Lately, the stock market has been tanking but biotech firms that are developing vaccines against the novel Covid-19 pandemic and hope to have one that is both safe and effective before the end of the year.
Since the pandemic began earlier this year, biotech companies have undergone studies and trials in efforts to develop the world’s first vaccine against Covid-19. Although there’s been a substantial amount of progress—a vaccine has yet to receive approval from the U.S. Food and Drug Administration.
In the great race to a vaccine, biotech firms are using different techniques to develop very different types of vaccines.
mRNA Leads the Way
Currently, the candidates leading the vaccine race use mRNA technology; Moderna, (Nasdaq: MRNA) along with the partnership of Pfizer (NYSE: PFE), and BioNTech (Nasdaq: BNTX).
are pursuing this type of vaccine.
The RNA vaccine is a new type of approach using nucleic acid RNA that codes for antigen genes of a specific disease. Unlike a traditional vaccine, in which substances called antigens are introduced artificially into the body to stimulate the immune system, RNA vaccines do not introduce antigens into the body. Instead, the body is injected with genetic information that gives the body instruction on creating the antigens. By way of a crude analogy, it's the difference between putting a turkey in the oven and putting a recipe for turkey in the oven that becomes a turkey.
The pros of the RNA approach is the vaccine is quicker to produce and safer for the host.
However, because this method is new, proof of concept isn’t on the side of biotech companies that use this type of approach for vaccines. In fact, mRNA technology has never been licensed for an infectious disease.
But make no mistake—all eyes will be on the biotech companies using mRNA technology in the next month for vaccine development.
Pfizer, which is developing its vaccine with BioNTech, has enrolled more than 42,000 participants in its late-stage trial with 36,000 receiving the second dose so far. While Pfizer says it has yet to conduct any interim efficacy analysis, the company will apply for an emergency use authorization if the data are positive in the third week of November. Last month, both Pfizer and BioNTech said they would expand their trials to 44,000 participants from 30,000.
As for Moderna, it announced last week that it fully enrolled the 30,000 participants it originally intended for its Phase 3 trial. Earlier this week, Moderna said that the U.K. has started the "rolling review process” for its Covid-19 vaccine candidate known as mRNA-1273.
Recently, Moderna has received $1.1 billion in deposits from pending governments in prepreparation of approval.
According to Motley Fool, Moderna expects its vaccine to be at least 60% effective in its phase 3 trial. While scientists have been hoping that a vaccine against Covid-19 would be at least 75% effective, the U.S.’s top infectious disease expert Dr. Anthony Fauci has said that he would accept a vaccine that is just 50% or 60% effective.
An mRNA vaccine might not be the best vaccine—but it might be the quickest approach that is acceptable enough to distribute.
Moderna along with the team of Pfizer and BioNTech could all have their final stage data available by sometime next month.
The Viral Vector Approach
Another approach that other leading vaccine players are oursuing is the viral vector method. This approach uses another type of virus to typically put a gene into the body in the hope of producing an antigen similar to Covid-19 to trigger an immune response.
AstraZeneca (Nasdaq: AZN) and Johnson & Johnson (NYSE: JNJ), which use the viral vector approach was forced to pause their Covid-19 vaccine trials because of two separate unexplained illnesses. However, both biotech firms are resuming their trials in the U.S. after the pause.
Understandably, question marks were raised about safety concerns. But Dr. Susan Little, who is heading the studies of both vaccines for the University of California San Diego says that it’s just a signal that the trials are following the typical rules.
“It’s, I hope, a reassuring set of checks and balances to the public that this safety process works, that we are not proceeding too fast,” Little said, as cited by The San Diego Tribune.
While still unclear what exactly went wrong, JNJ has found no evidence that the vaccine caused the illness.
“Based on the information gathered to date and the input of independent experts, the company has found no evidence that the vaccine candidate caused the event,” JNJ said in a statement earlier this week.
Now, with the vaccine trials resuming, JNJ has been said to be running the biggest one to date with plans to test the safety and efficacy of the vaccine candidate in 60,000 adults.
Importantly, JNJ has been using just one dose for its vaccine, which avoids the logistical hurdle associated with the two-dose vaccine that many others including Moderna, the team of Pfizer and BioNTech, and AstraZeneca use.
Meanwhile, both JNJ and AstraZeneca’s vaccine candidates use an adenovirus. Adenovirus-based vaccines need only to be refrigerated, while mRNA vaccines require freezing. This would make JNJ and AstraZeneca’s vaccine easier to distribute, particularly in poorer, less developed regions with substandard medical facilities.
The vaccine candidate of Chinese biotech firm CanSino Biologics (HKEX: 06185; OTC: CASBF) also uses an adenovirus. In early September, CanSino said that it would conduct a late trial of its vaccine candidate on about 40,000 participants in, Saudi Arabia, Russia, Mexico, and Pakistan.
While both AstraZeneca and JNJ are behind Moderna and Pfizer in the race due to clinical trial pauses—they are still among the top global leaders in vaccine development for Covid-19.
The Sub-Unit Approach
One Covid-19 vaccine player Novavax (Nasdaq: NVAX) is using the sub-unit approach. Thisapproach injects a portion of the protein of the Covid-19 into the patient to trigger an immune system response.
Currently, Novavax is running a smaller late-stage trial that has now been expanded to 15,000 patients. The trial has enrolled 5,500 volunteers to date.
Novavax is a little behind the other biotech leaders; it expects its Phase 3 trial to be fully enrolled by November and unveil the interim data as soon as the first quarter of 2021.
Don't Pick One, Choose Multiple Winners
As I made in an argument in my review of Chinese vaccine developer CanSino in late August—there will be more than one winner. So forget picking just one winner; investors should instead focus on multiple companies that have the best chance at developing a safe and effective vaccine.
There’s also one other thing to consider: Keith Speights of Motley Fool this week made the argument for how the vaccine race could change if things go wrong.
“Should any of the leading vaccine candidates stumble in late-stage testing or demonstrate clearly superior safety and efficacy, the landscape will look much different than it does right now,” he wrote.
However, with the markets tumbling recently on surging Covid-19 cases and lack of progress on economic stimulus—now might be a good time to look for a few buys in some vaccine developers.
All the companies aside from CanSino that I discussed are backed by the Trump administration’s Operation Warp Speed. According to the U.S. Department of Health & Human Services, the program aims to deliver 300 million “safe and “effective” vaccine doses by January.