WASHINGTON — Touted enthusiastically by the nation’s chief infectious disease specialist Dr. Anthony Fauci, the biotechnology giant Moderna announced on Monday that its vaccine for the novel coronavirus is 94.5% effective.
“These are obviously very exciting results. It’s just as good as it gets — 94.5% is truly outstanding,” Fauci told CNN early Monday morning.
Moderna, based in Cambridge, Massachusetts, is the second company in as many weeks to announce major breakthroughs in vaccine development against COVID-19. Last week, pharmaceutical giant Pfizer announced its vaccine was over 90% effective in treating the respiratory virus.
Moderna CEO Stephane Bancel said the company has “chased” the novel coronavirus since January.
“All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” he said in a statement Monday.
The third phase of Moderna’s trial on a coronavirus vaccine candidate involved some 30,000 participants, half of which took a placebo while the other half received the actual vaccine under development.
Of the 15,000 test subjects given a placebo, Moderna said Monday that only 90 of those individuals contracted Covid-19. Less than a dozen placebo-consumers contracted a more severe form of the virus.
Among the 15,000 participants who actually took the vaccine, just five became infected with COVID-19 and none became severely ill. Side effects from the clinical trial vaccine, for now, appear minimal.
“Preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups,” Moderna said in its announcement.
To expedite distribution, the company plans on pursuing emergency-use authorization from the Food and Drug Administration after it completes its final safety evaluations.
It is widely expected that any vaccine emerging in the months ahead, be it from Moderna or another company, will see limited initial distribution. Fauci said Monday he expects the first round of vaccines to be administered in late December.
Those doses will first go to the most vulnerable populations including the elderly or severely immunocompromised. Health care workers, nurses and doctors, among others combatting the virus on the front lines, will also receive the vaccine first. For now, the Centers for Disease Control and Prevention are expected to lead the coordination of the nationwide vaccine rollout.
Fauci said Monday he believes that by the end of April 2021, “everybody else” will start to get vaccinated. That process could take at least a few months to complete, he warned.
Moderna estimates at least 20 million doses will be available by the end of 2020. Pfizer projects a supply of 50 million doses available by the end of December as well.
Moderna’s vaccine, like Pfizer’s, uses something known as messenger ribonucleic acid or, mRNA to copy and synthesize proteins in the body that ultimately fend off the virus. Through mRNA, the vaccines direct a replication of spike proteins found atop the coronavirus cell. When this occurs, protective antibodies appear to be formed.
As part of administering both the Moderna and Pfizer vaccines, individuals must take two doses spread several weeks apart. Both vaccines also require special cold storage. But unlike Moderna’s vaccine, which can be stored at just -20 degrees Celsius, Pfizer’s candidate requires deep-freeze storage temperatures of -70 degrees Celsius.
This is a primary challenge to the supply chain, said Tinglong Dai, an assistant professor of operations and management and business analytics at Johns Hopkins University Carey Business School.
“Our cold- and ultra-cold-chain capacity might not be able to meet the transportation and storage requirements of the vaccines that will be chosen in the end,” Dai said in an email Monday. “Another challenge is we do not have adequate information systems for sharing vaccine availability information, placing requests for vaccines, and keeping track of who have been vaccinated and who have not.”
This will be “essential,” Dai told Courthouse News, when there could be not just one but two vaccines on the market, and those same vaccines are poised to initially require two doses per person.
The risk of having an abundance of ultra-cold or regular freezers and even overinvesting the federal purse into that market is possible. But Dai emphasized that the risk of the U.S. being unable to distribute a highly effective vaccine was obviously greater.
“In addition, it is essential for public health departments — at least at the state level — to build their information infrastructure as soon as possible,” he said.
Michael Breen, director of infectious disease and ophthalmology at the analytics group GlobalData, was encouraged by Moderna’s announcement Monday and, in particular, the way trials have underscored the potential success mRNA technology could have to treat emerging diseases.
But Breen also offered caution.
“With these two seemingly effective vaccines possibly weeks from entering the clinic through emergency-use authorization, the path forward for other developers now remains unclear,” Breen said in a statement. “While the most effective vaccines will ramp up production to meet global demand, the opportunity for less effective vaccines will wane — possibly leading the field to be winnowed sooner than later as developers may not see a lucrative future in a developing a vaccine, which, even if effective, may be used for only one year. Of course, the opportunity will still remain for multiple vaccines, even those with lower efficacy than offerings from Pfizer or Moderna, as those vaccines may not be available in all geographies, and those regions may go with their best vaccine option at the time.”
Moderna developed its vaccine candidate as part of a $1.5 billion contract from the U.S. government this August to produce and deliver 100 million doses, which is just enough for 50 million people. The United States has also retained an option in its contract with Moderna to purchase another 400 million doses after the initial rounds are administered.
That $1.5 billion deal was the result of the Trump administration’s vaccine task force, Operation Warp Speed. The research and development of the vaccine trials themselves were carried out thanks to a $955 million federal loan from the Biomedical Advanced Research and Development Authority.
Upon Moderna’s announcement, President Donald Trump — who has yet to concede his loss in the 2020 election to President-elect Joe Biden — took credit for the findings. Trump tweeted Monday: “Another Vaccine just announced. This time by Moderna, 95% effective. For those great ‘historians’, please remember that these great discoveries, which will end the China Plague, all took place on my watch!” [Punctuation in original.]
President-elect Joe Biden took a much different tack, saying the news of a second vaccine was “further reason to feel hopeful” but remain vigilant as the virus continues to course through America for its 10th month.
“What was true with the first vaccine remains true with the second: we are still months away,” Biden said. “Until then, Americans need to continue practice social distancing and mask-wearing to get the virus under control.”
As of Monday, the novel coronavirus has been on the rise in nearly all states. Since last week alone, the number of infections in America has jumped from 10 million cases to 11 million. Hospitalization and death rates are also on a steep incline across the U.S., which has lost 246,000 lives to the novel virus so far.
That death toll could double by the end of the year if the nation continues on its current trajectory, according to new projections from the University of Washington Institute for Health Metrics. Interviewed by CNN news anchor Jake Tapper on Sunday, Dr. Fauci agreed with the university’s grim assessment.
“I think that we likely will (see the doubling of fatalities from COVID-19), Jake, if we don’t turn around this surge.”
— By Brandi Buchman, CNS