer-reviewed and preferred not to comment. The ICMR’s plasma therapy study, PLACID, is the first and largest randomised control trial to be completed in the world.