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`16 Nov, 2020
`Pharmapeers cheer
`Moderna's unexpectedly
`strongCOVID- 19vaccine
`results
`Author
`Theme
`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'sAlbert Bourla tweeted to Moderna following
`the results,saying he was "thrilled. " GlaxoSmithKline PLC also welcomed
`the news and said multiple vaccines are needed.
` 
`Morgan Frey
`Healthcare & Pharmaceuticals
`5/16/24, 2:30 PM Pharma peers cheer Moderna's unexpectedly strong COVID-19 vaccine results | S&P Global Market Intelligence
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`Moderna 2178
`BioNTech-Pfizer v. Moderna
`IPR2023-01359
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`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
`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.
`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.
`5/16/24, 2:30 PM Pharma peers cheer Moderna's unexpectedly strong COVID-19 vaccine results | S&P Global Market Intelligence
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`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
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`5/16/24, 2:30 PM Pharma peers cheer Moderna's unexpectedly strong COVID-19 vaccine results | S&P Global Market Intelligence
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`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.
`5/16/24, 2:30 PM Pharma peers cheer Moderna's unexpectedly strong COVID-19 vaccine results | S&P Global Market Intelligence
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`"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.
`5/16/24, 2:30 PM Pharma peers cheer Moderna's unexpectedly strong COVID-19 vaccine results | S&P Global Market Intelligence
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