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‘Breakthrough’: More progress in COVID-19 fight


Matt Woodley


21/07/2020 4:17:45 PM

Two vaccines and a new treatment show signs of effectiveness against coronavirus, randomised controlled trials find.

Scientist working on a vaccine.
At least 155 vaccines are currently being developed to protect against COVID-19.

While debates on elimination versus suppression continue to rage, both camps can generally agree on one thing: life will struggle to return to normal until there is an effective treatment or vaccine for COVID-19.  
 
The relative success of remdesivir and dexamethasone has given doctors some weapons to use in the fight against coronavirus, but now recently released data from a phase I/II trial of a new vaccine has given rise to hopes of a prophylactic option, rather than a treatment or cure.
 
According to results published in The Lancet, ChAdOx1 nCoV-19 induces a strong immune response in both parts of the immune system, without producing any early safety concerns.
 
‘The vaccine did not lead to any unexpected reactions and had a similar safety profile to previous vaccines of this type,’ Professor Andrew Pollard, chief investigator of the Oxford Vaccine Trial, said.
 
‘The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial program to confirm this.
 
‘We saw the strongest immune response in participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination.’
 
The vaccine provoked a T-cell response within 14 days of vaccination and an antibody response within 28 days. Every participant who received a booster dose had detectable antibodies capable of neutralising activity against the coronavirus.
 
Meanwhile, another phase II trial of a separate, but similar, vaccine has also produced encouraging results.

The Ad5-nCOV vaccine, being developed by CanSino Biologics and China’s military research unit, reportedly induced ‘significant neutralising antibody responses to live SARS-CoV-2’ in the majority of recipients, and no serious adverse reactions were documented among any of the 50 participants.
 
While phase III large-scale clinical trials are required to determine how protective it is against the virus, it has already been approved for use by China’s military.
 
Lead of the Respiratory Molecular Pathogenesis Group at the University of Technology Sydney, Professor Brian Oliver, who did not participate in either of the vaccines’ development, said the findings are exciting.
 
‘Both studies have … taken what would typically be a harmless common cold virus and genetically engineered the virus to produce proteins from the SARS-CoV-2 virus. This might sound frightening, but [it] is a really common approach to producing vaccines,’ he said.
 
‘These studies do not show that vaccination prevents COVID-19, but show that vaccinated people do produce antibodies against the virus, and therefore it is likely that a vaccination would reduce the symptoms of a SARS-CoV-2 infection, just like the influenza vaccination does.
 
‘What is now needed are large scale vaccination clinical trials to work out how effective these approaches are to protect people against developing COVID-19.’
 
The phase I/II trial of ChAdOx1 nCoV-19 involved more than 1000 healthy adult volunteers aged 18–55 in a randomised controlled trial. A subset of these volunteers (10 people) received two doses of the vaccine.
 
A global clinical program to trial the vaccine’s efficacy is already underway and comprises a phase III trial in the US with 30,000 patients, a paediatric study, and phase III trials in low-to-middle income countries including Brazil and South Africa.
 
Should neither of these vaccines – nor any of the other 153 currently being developed – prove effective following phase III trials, doctors may still have other options.
 
Antibody treatments, designed for old coronaviruses but applied to SARS-CoV-2, have shown great promise in laboratories, while a UK pharmaceutical company has claimed to have had a ‘major breakthrough’ in the treatment of hospitalised COVID-19 patients.
 
The company, Synairge, released the statement alongside data from a small-scale trial of a new formulation of interferon beta, which is administered via an inhaler. Dubbed SNG0001, it reportedly reduced the odds of developing severe disease (ie requiring ventilation or resulting in death) during the treatment period (days 1–16) by 79% compared to patients who received a placebo.
 
No patients who received SNG001 died, compared with three in the placebo group, and they were also reportedly more than twice as likely to recover (defined as ‘no limitation of activities’ or ‘no clinical or virological evidence of infection’) over the course of the treatment period.
 
‘The results confirm our belief that interferon beta, a widely known drug that, by injection, has been approved for use in a number of other indications, has huge potential as an inhaled drug to be able to restore the lung’s immune response, enhancing protection, accelerating recovery and countering the impact of SARS-CoV-2 virus,’ the trial’s chief investigator Professor Tom Wilkinson said.
 
The treatment reportedly works by providing high local concentrations of interferon beta, a naturally occurring antiviral protein, into the lungs. This is said to restore the lungs’ ability to neutralise the SARS-CoV-2, or any mutation of the virus or co-infection with another respiratory virus such as influenza or RSV.
 
However, while promising, the study’s main findings of a 79% reduced risk of severe disease and doubled chance of recovery generated p-values of 0.046 and 0.043, respectively, meaning they were close to not being statistically significant. As such, further research and large-scale clinical trials will likely be required before it becomes approved for widespread use.
 
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