World’s biggest COVID-19 vaccine trial underway in the U.K
Efforts are being ramped up to come up with a medical solution earlier than the anticipated timeline of 12–18 months
With the number of global coronavirus infections surpassing well over 3 million, the pressure is mounting to come up with a medical solution for the contagion before it causes irreparable damage to the global economy and health of its population. In a positive development, the Coalition for Epidemic Preparedness Innovations (CEPI) said a vaccine could be available as early as this year for vulnerable groups like healthcare workers — a much shorter time frame from the 12–18 months given earlier.
The global alliance for developing vaccines against infectious disease is already supporting nine different COVID-19 vaccine projects, including the ones initiated by Moderna, Inovio Pharmaceuticals and Novavax — the former two are conducting human trials with technologies involving modified or otherwise manipulated genetic material.
Although a lot of American biotech companies seem to be at the front and center of these endeavors to come up with a vaccine for the current pandemic, the biggest and most expedited trials are being conducted across the Atlantic, in the U.K. The biggest trial yet of vaccine to treat COVID-19 patients is being set up under the auspices of Oxford University’s Jenner Institute.
Dubbed as the Recovery trial, the project kicked off with a Phase I clinical trial involving 1,100 people. A combined Phase II and Phase III trial would involve another 5,000 recruited from 165 NHS hospitals around the UK. While other companies are limping with smallish clinical trials, the recovery team has gotten a head start, since the vaccine has already proved the safety in a coronavirus inoculation, earlier last year. All these have to do now is to prove the effectiveness part.
“We’re guessing some time in June we may get the results. If it is really clear that there are benefits, an answer will be available quicker.” ~ Prof Horby, Lead Researcher
Recovery team researchers are confident that with the emergency approval by health regulators, the first few millions of doses could be available as early as September. And this might well be the case if you consider the encouraging results seen from the animal trials conducted at the National Institutes of Health’s Rocky Mountain Laboratory in Montana (U.S).
The Oxford vaccine was administered to six rhesus macaque monkeys. The animals were then subjected to heavy quantities of the COVID-19 virus — 28 days later and all six of them were found to be healthy. Scientists were excited at the results since rhesus macaque monkeys have the closest physiology to humans.
Apart from the main vaccine being tested, the recovery team would be working on a number of alternative trials:
- Anti-malarial drug hydroxychloroquine and antibiotic drug azithromycin are being tested separately as part of the Recovery trial.
- A combination of two antiretroviral drugs used in HIV treatment — Kaletra, and low-dose dexamethasone (steroid).
- One of the immunomodulatory drug tocilizumab to treat cytokine storm — a condition where the immune system goes into overdrive, as we have seen in the case of COVID-19.
- And finally, there are also discussions about introducing convalescent plasma — utilizing blood from recovered patients of the coronavirus who have created anti-bodies to fight and wave off the current pandemic.
Working on the same grounds, a Chinese company, CanSino, has also started clinical trials using a strain of the same respiratory virus that is found in humans, not chimps. Separately here, The Wall Street Journal reports that a group of billionaires and top researchers in New York are teaming up on developing antiviral drugs.
For the Oxford project, scientists are also working with drug manufacturing companies across Europe and Asia to prepare and scale the manufacturing of billions of doses as quickly as possible, that is if the vaccine is found to be effective and approved.
Of course, the scientists are hinging their hopes on the fact that there will still be widespread infections in the U.K as the trial progresses. If too few participants are infected in Britain, the Jenner Institute plans trials in other countries where the pandemic is still spreading, possibly in Africa or India.
According to the scientists, they would declare victory if as many as a dozen participants who are given a placebo become sick with Covid-19 compared with only one or two who receive the actual vaccine. “Then we have a party and tell the world,” Professor Hill of Oxford said.