“It was the best of times and it was the worst of times…” Thus begins Charles Dickens’ “A Tale of Two Cities”. And that describes the situation of Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) today. The pandemic definitely makes this one of the worst times in the recent past. But against the background of the corona virus, some leading vaccine manufacturers are experiencing their best moments.
Ten vaccines are currently in Phase 3 trials. But Moderna and Pfizer are probably the most likely to obtain Emergency Use Authorizations (EUAs) for their vaccine candidates. Both expect the results of the studies towards the end of the month, and interestingly, both companies are not developing conventional vaccines. Instead, their candidates use messenger RNA (mRNA) technology. Let’s take a closer look at the two companies’ development path so far – and what may lie ahead.
Moderna was at the center of attention when it became the first company to begin testing a vaccine candidate against the coronavirus in humans in March. Since then, the company’s path has been smooth, starting with positive data from Phase 1 trials. Here is what we know so far: In a study with 45 volunteers aged 18 to 55 years, all participants who received the vaccine produced neutralizing antibodies. These antibodies are critical because their role is to block the infection. In the group receiving the dose to be used later in the Phase 3 study, the level of neutralizing antibodies was 2.1 to 4.1 times higher than in recovered COVID 19 patients.
Later, a look specifically at older adults – aged 56 to 70 and 71 and older – showed that the more susceptible population also produced antibodies. The participants produced neutralizing antibody concentrations that were two to three times higher than those of the recovered patients.
Moderna started its Phase 3 trial in July. By the end of October, the company completed the recruitment of 30,000 volunteers. At that time, more than 25,650 volunteers had received their second vaccination in the two-dose program. Moderna is now required to submit two-month follow-up data to the US Food and Drug Administration (FDA) on at least half of the study participants. According to CEO Stephane Bancel, this schedule means that Moderna cannot apply for an EUA before November 25. Investors should keep an eye on whether the interim results published at the end of the month contain data on the efficacy of the vaccine in addition to information on the safety profile of the candidate.
Pfizer entered the game a bit later than Moderna. The Company merged with German biotech company BioNTech (NASDAQ:BNTX) in March and started its Phase 1/2 trial one month later. If their vaccine candidate is approved, Pfizer’s commercial power will help to distribute BioNTech’s mRNA drug worldwide. The interim results of the early phase study with about 120 participants were positive. Like Moderna, Pfizer and BioNTech have steadily advanced to Phase 3.
The company began by testing four candidates and then decided to push one. In participants aged 18 to 55 years, the vaccine produced 3.8 times higher concentrations of neutralizing antibodies than in recovered coronavirus patients. In participants aged 65 to 85 years, the concentrations were 1.6 times higher than in cured patients. In September, the partners changed their Phase 3 study protocol to expand recruitment from the original 30,000 to 44,000 participants. By November 2, more than 37,000 participants were enrolled.
Like Moderna, Pfizer and BioNTech are required to submit follow-up data for two months for half of the participants in the Phase 3 study. Pfizer CEO Albert Bourla recently said that these results would be available in the third week of November. If the data are positive, Pfizer will apply for an EUA “soon thereafter,” said Bourla.
A new kind of vaccine
As far as time and data quality are concerned, Moderna and Pfizer are on an equal footing so far. And if either or both of them make it to the finish line, they will introduce a vaccine that is different from any other on the market. Usually vaccines work by introducing a weakened form of the virus into the body. This allows the body to build antibodies to fight the infection.
But the candidates from Moderna and Pfizer work differently by harnessing the power of mRNA. These research vaccines are used to provide the body with “instructions” to make a protein from the virus, and the immune system creates independent antibodies, just as it would when injecting a weakened form of the virus. The success of one of these vaccines would not only combat the corona virus. It would also be a great victory for mRNA medicine. These would be the first vaccines of this kind to be launched on the market.
What about financing and production capacities? Here, too, Moderna and Pfizer are neck and neck. In August, Operation Warp Speed (OWS), the government’s attempt to bring a vaccine to market, offered Moderna $1.5 billion to supply doses of the vaccine, which are subject to approval. The government initiative had already granted Moderna up to $483 million for its program. OWS granted Pfizer up to $1.95 billion for its vaccine doses.
In terms of capacity, Moderna aims to produce 500 million to possibly 1 billion cans per year from next year. Pfizer has set itself the goal of producing about 1.3 billion cans by the end of next year.
What does this mean for investors?
Moderna and Pfizer are roughly equal in this late phase of the vaccine race. One of them could win. Or both could win a share of the coronavirus market price. The global need for a vaccine means that there is room for more than one vaccine manufacturer to benefit from the advantages. It is also possible that both will fail. Anything can happen in clinical trials.
It is not yet too late to take a stand on these stocks and to focus on the future of mRNA vaccines. However, investors with low risk tolerance should either watch from the sidelines – or choose Pfizer instead of Moderna. The huge range of commercialized products offered by big pharma means that they are not dependent on a coronavirus vaccine in terms of revenue and stock performance. The clinical phase of Moderna depends on the success of their coronavirus vaccine candidate, at least for the time being.
Whatever happens at the end of this month will be crucial for Moderna and Pfizer. But the story of the two companies may not be over by then. It could just be the beginning.