“It was the best of times, it was the worst …” So was Charles Dickens Tale of Two Cities Begins. This describes modern (Nasdaq: flexible) And the Pfizer‘s (New York Stock Exchange: PFE) Today’s positions. The pandemic sure makes this time one of the worst times in recent memory. But against the backdrop of the Coronavirus, some leaders in the vaccine race are living their best moments.
Ten programs are currently participating in Phase III trials. But Moderna and Pfizer are arguably the closest to earning Emergency Use Permits (EUAs) for vaccine candidates. They both expect experimental readings at the end of the month, and interestingly enough, neither players are developing conventional vaccines. Instead, their candidates use messenger RNA (mRNA) technology. Let’s take a closer look at each company’s development path to date – and what may lie ahead.
Moderna took center stage when, in March, it became the first company to start human trials of a coronavirus vaccine. The company’s path has been smooth since then, starting with positive first stage data. Here’s what we know so far: In a study of 45 volunteers between the ages of 18 and 55, all participants who received the candidate vaccine produced neutralizing antibodies. These antibodies are essential, as their role is to prevent infection. In the group that was given the dose to be used later in the third phase of the trial, neutralizing antibody levels were 2.1 to 4.1 times higher than those of recovering COVID-19 patients.
Later, a special look at older adults – ages 56, 70, 71, and over – showed that the more vulnerable populations also built up antibodies. Participants produced neutralizing antibody levels two to three times higher than those of recovered patients.
Moderna began the third phase of the study in July. By late October, the company had completed enrollment of 30,000 volunteers. At that time, more than 25,650 participants received the second vaccination on the two-dose schedule. Moderna must now provide the FDA with two-month follow-up data on at least half of the trial participants. CEO Stefan Bancel says the schedule means Moderna cannot order the EUA before November 25. Investors should monitor whether interim results released at the end of the month include event data as well as information about the candidate’s security profile.
Pfizer jumped into the game shortly after Moderna. Major pharmaceutical companies have joined German biotechnology Biotechnology (Nasdaq: BNTX) In March, the partners began phase 1/2 of the trial a month later. If their candidate vaccine is approved, Pfizer’s commercial strength will help distribute BioNTech’s messenger RNA drug worldwide. Interim results from an early-stage trial involving approximately 120 participants were positive. Like Moderna, Pfizer and BioNTech have steadily marched into Stage 3.
The company started testing four candidates, then decided to introduce one: BNT162b2. In participants between the ages of 18 and 55, the experimental vaccine produced neutralizing antibody levels 3.8 times higher than those in recovered coronavirus patients. In participants between the ages of 65 and 85, levels were 1.6 times higher than in the recovered patients. In September, the partners modified the Phase 3 pilot protocol to expand enrollment to 44,000 participants from the initial plan of 30,000. As of November 2, there were over 37,000 registered participants.
Like Moderna, Pfizer and BioNTech must provide two months of follow-up data for half of the Phase 3 trial participants. Pfizer CEO Albert Burla said recently that these results will be ready during the third week of November. If the data is positive, Pfizer will apply for the United States “soon after,” according to Burla.
A new type of vaccine
In terms of schedule and data quality, Moderna and Pfizer are equal so far. And if one or both of them reach the finish line, they will introduce a vaccine that has no parallel in the market. Usually, vaccines work by delivering a weakened form of the virus to the body. This allows the body to build antibodies to fight infection.
But Moderna and Pfizer filters work differently by harnessing the power of mRNA. These experimental vaccines use mRNA to deliver instructions for producing a protein from the virus, and the immune system creates antibodies to the protein just as if a weakened form of the virus was injected. The success of one of these vaccines will not only treat the Coronavirus. It would also be a major victory for mRNA medicine. These will be the first vaccines of this type to be marketed.
Now, what about finance and production capacity? There, too, our moderna and Pfizer Neck and Neck. In August, Operation Warp Speed (OWS), a government effort to sponsor a vaccine to market, offered $ 1.5 billion to deliver vaccine doses, subject to its approval. The government initiative had already awarded Moderna up to $ 483 million to fund its program. OWS has awarded Pfizer up to $ 1.95 billion for vaccine doses.
In terms of capacity, Moderna aims to produce 500 million to 1 billion doses per year starting next year. Pfizer aims to produce about 1.3 billion doses by the end of next year.
What does this mean for investors?
Moderna and Pfizer are roughly equal at this late stage of The vaccine race. One of them might win. Or, both may receive a portion of the Coronavirus Market Prize. The global need for a vaccine means that there is room for more than one vaccine maker to reap the benefits. It is also possible for both to fail. Anything can happen in clinical trials.
It’s never too late to take a stand on these stocks and bet on the future of mRNA vaccines. However, investors with low risk tolerance should either watch from the sidelines – or choose Pfizer over Moderna. The Great pharmaThe wide range of commercial products means that they will not rely on the Coronavirus vaccine for revenue and performance sharing. The modern clinical phase depends on the success of the candidate coronavirus vaccine, at least for now.
Whatever happens at the end of this month will be decisive for Moderne and Pfizer. But this story of the two companies may not end at that time. It could be just the beginning.