“It was the best of times, it was the worst …” That’s how Charles Dickens’ A story of two cities begin. And that describes Modern (NASDAQ: MRNA) and Pfizer‘S (NYSE: PFE) present day situation. The pandemic certainly made this one of the worst moments in recent memory. But in the coronavirus context, some of the leaders in the vaccine race are experiencing their best moments.
Ten programs are currently in phase 3 trials. But Moderna and Pfizer are believed to be the closest companies in earning Emergency Use Permits (EUA) for their vaccine candidates. Both are expecting trial readings around the end of the month, and interestingly, neither side has developed a traditional vaccine. Instead, their candidates use information RNA technology (mRNA). Let̵7;s take a closer look at each company’s path to date – and what might lie ahead.
Moderna became the hub when, in March, it became the first company to begin human trials of a coronavirus vaccine candidate. The company’s path has since been smooth, starting with positive Phase 1 test data. Here’s what we know so far: In a study of 45 volunteers aged 18 to 55, all vaccinated participants produced neutralizing antibodies. These antibodies are key, as their role is to prevent infection. In the group given the dose that will later be used in the phase 3 trial, the neutralization antibody level was 2.1 to 4.1 times higher than that of the recovered COVID-19 patient.
Then a specific look at the elderly – 56 to 70 and 71 years and older – shows that the more vulnerable population also produces antibodies. The participants produced two to three times higher levels of neutralizing antibodies than those who recovered.
Moderna started phase 3 research in July. By the end of October, the company had completed recruiting 30,000 volunteers. At that time, more than 25,650 participants had received a second vaccination on a two-dose schedule. Moderna is currently required to provide the US Food and Drug Administration (FDA) with two-month tracking data on at least half of the test participants. CEO Stephane Bancel says that schedule means Moderna cannot request EUA before Nov. 25. Investors should keep an eye on whether interim results released at the end of the month include effective data. Results beyond information about a candidate’s safety record or not.
Pfizer joined the game a bit later than Moderna. Major pharmaceutical corporations have cooperated with German biotechnology BioNTech (NASDAQ: BNTX) in March, and partners begin phase 1/2 testing a month later. If their vaccine candidate is approved, Pfizer’s commercial power will help distribute BioNTech’s mRNA drug worldwide. The provisional results from the early stage trial with about 120 participants are positive. Like Moderna, Pfizer and BioNTech have progressively reached stage 3.
The company began testing four candidates, then decided to promote one: BNT162b2. In participants 18 to 55 years of age, the research vaccine produced 3.8 times higher levels of neutralizing antibodies than recovered coronavirus patients. In participants aged 65 to 85 years, the level was 1.6 times higher than in those who recovered. In September, the partners revised their Phase 3 testing process to expand enrollment numbers to 44,000 participants from the original 30,000 plan. As of November 2, more than 37,000 people have registered.
Like Moderna, Pfizer and BioNTech had to submit two-month follow-up data about half of the participants in the phase 3 trial. Pfizer’s CEO, Albert Bourla, recently said that those results would be available. in the third week of November. If the data is positive, Pfizer will apply for the EUA “soon after,” according to Bourla.
A new vaccine
From a time and data quality point of view, until now, Moderna and Pfizer have been equal. And if one or both of them finish, they’ll recommend a vaccine unlike any other on the market. Usually, a vaccine works by introducing a weakened form of the virus into the body. This allows the body to make antibodies to fight the infection.
But the candidates for Moderna and Pfizer work differently by harnessing the power of mRNA. These investigative vaccines use mRNA to give instructions for the production of a protein from a virus, and the immune system makes antibodies to the protein just as if it were injected with a weakened virus. The success of either of these vaccines will not only address the coronavirus. It would also be a huge win for mRNA medicine. These will be the first vaccines of this type to be commercialized.
Now, what about funding and production capacity? There, so did Moderna and Pfizer. In August, Operation Warp Speed (OWS), a government effort to bring the vaccine to market, offered Moderna $ 1.5 billion to deliver vaccine doses, subject to approved by this organization. The government initiative granted Moderna up to $ 483 million in funding for its program. OWS has awarded up to $ 1.95 billion to Pfizer for vaccines.
In terms of capacity, Moderna is aiming to produce 500 million to 1 billion doses annually next year. Pfizer’s goal is to produce about 1.3 billion doses by the end of next year.
What does this mean for investors?
Moderna and Pfizer are tied in the late stages of the vaccine race. One of them might win. Or both of them can win a share of the coronavirus market award. The global demand for vaccines means that more than one vaccine manufacturer benefits. It is also possible that both will fail. Anything can happen in clinical trials.
It’s not too late to take a place in these stocks and bet on the future of the mRNA vaccine. However, investors with low risk should watch from the sidelines – or choose Pfizer over Moderna. The large pharmaceutical group’s vast range of commercialized products means it won’t depend on coronavirus vaccine for revenue and performance share. Moderna clinical stage depends on the coronavirus vaccine candidate’s success, at least for now.
Whatever happens later this month will be crucial for Moderna and Pfizer. But the story of these two companies may not be over. It could be just the beginning.