01 mRNA COVID-19 Vaccines
For fast-tracking coronavirus vaccines
As COVID-19 began its global rampage in early 2020, the health of a global population—and the fate of a global economy—hung in the balance. A vaccine couldn’t come fast enough. Yet most take a decade to develop, test and make their way to market. Even the fast-tracked 1967 mumps vaccine took four years from start to finish.
But two teams had a secret weapon. One team was U.S. biotech firm Moderna. The other was a collaboration between pharma giant Pfizer and German biotech company BioNTech. Both believed they could deliver COVID-19 vaccines in less than a year by using messenger RNA (mRNA). Instead of using the virus or viral proteins—which are expensive to create and difficult to store—mRNA uses the DNA code of a virus to direct a person’s cells to make specific proteins to fight infections.
By the end of 2020, both teams had delivered—and jabs were soon being administered around the world. Now researchers are examining how the tech might be used to combat other diseases, including malaria, cancer and cardiovascular disease.
“We believe our mRNA platform can solve the world’s greatest health challenges, from diseases impacting millions, to ultra-rare diseases impacting dozens, to medicines personalized down to the individual level,” said Moderna CEO Stéphane Bancel.
BioNTech CEO and co-founder Dr. Ugur Sahin echoed that sentiment: “The response to the pandemic has shown that science and innovation can transform people’s lives when all key stakeholders work together towards a common goal.”
Here are the critical milestones—and challenges—that marked the historically fast path for the mRNA vaccines.
11 January 2020
On the same day Chinese scientists publish the DNA sequence of the coronavirus, researchers at Moderna pin down the genetic sequence they plan to use for the vaccine, focusing on mRNA technology that had first been discussed in the 1950s, but not developed until 2005. The company had been eyeing mRNA’s potential to fight coronaviruses, and its researchers needed just two days to develop a vaccine they believed would be safe and effective.
25 January 2020
In Germany, BioNTech quickly ramps up, using mRNA technology and a proprietary software to design 10 vaccine candidates. “There was not even one day to lose,” Özlem Türeci, BioNTech’s chief medical officer, said in an August 2021 TED Talk. “This was the mindset of the entire team.”
24 February 2020
After collaborating with U.S. National Institute of Allergy and Infectious Diseases (NIAID) and Coalition for Epidemic Preparedness Innovations, Moderna ships the first batch of its mRNA-1273 vaccine to the U.S. National Institutes of Health—just 42 days after sequencing was shared. The agency soon approves it for human trials.
1 March 2020
With just 1,000 employees, BioNTech’s Sahin knows he needs a bigger team—and a strategic partner—to scale efforts. So he calls Pfizer executive Kathrin Jansen to propose a collaboration to develop, test and distribute the mRNA vaccines. Pfizer agrees and invests US$500 million to buy the equipment required to make tens of millions of vaccine doses.
16 March 2020
The first mRNA COVID-19 vaccine trial in the world starts at the Kaiser Permanente Washington Health Research Institute in Seattle, where a volunteer receives a Moderna shot. It happens just 66 days after the coronavirus sequence was published.
10 April 2020
Officials at the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) submit a proposal to HHS Secretary Alex Azar. The plan: Create a large-scale government effort dubbed “Operation Warp Speed” to help private-sector drugmakers develop a vaccine, while also helping manufacturers establish enough capacity to make hundreds of millions of doses in just a few months’ time. The government ultimately commits US$18 billion toward the effort.
23 April 2020
Pfizer/BioNTech narrows their vaccine candidates from 20 to just four and begins testing them on a group of volunteers in Germany.
1 May 2020
Using part of the US$2.48 billion in Operation Warp Speed funding it would eventually receive, Moderna announces a deal with Swiss manufacturer Lonza to make enough mRNA for up to 1 billion doses per year.
30 June 2020
U.S. and European regulators throw teams a curve, requiring late-stage trials to have 30,000 subjects instead of 8,000. In response, Pfizer/BioNTech make quick changes to a plant in Belgium, accelerating prep work to make more trial doses and adding another formulation machine at the facility. These shifts add US$10 million to the project budget (immediately approved)—but help the team triple production in a matter of weeks.
22 July 2020
The U.S. government announces a US$2 billion order for 100 million doses of the Pfizer/BioNTech vaccine with an option to buy 500 million more.
Three weeks later, it announces a deal to buy 100 million doses of Moderna’s mRNA vaccine for US$1.5 billion, with the option to purchase an additional 400 million.
27 July 2020
Both Moderna (in conjunction with the NIAID) and Pfizer/BioNTech launch an expanded vaccine trial in the United States to initiate phase 3 testing required by the FDA. Typically, phase 3 would not begin until two earlier phases were complete, but the FDA allows all three phases to run concurrently to accelerate development.
21 October 2020
After months of R&D to determine the best way to preserve the vaccine during shipping, Pfizer/BioNTech reveal they are prepared to send millions of doses from a facility specially designed to keep the vaccines at ultra-cold temperatures of minus-70 degrees Fahrenheit (minus-56.7 Celsius). Doses are slated to be shipped out in dry-ice-filled containers the size of suitcases.
18 November 2020
At completion of their phase 3 trial, Pfizer/BioNTech say their mRNA vaccine is found to be 95 percent effective against COVID-19 and days later ask the FDA for emergency use authorization for the vaccine. However, raw material supply-chain obstacles force the team to cut year-end global delivery projections in half to 50 million doses.
30 November 2020
Moderna reports its mRNA vaccine is 94 percent effective in preventing COVID-19 and asks the FDA for emergency use authorization.
2 December 2020
The U.K. grants emergency use of the Pfizer/BioNTech vaccine, becoming the first Western country to provide access to the general public.
11 December 2020
Pfizer/BioNTech’s mRNA vaccine is authorized for emergency use in the United States. Within days, a team of doctors and nurses receives the first approved doses—less than 11 months after BioNTech designed its first COVID-19 vaccines.
18 December 2020
The FDA tweets it has authorized Moderna’s mRNA vaccine for emergency use. Five days later, government health officials in Canada also greenlight the vaccine. In the weeks that follow, agreements are reached to supply the Pfizer/BioNTech or Moderna vaccines to countries across the world, including Costa Rica, Qatar, Belgium and South Korea.