In any discussion of the race to develop a vaccine against the new coronavirus that causes COVID-19, Modern (NASDAQ: MRNA) It will surely be mentioned Biotechnology was ranked among a select group of companies to receive significant funding as part of Operation Warp Speed, the US government program created to accelerate the development of the COVID-19 vaccine. He is undoubtedly one of the clear leaders in the development of a candidate for the COVID-19 vaccine.
But how are Moderna’s efforts behind the scenes really going? A recent Reuters report highlighted some potential problems with biotech’s COVID-19 vaccine program. Are there warning signs that investors should be concerned?
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Rookie problems?
Reuters spoke to three anonymous sources familiar with Moderna’s coronavirus vaccine project. The news agency reported several potential problems these sources attributed to “a lack of biotechnology personnel and expertise to oversee the most critical phase of human testing.” Moderna has never guided a program through advanced stage testing and has not yet obtained regulatory approval for any product.
Perhaps the most troubling issue in the Reuters report was that Moderna allegedly attempted to use a lower threshold to demonstrate the efficacy of the 1273 mRNA that the FDA wanted. Moderna’s management also reportedly rejected recommendations to closely monitor participants in their clinical trials of the COVID-19 mRNA-1273 vaccine candidate for changes in oxygen levels. One of the Reuters sources stated that Moderna viewed such monitoring as a “nuisance” that slowed down the clinical trial.
Another topic related to Moderna allegedly didn’t want to share details of its clinical trial plans with U.S. government officials and other drug makers. Reuters reported that Moderna would not allow its hired PPD investigator to reveal details of the mRNA-1273 test plans in a meeting with federal officials and leading companies developing COVID-19 vaccines.
Earlier this month, STAT News reported that the Moderna phase 3 study of the mRNA-1273 would be delayed. The company confirmed in a tweet that the study would not start as soon as originally planned. Reuters sources indicated that this delay was due to Moderna not having enough staff to complete trial protocols on time.
The other side of the story
Moderna admitted that her team did not always agree with the opinions of experts from the federal government. However, it is important to note that none of those disagreements has been a major obstacle.
Although Moderna will not begin its phase 3 study of mRNA-1273 as soon as expected, biotechnology still hopes to begin the late-stage study later this month, just a few weeks after its original plan. Modern continues side by side with AstraZeneca in clinical progress for its candidate for the COVID-19 vaccine.
The Reuters report noted that Moderna disputed at least a couple of issues. The company stated that it did not intentionally withhold information about its clinical trial plans. He told Reuters there was a “misunderstanding about the company’s presentation at the meeting” with federal officials and other drug manufacturers developing candidates for the COVID-19 vaccine.
Moderna also argued that his team has the experience necessary to conduct large-scale clinical studies. In addition, biotechnology said it “has aligned itself with the FDA’s guidance after discussions with the agency.”
The United States Department of Health and Human Services (HHS) seems to endorse Moderna’s side of the story. HHS told Reuters in a statement that the federal government’s collaboration with Moderna in developing the COVID-19 vaccine has been “extremely cooperative.”
Limits
Should investors worry about any of this? I do not think so.
One of the Reuters sources said about Moderna: “They try to test every limit.” With a global pandemic and coronavirus cases on the rise in the US, my opinion is that testing some limits is not necessarily a bad thing. And it seems that Moderna stays within limits when everything is said and done.
The biotechnology stock has shot up more than 270% so far this year. I suspect Moderna will continue to push the limits of how high it can go.
