US gets more help in raging battle against COVID-19 as FDA authorizes Moderna vaccine, the second allowed for emergency use

CAMBRIDGE, Mass. — Americans will soon have access to a second COVID-19 vaccine.

Stephen Hahn, commissioner of the U.S. Food and Drug Administration, granted emergency authorization Friday to a vaccine made by Moderna, a week after giving similar clearance to one made by Pfizer and its German collaborator, BioNTech.

His is “authorizing” rather than approving the vaccine, because longer-term research is needed to meet the full standards for approval, which officials don’t want to wait for during the public health emergency.

The speedy path to authorization was possible because the agency “cut through regulatory red tape,” Hahn said at a Friday night press conference. “We worked quickly based on the urgency of this global pandemic … We have not cut corners.”.

The announcement makes the U.S. The first country to authorize two COVID-19 vaccines that demonstrate “clear and compelling efficacy, Dr. Peter Marks — director of the Center for Biologics Evaluation and Research at the FDA — said during the press conference. Marks said it is “another milestone as we work to end the COVID-19 pandemic.”.

The move comes a day after the U.S. Reported its 17 millionth case of COVID-19 and an independent advisory committee reviewed data from human trials of Moderna’s mRNA-1273 vaccine, deciding its benefits outweighed its risks. The vaccine, according to a trial that included 30,000 volunteers, protected more than 94% of recipients from active disease, without causing major safety concerns.

Trucks will begin moving the vaccine this weekend, with the first of 5.9 million already manufactured Moderna shots expected to be given on Monday.

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It’s a triumphant moment for the 10-year-old Cambridge, Massachusetts, biotech company that until now had never brought a product to market.

Now, both its vaccine and the one by Pfizer-BioNTech are poised to change the course of the worst pandemic in a century.

The virus that causes COVID-19 has swept the world and particularly devastated the United States, which accounts for 4% of the world’s population but nearly 23% of its COVID-19 cases and 19% of its deaths.

During the current winter surge, an American is reported dead about every 34 seconds from the virus, and 150 are diagnosed every minute.

But it will take time to roll out vaccine across the country and the world, achieving the 70% protection – from both vaccination and natural disease – that experts say will be needed to stop widespread infections.

Moderna, which developed its vaccine in collaboration with government scientists, says it will be able to deliver 20 million doses of its vaccine by the end of December. Another 80 million will be available in the first few months of 2021, under a contract signed in August that brought the U.S. Government’s direct financial backing of the company to $2.5 billion.

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“It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccine’s rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public,” Dr. Francis Collins, director of the National Institutes of Health, said Friday.

Just last week, the government closed a deal for a second 100 million doses to be delivered in the second quarter of next year, bringing taxpayers’ total investment in mRNA-1273 up to $4.1 billion.

Another candidate vaccine, from Johnson & Johnson, fully enrolled its large-scale human trial Thursday and expects to report its first safety and effectiveness data in January.

A fourth, created by AstraZeneca and Oxford University, is a few weeks behind, and a fifth candidate, by vaccine developer Novavax of Gaithersburg, Maryland, is expected to begin its major U.S. Trial shortly.

If all or most of these come through, there should be plenty of vaccine by the end of next summer to cover every American who wants one.

“It’s just incredible science and human achievement,” said Dr. Steven Joffe, a professor of medical ethics and health policy at the Perelman School of Medicine at the University of Pennsylvania. “Not just the science that went into the vaccines, but the organizational effort to pull off those trials – it’s marvelous.”.

More than a decade in the making

Although Moderna moved extremely fast, winning authorization just 11 months after beginning work on mRNA-1273, it has been developing the technology behind its vaccine for a decade.

​The company was founded in 2010 on the banks of the Charles River, a short walk from the Massachusetts Institute of Technology, where one of its founders was a faculty member, and another a graduate and board member.

That MIT grad and board of trustees member, venture capitalist Noubar Afeyan, said he was intrigued at the time by the idea of making drugs inside the human body.

Messenger RNA, which the body uses to translate the DNA code into the proteins that do all the body’s work, seemed like the right tool to address a whole host of medical problems, he said.

Afeyan said he likes to start companies with big ideas that seem like science fiction and then “take the fiction out” by finding the science to make it real.

Moderna was initially named LS18 to indicate it was the 18th life sciences company Afeyan had started. (He’s lost track of whether his latest company is LS79 or LS80, he said.) The idea was seeded by a stem cell scientist at nearby Harvard University, Derrick Rossi, who was trying to commercialize his research using the body’s most versatile cells to make medicines.

Afeyan said it was a provocative concept. But by May of the following year, when the company was officially launched as Moderna, they had dropped the idea of using stem cells, which Afeyan said were too unstable in the body, and focused instead on messenger RNA (hence the name ModeRNA).

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Messenger or mRNA is the body’s own delivery system, taking “messages” from the DNA code in the cell’s nucleus to a protein manufacturing center.

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These proteins direct every activity of life, so figuring out how to make them on demand could help people who suffer severe diseases because their bodies make faulty proteins – as with sickle cell disease, cystic fibrosis and myriad rare diseases. Such proteins could also prime the immune system to target cancer cells, or infectious diseases.

Afeyan and his collaborators wanted to tackle this whole range of medical challenges.

But first, they needed a CEO to run the company.

Afeyan said he had been negotiating with a French entrepreneur who was, like him, a biomedical engineer. But Stéphane Bancel wasn’t sure he wanted to leave a stable job as CEO of an established diagnostics company for the risk of a startup with a never-before-tried idea.

Bancel was walking home across the Longfellow Bridge from Cambridge to Boston one winter night, when Afeyan called and turned on the hard sell.

Afeyan said he would never have a bigger idea to offer Bancel. If this becomes the next Genentech, “you’re going to hate yourself” for not being involved, Afeyan told him, referring to the South San Francisco company that launched the entire biotechnology industry with its birth in 1976.

Later that year, Bancel signed on to run Moderna and continues to lead the company, which has now made several founders and its CEO into billionaires.

The earliest seeds of Moderna.

There were a few key scientific advances that led mRNA to where it is today.

One came from another Moderna co-founder, Robert Langer, a professor at MIT and a serial entrepreneur.

Early in his career, Langer, who had recently earned his doctorate in chemical engineering from MIT, was struggling to find a job. He didn’t want to work in the oil industry, though he’d gotten 20 job offers, including four from Exxon alone.

After months of searching, Dr. Judah Folkman, a passionate doctor at what is now called Boston Children’s Hospital finally took a chance on him. Folkman believed he could cure cancer by cutting off the blood supply to tumors but he couldn’t figure out how to slowly release drugs to work effectively.

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Langer spent years developing a way to encapsulate nucleic acids – the same building blocks as in mRNA vaccines – into tiny particles that could make their way into cells.

“At first people didn’t think it was possible,” Langer said. He published a 1976 paper showing it could be done but still, it was a slog to get people to believe in its potential.

“After that paper came out, I must have had 10 years of people rejecting grants” to support the work, he said. (His work with Folkman provided the underlying science for the drug Avastin, which earned $7 billion in sales in 2019 and is used to treat many types of cancer as well as wet age-related macular degeneration, the leading cause of blindness in older adults.).

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Langer and others made additional improvements over the years, including adding polyethylene glycol to the surface of particles, which enabled them to survive in the body for longer. That’s one of the key ingredients of Moderna and Pfizer-BioNTech’s vaccines.

In 2010, when Langer was one of the world’s best known bioengineers and a leader in the field of drug delivery, Rossi came to see him with a scientific insight he hoped would be the basis for starting a company. Langer introduced him to Afeyan, and the idea for LS18 was born.

By the following year, Rossi moved on and the core group included Langer, Afeyan, Dr. Kenneth Chien, a prominent cardiologist and researcher, and Timothy Springer, an immunologist at Harvard Medical School.

The four met once a week to brainstorm, while a handful of scientists at Afeyan’s Flagship Pioneering advanced their ideas in the lab.

Moderna’s first real home was an underwhelming office – half basement, half ground floor just a few blocks away.

The vision from its earliest days, Langer said, was to build a “platform” that could be used as the basis for drugs, vaccines and even tissue engineering – another field he had helped pioneer.

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For several years, Moderna has been collaborating on vaccine development with scientists at the National Institute of Allergy and Infectious Diseases, the agency led by Dr. Anthony Fauci.

By the end of 2018 when Moderna went public, it was the biggest initial public offering ever for a biotech company, though shares fell 19% that first day as investors worried it was overpriced.

A year later the company was testing 20 different mRNA’s in humans – five or six times more research programs than the typical biotech.

That was enough, said Nina Deka, a senior research analyst at ROBO Global, for her fund to decide to make Moderna one of the 85 companies included in its portfolio of health care technology and innovation stocks.

Moderna had recently announced plans to develop a COVID-19 vaccine when ROBO Global decided to invest.

“Not because of what they did this year, but what they’ve done since the start of the company,” Deka said.

With two mRNA vaccines under development, ROBO Global expected that even if Moderna’s vaccine didn’t succeed, the technology would advance, buoying everyone in the industry.

“It’s not just vaccines. It’s also cancer. It’s also orphan drugs” for rare diseases, she said.

The company had just built a brand new production facility in the Boston suburb of Norwood, and it was using advanced artificial intelligence to direct its research, which ROBO Global appreciated, Deka said.

Plus, it was breaking speed records with its candidate COVID-19 vaccine.

“The next question is,” Deka said, “if they can do this quickly, what else can they do?”.

Contact Karen Weintraub at [email protected].

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

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