The COVID-19 vaccine candidate developed by Pfizer Inc. (NYSE:PFE) and BioNTech (NASDAQ:BNTX) may be the closest to the finish line, but the market can count on several other potential formulations that could help end the pandemic.
That is if we look at Europe and North America alone, considering China says it already has authorised four jabs for emergency purposes, developed by Sinovac, CanSino and Sinopharm.
READ: Pfizer to submit COVID-19 vaccine candidate for emergency use authorisation next week after positive late-stage trial data
Sinovac and Sinopharm are planning to begin commercial production on or before year-end, with a combined production capacity of 600mln units per year and 1bn units by end 2021.
CanSino is running slightly behind on its commercial production as it began Phase 3 trials only in August.
Sinopharm has started administering its vaccines to residents in Wuhan and Beijing. Residents now can make appointments to get the shot with students who need to travel abroad getting priority.
Meanwhile, President Vladimir Putin boasted the world’s first coronavirus vaccine to be registered on August 11, but its speed has been met with scepticism.
Moscow said it would start rolling out the jab, called Sputnik V, by the end of August.
The University of Melbourne also had an already available jab, being a repurposed formulation for tubercolosis, though trials will not conclude until June 2021.
New vaccine methods versus traditional techniques
Traditionally, vaccines are made of an inactivated virus; recombinant proteins that stimulate an immune response.
By providing the body’s defence mechanisms with advanced warning of the virus, they trigger production of the antibodies required to fight the real thing when it is contracted.
Pfizer’s drug, which will be submitted to US regulatory authorities next week, uses different tactics. Driving the process is messenger RNA, or mRNA, which plays a fundamental role in human biology by transferring the instructions stored in DNA to make the proteins required in every living cell.
Medicines based on mRNA instruct a patient’s own cells to produce proteins that could prevent, treat or cure disease.
Another Covid vaccine in the race, being Moderna Therapeutics (NASDAQ:MRNA), uses the same type of mRNA-based technology.
Moderna was the first biotech to take a COVID-19 vaccine into a phase III clinical trial and results of the study on 30,000 people are expected shortly.
The good news, analysts at Deutsche Bank have noted, is that on average once a vaccine for an infectious disease makes it to phase-three trials, it has an 85% chance of being approved.
There’s only one problem — no mRNA drug has ever been approved for human use.
Tal Zaks, the chief medical officer of Moderna, previously explained to Stephen Dubner on the Freakonomics Radio podcast just how and why his team might succeed where it and others have thus far failed.
“I think what we have done uniquely is leverage a decade of engineering and science on top of medicine to sort of break the riddle of how to get an mRNA to make enough protein,” he said.
“And the second element is, we already have proven time and again that we can generate neutralising antibodies with this vaccine.”
“So, the question ahead of us is not whether mRNA will work, the question ahead of us is whether neutralising antibodies are going to prevent Covid-19. And I think the likelihood of that answer is very, very high.”
CureVac (NASDAQ:CVAC) is also working on a mRNA-based inoculation, and is targeting large-scale human trials for the last quarter after the first phase showed it triggered an immune response in the participants.
Down the conventional route
Researchers used the copy of a chimpanzee viral vector based on a weakened version of a common cold virus, because it causes infections in the animals and contains the genetic material of the SARS-CoV-2 virus spike protein, at the basis of COVID-19.
After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
Now at the final stage of trials on 30,000 people globally, the FTSE 100 firm is expecting results before the end of the year.
While the study is expected to end in March 2023, the jab could be employed for emergency use in early 2021 based on interim data, with potential for 600-900mln doses to be produced by April.
It is using the same technologies adopted for the Ebola jab provided to people in the Democratic Republic of Congo in 2019.
Smaller cap Novavax Inc (NASDAQ:NVAX) is also at the final stage of trials, involving 15,000 volunteers in the UK and up to 30,000 in the US and Mexico, with enrolment to end this year.
The firm said it has made significant progress in large-scale manufacturing but experienced delays in meeting the original timeline.
The latter uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines with GSK’s established pandemic adjuvant technology.
GSK and Vir Biotechnology Inc (NASDAQ:VIR) are also developing an antibody-based treatment, as are Eli Lily & Co (NYSE:LLY) and partners Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Roche Holding AG (SWX:RO).
Unfortunately, approving a jab isn’t the silver bullet to put an end to COVID-19.
If the mRNA candidates end up being approved, the hurdles may extend to the distribution phase, since the formulation falls apart easily and needs to be kept in deep freeze right up to injection time.
This could be especially challenging for Pfizer, since its formulation needs two doses to complete the course.
Distribution will be a challenge for DNA-based jabs as well: only time will tell how effective it will be on the world’s population, how long it will take to be rolled out and what share of the population it will reach.
Even prior to that, we will see which countries will be able to put their hands on the approved inoculations first.
“Alongside developments on testing, all of these questions will help determine when the global economy can return to something closer to ’normal’,” analysts at ING Economics commented.
“We’ve assumed it may not be until mid-late 2021 before growth consistently returns to many economies.”