Unexpectedly strong results for Moderna Inc.'s coronavirus vaccine drew commendation from the CEO of pharmaceutical peer Pfizer Inc., underscoring the common goal among the industry to find a solution for a disease that has devastated economies across the world and killed more than a million people.
"Our companies share a common goal — defeating this dreaded disease — and today we congratulate everyone at Moderna and share in the joy of their encouraging results," Pfizer's Albert Bourla tweeted to Moderna following the results, saying he was "thrilled." GlaxoSmithKline PLC also welcomed the news and said multiple vaccines are needed.
The small Cambridge, Mass.-based biotech company was boosted into the spotlight when it joined big pharma competitors such as Pfizer and AstraZeneca PLC at the front of the COVID-19 vaccine race.
Results from two pivotal clinical trials have shown that tackling the spike protein on the coronavirus creates an immune response.
Source: Andriy Onufriyenko/Moment via Getty
Moderna has now found its mRNA vaccine is 94.5% effective after a first interim analysis, a figure much higher than the 74% the company needed to show the vaccine was effective at combating the virus.
The interim analysis occurred after 95 trial participants were confirmed to have COVID-19: 90 in the placebo arm of the trial and only five in the vaccine arm. None of the 11 severe cases of COVID-19 occurred in patients who received Moderna's vaccine. Preliminary safety results also found no significant serious events in trial participants.
This result is far greater than what Moderna executives anticipated during a third-quarter earnings call in October. At the time, Chief Medical Officer Tal Zaks said the company was hoping to achieve efficacy of 74% or greater at the first interim analysis.
"Months and months ago, I said I would be satisfied with a 70-75% efficacy and that something like a 95% was really aspirational. We would like to have seen it, but it was aspirational. Well, our aspirations have been met," said U.S. National Institute of Allergy and Infectious Diseases Director Anthony Fauci, whose agency co-developed the vaccine.
Shares of Moderna were trading sharply higher after the news, up 9.34% to $97.74 as of 9:46 a.m. ET on Nov. 16, from a previous close of $89.39.
"Moderna's vaccine's efficacy data exceeded expectations and could not have come at a better time," said Michael Breen, director of infectious diseases and ophthalmology at GlobalData, in a Nov. 16 statement.
Moderna will apply for an Emergency Use Authorization with the U.S. Food and Drug Administration after a final interim analysis is conducted once 151 cases of COVID-19 in the trial are confirmed. This milestone is expected in a few weeks, but Pfizer is likely to be first to file for an advanced authorization of a coronavirus vaccine in the U.S.
'Best in class'
The Moderna results come just days after Pfizer found its coronavirus vaccine was 90% effective in a late-stage clinical trial.
Morgan Stanley said the results make Moderna's candidate "best in class." The company has been developing mRNA-1273 with NIAID since January and has been part of Operation Warp Speed, but Fauci said the organization has been working with Moderna on its mRNA platform for years.
The mRNA technology used in Moderna's vaccine is similar to Pfizer's vaccine candidate. Many vaccines under development, including those by Inovio Pharmaceuticals Inc. and AstraZeneca PLC, target the SARS-CoV-2 spike protein.
"We have now shown with two vaccines that the immune response against the spike protein is a protective response," Fauci said during a press call following the Moderna results. "Although you never want to get ahead of yourself and make predictions before the results of the trial are in, conceptually this looks good and it looks like we're on firm ground for even continued positive results coming in because of the commonality of the immunogen involved."
The Moderna and Pfizer vaccines differ in one key way that could define which becomes the preferred candidate: Pfizer's vaccine has special cold storage requirements, while Moderna has found its inoculation is more stable.
In stability data released just prior to the efficacy results, Moderna showed its vaccine can last 30 days at 36 to 46 degrees Fahrenheit, the temperature of a typical refrigerator, versus the seven days the company originally thought. The vaccine is also stable for up to 6 months at -4 degrees Fahrenheit and can be held at room temperature for up to 12 hours.
"Moderna's stability data likely make it easier to widely distribute compared to Pfizer's BNT162b2, which requires cold-chain storage at -94 degrees Fahrenheit," Barclays analysts said, noting that Pfizer is working on a powdered version that could be stored at room temperature.
From concept to clinic
Morgan Stanley and GlobalData's Breen said Moderna's distribution profile will continue to differentiate mRNA-1273 from other mRNA vaccine competitors.
"Like Pfizer, the length of time from concept, to clinic, to data readouts for Moderna's vaccine — less than one year from the discovery of this novel coronavirus — is nothing short of remarkable," Breen said.
Moderna already has several manufacturing and distribution agreements with other countries including an agreement with Takeda Pharmaceutical Co. Ltd. for the production of 50 million doses for Japan and with Lonza Group Ltd. to manufacture up to 1 billion doses of the vaccine per year.
In a Nov. 16 release, the U.K. government said it expects doses of Moderna's vaccine to become available in the U.K. by spring 2021, but Moderna CEO Stéphane Bancel said he anticipates doses in Europe, including the U.K., early in the first quarter of 2021.