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Oct. 19, 2020, 11:49 p.m. EDT

Moderna CEO eyes December for COVID vaccine

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By Peter Loftus

Moderna Inc. Chief Executive Stéphane Bancel said the federal government could authorize emergency use of the company's experimental Covid-19 vaccine in December, if the company gets positive interim results in November from a large clinical trial.

Mr. Bancel, speaking during The Wall Street Journal's annual Tech Live conference Monday, said sufficient interim results from the study takes longer to get, government authorization of the vaccine may not occur until early next year.

Cambridge, Mass.,-based Moderna has one of the leading Covid-19 vaccines in development, along with a vaccine co-developed by Pfizer Inc. and BioNTech SE. Large U.S. trials for two other leading Covid-19 vaccines, from Johnson & Johnson and AstraZeneca PLC, have been paused, while the companies investigate unexplained illnesses among study subjects.

Mr. Bancel's comments suggest Moderna's timetable isn't far off from Pfizer's, which said last week it expects to seek U.S. authorization of emergency use of its vaccine by late November.

In July, Moderna started a 30,000-person study in the U.S. to test whether the vaccine safely protects people from symptomatic Covid-19 disease, and enrollment is nearly complete.

In the trial, half of the study subjects receive the vaccine and half receive a placebo, and researchers then count how many get symptomatic Covid-19.

The first interim analysis of the vaccine's efficacy will happen when 53 people in the entire study get symptomatic Covid-19. If there are significantly fewer vaccinated people than unvaccinated people among those 53 cases, the company may deem the results sufficient to seek government authorization of wider use.

That first analysis is likely to occur in November, but "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick," Mr. Bancel said.

The company also must monitor the safety of at least half of the study subjects for two months after vaccination before it can seek an authorization for emergency use. Mr. Bancel said Moderna was likely to reach that threshold in late November. If Moderna files for an emergency use authorization soon after, the Food and Drug Administration may take a few weeks to review the application before deciding in December.

If the vaccine doesn't demonstrate sufficient efficacy at the first interim analysis, the company will conduct a second analysis when 106 cases of symptomatic Covid-19 occur. Mr. Bancel said that would likely happen in December, which could push back any FDA decision to late January or early February.

Moderna codesigned its vaccine with the National Institute of Allergy and Infectious Diseases and began human testing in March while also starting to expand production of doses. Initial studies showed it induced immune responses in study volunteers and was generally safe.

Mr. Bancel said Monday the company continues to expect to produce about 20 million doses by the end of this year and at least 500 million doses next year. He said ramping up production is a challenge.

"Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal, but in our case we cannot do that," Mr. Bancel said. "We need all the ingredients to be there on time to be able to make a lot of vaccine. If one ingredient is missing, we cannot make a vaccine."

Mr. Bancel said Moderna and its contract-manufacturing partner Lonza Ltd. expect to produce enough doses in the U.S. to meet U.S. demand. Lonza also is manufacturing doses in Switzerland to meet demand outside the U.S., he said.

In August, Moderna signed a $1.5 billion contract with the federal government to supply 100 million doses of its vaccine for use in the U.S., with an option to supply more doses.

Factoring in additional federal funding that Moderna has received, the U.S. government is paying $25 per dose, Mr. Bancel said Monday. He said that because Moderna has never turned a profit, it is appropriate to make a reasonable profit but not to maximize profit from a Covid-19 vaccine.

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