The finding is based on alive virus neutralisation data from University College Oxford, UK, and Washington University School of Medicine, US, which showed that Evusheld (tixagevimab co-packaged with cilgavimab) retains neutralisation activity against the Omicron SARS-CoV-2 variant (B.1.1.529), the company said in a statement.
While the Omicron variant was not in circulation during the Evusheld clinical trials, the company added that it is continuing to collect further data to better understand the implications of this data in clinical practice. The findings from both studies were posted online on preprint server bioRxiv, and not peer-reviewed yet.
In early December, the US Food and Drug Administration granted emergency use authorisation (EUA) to Evusheld -- an injectable monoclonal antibody cocktail of tixagevimab co-packaged with cilgavimab -- for Covid-19 among people with weakened immune systems. It is the first antibody treatment against Covid-19 that has won an EUA from the drug regulator.
According to the researchers, the levels of neutralising potency are within the range of titres found in individuals who have been previously infected with and recovered naturally from Covid-19.
The data were generated from laboratory testing using actual live virus isolated from individuals who contracted the Omicron variant of Covid-19 -- considered a 'gold standard' for antibody neutralisation studies.
Evusheld is one of only two antibody therapies authorised for use that showed neutralising activity against Omicron and against all other variants of concern in these two studies.
"Consistent data across three independent studies now provide confidence that Evusheld -- a combination of two highly potent antibodies -- retains neutralising activity against the Omicron variant at a level that will continue to provide benefit to patients," said Mene Pangalos, Executive Vice-President, BioPharmaceuticals R&D, AstraZeneca.
"Evusheld is now available to help protect vulnerable populations, such as the immunocompromised, who are unable to mount an adequate response to vaccination and remain at high-risk of Covid-19," Pangalos added.
Besides the US, Evusheld has also won approval from drug authorities in other countries, including France and Italy.
A team led by researchers at the University of Oxford in the UK found that no safety concerns were raised in the study of 1,070 participants.
The study supports flexible use of these vaccines in primary immunisation schedules, which is crucial to help rapidly deploy these vaccines, especially in low- and middle-income countries where vaccine supply may be inconsistent.
"Thanks to studies such as these, we are now getting a more complete picture of how different COVID-19 vaccines can be used together in the same vaccine schedule," said Professor Matthew Snape, Associate Professor at the University of Oxford.
"Encouragingly, all these schedules generated antibody concentrations above that of the licensed and effective two dose Oxford-AstraZeneca schedule," said Snape, Chief Investigator on the trial.
When it comes to cellular immunity, the researchers said, having a first dose of the AstraZeneca vaccine followed by any of the other study vaccines generates a particularly robust response.
In addition, a significantly higher number of short-lived vaccine reactions were reported in volunteers who received a second dose of Moderna compared to those who received two doses of either AstraZeneca or Pfizer.
Using different types of vaccines within the same schedule as we have done here (for example mRNA vaccines, viral-vector vaccines or protein-based vaccines) is a relatively novel approach to immunisation," Snape said.
"As well as providing evidence for flexibility in deployment, these results suggest this approach can also help generate better immune responses," he added.
The researchers said the findings have implications beyond COVID-19 and will inform new approaches to immunisation against other diseases that are, as yet, not vaccine preventable.
The antibody treatment, known as AZD7442, has shown to be highly effective at preventing Covid-19 in people who may not respond well to vaccines, the company said in a statement.
About 2 per cent of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine. This includes people with blood cancers or other cancers being treated with chemotherapy, patients on dialysis, those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.
"These compelling results give me confidence that this long-acting antibody combination can provide my vulnerable patients with the long-lasting protection they urgently need to finally return to their everyday lives," said Hugh Montgomery, Professor of Intensive Care Medicine at the University College London, and AZD7442 principal investigator, in the statement.
"Importantly, six months of protection was maintained despite the surge of the Delta variant among these high-risk participants who may not respond adequately to vaccination," Montgomery added.
The phase three clinical trial was conducted across 87 sites in five countries: the US, the UK, Spain, Belgium and France. A total of 5,197 people took part, with 3,460 receiving 300 milligrams of AZD7442 and 1,737 being given a saline placebo.
The six-month assessment included data from 4,991 of the participants, who will continue to be assessed for 15 months.
In a separate trial, patients with mild-to-moderate Covid-19 had their risk of developing severe disease reduced by 88 per cent, when one dose of AZD7442 was given within three days of developing symptoms.A
Half of this triala¿s 903 participants were given 600 mg of AZD7442, while the other half were given a placebo.
Ninety per cent of those included in the second study were considered to be at high risk of developing severe Covid-19 if they contracted the virus. While the trials' full results have not yet been peer-reviewed, they are set to be submitted for publication in a peer-reviewed medical journal, the company said.
However, the results of both trials showed that AZD7442 was "generally well tolerated," it added.
"AZD7442 is the only long-acting antibody treatment that has phase three data to demonstrate efficacy in both preventing and treating Covid-19 with one dose," said Mene Pangalos, executive vice president of biopharmaceuticals R&D at AstraZeneca.
He added that the company will proceed with regulatory filings around the world "as quickly as possiblea.
In October, AstraZeneca announced it had asked the US Food and Drug Administration for emergency use authorisation for AZD7442 as a preventative treatment. It has not yet been granted.
The pharmaceutical giant has agreed to supply the US government with 700,000 doses of its antibody treatment if that request is granted.
Other companies developing antibody treatments include the US-based Regeneron's monoclonal antibodies, casirivimab and imdevimab, and Eli Lilly's drug bamlanivimab. These have been granted emergency use authorisation by the US Food and Drug Administration and in other countries. UK's GlaxoSmithKline and South Korea's Celltrion are conducting Phase II or III trials that are underway or forthcoming.
China is also set to approve the country's first monoclonal antibody therapy, co-developed by Tsinghua University, the Third People's Hospital of Shenzhen and Brii Biosciences, by December.
GBS is a serious nerve inflammation, which may cause temporary loss of feeling and movement (paralysis) and difficulty in breathing.
The European Medicines Agency (EMA), in a new update on Wednesday shared that a causal relationship between AstraZeneca vaccine and GBS was "considered at least a reasonable possibility".
Therefore, the condition should be "added to the product information as a side effect".
"The frequency category allocated is 'very rare' (that is, occurring in less than 1 in 10,000 persons), which is the category of the lowest frequency foreseen in EU product information," the EMA said in the update.
The incidence of the side effect remains extremely rare, with only 833 cases reported worldwide from about 592 million administered doses of the adenovirus-based AstraZeneca vaccine, as of July 25.
Reported cases concern suspected side effects, i.e. medical events that have been observed after vaccination, but which are not necessarily related to or caused by the vaccine, the regulatory body said.
The EMA further recommended that patients must talk to their healthcare professionals before taking AstraZeneca vaccine, if they previously had GBS after being given the vaccine.
It added that people should seek immediate medical attention if they develop weakness and paralysis in the extremities that can progress to the chest and face.
A study, published in the peer-reviewed medical journal Annals of Neurology in June, described an unusual variant of Guillain-Barre syndrome characterised by prominent facial weakness in seven cases from a regional medical center in Kerala, India. The cases occurred within two weeks of the first dose of vaccination.
"Six out of the seven patients progressed to areflexic quadriplegia and required mechanical ventilatory support," said Boby Varkey Maramattom, from the Department of Neurology, Aster Medcity, Kochi, Kerala.
"The frequency of GBS was 1.4 to 10 fold higher than that expected in this period for a population of this magnitude. In addition, the frequency of bilateral facial weakness, which typically occurs in less than 20 per cent of GBS cases, suggests a pattern associated with the vaccination," he added.
While the benefits of vaccination substantially outweigh the risk of this relatively rare outcome, the researchers stressed that clinicians should be alert to this possible adverse event and look for this rare neurological syndrome following administration of Covid-19 vaccines.
The Johnson & Johnson vaccine against Covid, developed using the same technology as AstraZeneca, was also listed for GBS recently.
The EMA has also included pain in legs and arms or stomach and influenza-like symptoms in the product information as side effects of the AstraZeneca vaccine.
Soriot's comments come as the UK is just "a few weeks away" away from officially announcing booster doses for all its citizens, The Telegraph reported.
"Moving too quickly to boost across the entire adult population will deprive us of these insights, leaving this important decision to rest on limited data," Soriot wrote in the newspaper.
"A third dose for all may be needed, but it may not. Mobilising the NHS for a boosting programme that is not needed would potentially add unnecessary burden on the NHS over the long winter months.
"Because NHS staff and resources are scarce, another national mobilisation would potentially leave us with fewer resources for cancer screenings and the other care provided by doctors and nurses each day," he said.
The UK drug maker chief noted that "this is important not just for the UK but for the rest of the world".
So far, 1.2 billion doses of AstraZeneca vaccine, Covishield in India, have been distributed.
The booster roll out in the UK is awaiting a green signal from the independent advisory body Joint Committee on Vaccination and Immunisation (JCVI), who are expecting study results on seven different booster vaccines.
Soriot further stated that it is critical to understand the need for a third dose, as the decision will have "real implications for how we deploy scarce NHS resources".
While booster doses may be "a sensible immediate precaution" for the vulnerable, the elderly or those with people with weak immune systems, the decision to jab the entire population must be based on "real world clinical effectiveness data, not simply antibody measurements", they noted.
"Indeed, we don't know what mix of antibodies and T-cells are needed to prevent serious illness -- the so-called correlates of protection. This is why we need the weight of the clinical evidence gathered from real world use before we can make an informed decision on a third dose," they pointed out.
On the other hand, US pharmaceutical major Pfizer's CEO Albert Bourla had announced that Covid vaccine recipients will "likely" need a third dose between six to 12 months after they're fully vaccinated. He also suggested the need for yearly vaccinations against coronavirus.
The US is also expected to soon roll out Covid booster vaccines for all its citizens, even as the World Health Organisation has called for a moratorium on boosters.
The US has already started a third dose for immunocompromised people.
Other countries include Israel, Italy, France, and Russia.
If any Indian citizen, who has taken the first dose of Covishield vaccine in a foreign country, can take the second dose in Odisha after prescribed time period and will also get a certificate for the same. At present, the gap between the first and second doses of Covishield vaccine is 12-16 weeks, the officials added.
After receiving instructions from the Central government, the Odisha Health and Family Welfare department's Additional Chief Secretary, P.K. Mohapatra informed all District Collectors, Municipal Commissioners and Chief District Medical and Public Health officials about the decision.
"If an Indian citizen beneficiary has taken first dose of Covishield or AstraZeneca (ChAdOx1 nCov-19) vaccine outside India, the beneficiary can register on CoWIN app at the time of taking the second dose of Covishield vaccine after prescribed time interval and details of first dose can be recorded on the CoWIN app at the same time," Mohapatra said in a letter to the local authorities.
The District and Municipal authorities have been asked to inform all programme officers, managers, vaccinators and verifiers engaged at Covid-19 vaccination sites to implement the decision immediately.
Earlier, the Central government had reduced the time gap between two doses of Covishield vaccine for people seeking to undertake foreign travel for educational purposes, employment opportunities and for India's contingent to the Tokyo Olympic games. The time interval was reduced to 28 days from 84 days only for the above category of beneficiaries.
While the AstraZeneca vaccine produced in Europe, branded Vaxzevira, has been greenlighted by the European Medicines Agency (EMA), the Indian version Covishield has not even requested for the market authorization, according to Stefan De Keersmaecker, the Commission's spokesman for health issues, the Xinhua news agency reported.
In the UK, where AstraZeneca is the prevalent vaccine in use, a share of the population has received the Indian-made jab, manufactured by Serum Institute of India (SII).
In total, five million doses were imported from India, but health authorities said they were not called Covishield and considered the same product as those produced in north Wales and Staffordshire, according to the BBC.
"Of course, the Covishield manufacturer is always free to request the authorization of this vaccine, but for the time being, it is not the case," said Keersmaecker.
An EU-wide Digital Covid Certificate officially entered into force on Thursday, allowing people to travel within the EU-plus area without restrictions if they can either prove to have been fully vaccinated with the EMA-approved vaccines, or have tested negative or recovered from the infection.
Meanwhile, EU member states have the right to accept travelers vaccinated with jabs approved by the World Health Organization (WHO), among which is the Covishield. Media reports said only a small number of the 27 member states have announced the acceptance.
In response to concerns that people from the UK may be denied entry when traveling to the EU, Keersmaecker said the European Commission is working to solve the problem.
"In order to assure a coordinated approach here, the Commission is obviously in contact in discussion with the member states to go through these different vaccines and to see which is the best coordinated approach," said the spokesman.
The Com-Cov trial, led by researchers from the University of Oxford, looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other. The results showed that all combinations worked well, priming the immune system, the BBC reported.
The study included 850 volunteers aged 50 and above, who were given the doses four weeks apart. The team found that people who took AstraZeneca shot followed by Pfizer showed higher antibodies and T cell responses than those who took Pfizer followed by AstraZeneca.
Both of these mixes induced higher antibodies than two doses of AstraZeneca, while the highest antibody response was seen after two doses of Pfizer, and the highest T cell response from AstraZeneca followed by Pfizer.
"We already know that both standard schedules are very effective against severe disease and hospitalisations, including against the Delta variant when given at eight to 12 weeks apart," lead investigator Professor Matthew Snape, from varsity was quoted as saying.
He however, added that the findings did not undermine the UK policy of giving people the same jab twice.
But, they do offer such flexibility for vaccine rollout in the future.
"Mixing doses could provide us with even greater flexibility for a booster programme, while also supporting countries who have further to go with their vaccine rollouts, and who may be experiencing supply difficulties," UK's deputy chief medical officer, Prof Jonathan Van-Tam, was quoted as saying by the BBC.
Two doses are important to give the fullest protection and teach the body to make antibodies and T cells to block and kill Covid.
Meanwhile, a pre-print study suggests that a third dose of AstraZeneca vaccine, given more than six months after the second, boosts the immune system, the BBC reported.
But, there is currently no data to support that a Covid-19 vaccine booster shot is needed for the general population, according to the US Centers for Disease Control and Prevention. An extra dose may be needed for more-vulnerable groups, such as older adults or organ transplant patients.
The study led by UK’s Public Health England (PHE) showed that people who took the first dose of either the Pfizer or AstraZeneca vaccines — and who became infected three weeks later — were between 38 per cent and 49 per cent less likely to pass the virus on than unvaccinated people, the BBC reported on Wednesday.
In the study, protection against Covid was seen from about 14 days after vaccination, with similar levels of protection regardless of age of cases or contacts, PHE was quoted as saying in a statement.
The protection was in addition to the reduced risk of a vaccinated person developing symptomatic infection in the first place, which is around 60 to 65 per cent — four weeks after one dose of either vaccine, the BBC report said.
“Vaccines are vital in helping us return to a normal way of life. Not only do vaccines reduce the severity of illness and prevent hundreds of deaths every day, we now see they also have an additional impact on reducing the chance of passing Covid-19 on to others,” Dr Mary Ramsay, head of immunisation at PHE, was quoted as saying.
The study, which has yet to be fully peer-reviewed, included more than 57,000 contacts from 24,000 households in which there was a lab-confirmed coronavirus case that had received a vaccination, compared with nearly one million contacts of unvaccinated cases. The findings showed households are among the most likely places for infection to spread, the report said.
While the findings are significant, the experts urged people to continue to take up vaccination and maintain Covid appropriate behaviours.
As the Covid pandemic inflicts a heavy toll on countries around the globe, the U.S. Chamber strongly encourages the administration to release the millions of AstraZeneca vaccine doses in storage – as well as other life-saving support – for shipment to India, Brazil, and other nations hard-hit by the pandemic, said Myron Brilliante, executive vice president and head of international affairs at the US Chamber of Commerce.
He said these vaccine doses will not be needed in the United States, where it’s estimated that vaccine manufacturers will be able to produce enough doses by early June to inoculate every American.
This move would affirm US leadership, including in initiatives such as COVAX, and as we work with partners around the globe because no one is safe from the pandemic until we are all safe from it, Brilliante said.
The US Chambers issued the statement after Indian External Affairs Minister S Jaishankar sought global help in fight against COVID-19. Will strive to ensure that our supply chains are as smooth as possible in a difficult global situation. The world must support India, as India helps the world, he said in a tweet.
US State Department Deputy Spokesperson Jalina Porter told reporters that the United States continues to work closely with India to facilitate the movement of essential supplies and also address the bottlenecks of the supply chains.
The COVID-19 situation in India is a global concern, she said.
We also continue to collaborate with our partners in India to battle this at the highest level. We know Secretary (of State, Tony) Blinken spoke to his counterpart on Tuesday and we remain deeply engaged with India at all levels as we work to combat this crisis of the pandemic together, Porter said.
Congresswoman Rashida Talib tweeted that the COVID-19 crisis in India is a harsh reminder that the pandemic is not over until the whole world is safe.
President Biden must support a patent waiver to ramp up global production now, she said.
As we look to our Indian friends battling this pandemic, we’ll also acknowledge the toll that it’s taking, not only on the people of India, but as well as all throughout South Asia and, quite frankly, all over the world, Porter said.
The Washington Post in a lead editorial hoped that all of India can seize the moment and begin to reverse the course of this disaster. India is not a faraway problem. In pandemic time and distance, every place is nearby, it said.
Major Democratic fundraiser for the Biden’s presidential campaign Shekar Narasimhan urged the US President to speak to Prime Minister Narendra Modi. We have to do something in the face of a humanitarian disaster. Every friend I know in the US with family in India reports that relatives have died or been affected, he said.
President please speak to Prime Minister and see if we can lend 10M doses of AZ vaccine like tomorrow. We must help now! he said.
According to a report in City A.M., AstraZeneca is aiming to deliver two billion doses of the drug by the end of the year. "We think it will protect for about a year," Astrazeneca CEO Pascal Soriot was quoted as saying on Bel RTL. The drugmaker last week said it had reached an agreement with Europe's Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford's Covid-19 vaccine, with deliveries starting by the end of 2020.
AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The company said it is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic.
The company has recently completed similar agreements with the UK, US, the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance for 700 million doses, and it agreed a licence with the Serum Institute of India for the supply of an additional one billion doses, principally for low- and middle-income countries.
Oxford University last month announced the start of a Phase II/III UK trial of the vaccine, named AZD1222, in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries.
(IANS)
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WHO Chief Scientist Soumya Swaminathan stated that the AstraZeneca's coronavirus vaccine candidate is the most advanced vaccine currently in terms of development.
"I think AstraZeneca certainly has a more global scope at the moment in terms of where they are doing and planning their vaccine trials," she told the media.
AstraZeneca's Covid-19 vaccine candidate developed by researchers from the Oxford University will likely provide protection against the disease for one year, the British drug maker's CEO told Belgian radio station Bel RTL this month.
The Oxford University last month announced the start of Phase II/III UK trial of the vaccine, named AZD1222 (formerly known as ChAdOx1 nCoV-19), in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries.
Last week, Swaminathan had said that nearly 2 billion doses of the Covid-19 vaccine would be ready by the end of next year.
Addressing the media from Geneva, she said that "at the moment, we do not have a proven vaccine but if we are lucky, there will be one or two successful candidates before the end of this year" and 2 billion doses by the end of next year.
Scientists predict that the world may have a Covid-19 vaccine within one year or even a few months earlier, said the Director-General of the World Health Organization even as he underlined the importance of global cooperation to develop, manufacture and distribute the vaccines.
However, making the vaccine available and distributing it to all will be a challenge and will require political will, WHO chief Tedros Adhanom Ghebreyesus said on Thursday during a meeting with the European Parliament's Committee for Environment, Public Health and Food Safety.
One option would be to give the vaccine only to those who are most vulnerable to the virus.
There are currently over 100 Covid-19 vaccine candidates in various stages of development.
(IANS)
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In a statement issued on Tuesday evening, the company said its "standard review process triggered a pause to vaccination to allow review of safety data".
AstraZeneca didn't reveal any information about the possible side effect except to call it "a potentially unexplained illness".
The health news site STAT first reported the pause in testing, saying the possible side effect occurred in the United Kingdom. An AstraZeneca spokesperson confirmed the pause in vaccinations covers studies in the US and other countries.
Late last month, AstraZeneca began recruiting 30,000 people in the US for its largest study of the vaccine. It also is testing the vaccine, developed by Oxford University, in thousands of people in Britain, and in smaller studies in Brazil and South Africa.
Two other vaccines are in huge, final-stage tests in the United States, one made by Moderna Inc. and the other by Pfizer and Germany's BioNTech. Those two vaccines work differently than AstraZeneca's, and the studies already have recruited about two-thirds of the needed volunteers.
Temporary holds of large medical studies aren't unusual, and investigating any serious or unexpected reaction is a mandatory part of safety testing. AstraZeneca pointed out that it's possible the problem could be a coincidence; illnesses of all sorts could arise in studies of thousands of people.
"We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," the company statement said.
It's likely the unexplained illness was serious enough to require hospitalization and not a mild side effect such as fever or muscle pain, said Deborah Fuller, a University of Washington researcher who is working on a different COVID-19 vaccine that has not yet started human testing.
"This is not something to be alarmed about," Fuller said. Instead, it's reassuring that the company is pausing the study to figure out what's happening and carefully monitoring the health of study participants.
Dr Ashish Jha of Brown University said via Twitter that the significance of the interruption was unclear but that he was "still optimistic" that an effective vaccine will be found in the coming months.
"But optimism isn't evidence," he wrote. "Let's let science drive this process."
Angela Rasmussen, a virologist at Columbia University in New York, tweeted that the illness may be unrelated to the vaccine, "but the important part is that this is why we do trials before rolling out a vaccine to the general public".
During the third and final stage of testing, researchers look for any signs of possible side effects that may have gone undetected in earlier patient research. Because of their large size, the studies are considered the most important study phase for picking up less common side effects and establishing safety.
The trials also assess effectiveness by tracking who gets sick and who doesn't between patients getting the vaccine and those receiving a dummy shot.
The development came the same day that AstraZeneca and eight other drugmakers issued an unusual pledge, vowing to uphold the highest ethical and scientific standards in developing their vaccines.
The announcement follows worries that President Donald Trump will pressure the US Food and Drug Administration to approve a vaccine before it's proven to be safe and effective.
The US has invested billions of dollars in efforts to quickly develop multiple vaccines against COVID-19. But public fears that a vaccine is unsafe or ineffective could be disastrous, derailing the effort to vaccinate millions of Americans.
Representatives for the FDA did not immediately respond to requests for comment Tuesday evening.
AstraZeneca's US-traded shares fell more than 6 per cent in after-hours trading following reports of the trial being paused.
(PTI)
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On September 6, the standard review process had triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees and international regulators.
The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume, AstraZeneca said on Saturday.
"AstraZeneca and the University of Oxford as the trial sponsor cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards," it added.
AstraZeneca is committed to the safety of the trial participants and highest standards of conduct in clinical trials.
"The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic," the company said.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
(IANS)
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According to a report in The Wall Street Journal on Wednesday, Oxford University said it had carried out a careful assessment of the case in Brazil and found that there were no concerns about the safety of the trial.
An independent assessment of the case did not present any concerns, AstraZeneca said.
The Wall Street Journal, citing local Brazilian press reports, said the volunteer was a man in his 20s from Rio de Janeiro. It was not immediately clear if the man received the vaccine or had been part of a placebo group.
An AstraZeneca spokesperson told Fox News that the company cannot comment on individual cases in an ongoing trial due to regulations.
However, they said the company has followed all required review processes.
"All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities," the spokesperson said.
"These assessments have not led to any concerns about continuation of the ongoing study," the spokesperson added.
In the US, clinical trials involving AstraZeneca were recently put on hold pending a FDA investigation into a "possible serious adverse event."
(IANS)
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The study, published in The Lancet medical journal, suggest that those aged over 70, who are at higher risk of serious illness and death from Covid-19, could build robust immunity to the novel Coronavirus.
"We were pleased to see that our vaccine was not only well-tolerated in older adults, but also stimulated similar immune responses to those seen in younger volunteers," Dr Maheshi Ramasamy, an investigator at the Oxford Vaccine Group, was quoted as saying to the BBC.
"The next step will be to see if this translates into protection from the disease itself," Ramasamy added.
According to the researchers, two weeks after the second dose, more than 99 per cent of participants had neutralising antibody responses. These included people of all ages.
The T-cell response - another measure of how well the immune system responds - peaked two weeks after the first dose of the vaccine, regardless of age.
"The robust antibody and T-cell responses were seen in older people in our study are encouraging. The populations at greatest risk of serious Covid-19 disease include people with existing health conditions and older adults," Ramasamy said.
"We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure," she added.
According to the study, older adults were also less likely to experience side-effects, which were usually mild. And there were no serious safety issues relating to the vaccine, called ChAdOx1 nCov-2019.
Three vaccines - Pfizer-BioNTech, Sputnik and Moderna -- have already reported good preliminary data from phase three trials, with one suggesting 94 per cent of over-65s could be protected from Covid-19.
Later in the day, CEO of Serum Institute of India, Adar Poonawalla during second session of the 18th edition of the Hindustan Times Leadership Summit announced that Oxford vaccine will be priced at Rs 500-600 for general public in India.
Oxford vaccine will be priced at Rs 500-600 for general public, CEO of Serum Institute of India, Adar Poonawalla during second session of the 18th edition of the Hindustan Times Leadership Summit#COVID19 pic.twitter.com/ykSwNAvBRy
— OTV (@otvnews) November 19, 2020
(With IANS Inputs)
Last week, drug maker Pfizer said that its coronavirus vaccine was 95% effective and had no serious side-effects, while biotech company Moderna also claimed 94.5% effectiveness in preventing COVID-19 disease. On the other hand, Russia's Sputnik V has shown 92% efficacy.
Amid this tough battle, the third phase human trial of Bharat Biotech's Covaxin is underway in Odisha. It is expected that the phase-3 trials would be over in a little over a month, and vaccine could be available by June next year, expects Dr E Venkat Rao, Principal Investigator in Covaxin human trial in Odisha.
"Phase-3 of the trial is crucial and tedious as we have to wait till the development of the disease which is dependent on the frequency of the disease in the population. So we need to recruit a large number of subjects and more than 25,000 volunteers were being recruited for the trial across the country. If everything falls in place, we will probably have a vaccine by June-July 2021," he said.
State Health Minister Naba Das also opined that Odisha is well prepared and as soon as the vaccine is available, phase-wise distribution would begin in strict adherence to the Centre's guidelines. Follow up action will be taken if any further communication is received from the Centre, Das said.
As far as the Covid scenario across the country is concerned, Covid toll is gradually increasing in 7 States including Odisha, Gujarat, Kerala, Himachal Pradesh, Bihar, Jharkhand, Assam. Here in Odisha, the death rate has refused to decline even as daily positives have come down to below 1000 over the last one week.
"There are many people who have taken adequate precautionary measures and are taking medicines accordingly, and there are others who do not undergo test and rather prefer isolating themselves at home. Patients succumbing to the disease are severe cases admitted to the hospitals," said an expert.
Furthermore, the apprehension of a second wave has deepened in Odisha in December with the pandemic situation worsening in Delhi, Gujarat, Assam and Maharashtra. Seeking a report on the management, the Supreme Court said, "We are hearing of a huge spike in the current month. We want a latest status report from all states. Worse things may happen in December if states aren't well prepared."
https://youtu.be/1DUjaHr6st4
Oxford AstraZeneca Vaccine 70% Effective In Preventing COVID-19..
AstraZeneca announced Monday that positive high-level results from an interim analysis of clinical trials of the Covid-19 vaccine candidate in the UK and Brazil showed it was highly effective in preventing the disease, the primary endpoint, and no hospitalisations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 Covid-19 cases in the interim analysis.
One dosing regimen showed vaccine efficacy of 90 per cent when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70 per cent.
In partnership with @AstraZeneca, we’re hoping to supply 3 billion doses of the vaccine and make it available to people around the world by the end of next year. The #OxfordVaccine can be stored at fridge temp & deployed quickly using existing infrastructure.
— University of Oxford (@UniofOxford) November 23, 2020
This project is the result of global collaboration and support from partners, funders and researchers around the world. We’re grateful for their cooperation and hard work - without them, the #OxfordVaccine wouldn’t have been possible.
— University of Oxford (@UniofOxford) November 23, 2020
All results were statistically significant. More data will continue to accumulate and additional analysis will be conducted, refining the efficacy reading and establishing the duration of protection.
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens.
AstraZeneca will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval. The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal.
Professor Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial at Oxford, said,
"These findings show that we have an effective vaccine that will save many lives. Excitingly, we've found that one of our dosing regimens may be around 90 per cent effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply. Today's announcement is only possible thanks to the many volunteers in our trial, and the hard working and talented team of researchers based around the world."
Pascal Soriot, Chief Executive Officer, said: "Today marks an important milestone in our fight against the pandemic. This vaccine's efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency. Furthermore, the vaccine's simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available, supplying hundreds of millions of doses on approval."
The pooled analysis included data from the Phase II/III trial in the UK and Phase III trial in Brazil. Over 23,000 participants are being assessed following two doses of either a half-dose/full-dose regimen or a regimen of two full doses of AZD1222 or a comparator, meningococcal conjugate vaccine called MenACWY or saline. The global trials are evaluating participants aged 18 years or over from diverse racial and geographic groups who are healthy or have stable underlying medical conditions.
Clinical trials are also being conducted in the US, Japan, Russia, South Africa, Kenya and Latin America with planned trials in other European and Asian countries. In total, the Company expects to enrol up to 60,000 participants globally.
The Company is making rapid progress in manufacturing with a capacity of up to 3 billion doses of the vaccine in 2021 on a rolling basis, pending regulatory approval. The vaccine can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months and administered within existing healthcare settings.
AstraZeneca continues to engage with governments, multilateral organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic.
(With agency inputs)
The partnership aims to harness and scale-up the use of this technology to improve early-stage detection of lung cancer in the markets involved, to reduce mortality rates and improve patient outcomes.
As part of the strategic collaboration, AstraZeneca will work with Qure.ai to explore the application of deep learning algorithms to identify patients with suspicious radiographic lung abnormalities and support their referral to arrive at a firm diagnosis.
AstraZeneca and Qure.ai will be covering the emerging market regions in Latin America, Asia, Middle East and Africa. The collaboration will also focus on overcoming barriers that limit access to diagnostic tools to support early lung cancer detection.
"Innovations such as this are critical for boosting the capabilities of healthcare ecosystem, and this partnership supports our bold ambition of eliminating cancer as a cause of death," Leon Wang, AstraZeneca EVP International and Country President, China, said in a statement.
The end goal of the partnership is to improve referral and diagnostic pathways for patients with possible lung cancers and increase lung cancer detection at an earlier stage - improving the patient journey and ultimately reducing lung cancer mortality rates around the world.
"We are delighted to partner with AstraZeneca in the early detection of lung cancer using our AI solution for automated interpretation of chest X-rays," said Prashant Warier, CEO and Co-Founder, Qure.ai.
According to the company, the software's ability to process analogue and digital chest X-rays in a minute can help physicians in incidental diagnoses of lung cancer by pointing out small lung nodules which could have been missed in a cursory review.
The solution also detects several other types of abnormalities from chest X-rays that are linked to infection, injuries and chronic diseases, and flags these to the physician, potentially creating other diagnostic pathways.
(With IANS Inputs)
Earlier on the day, the European Medicines Agency (EMA) confirmed that the cases of blood clots with low blood platelets were associated with the administration of the AstraZeneca Covid-19 vaccine, but should still be listed as very rare side effects.
In an interim statement on Wednesday, the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) said that the events under assessment are very rare, with low numbers reported among the almost 200 million individuals who have received the AstraZeneca vaccine around the world, Xinhua news agency reported.
However, specialized studies are needed to fully understand the potential link, and the GACVS said it will continue to gather and review further data.
Meanwhile, the GACVS added that rare adverse events following immunizations should be assessed against the risk of deaths from Covid-19 and the potential of the vaccines to prevent infections and reduce deaths. According to the WHO’s statistics, as of Wednesday, at least 2.6 million people have died of Covid-19 worldwide.
Several European countries have already halted or suspended the rollout of the AstraZeneca vaccine in view of the reported risks. On Wednesday, the WHO said that the side effects, mostly mild and local in nature, are “expected” and “common” within two or three days following vaccination.
It also recommended that individuals who experience any severe symptoms, such as shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms such as severe and persistent headaches or blurred vision, tiny blood spots under the skin beyond the site of the injection, from around four to 20 days following vaccination should seek urgent medical attention.
“In extensive vaccination campaigns, it is normal for countries to identify potential adverse events following immunization,” the GACVS said. “This does not necessarily mean that the events are linked to the vaccination itself, but they must be investigated to ensure that any safety concerns are addressed quickly.
“Vaccines, like all medicines, can have side effects. The administration of vaccines is based on a risk versus benefit analysis,” it added.
The drug maker has partnered with global pharma giant AstraZeneca and the Oxford University for making the vaccine and is conducting trials in India. Indian drug regulatory body is looking at the UK's approval to this vaccine before giving nod for Emergency Use Authorization to its Indian counterpart developed by SII.
"We have 40-50 million doses of Covishield stockpiled. Once we get regulatory approvals in a few days, it will be down to the government to decide how much they can take and how fast. We will be producing around 300 million doses by July 2021," Serum Institute CEO Adar Poonawalla told a press conference.
He added, "India is a part of COVAX. We will keep giving 50 per cent of everything we make to India and to COVAX at the same time. India has such a large population that we will probably end up giving the majority of those 50 million doses to India first."
'COVAX' was launched in April by the WHO, Gavi Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations for a solution to accelerate the development and manufacture of COVID-19 vaccines and equitable access to them for people in all countries.
India currently has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorization in near future. Serum Institute-Oxford's Covishield, Bharat Biotech's Covaxin and Pfizer vaccine are in the fray for emergency use authorisation.
The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with comorbidities.
"The first six months of 2021 will see a shortage globally. Nobody can help that. But we will see easing off by August-September 2021 as other vaccine manufactures also being able to supply," Poonawalla added.
(With IANS Inputs)
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.
"These new data provide an important verification of the interim data that has helped regulators such as the MHRA in the UK and elsewhere around the world to grant the vaccine emergency use authorisation," co-author Andrew Pollard, Chief Investigator of the Oxford Vaccine Trial, said in a statement.
"It also helps to support the policy recommendation made by the Joint Committee on Vaccination and Immunisation for a 12-week prime-boost interval, as they look for the optimal approach to roll out, and reassures us that people are protected 22 days after a single dose of the vaccine," Pollard added.
The analysis also showed the potential for the vaccine to reduce asymptomatic transmission of the virus, based on weekly swabs obtained from volunteers in the UK trial.
The data showed that PCR positive readings were reduced by 67 per cent after a single dose, and 50 per cent after the two dose regimen, supporting a substantial impact on transmission of the virus.
The primary analysis for efficacy was based on 17,177 participants accruing 332 symptomatic cases from the Phase 3 in UK, Brazil and South Africa trials led by Oxford University and AstraZeneca, a further 201 cases than previously reported.
The analysis also showed that the vaccine is safe and effective at preventing Covid-19, with no severe cases and no hospitalisation, more than 22 days after the first dose.
AstraZeneca continues to engage with governments, international organisations and collaborators around the world to ensure broad and equitable access to the vaccine at no profit for the duration of the pandemic, the company said.
"In the fight against the global pandemic, as on February 19, till 8 a.m., the cumulative vaccine doses administered to healthcare and frontline workers against Covid-19 in the country have surpassed 1 crore," the Health and Family Welfare Ministry said.
The country took 34 days to achieve the landmark feat of 1 crore vaccinations, which, the ministry claimed, is the second fastest in the world.
"A total of 1,01,88,007 vaccine doses have been administered through 2,11,462 sessions, as per the provisional report till 8 a.m. today. These include 62,60,242 HCWs (1st dose), 6,10,899 HCWs (2nd dose) and 33,16,866 FLWs (1st dose)," it added.
The nationwide immunisation drive against Covid-19 was started on January 16 with two vaccines -- Covishield by the Serum institute of India and Covaxin by Bharat Biotech -- which were given emergency use authorisation by India's drug regulator.
The drive started with vaccination planned for around 1 crore healthcare workers first followed by 2 crore frontline workers (FLWs) who registered as vaccine beneficiaries.
The 2nd dose of vaccination started on February 13 for those beneficiaries who have completed 28 days after receipt of the 1st dose. Vaccination of the FLWs started on February 2.
"Till day 34 of the vaccination drive (February 18), total 6,58,674 vaccine doses were given. Of which, 4,16,942 beneficiaries were vaccinated across 10,812 sessions for 1st dose (HCWs and FLWs) and 2,41,732 HCWs received 2nd dose of vaccine," the Health Ministry said.
It also said that eight states have accounted for 57.47 per cent of the total vaccinations. Uttar Pradesh tops the chart, with 10.5 per cent (10,70,895) of the vaccination alone.
Meanwhile, seven states account for 60.85 per cent of the second vaccine doses administered in India. Telangana leads all the states with a 12 per cent share of second doses (73,281 beneficiaries) administered in the country, it said.
Besides, 16 states/UTs have not reported any Covid deaths in the last 24 hours. These are Gujarat, Himachal Pradesh, Goa, Jharkhand, Meghalaya, Puducherry, Chandigarh, Manipur, Mizoram, Lakshadweep, Sikkim, Arunachal Pradesh, Ladakh, Tripura, Andaman and Nicobar Islands and Daman and Diu, as per the information released by the Health Ministry.
Fifteen states/UTs reported 1-5 deaths and 3 states/UTs reported deaths between 6 to 10 deaths in the same duration.
A total of 13,193 new cases and 97 fatalities due to Covid-19 have been recorded in the country in the last 24 hours, the Health Ministry had said on Friday morning.
Oxford-AstraZeneca's Covishield is being manufactured by Pune-based Serum Institute of India (SII) which has collaborated with Oxford University and pharmaceutical company AstraZeneca for making the vaccine.
An Air India aircraft carrying the consignment of COVID-19 vaccines landed at the Tribhuvan International Airport in the morning, according to sources at the Indian Embassy here.
One million doses of Covishield arrive in Nepal
The consignment is part of the two million doses of vaccine for which the government signed a procurement deal with the Indian manufacturer on Wednesday.https://t.co/OMqVhmruYn — photos by @sthemanta & @AngadDhakal pic.twitter.com/kNirNRAatE
— The Kathmandu Post (@kathmandupost) February 21, 2021
The Nepal government has decided to procure a total of two million doses of the vaccine manufactured by the SII.
Last month, India gifted one million doses of Covishield vaccine to Nepal.
The Nepal government has already started administering the vaccines on health workers, security personnel and journalists on priority basis.
It is planning to soon start a vaccine rollout for elderly citizens, according to the Health Ministry.
Nepal has so far reported 2,73,431 COVID-19 cases and 2,061 fatalities.
India is one of the world's biggest drug makers and an increasing number of countries have already approached it for procuring the coronavirus vaccines.
India has sent consignments of domestically produced coronavirus vaccines under grant assistance to Bhutan, Maldives, Nepal, Bangladesh, Myanmar, Mauritius and Seychelles.
It is also undertaking commercial supplies of the doses to a number of countries, including Saudi Arabia, South Africa, Brazil and Morocco.
The Covid-19 vaccine developed by AstraZeneca and the University of Oxford has been suspended in a number of countries across Europe and Asia, following reports of blood clots in some vaccinated people, reports Xinhua news agency.
"WHO is aware that some countries have suspended the use of AstraZeneca vaccines, based on reports of blood clots in some people who received doses of the vaccine from two batches. This measure was taken as a precaution while a full investigation is finalized," Tedros said at a press briefing on Friday.
A number of countries like Denmark, Norway, Iceland, Romania and Thailand have suspended the rollout of the AstraZeneca/Oxford vaccine after it was linked to blood clots in recipients, while Austria and France have decided to continue using it.
"It is important to note that the European Medicines Agency has said there is no indication of a link between the vaccine and blood clots, and that the vaccine can continue to be used while its investigation is ongoing," the WHO chief said.
The European Commission said on Thursday that the AstraZeneca vaccine is still safe to use, adding that the European Medicines Agency (EMA) had adopted a preliminary review on the case in Austria "where they said there is no specific indication that the vaccination led to these conditions".
"As soon as WHO has gained a full understanding of these events, the findings and any changes to our current recommendations will be communicated immediately to the public," Tedros said.
The WHO chief also said that more than 335 million Covid-19 vaccine doses have been administered globally so far, and no deaths have been found to have been caused by them.
"But at least 2.6 million people have been killed by the virus. And more will continue to die the longer it takes to distribute vaccines as rapidly and as equitably as possible," he said.
As countries roll out Covid-19 vaccines, the WHO is continuing to keep a close eye on their safety, Tedros added.
Also on Friday, the WHO gave emergency use listing to Johnson & Johnson's Covid-19 vaccine, making it the fourth to receive the health agency's approval.
Emergency use listing is the green light for a vaccine to be procured and rolled out by COVAX, he said, referencing the global WHO-led initiative to ensure vaccine equity.
As the world is struggling to contain the pandemic, vaccination is underway in an increasing number of countries with the already-authorised coronavirus vaccines.
Meanwhile, 263 candidate vaccines are still being developed worldwide, 81 of them in clinical trials, according to the WHO.
The suspensions have come amid several reports of blood clots following vaccinations with the Covid jab developed by the British-Swedish pharmaceutical giant and the University of Oxford.
"Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine," the company said in a statement on Sunday.
"A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country," it added.
So far across the EU and UK, there have been 15 events of DVT (a condition arising out of blood clot forming in a vein) and 22 events of pulmonary embolism (blockage in one of the pulmonary arteries in lungs due to clood clots) reported among those given the vaccine, based on the number of cases the company has received as of 8 March, AstraZeneca said.
The company said that this is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed Covid-19 vaccines.
"Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population," Ann Taylor, Chief Medical Officer at AstraZeneca, said in a statement.
"The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety."
In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world, the company said.
Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern, it added.
AstraZeneca accepted the proposal and will begin clinical trials of its vaccine in combination with Sputnik V's human adenoviral vector type Ad26 by the end of 2020. This research will allow AstraZeneca's scientists to study the possibility of boosting their vaccine's efficacy through the application of this combined approach.
Sputnik V is among the world's most effective and safe vaccines due to its unique technology combining two different human adenoviral vectors, providing for a stronger and longer-term immune response compared to vaccines using the same component for both inoculations.
The regimen with two different adenoviral vectors for a prime and a boost immunisation is a unique and ground-breaking discovery of the Gamaleya centre scientists. It helps to completely avoid immunity to the first vector, which forms after the first inoculation and thus to raise efficacy and create long-term immunity.
Among the leading Covid-19 vaccines, only Sputnik V is using the two-vector technology.
RDIF's offer to AstraZeneca was an example of Russia's proactive approach: it has not only created one of the world's most effective vaccines to date against coronavirus, but is ready to share Sputnik V vectors with those willing to produce vaccines using the two-vector technology.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said: "This unique example of cooperation between scientists from different countries in jointly fighting coronavirus will play a decisive role in achieving a final victory over the pandemic globally. Russia's Sputnik V vaccine is already saving people's lives in Russia today through a large-scale vaccination programme.
The decision by AstraZeneca to carry out clinical trials using one of two vectors of Sputnik V in order to increase its own vaccine's efficacy is an important step towards uniting efforts in the fight against the pandemic. We welcome the beginning of this new stage of cooperation between vaccine producers. We are determined to develop this partnership in the future and to start joint production after the new vaccine demonstrates its efficacy in the course of clinical trials. We hope that other vaccine producers will follow our example."
Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF's management company is based in Moscow.
(IANS)
According to The Times, the idea is that by using different vaccines, each shot may prompt a stronger immune response.
AstraZeneca, the bio-pharmaceutical major which produces the Oxford University's vaccine, currently awaiting regulatory approvals, has agreed to collaborate with Sputnik in a deal apparently sealed after an offer was made on Twitter, the newspaper said.
Early results from the final-stage trial of the Sputnik vaccine showed it was 90 per cent effective and findings that involved more cases with the Oxford vaccine indicated it was 62 per cent effective in one regimen and 90 per cent in another.
The new chapter of vaccine co-operation has started today. We made an offer and AstraZeneca accepted it, claimed Sputnik's Twitter account.
AstraZeneca confirmed that it would collaborate with the Gamaleya Research Institute, which designed the Sputnik vaccine.
Combinations of different COVID-19 vaccines may be an important step in generating wider protection, it said in a statement.
Both vaccines use adenovirus to infect cells and trick them into making the spike protein of the coronavirus.
Russia has already begun its vaccination campaign but it has had a low uptake so far. The AstraZeneca collaboration is expected to help increase confidence in the Sputnik vaccine.
Mixing and matching different vaccines is known as a heterologous prime-boost and has been used in vaccination programmes against other diseases.
(With PTI Inputs)
The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with comorbidities.
Three vaccine candidates - Serum Institute-Oxford's Covishield, Bharat Biotech's Covaxin and Pfizer vaccine are in the fray for emergency use authorization. The Central Drugs Standard Control Organisation (CDSCO) has sought additional data from the Serum Institute as well as Bharat Biotech to get approval.
Speaking about the logistics of the vaccine after it is granted approval, Dr. Satish D. Ravetkar, Executive Director of Serum Institute of India said, "The funding for such large scale distribution would be huge, and India should be ready with a funding of around Rs 80,000 crore for next one year for distribution of the Covid-19 vaccine."
The Executive Director added that India would further have to ensure adequate power supply that could help maintain the temperature required to keep the vaccine safe in the remote areas of the country.
"It is a huge challenge, and all the stakeholders have to work together to take up the challenge of such large scale operation," he said at NASSCOM's webinar on 'Vaccine Trials - Optimizing the Supply Chain', emphasizing on the need for a clear communication from the Central government.
Dr. Ravetkar said, "Everything starts with government getting into action. IT-enabled supply chain management should be established as at Serum Institute we produce 1.6 million doses annually. So, we can roll out this vaccine fast. He said that it will be easier for all manufacturers to plan their production"
Alluding to the menace of counterfeiting, he said, "We have experience in counterfeiting and in this Covid-19, this is bound to happen as there is a huge demand for it. We have to establish machinery and system to control this."
India has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorization in near future.
It includes AstraZeneca and Oxford university developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech Limited, ZyCoV-D by Zydus Cadila and Russian vaccine candidate Sputnik-V.
The list also contains NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines-Recombinant Protein Antigen based vaccine by Biological E Limited-and Inactivated rabies vector platform by Bharat Biotech.
(With IANS Inputs)