Oxford University's coronavirus vaccine trials could resume just days after a British volunteer was hospitalized with suspected spinal cord swelling.
British drug giant AstraZeneca, which owns the rights to the vaccine, announced that all studies of the sting have been suspended indefinitely while investigating whether the patient's side effect is related to the vaccine.
The volunteer is believed to have had symptoms of transverse myelitis (TM), a rare inflammatory disease that affects the spinal cord.
This means that no one else will be given the vaccine until the investigation is complete.
However, health industry website Stat reported that a woman was suspected of having TM but the diagnosis was not confirmed and she was due to be discharged from the hospital last night.
Astrazeneca chief Pascal Soriot said the trial freeze was a "temporary pause" and an independent committee of experts would investigate.
Oxford University's coronavirus vaccine trials could resume within days after a British volunteer was hospitalized with suspected spinal cord swelling. Pictured: Jacob Serrano, 23, who lost seven relatives to Covid-19, was the first American to take part in the trial
“This is a routine measure that must be carried out whenever there is a potentially unexplained disease in one of the studies. . . In large clinical trials, diseases will occur randomly and need to be independently verified, ”a spokesman told The Times.
TM can be caused by viral infections that cause pain, muscle weakness, and numbness.
Ian Jones, Professor of Virology at the University of Reading, said, "It is inflammation of nerve tissue that can be caused by a number of drugs, one of which is viruses.
"The interruption could be because the symptoms are plausibly related to the vaccine, when it could be something else."
Trials for AstraZeneca's shot are in progress in the USA, Great Britain, Australia, Brazil (photo) and other countries. Phase 3 testing will now pause while the security data is reviewed
The condition can be treated with steroids, and patients usually recover within weeks of the first symptoms of TM.
The development is a worrying blow to global hopes that a sting will be ready by Christmas, as the Oxford vaccine was viewed as a trailblazer by many – including the World Health Organization.
Health Secretary Matt Hancock said the Oxford vaccine trial hiatus was not necessarily a setback, and the sting trials were suspended in the summer when a patient became ill.
He told Sky News, “It's obviously a challenge for this particular vaccine. It's not the first time it has happened to the Oxford vaccine, and it's a standard practice in clinical trials. & # 39;
When asked if this will drive back the introduction of the vaccine, Hancock said, “Not necessarily – it depends on what you find on the investigation. At the beginning of summer there was a break that could easily be resolved. & # 39;
AstraZeneca's vaccine candidate known as AZD1222 is in Phase 3 trials – the final phase before safety and efficacy data can be submitted to regulatory authorities. Pictured: a Brazilian volunteer receiving the Oxford vaccine on July 24th
Professor Terry Nolan of the University of Melbourne said it was entirely plausible that the volunteer had transverse myelitis (TM) as a direct result of the vaccine.
The exact cause of TM is unknown, but it has been reported to occur after infections and vaccinations.
WHAT IS TRANSVERSE MYELITIS? HOW FAILURE CAUSES IGNITION OF THE SPINAL CABLE AND CAN LEAD TO PARALYSIS
The term myelitis refers to inflammation of the spinal cord, transverse refers to the pattern of changes in sensation.
Transverse myelitis is the common name of the disease and there are several sub-types.
Causes of the disease include infections sometimes caused by bacteria in raw food, disorders of the immune system, and other disorders that can damage or destroy myelin, the fatty-white insulating substance that covers nerve cell fibers.
Inflammation in the spinal cord disrupts communication between the nerve fibers in the spinal cord and the rest of the body, affecting the feeling and nerve signals below the injury.
This can lead to paralysis.
The condition can affect people of any age, gender, or race. It doesn't appear to be genetic or run in families.
Some people recover from transverse myelitis with little or no long-term problems, but most have permanent impairments that affect their ability to perform normal tasks of daily living.
There is no cure for the disease.
Medical news site Stat first reported on the pause in the study, saying the possible side effect occurred in a test volunteer in the UK who was expected to be recovering.
Developed by Oxford University, the vaccine is being tested on thousands of people in the UK and US, and in smaller study groups in Brazil and South America.
Jacob Serrano, 23, who lost seven relatives to Covid-19, was the first American to take part in the trial.
He said, "I'd rather bring us one step closer, no matter what it takes."
An AstraZeneca spokeswoman said the break is part of a standard review process that occurs in the court hearing when a subject is reported to have a "potentially unexplained illness" and the subject's illness could also be random.
"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard screening process has been triggered and we have voluntarily suspended vaccination to allow an independent committee to review the safety data," the spokeswoman said in a statement.
“This is a routine action that must be performed whenever any of the studies has a potentially unexplained disease while it is being investigated to ensure the integrity of the studies is maintained.
“Diseases occur randomly in large studies but need to be independently verified to be carefully verified.
& # 39; We're working to speed up the review of each event to minimize any potential impact on the testing schedule. We are committed to the safety of our participants and to the highest standards of behavior in our experiments. & # 39;
No details were given about the patient suffering from the possible side effect or the nature of the reaction.
Temporary interruptions in large medical studies are not uncommon, and investigating unexpected reactions is a mandatory part of safety testing. It wasn't immediately clear how long AstraZeneca's break would be.
Two other vaccines are in large end-stage testing in the US, one from Moderna Inc and the other from Pfizer and BioNTech in Germany.
In the statistics, a total of nine vaccine candidates were reported in late-stage or phase 3 studies, with AstraZeneca's first study known to have been suspended.
Despite some figures like US President Donald Trump insisting that a vaccine will be ready in a few months, Oxford University has stated that a vaccine may not be ready before 2022.
The university emphasized that clinical studies must be carried out with the greatest care.
“It takes time to develop safe and effective vaccines – usually five to ten years on average. Despite promising reports of potential coronavirus vaccines being developed around the world, it is estimated that it could take 12 to 18 months to develop such a vaccine, ”a document posted on the university's website on Aug. 25 said.
WHICH COUNTRIES HAVE ALREADY ORDERED OXFORD'S Vaccine?
The UK is hosting the research and development effort on the vaccine, which was developed by researchers at Oxford and manufactured by AstraZeneca, a Cambridge-based company.
The UK government has ordered 100 million doses of the sting and has already started manufacturing them so they will be ready for use if clinical trials are successful. The price paid was not disclosed.
The U.S. government has ordered 100 million doses of the vaccine and has contributed $ 1.2 billion (£ 910 million) to research and development of the sting.
European Union (EU)
The European Commission has reached an agreement for 300 million doses of the vaccine if its clinical trials work, with the option to buy an additional 100 million. The agreement was concluded on behalf of countries in the EU. The amount of money is unknown.
Australia has confirmed that it has ordered enough doses of the vaccine to deliver one to its entire population of 25 million people. It is not clear how many cans the nation ordered. Britain – with a population of 66 million but on the order of 100 million – has ordered more than it needs.
A company in China has signed a contract with AstraZeneca to manufacture at least 100 million doses of the vaccine.
Shenzhen Kangtai Biological Products, based in Shenzhen, will increase capacity to 200 million per year by the end of 2021.
A Russian company, R-Pharm, has also signed a contract to manufacture and distribute the vaccine. However, it is unclear how many of these will be made or what will be paid to AstraZeneca.
Brazilian officials have allocated $ 360 million (£ 274 million) for at least 100 million doses of the vaccine. Brazil is currently in one of the worst Covid-19 crises in the world, with more than 3.6 million official cases and 114,000 deaths.
'It is important that clinical trials are conducted with great care to ensure the safety of participants and to fully define the safety profile of the new products.
"During the tests, safety is guaranteed both by the national regulatory authority with an obligation to report safety to the testers throughout the test and by inspections of the test processes and procedures by the regulatory authority and an independent safety monitoring committee that actively reviews safety during the test, closely monitored the implementation of the clinical study.
"When an application for use of the vaccine is submitted to a regulatory agency, they will fully assess the safety and efficacy data from the studies and use this to inform their decision on possible use."
The development of the AstraZeneca vaccine and eight other vaccines in Phase 3 trials are being closely monitored in the hope that they can contain the coronavirus pandemic that killed more than 894,000 people worldwide, including nearly 190,000 Americans, and the have cost tens of millions of their jobs.
It did after vaccine developers – including AstraZeneca – pledged not to cut back on safety and efficacy tests, despite U.S. President Trump urging the Food and Drug Administration (FDA) to get an emergency vaccine approval before the Nov. 3 election granted.
"As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard screening process has been triggered and we have voluntarily suspended vaccination to allow an independent committee to review the safety data," an AstraZeneca spokesman told DailyMail .com.
“This is a routine action that must be performed whenever any of the studies has a potentially unexplained disease while it is being investigated to ensure the integrity of the studies is maintained.
“Diseases occur randomly in large studies but need to be independently verified to be carefully verified. We're working to speed up the review of each event to minimize any potential impact on the test schedule. We are committed to the safety of our participants and to the highest standards of behavior in our experiments. & # 39;
AstraZeneca's vaccine candidate known as AZD1222 is in Phase 3 trials – the final phase before safety and efficacy data can be submitted to regulatory agencies for approval – in dozens of locations in the US and around the world.
Together with Pfizer and Moderna, AstraZeneca and its partner Oxford University had hoped to know if the shot worked and was safe by the end of the year.
Mr Hancock said Monday that the UK's "best case scenario" is to get the vaccine to the most vulnerable patients within months. That timeframe now seems less likely.
"We have already completed 30 million cans with AstraZeneca," he said on British radio station LBC.
“In fact, they start making these cans before approval, so the approval should get through – and it's still not certain, but they look it up – if that approval does get through, we're ready to bring them in.
& # 39; The best scenario is for it to happen this year. I think the beginning of next year is more likely – the first few months of next year is the most likely.
"But we also bought vaccines before they were approved by an entirely different set of international vaccines."
More than 50,000 people around the world took part in Phase 3 trials to see if the Oxford shock could actually prevent people from becoming infected with Covid-19.
In these tests, the vaccine will be given to tens of thousands of people in real-world settings to see if it is preventing them from catching Covid-19 in the community.
While safety data review studies aren't necessarily harmful, the hiatus in AstraZeneca's study may very well delay the highly anticipated results and the completion of one of the fastest vaccine development pipelines in human history.
The surge was expected in late 2020, but its creators had to soften expectations after the UK community broadcast began to hiss and crucial attempts were halted that were needed to seal its approval. It was called ChAdOx1 nCoV-19 before Oxford partnered with AstraZeneca to make it
AstraZeneca's shares fell eight percent in after-hours trading
Market confidence in the pharmaceutical giants was severely affected as soon as reports of the trial freeze became known.
AstraZeneca's shares fell eight percent in after-hours trading.
President Donald Trump has indicated that he believes a vaccine may be ready before a "special date" – likely before the November 3rd election
The company is currently in damage control mode to try to stay as close as possible to the study completion date.
AstraZeneca is working to "expedite the review of each event to minimize any potential impact on the test schedule," the spokesman told Stat News.
While any signs that could point to possible flaws in a leading vaccine for the disease that killed nearly 190,000 Americans are troubling, trying to abandon a trial over safety concerns can be comforting to some.
Hours before the trial was temporarily canceled, AstraZeneca and eight other companies working on COVID-19 vaccines signed a pledge to make the safety of their shots a priority over rapid development.
They pledged to "maintain the integrity of the scientific process as they work toward potential global filings and approvals of the first COVID-19 vaccine".
The pledge was made in response to growing concerns that governments would urge corporations and research institutes to speed up a vaccine through trial and approval processes in order to bolster political capital and restore normalcy amid the pandemic.
Last week, the U.S. Centers for Disease Control and Prevention (CDC) sent instructions to state health officials to prepare for the possible arrival of one of two coronavirus vaccines by the end of October.
President Trump then pointed out the hopeful possibility that a vaccine could be ready before a "special date", leading to speculation that it was referring to the November 3 presidential election – just days after the possible finish line in late October CDC guidance.
Health officials like infectious disease expert Dr. Anthony Fauci, U.S. surgeon general Dr. Jerome Adams and Trump's own vaccination czar Dr. Moncef Slaoui were quick to reassure the American public that it was possible, but unlikely, that a shot would be ready by then, and that the FDA would not look at the date, only the dates, to determine when a vaccine would be available for distribution ready.
However, Pfizer confirmed that he hoped to have sufficient experimental data to know whether his shot was safe and effective by the end of October, and that he would apply for FDA approval "immediately" thereafter.
Most experts and observers speculate that the two unnamed recordings mentioned in the CDC manual were Modernas and Pfizers, not AstraZeneca.
The study also casts additional doubts on the possibility that the company's vaccine will be the first to be ready for the U.S. market.
Operation Warp Speed, the Trump administration's drive to accelerate vaccine development, largely by providing funding to private companies working on shots, announced AstraZeneca in May would provide up to $ 1.2 billion for the Vaccine development is obtained.
The US has signed a deal with AstraZeneca for 300 million doses of its shot – if the vaccine is highlighted green by the FDA as safe and effective – and is aiming for an approval date as early as October that seems increasingly unlikely.
What vaccines does the UK have safe business for?
1. GlaxoSmithKline and Sanofi Pasteur: 60 million cans
The government announced on July 29 that it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could start vaccinating priority groups as early as the first half of next year, e.g. B. Frontline health and social workers and those at increased risk for coronavirus, Department of Corporate, Energy and Industrial Strategy (BEIS) said.
Human clinical trials of the vaccine will begin in September, followed by a phase 3 trial in December.
The vaccine is based on the existing technology used to manufacture Sanofi's seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells – the basis of Sanofi's influenza product – and then injected to elicit an immune response in a human patient.
2. AstraZeneca (Manufacturing University of Oxford): 100 million
AstraZeneca, which works with Oxford University, is already making the experimental vaccine after a deal was closed on May 17th.
Professor Sarah Gilbert, who leads the Oxford team, is confident that the push could be ready for the most vulnerable by the end of the year.
Their comments came after the results of the first phase, published July 20 in The Lancet, were encouraging.
The team genetically engineered a virus so that it looks like the coronavirus – it has the same spike proteins on the outside – but cannot cause infection inside a person. This genetically-weakened virus is a type of virus called adenovirus, just like the ones that cause colds and were taken from chimps.
3. BioNTech / Pfizer: 30 million
The US drug giant Pfizer – known for the manufacture of Viagra – and the German company BioNTech signed a contract with the British government on July 20th.
Positive results were reported from the ongoing Phase 2/3 clinical trial, named BNT162b1, on July 1. The company is currently conducting phase 2 studies.
Pfizer's vaccine is a so-called mRNA vaccine that does not inject pieces of virus directly into the body, but instead sends genetic material.
mRNA vaccines program the body to produce parts of the virus itself by injecting a molecule into the body that tells disease-fighting cells what to make. The immune system then learns how to fight it.
4. Valneva: 60 million
The government has given Valneva – whose vaccine is in preclinical development – an undisclosed amount of money to expand their factory in Livingston, Scotland.
While the government announced a 60 million dose deal on July 20, the company said it had, in principle, reached an agreement with the UK government to provide up to 100 million doses.
Valneva's sting is an inactivated whole virus vaccine, which means it injects a damaged version of the coronavirus into the body itself.
The virus has been destroyed in such a way that it cannot cause infection, but the body still recognizes it as a dangerous invader and therefore triggers an immune response that it can remember in the event of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30 million
The government has agreed to buy 30 million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company develop the jab by co-funding a global clinical trial. The first human trials with Janssen's sting began in mid-July and are being carried out on adults over the age of 18 in the USA and Belgium.
The sting is called Ad26.COV2-S, recombinant, and it is a type of sting known as a recombinant vaccine against viral vectors.
Proteins that occur outside of the coronavirus are reproduced in a laboratory and then injected into the body to stimulate an immune response.
The ad portion of the vaccine name means that an adenovirus – a virus best known for causing colds – is used as a vehicle to transport coronavirus genetics into the body.
6. Novavax: 60 million
The UK has ordered 60 million doses of a vaccine being developed by US-based Novavax. It will help fund late-stage clinical trials in the UK and advance plans to manufacture the vaccine in the UK.
Novavax 'shock, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 percent of people who received it, the company said, and was safe and "generally well tolerated."
Novavax 'candidate is also a recombinant vaccine and transports the spike proteins located on the outside of the coronavirus into the body to provoke the immune system.
7. Imperial College London: Unknown crowd
Scientists at Imperial College London are working on Britain's second hope for a stab. The candidate is slightly behind Oxford's vaccine in terms of progress through clinical trials, but is still a major player.
The UK government is believed to have agreed to buy the vaccine if it works, but details of a deal have not yet been released.
The Imperial shock is currently in the second phase of human testing after initial tests showed it appeared safe.
Imperial College London will attempt to provide genetic material (RNA) from the coronavirus that will program cells in the patient's body to restore the spike proteins. It transports the RNA in droplets of liquid that are injected into the bloodstream.
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