SII rejects Covishield volunteer's allegations; PM to interact with 3 teams making COVID vaccine today
A 40-year-old man who took part in the 'Covishield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought compensation of Rs 5 crore
With 41,810 more testing positive in a span of 24 hours, India's coronavirus caseload on Sunday inched closer to 94 lakh mark, while the countrywide recovery rate touched 93.71 percent, said the Union health ministry in its morning update.
The total number of cases had crossed 20 lakh on 7 August, 30 lakh on 23 August and 40 lakh on 5 September. It surged past 50 lakh on 16 September 16, 60 lakh on 28 September, 70 lakh on 11 October. The tally crossed 80 lakh on 29 October, and surpassed 90 lakh on 20 November.
At 4,53,956, active COVID-19 cases remained below five lakh for the 19th consecutive day. Such cases comprise 4.83 percent of the total caseload, showed the ministry's the data.
The Serum Institute of India (SSI) termed as 'malicious and misconceived' the allegations of serious side effects by a 40-year-old man who took part in the third phase of the the 'Covishield' vaccine trial in Chennai.
The vaccine manufacturer's statement came as officials said the Drugs Controller General of India (DCGI) and institutional ethics committee are investigating the business consultant's claims that he suffered serious neurological and psychological symptoms after taking a dose of the vaccine.
The man has sought a compensation of Rs 5 crore, besides seeking that the testing, manufacturing, and distribution of the vaccine be stopped immediately.
Toll in India reaches 1,36,696
The total coronavirus cases mounted to 93,92,919 while the toll climbed to 1,36,696 with 496 new fatalities on Sunday, as per the health ministry's data updated at 8 am.
The number of people who have recuperated from the novel coronavirus infections surged to 88,02,267, with 42,298 new recoveries while the COVID-19 case fatality rate stands at 1.46 percent, according to the ministry.
Nearly 71 percent of the 496 new COVID-19 fatalities reported 24 hours were from eight states and Union Territories (UTs) with Delhi recording the highest number of 89 deaths, followed by Maharashtra with 88 and West Bengal with 52, the ministry said.
It further said that 22 states and UTs have recorded case fatality rates lower than the national average of 1.46 percent.
Maharashtra recorded the highest positive change with the addition of 1,940 cases, whereas Delhi recorded the highest negative change with a decrease of 1,603 active cases in a span of 24 hours, the ministry said.
The ministry said 70.43 percent of the daily new cases were contributed by eight states and UTs — Kerala, Maharashtra, Delhi, West Bengal, Rajasthan, Uttar Pradesh, Haryana, and Chhattisgarh.
Kerala leads the tally with 6,250 new COVID cases. Maharashtra recorded 5,965 new cases, while Delhi followed with 4,998 new infections.
The ministry said 68.73 percent of the new recovered cases were observed to be concentrated in eight states and UTs. Delhi has reported the highest number of 6,512 single-day recoveries followed by 5,275 in Kerala and 3,937 in Maharashtra, it said.
According to the ICMR, over 13.95 crore samples have been tested up to 28 November with12,83,449 samples being tested on Saturday.
SII rejects 'malicious' allegations
Meanwhile, SII rejected the charges from a Chennai man that Covishield had adverse effects on him and threatened to seek heavy damages for "malicious" allegations.
The Pune-based Serum Institute has collaborated with Oxford University and pharmaceutical company Astra Zeneca for making the COVID-19 vaccine, 'Covishield', and is conducting trials in India.
"The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer's medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer," SII said in the statement.
The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial, it added.
"The claim is malicious because the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. In spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company," Serum Institute said.
"It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India, will seek damages in excess of 100 crore for the same and will defend such malicious claims," Serum Institute added.
The 40-year-old man who took part in the 'Covishield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to Serum Institute, the Director General of ICMR, the Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, professor Andrew Pollard, chief investigator, Oxford Vaccine Trial and the vice-chancellor of Sri Ramachandra Higher Education and Research
The man has also sought that the trial be halted.
He was administered the shot Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on 1 October.
As per a legal notice, though there was no side effects for the first 10 days, he subsequently had episodes such as severe headache and vomiting. A doctor suggested investigations like a CT-scan as the man was oblivious of what was happening around him and could not respond to questions.
The man, the notice alleged, suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.
The trauma he underwent after taking it 'clearly proves' that the vaccine was not safe as made out to be and all the stakeholders were trying to hide the adverse effect that the vaccine has had on him, the notice claimed.
He would not have volunteered for the test vaccine if all the potential risk factors of the test vaccine had been known to him. But on the other hand, there was a clear assertion of the safe nature of the test vaccine in the 'Participant Information Sheet (PIS) which led him to become a volunteer, the notice stated.
An electroencephalogram (EEG) test showed that the brain was affected partially (dysfunction involving both hemispheres and the ascending sensory pathways on both sides from both the lower extremities).
A pyschiatric evaluation revealed a mild deficit in verbal and visual memory functions and an under-functioning in overall cognitive functions, it said.
"He has gone through extreme sufferings, both neurologically and psychologically. The vaccine had led to a virtual neurological breakdown in him."
The notice said it is impossible to "quantify monetarily, the sufferings, trauma, pain and humiliation (of hands, legs and body being tied and fastened firmly to the bed), which he and his family have undergone and are likely to undergo for a long time to come".
Though he suffered severe adverse reaction to the vaccine, the stakeholders failed to follow any of the guidelines mandated by World Health Organisation (WHO), the notice claimed.
The notice given on 21 November by a law firm on the man's behalf said, "Our client states that he must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future."
"He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, for all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs 5 crores within two weeks from the receipt of this notice," it said.
The notice also said that testing, manufacturing and the distribution of the vaccine should also be stopped immediately, "failing which he has no other option except to take appropriate legal action against all the concerned parties, who would be made responsible for all the costs and consequences".
When contacted by news agency PTI, a spokesperson for Ramachandra said, "we also have got the notice," but declined to elaborate.
'Ethics committee and DCGI probing claims'
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.
"Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti- Coronavirus vaccine," PTI quotes Dr Panda as saying.
The DCGI had on 11 September directed SII to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study.
However, on 15 September, it permitted the Serum Institute of India to recommence the trial.
Modi to interact with three teams for COVID-19 vaccine
Prime Minister Narendra Modi, who visited Ahmedabad, Pune and Hyderabad on Saturday to review the anti- Coronavirus vaccine development and manufacturing, will interact with three teams involved in developing COVID-19 vaccine via video-conferencing on Monday.
The Prime Minister's Office said in a tweet on Sunday that the three teams are from Gennova Biopharma, Biological E and Dr. Reddy's.
Tomorrow, on 30th November 2020, PM @narendramodi will interact, via video conferencing, with three teams that are involved in developing a COVID-19 vaccine. The teams he will interact with are from Gennova Biopharma, Biological E and Dr. Reddy’s.
— PMO India (@PMOIndia) November 29, 2020
With inputs from PTI
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