Around the world, about 35 companies and institutions are racing to craft the much-needed vaccine for COVID-19, and The Guardian reports, that at least four of them have candidates ready for human trials.
At the forefront of these candidates is a proposed vaccine from Boston-based biotech Moderna, which is expected to enter trials very soon. In the meanwhile, China has just begun its first phase of vaccine clinical trials, delivering the vaccine candidate to about 108 volunteers, ageing from 18 – 60.
After about only 4 months from the first confirmed case of COVID-19, the speed at which these vaccines are being made is unprecedented. This is in part, thanks to early Chinese efforts in genetic sequencing on the biological material of SARS-CoV-2, the virus behind the novel coronavirus, amongst other reasons. China managed to map out and share the sequence in early January, which allowed research firms around the world to cultivate and study the live virus.
Another reason for this head start is that scientists have predicted for many years that the next global pandemic would be caused by the flu. Because of this vaccinologists had been working on a series of ‘prototype’ pathogens.
“The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses,” says Richard Hatchett, CEO of the Oslo-based nonprofit the Coalition for Epidemic Preparedness Innovations (Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.
There have been two other epidemics caused by coronaviruses in history, namely the 2002 – 2004 severe respiratory syndrome (SARS) in China, and the Middle East Respiratory Syndrome (MERS) in Saudi Arabia in 2012. Work began on vaccines in both cases but as these outbreaks were contained, the vaccines were dropped.
Now, companies like US-based Novanox is repurposing these same vaccines for SARS-CoV-2, which shares between 80% and 90% of the same genetic material as the SARS virus. Moderna, on the other hand, built their vaccine upon the previous work on the MERS virus.
Clinical Trials
An essential step to regulatory approval, clinical trials happen in three phases. The first phase begins testing the vaccine on a few dozen healthy volunteers. The volunteers are monitored for any side effects. After this, if the vaccine has proven safe it is tested on several hundred people, usually in a place where the illness is prevalent. This phase will test if the vaccine is effective.
The final phase involves testing several thousand people. Often times, several trial versions of a vaccine are tested at once, with many falling by the wayside as they are proven either dangerous or ineffective. “Not all horses that leave the starting gate will finish the race,” says Bruce Gellin, who runs the global immunisation programme for the Washington DC-based nonprofit, the Sabin Vaccine Institute.
Screening out dangerous and ineffective duds is essential, and as such, the trials can’t be skipped or hurried.
Another complication that could slow down vaccine approval is that no vaccines made from genetic material, be it RNA or DNA has ever been approved, so the COVID-19 candidates have to be treated as brand new vaccines, as Gellin says “While there is a push to do things as fast as possible, it’s really important not to take shortcuts.”
When can we expect it?
Annelies Wilder-Smith, professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine, says, echoing that sentiment of other vaccinologists, that “I don’t think this vaccine will be ready before 18 months.” Meaning only around September 2021 will a vaccine reach the mass-manufacturing stage, which opens up a whole new can of potential problems.
18 months is, in fact, extremely quick. It usually takes up to a decade for a brand new vaccine to go from inception to manufacturing to being deployed in the general public.
There is no reason to panic yet, however, as Wilder-Smith says there is a high probability that the current coronavirus pandemic “will probably have peaked and declined before a vaccine is available.”
However, a vaccine will still save many lives as in the case that the virus becomes endemic – meaning that people could talk about the coronavirus like they talk about the flu – but until then, the best hope to spare as many lives as possible is to contain the spread of the virus as much as possible. We can see this being done all over the world as countries are turning to nation-wide lockdowns to flatten the curve of infection.
Across the World
Here’s how countries across the world are preparing to fight against the pandemic, via Clinical Trials Arena:
- In the UK
Researchers from the University of Oxford are undergoing clinical trials for the assessment of different drugs as potential treatment options for COVID-19 in adult patients.
The trial has been named RECOVERY and is evaluating HIV drugs lopinavir and ritonavir, as well as anti-inflammation medication dexamethasone.
“There is an urgent need for reliable evidence on the best care for patients with Covid-19. Providing possible new treatments through a well-designed clinical trial is the best way to get that evidence,” says the chief investigator and Oxford professor Peter Horby.
“Adults admitted to hospital with COVID-19 should be offered the opportunity to participate in this trial and contribute to improving care for everyone. All patients will receive the standard full medical care, regardless of which treatment group they are placed in.”
- In Canada
The Heart Institute’s Research Center in Montreal is likewise undergoing a clinical trial to assess short-term therapy for mitigating the risk of pulmonary complications and deaths in COVID-19 patients.
COLCORONA, the name of the trial, is funded by the Government of Quebec and seeks to investigate the inflammatory storm characterised in adults with severe COVID-19 complications, as well as a treatment that could reduce disease complication in around 6000 participants.
- In Europe
Referred to as ‘Discovery’, this trial has been launched by French firm Inserm to assess potential treatments as part of the Reacting Consortium.
The study will analyse the safety and efficacy of four investigational therapies in a minimum of 800 severe COVID-19 patients in France.
Trial lead Florence Ader says “We analysed data from the scientific literature on SARS and MERS coronaviruses and the first publications on SARS-COV2 from China in order to come up with a list of antiviral molecules to be tested. Remdesivir, lopinavir and ritonavir in combination, the latter being administered with or without interferon beta and hydroxychloroquine.”
The Discovery trail is expected to enrol 3,200 participants across France, Belgium, Germany, Luxembourg, the Netherlands, Spain, Sweden and the UK.
