The research, posted as a pre-print and yet to be peer-reviewed, estimated the effect of both the COVID-19 vaccines on laboratory confirmed symptomatic disease in individuals aged 70 years or older in England.
The results of the analysis from a phase 3 randomised controlled trial, published in The Lancet journal, suggest that the interval between doses can be safely extended to three months given the protection a single dose offers.
“ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic Covid-19 in this interim analysis of ongoing clinical trials,” the Lancet said.
Canada has an agreement with AZ to receive 20 million doses. The approval to Verity Pharmaceuticals Inc./Serum Institute of India product has come on the basis of a comparability assessment with the AZ produced version of the vaccine.
The company announced that in a small subgroup of the trial participants the vaccine showed better efficacy when administered a half dose first and a full dose after a month. This announcement triggered a series of questions on the company’s trial protocol.
The subject expert committee in India is awaiting a nod from the UK's regulator to sign off on the marketing authorisation for SII to deliver the vaccines in India.
India is likely to get the first lot of anti-Covid shots in late January-early February. This will be possible as India plans to give Serum Institute of India emergency use approval for the Oxford-AstraZeneca vaccine candidate soon after it gets similar approval in the UK. The government, which will make bulk purchases, has also negotiated a better price — almost half that of the likely MRP of Rs 500-600 for the two-shot vaccine.
A phase I/II trial conducted by University of Witwatersrand and Oxford University on 2,000 volunteers with a median age of 31 years found that though the vaccine prevented severe disease and death in the volunteers, its efficacy against mild and moderate Covid-19 cases was 21.9%, well below the 50% threshold required for vaccine approval.
Pinker, a retired maintenance manager, paid tribute to the scientists who had developed the shot, saying he was looking forward to celebrating his wedding anniversary.
"I think the jury is out on that at the moment, but all developers are preparing new vaccines so if we do need them, we'll have them available to be able to protect people," Andrew Pollard, Chief Investigator on the Oxford vaccine trial said.
U.K. Health Secretary Matt Hancock said he had asked the Medicines and Healthcare Products Regulatory Agency to determine whether the vaccine "meets rigorous safety standards."
The University of Witwatersrand, Johannesburg, which conducted the trial, said in a statement that the vaccine "provides minimal protection against mild-moderate Covid-19 infection" from the variant.
The vaccine is "safe and effective", according to data published by The Lancet medical journal on December 8, with only one of the of the 23,754 volunteers who participated in the trials experiencing "possibly-related severe side effects".
AstraZeneca, Oxford expect 'next generation' COVID-19 vaccine to tackle variants by autumn - executive
Asked when AstraZeneca could produce a next generation vaccine to tackle new variants, AstraZeneca research chief Mene Pangalos said "as rapidly as possible".
With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots.Covid-19: Oxford vaccine likely to be first to get India's nod for emergency use
The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said.Covid-19: Serum Institute seeks emergency authorisation for Oxford vaccine Covishield in India
Anthony Fauci, top infectious disease expert in the US, had said the over 90% efficacy of Pfizer vaccine candidate ‘is just extraordinary’ and would have a “major impact” going ahead.
In a statement Tuesday, the EU regulator said it has received a request for the vaccine to be green-lighted under an expedited process and that it could be approved by Jan. 29 during an EMA meeting, "provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete."
Vaccine major Serum Institute of India on Thursday said the Covid-19 vaccine developed by AstraZeneca and Oxford University is safe and effective, and the Indian trials are progressing smoothly with strict adherence to all protocols.
She cited reports according to which the UK's medicines and healthcare products regulatory agency (MHRA) is likely to grant EUA by mid December. A couple of weeks later, she said, the drugs controller general of India (DCGI) could allow it for emergency use in India.
On Monday, AstraZeneca had said one dosing regimen showed vaccine efficacy of 90 per cent when the vaccine was given as a half-dose followed by a full dose at least one month apart, while another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart.
While skill and hard work drove development, AstraZeneca said it was a minor mistake that made the team realise how they could significantly boost the shot's success rate, to as much as 90% from around 60%: by administering a half dose, followed by a full dose a month later.
India's Drugs Controller General of India (DCGI) has given the mandatory regulatory approval to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. Meanwhile, state health ministers are holding review meetings and onsite inspections of vaccination centres as they expect the vaccine doses to arrive over the next week and the vaccination drive to begin around January 14.
ET rounds up facts and some questions on Covishield and Covaxin, approved by DCGI on Sunday
The government also approved the use of a vaccine developed by AstraZeneca and Oxford University which will be the lead vaccine in India's immunisation programme until other shots are approved.
While the coronavirus vaccine has been approved by many countries all over the world, Somalia is one of the few places where the pandemic has not been taken as seriously and that the repercussions has been worse than anyone knows.
India has approved emergency use of two vaccines for coronavirus on Sunday. Developed by AstraZeneca-Oxford University and India's Bharat Biotech, the approval is set to pave the way for one of the biggest vaccination drives.
The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.
The vaccine, which is being produced by bio-pharmaceutical giant AstraZeneca and also has a tie-up with the Serum Institute of India, is being evaluated by the UK's independent Medicines and Healthcare products Regulatory Agency (MHRA) after the final cut of data was submitted by the government last Monday.
"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.
India, the world's biggest vaccine-making country, wants to start inoculating its citizens next month and is also considering emergency use authorisation applications for vaccines made by Pfizer Inc and local company Bharat Biotech.
The ministry further stated that it was advisable to receive a complete schedule of the anti-coronavirus vaccine irrespective of past history of infection with COVID-19 as this will help in developing a strong immune response against the disease.
As per the report of People's Vaccine Alliance, nine out of 10 people in dozens of poor nations could miss out on getting vaccinated against COVID-19 next year because of the hoardings by rich countries. Also, while AstraZeneca and the University of Oxford have pledged to provide 64% of their doses to people in developing nations, that would only reach 18% of the world's population by next year "at most", the report added. People's Vaccine Alliance is a coalition including Oxfam, Amnesty International and Global Justice Now.
Three COVID-19 vaccines, developed by Bharat Biotech, Serum Institute of India and Pfizer, are currently under active consideration of India's drug regulator. The Union health ministry, meanwhile, said that there is hope that early licensure is possible for all or any of them.
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.
According to a report by AFP, hopes for a first wave of vaccinations before the end of 2020 received a boost with US firm Moderna saying it was filing Monday for emergency authorization of its Covid-19 vaccine in the United States and Europe. After top US scientists warned Americans to brace for a "surge upon a surge", Moderna reported full results had confirmed a high vaccine efficacy estimated at 94.1 percent.
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
Government's communication on the vaccine has to be clear and transparent - all certainties and uncertainties have to be shared with people.
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.
While an announcement Monday by Astra and Oxford showed their shot was 70% effective on average in a late-stage study, the scant details released by the U.K. partners have sparked worries about whether regulators would clear it. In a later statement, Oxford said a difference in manufacturing processes led to some participants being given a half dose instead of a full one.
he way the global scientific community has come together to focus on ensuring affordable access to new vaccines and therapies for humanity is one of the silver linings of the current crisis.
The recent developments about coronavirus vaccines have given the world a boost as the outbreak remains rampant. While governments all over have started preparing for a vaccine, any return to normalcy seems like a long way off. About 58.9 million people have been infected by the virus and about 1.4 million people have died.
Sarah Gilbert, professor at Oxford's Nuffield Department of Medicine, said the better result with a smaller initial dose could be because this better "mimics what happens in a real infection".
Adar Poonawalla 'delighted' at low-cost Covishield vaccine announcement; Mahindra says it's time to get the show on the road
India Inc sounded quite optimistic about the Monday announcement.
"We don't know yet if this virus will be mutating away from the immune response," the Oxford vaccine group's director Andrew Pollard told reporters at a briefing, adding: "There is no evidence of that yet."
Speaking in a briefing, Andrew Pollard, director of the Oxford Vaccine Group, said it is hard to explain the different efficacy rates between the AstraZeneca/Oxford shot and the other vaccines developed by Pfizer and BioNTech and one by Moderna.
'Really good news': British Health Secretary Matt Hancock welcomes Oxford/AstraZeneca vaccine results
"These figures ... shows that the vaccine in the right dosage can be up to 90% effective," British Health Secretary Matt Hancock told Sky News, after an announcement from AstraZeneca.
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.
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.
Covid-19 vaccine being developed by British-Swedish pharmaceutical firm AstraZeneca and Oxford University produced a strong immune response in older adults, raising hopes that it can protect the age groups most at risk from the virus.Oxford Covid vaccine shows strong immune response in older adults
Asked if it was too early to say whether the vaccine, which is licensed to AstraZeneca, stops disease developing, Andrew Pollard, director of the Oxford Vaccine Group, said: "We haven't quite got to that point yet. We're obviously not going to rush that."
The findings published in ‘Lancet' on Thursday based on 560 healthy adult volunteers shows that the ChAdOx1 nCoV-19 vaccine is “safe and well-tolerated” with a lower reactogenicity profile in older adults than in younger adults, meaning the older age groups could build immunity to the disease.
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
“India will have to focus on the indigenous vaccines and the AstraZeneca-Oxford vaccine. These vaccines are being tested in the India population and this is a major advantage over any other potential candidate,” said a senior government official.
The Union Cabinet on Wednesday approved a proposal to invest Rs 1,810 crore for 210 MW Luhri Stage-I hydropower project on river Satluj in Himachal Pradesh. "The Cabinet Committee on Economic Affairs (CCEA) chaired by Prime Minister Narendra Modi has approved the investment of Rs 1,810.56 crore for 210 MW Luhri Stage-I Hydro Electric Project located on river Satluj which is situated in Shimla and Kullu districts of Himachal Pradesh," an official statement said.CCEA approves Rs 1,810-cr investment for 210 MW hydropower project in Himachal
Most of the rich countries have already purchased 3.8 billion doses of yet-to-be-approved Covid-19 vaccines, with an additional 5 billion doses reserved or under negotiation, according to data compiled by Duke Global Health Innovation Center, which looked at advance purchase agreements from across the world.
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
Two male volunteers were administered the vaccine at Bharti Vidyapeeth's Medical College and Hospital, a senior office-bearer of the hospital said.
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.
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
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.
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.
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. '
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.
Israeli studies have found the Pfizer vaccine to be 95 percent effective one week after a second jab, while the Lancet report focused on more than 9,000 medical staff at Sheba hospital near Tel Aviv.
The new mid-stage trial will determine whether the vaccine is effective on people between the ages of 6 and 17, according to an emailed statement from the university.
Scientists in South Africa said Sunday that a similar problem held for people who had been infected by earlier versions of the coronavirus: The immunity they acquired naturally did not appear to protect them from mild or moderate cases when they were reinfected by the variant, known as B.1.351.
The recommendation was given by the Strategic Advisory Group of Experts on Immunisation (SAGE), which is charged with advising WHO on overall global policies and strategies ranging from vaccines to technology.
Vaccines that have not undergone a bridging trial will not be accepted, a senior government official told ET. A bridging trial is a study conducted in a new region that builds on clinical data from another region.
The Standing Vaccine Commission, Germany’s main public health agency, recommended that the AstraZeneca-Oxford vaccine only be used for people aged 18 and 64 years, citing “insufficient data currently available to ascertain how effective the vaccination is above 65 years”, according to a report in Financial Times.
The company, which transferred its vaccine technology to Serum Institute of India for distribution in India and middle-income countries, is banking on ease of storage and pricing of its jab to take on the early movers in the race.
The UK government described this as good news for the world because the impact of COVID vaccines on transmission has been a crucial unknown in the fight against the pandemic.
While AstraZeneca says it expects 2 million doses of the Oxford University vaccine to be ready each week in just over a fortnight, Pfizer BioNTech said the number of doses it has now sent to the UK is "in the millions".
At present, India is giving the second dose of Covishield after a gap of 28 days. However, new evidence suggests that efficacy is better when the second dose is given after 8-12 weeks.
India's Permanent Representative to the UN Ambassador T S Tirumurti tweeted on Saturday that Guterres, in a letter dated February 17, "extends his personal gratitude" to External Affairs Minister S Jaishankar for "India's offer of 200,000 doses" of COVID-19 vaccines for UN peacekeepers.
Serum Institute of India is one of the manufacturers that has signed up to supply up to 400 million doses of vaccines to the Covax Facility. In the first quarter, the company is expected to supply 200 million doses of the AstraZeneca/Oxford vaccine which it has developed in India and branded as Covishield.
The emergence of mutant strains of the SARS Cov2 virus has raised fear of another wave of the pandemic that could lead to ineffective vaccines.
This will be Modi's first interaction with chief ministers following the recent approval of two coronavirus vaccines for restricted emergency use by India's drug regulator.
Vaccine development perils are well known and most companies that embark on the task usually take at least five years to come out with one. The pandemic, however, changed that and Poonawalla’s bet has given the world a much-needed shot of hope.
Suggestions to tweak dosage strategy to overcome a supply crunch are not rooted in solid evidence and hence such a move could put public health at risk, US Food and Drug Administration commissioner Stephen M Hahn said on Monday night.
Oxford University scientists who developed the ChAdOx1-nCoV19 vaccine have found that it remains effective against at least one of the new variants of the disease, called the B.1.1.7 'Kent' coronavirus strain after the south-east England region where it was first discovered late last year.
The primary analysis of the Phase 3 clinical trials, published as a preprint in The Lancet, also showed that with an inter-dose interval of 12 weeks or more, vaccine efficacy increased to 82 per cent.
Phase 2 of Covid vaccination: People with comorbidities will need medical certificate to get the jab
There are currently two vaccines in use in India – Covishield, the AstraZeneca/Oxford vaccine made by of Serum Institute of India, and Bharat Biotech’s Covaxin.
Companies such as Zydus Cadila, Bharat Biotech, Dr Reddys-Gamaleya Institute, Serum Institute-AstraZeneca and Gennova are expected to submit their safety and efficacy data for approval with the drug regulator.
Canada has not yet signed a procurement agreement with Serum Institute of India (SII) for the supply of the AstraZeneca-University of Oxford Covid-19 vaccine.
The company is ready to start rolling out supplies of its Covishield vaccine in a week’s time, Poonawalla said. SII is waiting for a formal procurement contract for the vaccine from the Indian government with regard to pricing and distribution.
SII has already manufactured around 50 million doses of its Covid vaccine called Covishield, which is based on the technology from drugmaker AstraZeneca and Oxford.
Serum Institute of India (SII) last week also had submitted some additional data required by the Drug Controller General of India (DCGI), the sources said.
"I'm optimistic that we could reach that point before the end of this year," chief trial investigator for the vaccine, Andrew Pollard said of presenting trial results this year. Asked if the vaccine would be ready by Christmas he said: "There is a small chance."