The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.
"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", said Adar Poonawala, CEO of Serum Institute of India in a statement.
Earlier this week, the UK-Swedish company reportedly froze the trials after discovering that one participant was sick with transverse myelitis. This condition results in the inflammation of parts of the spinal cord and may be caused by infections, among other things.
Phase I human trials were completed in the UK. In India, the volunteers will be administered two doses of the potential vaccine. Thereafter, four weeks apart, its safety and immunogenicity will be assessed.
Days after Astra Zeneca said it has paused trials of its experimental coronavirus vaccine, the World Health Organization’s (WHO) chief scientist asserted that it a ‘wake-up call’ to recognize that there are ups and downs in clinical development and that we have to be prepared. However, researchers should not be discouraged as these things happen, said Soumya Swaminathan, while addressing a virtual briefing from Geneva.Astra Zeneca-Oxford vaccine trial pause a ‘Wake-up Call’, Says WHO
The Drugs Controller General of India (DCGI) has given approval to Serum Institute of India (SII), Pune, to conduct Phase II and III clinical trials of Oxford University. According to the World Health Organization (WHO), a number of vaccines are now in phase-3 clinical trials. Covid-19: India to start late stage clinical trials of Oxford vaccine
Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials.
The second phase trial of COVID-19 vaccine developed by Oxford University, which would be manufactured by Serum Institute of India, began here with the vaccine candidate administered to two volunteers at Bharati Vidyapeeth Medical College. Dr Sanjay Lalwani, Medical Director of Bharati Vidyapeeth Medical Hospital and Research Centre, said that five volunteers were tested for RT-PCR and antibodies and reports of three showed they have anti-bodies and vaccine was administered to two volunteers.COVID-19 vaccine: Phase II trial of Oxford vaccine begins at Pune hospital
In what could be termed as the biggest breakthrough of the year in the fight against the novel coronavirus pandemic, preliminary results showed Oxford/AstraZeneca COVID-19 vaccine candidate is safe and induced immune response. WHO gives its take on the Oxford vaccine trials, says that the results are positive but have a long way to go. WHO on Oxford vaccine trials: Results are positive but a long way to go
SII, the largest vaccine manufacturer in the world, has tied up with AstraZeneca to manufacture the Covid-19 vaccine. SII’s vaccine candidate is undergoing a bio safety trial at the government's Central Drug Laboratory (CDL), Kasauli.
Two male volunteers were administered the vaccine at Bharti Vidyapeeth's Medical College and Hospital, a senior office-bearer of the hospital said.
With the pandemic refusing to die down, the world has begun learning to live with the virus around, soldering on with the search for a vaccine. However, any vaccine development underway is for adults only.
UK-based biopharma giant AstraZeneca has said that the phase 3 testing of its COVID-19 vaccine being developed with Oxford University has been put on hold, due to a suspected serious adverse reaction in a participant in the United Kingdom. The vaccine, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization (WHO) as probably the world's leading candidate and the most advanced in terms of development.AstraZeneca pauses COVID-19 vaccine trial in UK due to unexplained illness of participant
Director General of Indian Council of Medical Research, Dr Balram Bhargava on August 04 stated that Oxford vaccine, being manufactured by Serum Institute of India, got approval for phase 2 and 3 clinical trials which are starting within a week at 17 sites. Earlier, the Drugs Controller General of India (DCGI) has given approval to Serum Institute of India (SII), Pune, to conduct Phase II and III clinical trials of Oxford vaccine.Covid-19: Oxford vaccine's late stage trials to start in a week in India, says ICMR
Panel recommends Serum Institute's name for phase 2, 3 human clinical trials of Oxford vaccine candidate
The recommendations of the committee at the Central Drugs Standard Control Organisation have been sent to the Drugs Controller General of India for approval.
SII's Oxford vaccine is one of the front runners in the fight against Covid-19. On July 20, researchers at the University of Oxford published their data from Phase 1 and 2 trials of the vaccine candidate. The researchers said the trials involving 1,077 healthy adults found that the vaccine induced strong antibody and T-cell immune responses up to day 56.
AstraZeneca is one of the leaders in the race to develop COVID-19 vaccine. Other companies that have COVID-19 vaccines in phase 3 trials include Moderna Inc and Pfizer Inc.
After the STOXX 600 saw its biggest daily gain in almost two weeks on Monday, the bullish mood continued throughout the New York and Asian sessions.
It is believed that the two local candidates — which are in early stages of human trials — will enter the market with a lag of a few weeks as compared to the Oxford candidate.
'The recent rally that we have seen in tech stocks, in Nasdaq and the stocks just jumping way too ahead suggest we might be in for a short-term shakeup. '
The British drug maker also reached a $750m agreement with Coalition for Epidemic Preparedness Innovation (CEPI) and Gavi to support the manufacturing, procurement and distribution of 300 million doses of the potential vaccine, with delivery starting by the end of the year.
Initial study shows that the Oxford-AstraZeneca vaccine for Covid-19 triggers antibody response and is safe. ET’s Divya Rajagopal gives an in-depth analysis of the vaccine which will go on trial in India soon. WatchOxford University Coronavirus vaccine: Why it raises hope
Amid recent acknowledgement from the World Health Organisation (WHO) over emerging evidence of airborne spread of the novel coronavirus, the head of India’s premier R&D body has said that airborne transmission of SARS-CoV-2 is indeed a “distinct possibility” and suggested wearing masks even in “enclosed” spaces.
As global vaccine companies race up for covid-19 vaccine, Indian companies though late in the launch are catching up. The following companies are leading the Indian vaccine landscape for Covid-19.India's Covid vaccine landscape: Here is a look at leading candidates
The royal looked at a laboratory where samples from the clinical trial were being examined by researchers.
AstraZeneca plans to begin delivering the vaccine to European countries by the end of this year under the agreement with the Inclusive Vaccine Alliance, formed this month by France, Germany, Italy and the Netherlands.
The researchers, working in an “unprecedented” vaccine development effort to prevent COVID-19, said they have started screening healthy volunteers (aged 18-55) from Friday for their upcoming trial in the Thames Valley Region of England. The vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 or COVID-19 spike protein is already in production.
The experts say that the novel analysis provides even greater clarity and detail about how the vaccine successfully provokes a strong immune response.
This is the next "challenge" we need to tackle, he said, also tagging the prime minister's office. "I ask this question because we need to plan and guide, vaccine manufacturers both in India and overseas to service the needs of our country in terms of procurement and distribution," Poonawalla added.
British scientists are beginning a small study comparing how two experimental coronavirus vaccines might work when they are inhaled by people instead of being injected.
AstraZeneca Plc said it had paused global trials, including large late-stage trials, of its experimental coronavirus vaccine due to an unexplained illness in a study participant.
The government expert group on vaccines, which looks into the procurement of Covid-19 vaccines from India and abroad and the guiding principles for prioritisation of groups for vaccination, has proposed setting up a digital platform to track procurement and record administration.
The Drugs Controller General of India, Dr V G Somani, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established.
Centre estimates to utilise 40-50 cr COVID-19 vaccine doses on 20-25 cr people by July 2021: Vardhan
During an interaction with his social media followers on 'Sunday Samvad' platform, he said a high-level expert group is going into all the aspects of vaccines and the health ministry is preparing a format in which states will submit lists of priority population groups.
“Nationally, nearly 30 Covid-19 vaccine candidates are under development, by both industry and academia. These vaccines are in different stages of pre-clinical and clinical development,” said Harsh Vardhan, Union Minister for Health and Family Welfare, in the Lok Sabha last week.
There were several developments regarding vaccines and drugs this week, including the tie-up between the makers of Russia’s Sputnik V vaccine and Dr Reddy’s.
Serum Institute looking for a $1 billion shot to fight covid, talks on with Blackstone, KKR and others
The company, privately owned by Cyrus Poonawalla and his son Adar Poonawalla, plans to float a special purpose vehicle (SPV) for its vaccine candidates, ET has learnt. The amount raised would go to this entity and not to SII. The company expects to close the fundraising exercise by September.
According to the minutes of the meeting, the SEC has asked Serum to distribute clinical trial sites pan India, demarcate the phase II and Phase III part of the protocol. ET has seen the minutes of the meeting.
The vaccine candidate under trial by University of Oxford scientists in collaboration with pharmaceutical giant AstraZeneca is the furthest in the process of trials and, according to a report in ‘The Times', it could be given the required clearances by Christmas in December.
Kirill Dmitriev, head of the Russian Direct Investment Fund, said in an interview on Friday that Moscow did not need to steal secrets as it already had a deal with AstraZeneca to manufacture the potential British vaccine in Russia. "AstraZeneca already has an agreement.... with R-Pharm (a Russian portfolio company).
Harsh Vardhan also said that the government is considering emergency authorisation of Covid-19 vaccination to senior citizens and people working in high-risk settings. "This shall be done after a consensus has been reached," he added.
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India. Vaccines normally require years of testing and additional time to produce at scale, but scientists are hoping to develop a vaccine within months.
Covid-19 cases rising due to aggressive testing and casual attitude of people: Health minister Harsh Vardhan
Union health minister Dr Harsh Vardhan has attributed the record daily spike in new Covid-19 cases in India to “aggressive testing” and “casual attitude” of the people.
The vaccine, named ChAdOx1 nCoV-19, is based on a weakened version of the common cold that causes infections in chimpanzees. It also contains the genetic material of the spike protein of SARS-CoV-2 – the strain of coronavirus that causes the COVID-19 illness. The Oxford University vaccine is one of more than 100 in development as the novel coronavirus continues to spread.
The Central Drugs Laboratory in Kasauli, Himachal Pradesh, is testing the first batch of the vaccine candidate to determine its sterility — to find out if the vaccine is of standard quality and is safe to be injected — sources in health ministry told ET.
Govt eyes 50 lakh doses of Covid vaccine in 1st order for front-line workers, army personnel and certain other categories
The prioritisation of the vaccine once it passes regulatory requirements and becomes available has been under discussion in government along with planning supply chains and distribution.
The regulator had issued a show cause notice to SII on Wednesday evening asking it to explain why trials shouldn’t be suspended. SII had said earlier that it would be continuing with trials despite the global halt.
The newsletter, Parsi Junction, reported that Poonawalla acceded to the request of former Bombay Parsi Panchayat (BBP) chairman Dinshaw Rusi Mehta, who asked for reserving atleast 60,000 vials for the Parsi community in the first batch.
The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work.
Serum Institute of India seeks DCGI permission for phase 2/3 clinical trials of Oxford's COVID 'vaccine'
The sources told that the Pune-based drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of 'Covidshield'.
In the situation of a grave pandemic engulfing almost all the countries alike, hopes for a cure have brightened with encouraging developments in both fronts, vaccines and drugs.
In reference to the vaccine being worked on by the University of Oxford, Johnson stressed the importance of equitable access of any successful vaccine because the health of every country depends on the whole world having access to a safe and effective vaccine, wherever a breakthrough might occur.
While the vaccine could be available at USD 3-6 (Rs 225 to Rs 550) per dose, herd immunity might be two years away due to implementation challenges, the brokerage said, adding the experience in large scale adult vaccination programmes is thin.
Peter Openshaw said the new “rule of six” restrictions on large gatherings which comes in force from Monday is extremely crucial.
If the vaccines are found safe and successful in clinical trials, both could be delivered to the UK in mid-2021 and would be given first to priority groups such as frontline health and social care workers, ethnic minorities, adults with serious diseases, and the elderly.
A total of 510 healthy volunteers, aged 18 to 55, will take part in the trial. While some participants will receive the vaccine – called ChAdOx1 nCoV-19 - others will take a control injection for comparison. The trial will continue over a couple of weeks.
Most vaccines in human testing require two shots for effectiveness, and developers still aren’t even sure if they’ll prevent infections. Scientists are hoping to generate superior immune responses with inhaled vaccines that directly target the airway cells the virus invades.
A high-level Group of Ministers was informed that as of Saturday, eight states - Maharashtra, Karnataka, Andhra Pradesh, Tamil Nadu, Uttar Pradesh, West Bengal, Odisha and Telangana - contribute around 73 per cent of the active caseload.
The vaccine candidate has been developed by the Jenner Institute, a part of the Nuffield Department of Medicine at the University of Oxford. The formulation is backed by AstraZeneca PLC, a British-Swedish pharmaceutical company.
The Drugs Controller General of India (DCGI) has permitted two vaccines -- one developed by Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and another one by Zydas Cadila Healthcare Ltd to go in for the first and second phase of human clinical trials.
A targeted recruitment programme broadcast in Gujarati, Punjabi, Bengali and Urdu is among the measures being deployed to reach out to different communities. Over 1,00,000 people have volunteered to take part in vaccine trials across Britain as part of efforts to speed up the discovery of a safe and effective vaccine that protects against the deadly coronavirus.
Oxford’s effort involves its multidisciplinary Vaccine Group, set up in 1994 to study new and improved inoculations, and the Jenner Institute, which works on both human and livestock diseases. It is based on a chimpanzee adenovirus — a common cold virus —which has been genetically changed to stop Covid-19 replicating in humans.
Cautioning that a vaccine is still months, maybe even a year away, experts said the US-based biotechnology firm's results have propelled it to a pole position in the race of 118, say experts.
Brazil is testing an experimental coronavirus vaccine, but interim Health Minister Eduardo Pazuello acknowledged Tuesday that the government has yet to strike a deal to get it if it works. Other nations have already secured hundreds of millions of doses of the shot created by Oxford University.
Global Indian giants would come from the IT pack because we do IT the best globally
Producing vaccines and deploying them to the world’s population in the midst of a pandemic would be a massive challenge even if researchers are able to deliver one-dose inoculations. A need for two would make manufacturing and logistics even more complex.
Six months from the first nationwide lockdown in March, with a sharp economic contraction looming large, all eyes are on the shape of the recovery graph. Macroeconomic outlook resembles an alphabet soup.
Elisa Granato is the first volunteer in an initial group of 800 to be part of the ground-breaking trial, which is hoped will be the answer for immunisation against the deadly virus and help with the easing of lockdown measures in place to curb its rapid transmission.
About 100 research groups are pursuing vaccines with nearly a dozen in early stages of human trials or poised to start. It's a crowded field, but researchers say that only increases the odds that a few might overcome the many obstacles that remain.
This enables the procurement and supplies of this vaccine to UNICEF, Pan-American Health Organisation (PAHO) and GAVI-supported countries, the Hyderabad-based company said in a statement.