Moderna<span> Inc.</span> Chief executive Stephen Bansell said the federal government could authorize emergency use of the company's experimental Kovid-19 vaccine in December if the company received positive interim results in November from a large clinical trial.
Speaking on Monday during the Wall Street Journal’s annual Tech Live conference, Mr. Bansell said that if the study takes longer to get enough interim results, the vaccine’s governmental authority may not be in place until early next year.
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Larger US trials for two other major Kovid-19 vaccines from Johnson & Johnson and AstraZeneca PLC have been halted, while the companies investigate unexplained diseases among study subjects.
Mr Bansell’s comments suggest that Moderna’s timetable is not far from Pfizer’s, which said it expected to seek US authorization of emergency use of its vaccines by the end of November last week.
In July, Modern began a study of 30,000 people in the US to test whether the vaccine safely protects people from Kovid-19 disease, and enrollment is nearly complete.
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In the trial, half of the study subjects received the vaccine and half received a placebo, and researchers count how many symptomatic Kovid-19s receive.
The first interim analysis of the vaccine’s efficacy will occur when 53 people received symptomatic Kovid-19 in the entire study. If out of those 53 cases there are far fewer vaccinated people than disqualified people, the company can achieve enough results to seek governmental authorization of widespread use.
This first analysis is likely to be in November, but “it is difficult to predict exactly which week as it depends on the cases, the number of people who get sick,” Mr. Bansell said.
The company should monitor the safety of at least half of the study cases until two months after vaccination, before it can seek authorization for emergency use. Mr Bansell said Moderna was likely to reach that limit in late November. If Modern files for an emergency use authority soon, the Food and Drug Administration may have a few weeks to review the application before deciding in December.
If the vaccine does not demonstrate sufficient efficacy in the first interim analysis, the company will conduct a second analysis if there are 106 cases of symptomatic Kovid-19. Mr. Bansell said that would likely happen in December, which could withdraw any of the FDA’s decisions in late January or early February.
Modern coded his vaccine with the National Institute of Allergy and Infectious Diseases and began human trials in March, while also starting to produce supplements. Initial studies showed induced immune responses in study volunteers and were generally safe.
Mr. Bansell said that the company expects to produce around 20 million doses by the end of this year and produces at least 500 million doses each year. He said that it is a challenge to speed up production.
“Sometimes when you make a recipe at home, on the contrary, if you miss an ingredient, you can still decide to go ahead and make your meal, but in our case we can’t do it Are “, said Mr. Bansell. “We need all the ingredients to be on time so that there can be lots of vaccines. If a component is missing, we cannot make a vaccine. ”
Mr. Bansell said that Modern and its contract-manufacturing partner Lonja Ltd expected to produce a sufficient quantity of supplements in the US to meet US demand. He said that Lonja is manufacturing supplements in Switzerland to meet demand outside the US.
In August, Modern signed a $ 1.5 billion contract with the federal government to supply 100 million doses of its vaccines for use in the US, with the option to supply more doses.
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Mr. Benkel said that by factoring in the additional federal funding that Modern has received, the US government is paying $ 25 per dose. He said that because Modern has never made a profit, it is appropriate to make a reasonable profit, but not to make the most profit from the Kovid-19 vaccine.
Write Peter Loftus at [email protected]
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