All eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
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Yesterday was a historic day as the first person in the U.S., ICU nurse Sandra Lindsay, with Long Island Jewish Medical Center in Queens, New York, received the Pfizer-BioNTech COVID-19 vaccine. Now all eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.
If the pathway follows the one by Pfizer and BioNTech, and there’s little reason to think it won’t, it could be authorized on Friday and vaccinations could begin by Monday, December 21 or earlier.
This would be a very good thing. The Pfizer-BioNTech vaccine is still in limited supply and likely will remain so for several months. By adding more capacity with the Moderna vaccine, broader inoculations can occur while manufacture and distribution scales up. Both vaccines have demonstrated about 94-95% efficacy in clinical trials. The Pfizer-BioNTech vaccine requires extremely cold temperatures for storage, about -94 degrees F, while the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.
Pfizer-BioNTech had original plans to roll out 100 million vaccines globally by the end of this year, but are now saying 50 million. They still believe they can manufacture about 1.3 billion in 2021, enough for about 650 million people. The downgrade of this year’s 100-million-dose goal to 50 million was caused by supply-chain issues.
Moderna has said it believes it will have 20 million doses—enough for 10 million people—available by the end of the year and should be able to produce between 500 million and 1 billion doses in 2021.
Unlike Pfizer-BioNTech, which accepted no development monies from the U.S. government’s Operation Warp Speed, Moderna has been working with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). The U.S. government provided almost $1 billion for research and other preparations while agreeing to acquire 200 million doses for about $3.1 billion. The U.S. government, though not funding Pfizer-BioNTech’s research, did buy $1.95 billion worth of vaccines.
To date, the research into the vaccines indicates it prevents symptomatic COVID-19 and appears to prevent severe disease. It is not clear yet if it can prevent infections from asymptomatic vaccinated people. Nor is it yet known how long the vaccine’s effects last. It may require a yearly booster.
Side effects from the vaccines are generally minor and transient—soreness at the injection site, in some cases fever, chills and achiness that passes within a day or so. With the Pfizer vaccine, there were two cases of severe anaphylactic shock in the UK in people who had severe allergies and carried EpiPens. They have since recovered.
Both the Moderna and Pfizer-BioNTech vaccines use a technology that has so far not received approval for use. Note that emergency authorization, such as has been given for the Pfizer-BioNTech vaccine, is not the same as full approval. Both use mRNA, which codes for a portion of the virus’s spike protein. The mRNA is encapsulated in a tiny fat blob called a nanolipid particle. When injected into the body, the mRNA enters the cells, causing the cells to churn out the spike molecule which trains the body’s immune system to attack the virus if it encounters it.
Moderna’s senior director of vaccine access and partnerships at Moderna, is 35-year-old Hamilton Bennett. She holds graduate degrees from the University of Washington in Environmental Health and Microbiology, and a certificate in Epidemiology from the London School of Hygiene and Tropical Medicine.
“We’ve come a long way in 12 months,” Bennett told ABC News.
Bennett was asked by Moderna leadership in January, as the pandemic grew out of control in Wuhan, China, to begin working on a COVID-19 vaccine as soon as the virus’s genome sequence was available. The company already had a template to leverage, having invested several years in designing experimental mRNA vaccines for the Middle East Respiratory Syndrome coronavirus (MERS-CoV) and the Zika virus. They had also been partnered with the NIH on bringing mRNA vaccines to market.
As was the case at biotech companies globally, there was internal debate on how many resources to place on the vaccine. During earlier outbreaks, companies had invested hundreds of millions of dollars into research only to have the outbreaks peter out, leaving them with a vaccine with no market or merely having wasted millions of dollars. Many outbreaks do burn themselves out and there was speculation that the COVID-19 pandemic would follow the route of many others, such as SARS and MERS.
But Bennett said she felt strongly it was Moderna’s moral and social obligation to develop the vaccine and advocated for the effort and investment.
“We believe that our platform is going to make a difference, and we believe that we’re uniquely capable of responding to this pandemic,” Bennett said. “And if we don’t do it, maybe no one else will.”
Only two days after the first viral genome was mapped and published in early January, Moderna had finalized their vaccine.
One of the biggest advantages of mRNA is it is fast and easy to manufacture the mRNA sequences needed. This allowed for a very fast design of the vaccine.
“Every day we just accelerated that timeline faster and faster,” Bennett said. “I was so focused on the program, and I would leave the office at 10 o’clock at night. I would come back by 7 a.m. It almost felt like the world around us was shifting, but for those of us on the program, our entire world was the program.”
If the FDA grants authorization to Moderna’s vaccine this week, it will be the company’s first marketed product.
Although Moderna is very much in the public eye now, it was well known within biopharma circles, especially among biotech venture capital firms and investors. Even before the company’s record-setting initial public offering (IPO) in December 2018, where it raised more than $600 million, giving it a market valuation of about $7.5 billion, investors had been intrigued by the company’s technology and its hard-driving chief executive officer, Stephane Bancel, who has garnered comparisons—both positive and negative—with Apple’s legendary co-founder and chief executive officer Steve Jobs.
Since its founding in 2010, Moderna had raised more than $2.6 billion in equity financing. It had a pipeline of 21 programs, with 10 in the clinic at the time of the IPO. There was skepticism as to whether the company could live up to its expectations, despite the unusual size of its pipeline. Most biotechs when they launch an IPO have no products in the clinic, or perhaps have one or two in early-stage trials. It is a very common strategy for biotech companies to raise money to develop drugs through about Phase II, where if successful, they will then partner with large biopharma companies—or be acquired by them—to continue through the larger, more expensive Phase III trials and into regulatory submissions and marketing.
With this week’s announcement expected, Moderna has more than lived up to its expectations.
