When Pfizer (PFE 1.00%) and BioNTech (BNTX 1.38%) announced last week that the vaccine candidate they had developed was 90% effective at preventing COVID-19 infection, the market (and everyone else) celebrated. This seemed like a high bar to clear for other companies working on a vaccine to fight the novel coronavirus. But now, another company using the same gene-based approach is saying "not so fast" to those who last week thought the vaccine race had been won.
Moderna (MRNA 3.01%) just released preliminary results for its 30,000-person study of the company's two-dose vaccine using messenger RNA (mRNA) technology, similar to the candidate from Pfizer and BioNTech. The result is giving billions of people hope that there is a light at the end of the pandemic tunnel.
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How did we get here?
Moderna has always been a highly celebrated and cutting-edge biotech, even though it doesn't currently have any products on the market. The company had the highest value for any private biotech before going public in a splashy 2018 initial public offering (IPO). The stock stayed around that IPO price until reports of novel coronavirus infections in the U.S. began hitting the headlines earlier this year -- and then it shot higher.
Previously criticized for being too secretive and failing to share data on drug development or trial results with investors, management has opted for transparency while developing its COVID-19 vaccine candidate. The drug, which uses genetic material to prompt an immune response in the body, was developed in only 63 days after China shared the genome sequence of the virus in early January. Human trials began in mid-March.
What was just announced?
The phase 3 clinical trial of the biotech's vaccine candidate involved 30,000 participants. Half were given two doses of the drug, three weeks apart, and half were injected with a placebo. To determine effectiveness, the company had to wait until there were enough infections in the groups to compare the two with statistical confidence that any significant differences were due to the drug.
Preliminary results were extremely positive. Data released on Monday show the candidate is 94.5% effective at preventing COVID-19. Of the two groups, only five of those who received the vaccine were infected, while 90 of the participants in the placebo group contracted the disease. Although these might seem like small numbers, they are large enough to draw some early conclusions. Also notable is the fact that there were no significant safety concerns with the vaccine. The result is another shot of optimism that the end of the pandemic could be in sight. Moderna's shares jumped more than 12% in Monday's premarket trading. However, challenges remain to get the vaccine into the hands of those most at risk.
What comes next?
Moderna plans to file for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) in the coming weeks. This designation would allow the vaccine to reach high-risk individuals during the current state of emergency. Early indications suggested a price per vaccination between $32 and $37 during the pandemic. Many of the potential doses have already been accounted for through the company's global agreements. The U.S. has signed on for 100 million doses and added an option for 400 million more, Japan is slated to receive 50 million doses, Canada 20 million, and Qatar an unknown quantity. Management has indicated it is on track to deliver 20 million doses by the end of the year and between 500 million and 1 billion through 2021.
The greatest challenge may lie in getting all of those vaccine doses across the globe. In order to scale production efforts, Moderna's management has signed a 10-year deal with Swiss specialty chemical manufacturer Lonza Group. Distribution may be where the Moderna vaccine candidate shines the most. Unlike the Pfizer vaccine, which must be kept frozen at negative 94 degrees Fahrenheit, Moderna's vaccine is stable between 36 and 46 degrees -- a normal refrigeration temperature -- for up to 30 days, and can be stored at negative four degrees for six months. This is a huge advantage in a global supply chain not equipped to provide super-cold temperature from beginning to end like the Pfizer vaccine requires.
A few questions remain. The data isn't clear on how well the vaccine prevents serious illness or if it just helps prevent the spread of the disease. The trial didn't indicate that the vaccine lost any potency with the age of the participant, but that will only be confirmed with more data. Finally, it isn't known how long the protection from Moderna's vaccine will last. Despite these lingering questions, Moderna's good news is yet another in a string of positives that indicate the pandemic may finally have an end as we close 2020 -- and that's what everyone is talking about.
