Vaccine trials should NOT be stopped even in the event of death, scientists say as Brazilian doctor, 28, dies from Covid-19 after getting placebo dose in Oxford University's study
- A volunteer in the Brazilian arm of the coronavirus vaccine trial died
- Dr João Pedro R. Feitosa, a 28-year-old from Rio De Janeiro, died of Covid-19
- Reports say he was not part of the group that received the experimental jab
- Scientists said he was a powerful message for why the trial must continue
- A death could also happen in the vaccine arm because 'no vaccine works 100%'
- Oxford and Brazilian health authority Anvisa say the trial will resume
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
Vaccine trials should not be stopped even in the event of death, scientists have said today following the death of a Brazilian doctor who was given a placebo dose in Oxford University's study.
Dr João Pedro R. Feitosa, 28, is reported to have died from complications of Covid-19 on October 15.
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.
Reacting to the news, Professor Gareth Williams, of the University of Bristol, told MailOnline: 'He's a very powerful message for a need for a vaccine, and to carry on with the trial to find what the answer is, and the need to educate people on how this matters.'
He said the 'exceptional event' still could have occurred had Dr Feitosa been given the experimental vaccine because no vaccine is 100 per cent effective. Professor Williams, who has written scientific papers on vaccines, says deaths should not stop trials going ahead.
Professor Ian Jones, a virologist at the University of Reading, said: 'What we have to remember is that in any large trial the normal processes of morbidity and mortality are still operating. The trial should continue to bring the vaccine to a decision point as soon as possible.'
Oxford University has since stated the phase three trial will continue, adding that an independent review had revealed no safety concerns.
Around 8,000 volunteers have been vaccinated so far in Brazil, one of the worst affected countries in the pandemic, and more than 20,000 worldwide, it said.
Results from the final trials are expected later this year, after early results showed a 'robust immune response' and no serious side-effects - making the Oxford vaccine one of the most promising hopes of bringing the pandemic to a standstill.
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
Dr Feitosa (pictured) had been treating Covid-19 patients since March in the emergency rooms and intensive care units at two hospitals in Rio de Janeiro
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.
'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 three 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.
No details were confirmed by Brazilian authorities, Oxford University or AstraZeneca due to confidentiality. But it is understood Dr Feitosa was in the placebo group, according to local media reports.
Professor Williams, the author of a book on smallpox (Angel of Death) and polio (Paralysed with Fear), said Dr Feitosa was an example of why vaccine trials must continue in order to save lives.
He told MailOnline: 'It just makes the point very tellingly, here was a dedicated young person. He was only 28 years old. He is of the age that many youngsters think if they get it, it won't harm them. But he's a good example of the fact you can be young and unlucky.'
Typically in a trial, researchers will not know which participants have been given the placebo or the drug or vaccine under experiment in order to avoid bias. The participants do not know either.
But in this case, scientists would have broken this rule to find out which group Dr Feitosa was in, and if the death could have been prevented, or caused, by the vaccine.
Professor Williams said: 'This is an exceptional event. Clearly they were under pressure to crack the code early and see the result.
'It's interesting because I can't think of any vaccine that is 100 per cent effective, even those in use.
'So even if he'd been on the active arm, got Covid and died, that could just be bad luck. We don't know what makes people susceptible and [at risk] of dying of it. Clearly he was at very high risk anyway, given his work environment.
'You could still argue that even if he'd discovered to be on the active arm and been given the vaccine, you could argue I think on first principle that wouldn't be enough to stop the trial.
'If the vaccine is 99.9 per cent effective, you could still get one case that would wiggle through. It doesn't necessarily undermine the benefits of the 99.9 per cent protection to the population overall.
'It might raise early worries, but you won't get the answer till you have big enough number to tell how well it works.'
Eleanor Riley, professor of immunology and infectious Disease, University of Edinburgh, agreed, saying: 'Even if they had received the active vaccine it would be remarkable if it were 100 per cent effective.'
Speaking before it was confirmed Dr Feitosa received a placebo jab, Professor Riley said: 'Whilst to be greatly regretted, a death from Covid-19 among clinical trial participants (if that is what has happened, as some media reports are suggesting) is not unexpected.'
Andrew Freedman, an infectious disease expert at 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.'
Dr Sarah Chapman, a lecturer in behavioural medicine, University of Bath, said telling the public about adverse effects to the placebo will be important to ensure trust in any vaccine.
Adverse events in placebo arm of trials are very common, she said, known as the 'placebo effect', because volunteers are actively looking out for symptoms which may not be caused by the jab itself.
For example, in trials of Sinopharm's jab dubbed BBIBP, four per cent of Covid-19 vaccine participants reported experiencing a fever. But a higher six per cent of those given the placebo reported this.
Dr Chapman told MailOnline: 'When and if a new coronavirus vaccine is introduced it will be really important that it is made clear how many adverse events were reported in the placebo group as well as the vaccine group so that people don’t chalk up all adverse events that happen to occur in the vaccine group as occurring due to the vaccine.
'This will mislead people, could lead to distrust in the vaccine. It looks like the people running the trial have been as transparent as they could be in this case to try to increase trust and make this clear.'
Upon the news of the death, AstraZeneca shares turned negative and were down 1.7 per cent, 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.'
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.
Microbiologist Natalia Pasternak told Brazilian media: 'People who participate in clinical tests are people, they can die from the most diverse causes.'
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 Dr 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,' it read.
'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.'
Participants in the Brazilian study must be doctors, nurses or other health sector workers who come into regular contact with the virus.
This is to speed up getting results because if cases are low in the community, few participants will catch the virus and the effectiveness of the vaccine can't be studied quickly.
In June, Brazil's government announced a deal with Oxford University and AstraZeneca to purchase 100million 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.
However, on Wednesday President Jair Bolsonaro said his government will not buy China's Sinovac vaccine, one day after the health minister said it would be included in the nation's immunisation program.
The South American country has had the second deadliest outbreak of coronavirus, with more than 154,000 Covid-19 fatalities, behind only the US.
It is the third worst outbreak in terms of cases, with more than 5.2million infected, after the United States and India.
Oxford and AstraZeneca previously had to suspend testing of the vaccine in September when a volunteer in Britain developed an unexplained illness.
The late-stage study was paused on hold on September 8 after the event in which 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.
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.
But the US Food and Drug Administration (FDA) has kept the American arm of AstraZeneca's trial on hold.
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.
- AstraZeneca shares turn negative after Brazilian health authority says volunteer in Covid vaccine study dies
- Bloomberg - Are you a robot?
- Volunteer in AstraZeneca Covid-19 vaccine trial dies in Brazil
- Voluntário brasileiro que participava dos testes da vacina de Oxford e morreu com a Covid era médico e ex-aluno da UFRJ | Rio de Janeiro | G1
- globo.com - Absolutamente tudo sobre notícias, esportes e entretenimento
Most watched News videos
- Russian soldiers catch 'Ukrainian spy' on motorbike near airbase
- Helicopters collide in Malaysia in shocking scenes killing ten
- Rayner says to 'stop obsessing over my house' during PMQs
- Moment escaped Household Cavalry horses rampage through London
- New AI-based Putin biopic shows the president soiling his nappy
- Vacay gone astray! Shocking moment cruise ship crashes into port
- Shocking moment woman is abducted by man in Oregon
- Prison Break fail! Moment prisoners escape prison and are arrested
- Ammanford school 'stabbing': Police and ambulance on scene
- Columbia protester calls Jewish donor 'a f***ing Nazi'
- MMA fighter catches gator on Florida street with his bare hands
- Sir Jeffrey Donaldson arrives at court over sexual offence charges