Coronavirus outbreak: Serum Institute pauses COVID-19 vaccine trials in India
We are following DCGI's instructions and will not be able to comment further on trials, the Serum Institute of India said
The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, on Thursday paused the clinical trials of the vaccine in India.
In a statement, the Serum Institute of India said: "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials."
The Serum Institute of India (@SerumInstIndia), which was conducting the India trials for the coronavirus vaccine being developed by #OxfordUniversity, on Thursday paused the clinical trials of the #vaccine in India.#COVID19vaccine #COVID__19 pic.twitter.com/kMmUGEVmTU— IANS Tweets (@ians_india) September 10, 2020
The declaration by the Pune-based vaccine manufacturer came a day after the Drug Control General of India (DCGI), V.G. Somani, issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.
The notice was issued in the wake of an advert incident where one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and University of Oxford, on Tuesday.
"Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," the notice by DGCI read.
The DGCI further asked the institute why the authority does not suspend the permission given to the SII for the clinical trials of Covishield.
"In view of the above, I, Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.
SII is the partner of the University of Oxford's Jenner Institute's to conduct the vaccine trials. SII is currently progressing the second and third phase study of the vaccine candidate at 17 trial sites across India.
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Russia became the first country to register the world's first COVID-19 vaccine that "forms stable cell and antibody immunity". The vaccine Sputnik V, which is named after the space satellite launched by Moscow in 1957, was registered on August 11, 2020. Russia President Vladimir Putin said that one of his daughters has already been inoculated and she is feeling well.
Russia is the fourth worst-hit nation by the pandemic after the US, Brazil, and India. The vaccine has been jointly developed by the Gamaleya Research Institute and the Russian Defence Ministry.
According to Johns Hopkins University, the overall number of coronavirus cases across the globe has reached 21.7 million, while the death toll has reached 7,75,244. As of August 16, Russia has tallied a total of 917,884 cases, with 15,617 deaths.
The COVID-19 vaccine by Russia is expected to enter into civilian circulation on January 1, 2021. Russian Health Minister Mikhail Murashko said that teachers and medical workers will be the first to get the COVID-19 vaccine. He also said that two sites - the Gamaleya Research Institute and pharmaceutical company Binnopharm JSC - will be used for producing the vaccine.
Russian President Vladimir Putin himself endorsed the vaccine and said that it has passed all necessary checks. However, the country has faced criticism from different quarters for rushing the vaccine into production.
The third stage of the research on the world's first registered vaccine against the novel coronavirus, called Sputnik V, may begin in 7-10 days, a report has said. Several tens of thousands of people are expected to take part in this research of the vaccine that will be conducted in the Moscow Region.
In photo: The COVID-19 vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Pic/Russian Direct Investment Fund/AFP
After Russia registered the first COVID-19 vaccine, the All India Institute of Medical Sciences (AIIMS) director Randeep Guleria, who is one of India's leading medical experts, said that the COVID-19 vaccine development has moved so rapidly because of the collaborative work between various countries.
In India, three vaccine candidates are in different stages of human clinical trials - one developed by the University of Oxford by Pune's Serum Institute of India, the second is inactivated virus vaccine by Bharat biotech and the third is DNA vaccine by Zydus Cadila.
In his address to the nation on 74th Independence Day, Prime Minister Narendra Modi had said that the fight against the pandemic was progressing in the right direction and at the right pace. He said that three vaccines are currently under testing phase in India and their mass production will begin as soon as the scientists give the green signal.
According to the World Health Organisation (WHO), there are currently over 165 COVID-19 vaccines in different stages of development. Talking about the Russian COVID-19 vaccine, an official of the UN health agency said that WHO does not have sufficient information about the vaccine to comment on its effectiveness.
In photo: A view of the pharmaceutical factory Binnofarm in the town of Zelenograd outside Moscow, where Russia is starting to produce the anti-coronavirus vaccine.
A top respiratory doctor quit the Russian health ministry's ethics council after the country decided to go ahead with the registration of the vaccine even before conducting a crucial Phase 3 trial. Professor Alexander Chuchalin wanted to block the registration of the vaccine on "safety" grounds, before quitting the ethics council.
Five days after the registration of the COVID-19 vaccine, Russia began production of the first batch of vaccines against COVID-19. Health Minister Mikhail Murashko said Russia will offer the vaccine to other countries once its own citizens are vaccinated. He also said that doubts over the effectiveness of the vaccine were unfounded.
Meanwhile, Adar Poonawalla, CEO of Serum Institute of India (SII), had said that as per the arrangement with AstraZeneca, SII will be making one billion doses of Covishield vaccine over the next one year for India and other low-and-middle-income countries (GAVI countries).
The vaccine developed by the University of Oxford by Pune's Serum Institute of India will be called Covishield and will be distributed free to the government. Poonawalla also said that a few million vaccine doses would be available by November-December and 300 million doses by January-March 2021. On the other hand, SII will introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than Rs 250 per dose in India.
Russia, which last week became the first country to grant regulatory approval to a COID-19 vaccine amid scepticism from the global scientific community, has started manufacturing vaccine Sputnik V. Russia also released a 38-second video, created by the Russian Direct Investment Fund, showing how Sputnik V will slowly eradicates coronavirus. Meanwhile, Prime Minister Narendra Modi said that three vaccines are in the stage of clinical testing in India and mass production will begin as soon as scientists give green signal. (All photos/AFP)
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