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Dr João Pedro R. Feitosa (pictured), a 28-year-old from Rio De Janeiro, Brazil, was confirmed to be the volunteer who died in the Brazilian arm of AstraZeneca and the University of Oxford’s coronavirus vaccine trial
A Brazilian doctor who died with Covid-19 after volunteering for AstraZeneca and Oxford University’s vaccine trial was not part of the experimental group that received the jab, according to reports.
Dr João Pedro R. Feitosa, 28, is reported to have died from complications from the virus on October 15, website G1 Rio in Brazil has confirmed.
Brazilian newspaper Globo and news agency Bloomberg said he was in the control group and had received a placebo rather than the test vaccine, citing sources close to the trials.
Dr Feitosa had been treating Covid-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro, Globo said.
He graduated from medical school last year, and was in good health prior to contracting the disease, family and friends told the newspaper.
Oxford University has since stated the trial will continue after the death of the volunteer, adding an independent review had revealed no safety concerns.
‘Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,’ a spokesman for the university said in a statement.
The Federal University of Sao Paulo, which is coordinating phase 3 trials in Brazil, said an independent review committee had also recommended the trial continue.
‘Everything is proceeding as expected, without any record of serious vaccine-related complications involving any of the participating volunteers,’ the university said.
Upon the news, AstraZeneca shares turned negative and were down 1.7 percent, but confirmed in a statement to NBC News that the trial would go on.
‘We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality and clinical trial regulations, but we can confirm that all required review processes have been followed,’ the statement said.
‘All significant medical events are carefully assessed by trial investigators, an independent safety monitoring committee and the regulatory authorities. These assessments have not led to any concerns about continuation of the ongoing study.’
Experts believe Oxford and AstraZeneca’s vaccine could be the first available as scientists around the world are racing to find a cure for Covid-19.
Reports say he was not part of the group that received the experimental jab and that he died from COVID-19 complications on October 15. Pictured: Brazilian pediatrician Dr Monica Levi, who received the COVID-19 vaccine, works at the Specialized Clinic in Infectious and Parasitic Diseases and Immunizations in Sao Paulo, Brazil, July 24
Oxford and Brazilian health authority Anvisa say testing will continue and that there are no safety concerns. Pictured: AstraZeneca’s offices in Macclesfield, Cheshire, England, July 21
Anvisa, the Brazilian health authority, learned of Dr Feitosa’s death on October 19. An investigation was carried out by the International Safety Assessment Committee.
The D’Or Teaching and Research Institute (IDOR), which is helping organize the tests in Brazil, said the independent review had ‘raised no doubts about the safety of the study, and recommended it continue.’
The Federal University of Rio de Janeiro, of which Feitosa was an alum, released a statement expressing condolences on behalf of his girlfriend and friends.
‘João, I think that in this little text I could remember how good an exemplary doctor and student you were, but I think the memory that I will mention to everyone here will be different. I want to keep the memory forever how good a boyfriend, brother and friend you were.
‘The pain in the chest, the emptiness and longing since you left are growing every moment and what gives us strength in that moment besides the affection of so many friends you made in life is remembering what you were like.’
Covid-19 vaccines may not prevent people from getting severely sick or dying, it was claimed today.
Trials of hundreds of thousands of volunteers are investigating whether experimental Covid-19 jabs stop a person from picking up the infection.
But Professor Peter Doshi, the associate editor of the British Medical Journal, points out scientists are not waiting to see whether volunteers are protected from severe disease or death if they do catch it — which would only be the case if the vaccine didn’t work very well — before they are rolled out.
This is a particular concern for the elderly, who are the most at risk of severe Covid-19 outcomes, because the vaccine may not be as effective at protecting them from catching the coronavirus in the first place.
Vaccines typically do work as well for those over the age of 60 because they have an aged immune system.
Professor Doshi, of the University of Maryland, also revealed that the studies will not prove transmission between people can be curbed. Scientists are not measuring if those who catch it pass it on to friends and family, regardless of whether they get sick themselves.
None of the front-runners — Moderna, Pfizer, AstraZeneca, Janssen, Sinopharm, or Sinovac — are measuring if their vaccines will save lives in their final stage trials.
But in response to Professor Doshi’s paper, scientists say there are ‘excellent’ reasons for running the trials, the main one being to speed up finding a vaccine which could otherwise take years because so few Covid-19 patients become severely ill.
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
Trials resumed after British regulators and an independent review concluded the illness was not a side effect of the vaccine. Half the volunteers in the final-stage clinical trial — a double-blind, randomized, controlled study — receive a placebo, IDOR said.
Experts in the UK said since it appeared the volunteer’s death was not vaccine-related, there was no reason the trials should be stopped.
‘Without details it’s impossible to know what has happened in this case but as the trial is continuing, I think we can assume the circumstances of the death were such that it was clearly not vaccine related,’ Ian Jones, Professor of Virology at the University of Reading, said in a statement issued by independent science publicity group the Science Media Centre.
‘What we have to remember is that in any large trial the normal processes of morbidity and mortality are still operating and that sometimes an event will occur in a trial participant which would have occurred anyway, trial or not.
‘The case will have been carefully examined and, as vaccine relatedness has presumably been ruled out, the trial should continue to bring the vaccine to a decision point as soon as possible.’
University of Edinburgh Professor of Immunology and Infectious Disease Eleanor Riley said: ‘Every reputable clinical trial, such as this trial being undertaken by the Oxford/Astra Zeneca partnership, is overseen by an independent data and safety monitoring board.
‘This board will have reviewed the case in detail before reviewing the data in detail before liaising with the Brazilian and international regulators before determining that the trial can continue.’
Andrew Freedman, Reader in Infectious Diseases and Honorary Consultant Physician at the Cardiff University School of Medicine, said: ‘Fortunately, deaths resulting from the administration of a trial drug or vaccine are very rare and would normally lead to the immediate discontinuation of the trial.’
Around 8,000 volunteers have been vaccinated so far in Brazil, and more than 20,000 worldwide, it said.
Study participants must be doctors, nurses or other health sector workers who come into regular contact with the virus.
In June, Brazil’s government announced a deal with Oxford University and AstraZeneca to purchase 100 million doses of its potential Covid-19 vaccine.
A competing vaccine from China’s Sinovac Biotech Ltd is being tested by Sao Paulo state’s research center, though President Jair Bolsonaro rejected the announced purchase of 46 million doses of a vaccine being developed by the Chinese company.
The South American country has the second deadliest outbreak of coronavirus, with more than 154,000 killed by Covid-19, following only the US.
It is the third worst outbreak in terms of cases, with more than 5.2 million infected, after the United States and India.
It comes as the US Food and Drug Administration (FDA) keeps the American arm of AstraZeneca’s trial on hold.
The late-stage study was paused on hold on September 8 when a British participant was rushed to the hospital after suffering a serious reaction.
An internal safety report revealed the patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.
The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.
This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel — and can even lead to permanent paralysis.
Testing had resumed at all other sites, but not in America.
On Tuesday, it was revealed that the FDA had completed its review of safety data and was planning to let the trial resume in the US.
Allowing testing to resume likely means the FDA believes illness suffered by the British patient was not linked to the experimental vaccine.
However, the FDA is requiring researchers conducting the trial to add information about the incident to consent forms signed by study participants, a source told Reuters.
It is unclear if the death of the Brazilian patient will reverse this decision.
As scientists race to develop a coronavirus vaccine to bring the world back to normal, MailOnline has taken a look at the prospective candidates.
Vaccine trials were halted on Wednesday but it may still be ready this year
The Oxford Vaccine
When will it be ready?: The end of 2020/ early 2021. Despite the trials being suspended on Wednesday, its developers and Number 10 remain confident that the vaccine could be ready for use either at the end of this year or early next year. They say a pause is common in trials, and that its development was also stopped in July after a suspected side-effect was detected.
How does it work?: The vaccine works by exposing participants to a weakened common cold adenovirus which has had proteins from the coronavirus SARS-CoV-2 attached to its surface. The idea is that the exposure allows the immune system to build an immune response, meaning they are protected if they are infected by the real virus.
Has the UK secured doses?: Yes, 100 million. The US has secured a further 300 million doses, along with several other countries. These will be rolled out in an equitable manner.
How much does it cost?: AstraZeneca, which is developing the vaccine with Oxford University, has said it will not profit from the it, but may earn extra royalties if the coronavirus becomes an endemic infection like flu. The US has spent $1.2 billion (£930 million) securing doses, meaning they are worth $4 (£3.10) each.
Biontech vaccine may be ready this year
When will it be ready?: At the end of this year, say researchers. The vaccine is being developed by a German company in partnership with American drugmaker Pfizer. It is recruiting 30,000 volunteers to its stage three trials.
How does it work?: This is an RNA vaccine, a type that has never been approved by regulators before. It will involve injecting a fragment of genetic material from coronavirus into participants. This will expose their immune systems to a weakened version of the virus and, hopefully, trigger a response which will protect them from the real virus.
Has the UK secured doses?: Yes, 30 million doses. The US has also ordered 100 million doses.
Price?: The US is paying $2 billion (£1.5 billion) for its doses, or about $20 (£15) a jab.
Moderna vaccine entered human trials
When will it be ready?: Very end of this year or next year. The vaccine has recruited 20,000 participants for its stage three trials. Providing no potential side effects are observed, it will then go through to a second test on more patients next month. This means it could be available by the end of 2020.
How does it work?: This is an RNA-based vaccine, similar to the one being developed by Biontech.
Has the UK secured doses?: No. Reports suggest the UK’s task force has not managed to secure any doses of this vaccine.
How much does it cost?: The US has ordered 100 million doses at a price of $1.5 billion (£1.1 billion). This means one jab costs $32 (£25).
Sanofi and GlaxoSmithKline, UK and France
Sanofi vaccine won’t be available this year
When will it be ready?: First half of 2021. The vaccine entered phase two clinical trials in September, involving 440 adults. It will reach phase three trials in December this year. There may be setbacks along the way, meaning the vaccine could take longer to develop.
How does it work?: Participants are injected with DNA coding for the antigens of the coronavirus and a chemical which makes it more potent. It is hoped this will trigger an immune response.
Has the UK secured doses?: Yes. Up to 60 million will be supplied should the vaccine be shown to work.
How much does it cost?: Unknown. This information has not been provided.
Sputnik V, Russia
Sputnik V is safe, according to Kremlin, but it has been criticised by scientists
When will it be ready?: ’Imminently’. The Russian medical research institute and Russian defence ministry have developed this vaccine. But it has faced serious criticism both inside and outside Russia because results from its human trials are yet to be published. It also hasn’t cleared large human trials, with researchers only launching one involving 40,000 volunteers on 26 August. Scientists say the vaccine has been rushed without proper checks, and could pose a risk to those taking it. The Kremlin began appealing for volunteers for the vaccine this week after a first batch was produced, according to the TASS news agency.
How does it work?: The Russian vaccine works by carrying a piece of the coronavirus genetic code into a participant via another virus. It is hoped this will produce an immune response.
Has the UK secured doses?: No. Countries lining up to try the vaccine include Mexico, which has secured 32 million doses, and Kazakhstan, which is set to buy two million.
How much does it cost?: The price of the vaccine is yet to be revealed.
It is not clear when the Sinovac vaccine will be available
When will it be ready?: Unknown. The vaccine entered final-stage trials in Brazil in July, and then in Indonesia in August. Results show that while younger and middle-aged people produced antibodies, older people had a weaker immune response. The vaccine was given emergency approval for limited use in July, reports suggest, although it appears to still be subject to testing. It was previously reported as being second only to the Oxford vaccine, but its complete test results are yet to be published. It is one of four vaccine candidates in development in China.
How does it work?: It involves injecting patients with an inactivated form of the virus, prompting their immune systems to develop a response.
Has the UK secured doses?: Unknown. Reports suggest no doses have been secured.
How much does it cost?: China is yet to publish this information.