White House insiders claim the US President is considering pushing for approval for emergency use of the jab, which is one of the world’s most promising candidates.
Early trials have shown promising results, with tests showing the vaccine — being mass-produced by pharmaceutical firm AstraZeneca — is safe to use in humans and appears to provoke an immune response.
Risks of using jabs that have not been tested thoroughly include damaging side effects or administering one that doesn’t really work. If something goes wrong with an official vaccine, it could further dent already-fragile public faith in vaccinations.
Getting a vaccine into use and slowing down the US’s devastating coronavirus crisis — the worst in the world — could look good for Mr Trump ahead of the presidential election in November.
He will be running against Democratic candidate Joe Biden, who was vice-president to Barack Obama between 2009 and 2017.
Mr Trump has already vented his frustration at the slow process of getting a vaccine, accusing the Food and Drug Administration (FDA) of deliberately delaying evaluations until the election is over.
He did announce significant progress yesterday, however, when he confirmed that US hospitals could now use blood plasma from recovered Covid-19 patients as an emergency treatment, claiming that it could reduce the risk of death by a third.
On the news that Mr Trump was considering fast-tracking the vaccine, one of the UK’s top medical officers warned that there should be ‘fair distribution’ of any working jab and that richer countries should not hoover up all the supplies.
US President Donald Trump has watched his country gripped by one of the worst Covid-19 crises in the world with more than 5.7million officially confirmed cases of the disease
The President’s best hope for getting the jab used before clinical trials have finished would be to get authorisation for ’emergency use’ from the FDA.
This is the course of action people briefed on the situation said he is considering taking, the Financial Times reported.
AUSTRALIA BUYS OXFORD VACCINE BUT EXPERTS WARN AGAINST RUSHING
Australian Prime Minister Scott Morrison has locked in a deal with pharmaceutical giant AstraZeneca to secure a potential coronavirus vaccine, if its Oxford University phase three trials prove successful.
But doctors have warned a coronavirus vaccine may create dangerous side-effects and argued against a ‘no jab, no play’ policy.
Vaccine development is typically a long and complex process that can take up to 15 years.
Because of the urgency of the coronavirus pandemic, researchers are fast-tracking their testing, hoping to produce a safe and effective innoculation by next year.
Australian Medical Association president Omar Khorshid said even positive phase three trials – mass testing on members of the public – would not prove the vaccine candidate is safe.
‘We have to acknowledge it is a rushed approval process and even if the phase three trials on this Oxford vaccine go really well, it’s still not absolutely proven that it is safe, not as proven as is normally the case,’ he told The Age newspaper.
‘That does increase the risk that there might be rare side effects … that we just don’t know about.’
Australia’s Commonwealth Scientific and Industrial Research Organisation (CSIRO) has been involved in fast-tracking the testing of the Oxford University candidate vaccine.
In May, the CSIRO said it was already at the stage of pre-clinical trials – a position that typically takes up to two years to reach.
Dr Khorshid said it was expected the Oxford coronavirus vaccine would only be approved for adults in Australia at first.
He said the Australian Government’s proposal of forcing people to take the AstraZeneca vaccine by tying it to services such as childcare, school or social security payments could not be justified because it had been rushed through clinical trials.
Mr Morrison has said he wants to make an approved vaccine ‘as mandatory as possible’, but it is not going to be compulsory.
Deputy chief medical officer Nick Coatsworth said possible punishments for unvaccinated people could include not being able to go to restaurants, travel internationally or catch public transport.
Monash University Institute of Pharmaceutical Sciences Professor Colin Pouton told The Age it was important that people should have the right to refuse.
University of London School of Hygiene and Tropical Medicine Professor Heidi Larson, said it was precisely the ‘no jab, no play’ policies that had sparked the anti-vaccination movement worldwide.
Emergency use authorisation allows officials to push through medical products without proper testing because there is a clear immediate need for them.
It has already been used during the Covid-19 crisis for drugs including the antiviral medication remdesivir, which scientists suggested could reduce the risk of death.
If emergency use were to be granted for the vaccine, it could mean it being pushed out after trials on only 10,000 people even though the FDA standard is for 30,000 people or more.
Large trials are under way in Britain and around the world, but results are not expected for months to come.
But approval for the jab could be made as soon as September, according to an FT source briefed on a meeting between US politicians.
Chief of staff at the White House, Mark Meadows, and the US Treasury secretary, Steven Mnuchin, reportedly confirmed the plan to Democrats at the end of July.
Senior Democratic politician Nancy Pelosi allegedly warned the government against ‘cutting corners’.
Top officials have said they would not stand for it if Mr Trump forced through the vaccine without data to prove it was safe.
Dr Peter Marks, director of the Center for Biologics Evaluation and Research within the FDA, said he would resign if it happened.
And the assistant secretary for the US Health and Human Services Department, Michael Caputo, denied that emergency use authorisation would be given.
Mr Caputo, who was a member of Donald Trump’s campaign team in 2016, said: ‘Irresponsible talk of an unsafe or ineffective vaccine being approved for public use is designed to undermine the president’s coronavirus response,’ the FT reported.
Commenting on the prospect of the vaccine being fast-tracked in the US, England’s deputy chief medical officer Dr Jenny Harries said that everyone around the globe should have ‘fair and safe access to vaccine development’.
Dr Harries told Sky News: ‘We have a global crisis… It is really important that everyone around the world has fair and safe access to vaccine development.
‘Obviously those countries which are more developed have the facilities to develop the vaccine and get it safely out to their populations. But I think all public health colleagues would be wanting fair distribution.’
The US has been one of the worst hit countries in the world during the Covid-19 pandemic.
More than 5.7million cases have been officially diagnosed and at least 176,808 people have died, according to Johns Hopkins University, which has kept a track on the pandemic since it began in December.
President Trump has been accused of mishandling the crisis and refusing to face up to his government’s mistakes, shifting the blame to others and disputing statistics.
Last week the president lashed out at the FDA and accused them of dragging out the process of getting a vaccine ready to go.
He said in a tweet: ‘The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics.
‘Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!’
The only country to have officially approved a coronavirus vaccine is Russia but the circumstances around it have drawn harsh criticism from scientists.
Pharmaceutical company AstraZeneca (pictured, a chemist at its HQ in Sydney, Australia) is already manufacturing the vaccine developed by Oxford University so that millions of doses will be ready if it is proven to work
The Oxford University jab is being trialled in the UK but also in other countries such as Brazil and South Africa because they have more cases of Covid-19 than Britain does so it will be easier to test (Pictured: A trial participant in South Africa receives the jab)
The jab — given to President Vladimir Putin’s own daughter — was reportedly tested on fewer than 40 people before being officially approved.
One scientist blasted Putin’s move as ‘unethical’ because an ‘improperly tested vaccine’ could have ‘disastrous’ effects on public health.
WHICH COUNTRIES HAVE ORDERED OXFORD’S VACCINE ALREADY?
The UK is the host of research and development efforts of the vaccine, which has been developed by researchers in Oxford and will be manufactured by AstraZeneca, a company based in Cambridge.
The British Government has ordered 100million doses of the jab and has already started manufacturing them so they’re ready to go if and when clinical trials are successful. The price paid has not been disclosed.
The US Government has ordered 100million doses of the vaccine and contributed $1.2billion (£910m) to the research and development of the jab.
European Union (EU)
The European Commission has agreed a deal for 300million doses of the vaccine if its clinical trials work, with the option to buy a further 100million. The deal has been made on behalf of countries in the EU. The amount of money spent is unknown.
Australia has confirmed it ordered enough doses of the vaccine to give one to its entire population of 25million people. It is not clear how many doses the nation has ordered. The UK – with a population of 66m but an order of 100m – ordered more than it needs.
One company in China has agreed a deal with AstraZeneca to make at least 100million doses of the vaccine.
Shenzhen Kangtai Biological Products, based in the city of Shenzhen, will increase capacity to 200m per year by the end of 2021.
A Russian company, R-Pharm, also has a deal to produce and distribute the vaccine, but it is unclear how many it will make or what it will pay to AstraZeneca.
Brazilian officials have set aside $360million (£274m) for at least 100million doses of the vaccine. Brazil is currently in one of the worst Covid-19 crises in the world with more than 3.6million official cases so far and 114,000 deaths.
While others warned that there is ‘no data’ to tell whether the Russian vaccine is effective.
Another expert warned that ‘the damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably’.
One expert in Britain said it was ‘disturbing’ that world leaders might fast-track vaccines or force them through without proper safety testing in order to make political gains.
Professor Danny Altmann, an immunology expert at Imperial College London, said: ‘It should be incredibly disturbing to the global medical community to see any potential attempts by any politicians, whether in Russia, the USA or elsewhere, to seek to manipulate, short-circuit or exert influence in any way over the agreed scientific protocols that are in place to carefully evaluate comparative safety, immunogenicity and efficacy of vaccines.
‘In decades to come, we won’t remember which politician polled a few more or less votes, but we really won’t forget any failed opportunities to put in place the safest most effective possible global programmes to eradicate this pandemic.’
While small trials can show whether a vaccine is likely to be safe, the months or years-long Phase III tests which measure effectiveness have not yet taken place, while the WHO has not yet granted approval for the jab.
Oxford University’s vaccine, which is being developed with the pharmaceutical company AstraZeneca, is now in phase three trials in the UK and Brazil.
In these tests the vaccine is being given to tens of thousands of people in real-world environments to see if it protects them from Covid-19. It is the most advanced coronavirus vaccine trial in the world.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people in society by the end of the year.
The team have genetically engineered a virus to look like the coronavirus — to have the same spike proteins on the outside — but be unable to cause any infection inside a person.
This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
The UK Government is not expected to start using the jab until large trials have proved it is safe.
Professor Chris Whitty, England’s chief medical officer, said on Saturday it would be ‘foolish’ to assume a vaccine would be ready before 2021.
Professor Whitty said: ‘I would obviously be delighted if it came earlier rather than later but I’d be quite surprised if we had a highly effective vaccine ready for mass use in a large percentage of the population before the end of winter, certainly before this side of Christmas.
‘Now that may be wrong, a lot of people are doing a huge amount scientifically, logistically to make sure that’s a pessimistic statement, to try and see if we can get a vaccine at extraordinarily fast speed but we have to check it works and we have to make sure it’s safe and these things do take time.
‘So I think if we look forward a year I think the chances are much greater than if we look forward six months and we need to have that sort of timescale in mind.’
WHICH TOP VACCINE CANDIDATES HAVE THE UK SECURED DEALS FOR?
1. GlaxoSmithKline and Sanofi Pasteur: 60million doses
The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said.
Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December.
The vaccine is based on the existing technology used to produce 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 provoke an immune response in a human patient.
2. AstraZeneca (manufacturing University of Oxford’s): 100million
AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.
Her comments came after the results from the first phase, published in The Lancet on July 20, showed promise.
The team have genetically engineered a virus to look like the coronavirus – to have the same spike proteins on the outside – but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
3. BioNTech/Pfizer: 30million
US drug giant Pfizer – most famous for making Viagra – and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.
Pfizer’s vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.
mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.
4. Valneva: 60million
The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland.
While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses.
Valneva’s jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.
The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30million
The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen’s jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.
The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.
Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.
The ‘Ad’ part of the vaccine’s name means it works using an adenovirus – a virus best known for causing the common cold – as a vehicle to transport the coronavirus genetics into the body.
6. Novavax: 60million
Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.
Novavax’s jab, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 per cent of people who received it, the company said, and was safe and ‘generally well-tolerated’.
Novavax’s candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system.
7. Imperial College London: Unknown quantity
Imperial College London scientists are working on Britain’s second home-grown hope for a jab. The candidate is slightly behind Oxford’s vaccine in terms of its progress through clinical trials, but is still a major player.
The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised.
Imperial’s jab is currently in second-phase human trials after early tests showed it appeared to be safe.
Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient’s body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream.
Fury over Donald Trump’s approval of using blood from Covid-19 survivors to treat infected patients as top scientists warn there is no proof it works
Fury erupted today over the controversial decision by the US to approve treating Covid-19 patients using the blood of coronavirus survivors.
Top scientists warned there is no proof the century-old treatment works, despite several studies offering promising results.
The Food and Drug Administration last night gave doctors emergency authorisation to use convalescent plasma, saying the ‘known and potential benefits of the product outweigh the known and potential risks of the product’.
Donald Trump called it a ‘very big day’ at a White House briefing yesterday, adding that the approval was a ‘truly historic’ moment. The US President also claimed that the treatment was proven to reduce the chance of death from coronavirus by more than one third.
But scientists criticised US officials for making the ‘bad conclusion’ because the therapy has not been put through the most rigorous human trials, meaning there is no conclusive proof that the treatment works.
One expert, however, called it ‘good news’ and said he hopes the UK can soon begin to use convalescent plasma routinely.
British researchers leading a major trial into promising therapies — which found that dexamethasone can cut the risk of death in critically-ill coronavirus patients — said the move was ‘ripping up good science that protects patients’.
The FDA said more than 70,000 patients had already been treated with convalescent plasma, which sees infected patients given the antibody-rich blood of survivors in an attempt to boost their immune response and fight the disease.
It comes just days after top US experts, namely Dr Anthony Fauci and Dr Francis Collins, reportedly stepped in to pause the authorisation of convalescent plasma because the evidence was not strong enough to do so.
Trump lashed out at the FDA at the weekend and accused the agency of attempting to delay the approval of Covid-19 therapeutics until after the president election in November.
‘This is a very big day,’ President Trump said at a White House briefing on Sunday, adding the approval was a ‘truly historic’ moment
Dr Eric Feigl-Ding, an epidemiologist from Harvard, said: ‘What the hell – This is a bad convalescent plasma conclusion—it was not a randomized trial’
Martin Landray, a professor of medicine and epidemiology at the University of Oxford, who is leading the RECOVERY trial, did not welcome the FDA’s authorisation
WHAT IS CONVALESCENT PLASMA AND WHERE HAS IT BEEN USED?
Convalescent plasma has been used to treat infections for at least a century, dating back to the 1918 Spanish flu pandemic.
It was also trialed during the 2009-2010 H1N1 influenza virus pandemic, 2003 SARS epidemic, and the 2012 MERS epidemic.
Convalescent plasma was used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate.
It has been proven ‘effective and life-saving’ against other infections, such as rabies and diphtheria, said Dr Mike Ryan, of the World Health Organization.
‘It is a very important area to pursue,’ Dr Ryan said.
Although promising, convalescent plasma has not been shown to be effective in every disease studied, the FDA say.
Is it already being used for COVID-19 patients?
Before it can be routinely given to patients with COVID-19, it is important to determine whether it is safe and effective through clinical trials.
The FDA said it was ‘facilitating access’ for the treatment to be used on patients with serious or immediately life-threatening COVID-19 infections’.
It came after New York Governor Andrew Cuomo said that plasma would be tested there to treat the sickest of the state’s coronavirus patients.
COVID-19 patients in Beijing, Wuhan and Shanghai are being treated with this method, authorities report.
Lu Hongzhou, professor and co-director of the Shanghai Public Health Clinical Centre, said in February the hospital had set up a special clinic to administer plasma therapy and was selecting patients who were willing to donate.
‘We are positive that this method can be very effective in our patients,’ he said.
Meanwhile, the head of a Wuhan hospital said plasma infusions from recovered patients had shown some encouraging preliminary results.
The MHRA has approved the use of the therapy in the UK, but it has not been revealed which hospitals have already tried it.
How does it work?
Blood banks take plasma donations much like they take donations of whole blood; regular plasma is used in hospitals and emergency rooms every day.
If someone’s donating only plasma, their blood is drawn through a tube, the plasma is separated and the rest infused back into the donor’s body.
Then that plasma is tested and purified to be sure it doesn’t harbor any blood-borne viruses and is safe to use.
For COVID-19 research, people who have recovered from the coronavirus would be donating.
Scientists would measure how many antibodies are in a unit of donated plasma – tests just now being developed that aren’t available to the general public – as they figure out what’s a good dose, and how often a survivor could donate.
There is also the possibility that asymptomatic patients – those who never showed symptoms or became unwell – would be able to donate. But these ‘silent carriers’ would need to be found via testing first.
Japanese pharmaceutical company Takeda is working on a drug that contains recovered patients antibodies in a pill form, Stat News reported.
Could it work as a vaccine?
While scientists race to develop a COVID-19 vaccine, blood plasma therapy could provide temporary protection for the most vulnerable in a similar fashion.
A vaccine trains people’s immune systems to make their own antibodies against a target germ. The plasma infusion approach would give people a temporary shot of someone else’s antibodies that are short-lived and require repeated doses.
If US regulator the FDA agrees, a second study would give antibody-rich plasma infusions to certain people at high risk from repeated exposures to COVID-19, such as hospital workers or first responders, said Dr Liise-anne Pirofski of New York’s Montefiore Health System and Albert Einstein College of Medicine.
That also might include nursing homes when a resident becomes ill, in hopes of giving the other people in the home some protection, she said.
The new FDA authorisation means those who had coronavirus and recovered can now donate their blood to be used as a treatment for those currently suffering from the disease.
The FDA approves emergency use authorisations during public health emergencies to speed along unapproved therapeutics to treat or prevent serious diseases where there are no other adequate and available alternatives.
For instance, on May 1, the FDA authorised the emergency use of Gilead Science’s experimental antiviral remdesivir to treat patients.
‘Today I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,’ Trump said last night as he was flanked by Secretary of Health and Human Services Alex Azar and FDA Commissioner Stephen Hahn.
The president also claimed the treatment has proven to reduce the chance of death from coronavirus by more than one third.
Mr Azar said: ‘I just want to emphasise this point because I don’t want you to gloss over this number. We dream in drug development of something like a 35 per cent mortality reduction.’
‘This is a major advance in the treatment of patients. This is a major advance.’
Trump claimed that over 100,000 Americans have already enrolled to receive this treatment.
‘Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective,’ Trump assured.
He highlighted that he was not the one pushing for the approval.
Mayo Clinic researchers revealed findings last week that suggested convalescent plasma could improve survival odds for Covid-19 patients.
The study assessed 35,000 patients given convalescent plasma, including a high number who were critically ill.
But the study compared patients who had received the treatment with each other. It looked at mortality rates between patients given high or low doses of antibodies, and between those treated early and later.
This is different to a randomised placebo controlled study — when an experimental drug or therapy is compared with a placebo or alternative medicine to see if it truly offers better survival rates.
Randomised trials are deemed the gold standard for testing if a therapy truly works because they eliminate any bias.
The findings were published on a pre-print server, MedRxiv, on August 12. Because they are not in a medical journal, they have not been scrutinised by other scientists yet, which helps to flag flaws.
The findings show 8.7 per cent of patients treated with convalescent plasma within three days of diagnosis died after seven days, compared to about 12 per cent of patients who were treated four days or more after their diagnosis — a statistical difference of around 37 per cent.
Those treated with plasma containing the highest levels of antibodies had a 35 per cent lower risk of dying within a week compared to those treated with less-rich plasma.
Dr Eric Feigl-Ding, an epidemiologist from Harvard, pointed out the 35 per cent reduction in mortality was not between the experiment group and control group.
Reacting to the news of the FDA’s authorisation on Twitter, he said: ‘What the hell. This is a bad convalescent plasma conclusion — it was not a randomized trial. Trump doesn’t care, but FDA head should know better!’
There are two randomised control trials of convalescent plasma therapy ongoing in the UK — the REMAP-CAP trial is seeing if it will help patients in intensive care, while the RECOVERY trial is looking at hospitalised patients.
Martin Landray, a professor of medicine and epidemiology at the University of Oxford, who is leading the RECOVERY trial, did not welcome the FDA’s authorisation.
He wrote on Twitter: ‘Convalescent plasma for COVID-19. It may work. We hope it will work. But nobody knows if it does. That’s why we are studying it in the #RECOVERYtrial. Then we’ll know & wont have to guess.’
Another RECOVERY trial lead, Peter Horby, professor of emerging infectious diseases at Oxford, said: ‘Allowing widespread use of unproven treatments creates confusion and undermines chances of improving care through proper science.
‘This is not “cutting red tape” it’s ripping up good science that protects patients.’
But Professor Lawrence Young, a virologist from University of Warwick, was pleased with the developments.
He told MailOnline: ‘The FDA emergency use authorisation for convalescent plasma to treat Covid-19 is great news.
‘I’ve been a strong advocate for this approach since the beginning of the outbreak and, with other colleagues, petitioned the government to investigate its use.
‘Convalescent plasma therapy has been used to the prevention and treatment of many infectious diseases for more than a century. Over the past 20 years this approach has been successfully used in the treatment of SARS, MERS and 2009 H1N1 pandemic flu with good safety profile and efficacy.
‘I hope the UK trial reports soon and we can begin using convalescent plasma routinely to treat patients with Covid-19.’
Dr Feigl-Ding pointed out that the 35 per cent reduction in mortality was not between the experiment group and control group
Another RECOVERY trial lead, Peter Horby, professor of emerging infectious diseases at Oxford, said: ‘Allowing widespread use of unproven treatments creates confusion and undermines chances of improving care through proper science’
‘We dream in drug development of something like a 35 per cent mortality reduction,’ Azar said of the convalescent plasma treatment. ‘This is a major advance in the treatment of patients