Moderna Inc expects the experimental coronavirus vaccine to be effective by next month.
In a call for profits on Thursday, the Cambridge, Massachusetts-based company announced that Phase III interim results are expected in November.
The company completed registration of 30,000 volunteers for the final stages with a more diverse group – including at least 5,000 who received their second of two thrusts.
Should the results be positive – and with the required two months of safety data – Moderna announced plans to immediately apply for an emergency authorization (EUA) from the US Food and Drug Administration (FDA).
"We plan to file an EUA application in the US for our experimental COVID-19 vaccine based on positive efficacy," said Stephane Bancel, CEO of the biotech giant.
Moderna Inc is anticipating the interim results of the Phase III of its coronavirus vaccine study in November and, if the results are positive, will apply to the FDA immediately for emergency approval. Pictured: Volunteers receive the Moderna vaccine at the Henry Ford Health System in Detroit on Aug. 5
The company is also preparing for a global launch and has received $ 1.1 billion in deposits from governments around the world. Pictured: Atlanta-based Norman Hulme (65) (left) prepares to have a blood drawn as part of the trial of Moderna at Emory University's Hope Clinic in Atlanta in May 2020
The countries with treaties already include the USA, Canada, Japan, Switzerland, Israel and Qatar. Talks are currently underway with the European Union. Pictured: A sign marks Moderna's headquarters in Cambridge, Massachusetts, May 2020
Moderna added that it is preparing to launch its vaccination worldwide and has already received $ 1.1 billion in deposits from governments around the world.
In August, the federal government signed a $ 1.5 billion contract with Moderna ordering 100 million cans for the US – enough for 50 million people.
The contract with the Trump administration has the option to purchase one an additional 400 million cans.
Japan has signed a 50 million can contract and Canada's contact is calling for 20 million cans with an option for an additional 36 million cans.
Moderna also has agreements with Switzerland, Israel and Qatar and is in "advanced talks" with the European Union delivers between 80 and 160 million cans.
The vaccine is expected to cost anywhere from $ 32 to $ 37 per dose for smaller orders, but will give the US a discount by valuating the initial 100 million doses at $ 25 each.
The biotech company is currently in talks with the COVAX initiative to develop a tiered pricing plan for its vaccine called mRNA-1273.
"We are actively preparing for the launch of mRNA-1273 and have signed a number of supply agreements with governments around the world," said Bancel.
"Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273."
Another Moderna official added, "From a distribution standpoint, we are ready."
In September, the company announced it would slow enrollment to recruit more minorities such as blacks, Hispanics and Indians after falling short.
Now the drug company says that 37 percent of all participants are black, 20 percent are Hispanic, 10 percent are black, four percent are Asian, and three percent represent all other groups.
Additionally, 42 percent of volunteers are people at high risk of getting seriously ill from COVID-19, either because they are over 65 or have underlying medical conditions.
In the call for results, Moderna said the three most common pre-existing conditions are diabetes, obesity and heart disease.
Moderna's vaccine was developed in collaboration with the National Institutes of Health.
It uses part of the pathogen's genetic code called messenger RNA or mRNA to trick the body into recognizing the coronavirus and attacking it when a person becomes infected.
The candidate fools the body into producing some of the viral proteins that the immune system then recognizes and builds a defense against.
Early clinical data showed that people who received the vaccine had higher levels of antibodies than COVID-19 survivors.
For the study, one group will receive the vaccine and another group will receive the placebo.
The researchers will then wait for 53 participants to contract the virus and develop symptoms.
If the number of people infected is significantly higher in the placebo group, the sting is considered effective.
However, if the first analysis doesn't show the vaccine's effectiveness, a second analysis will be done and the researchers will wait for 106 people to become infected with COVID-19.
Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, says it is currently unclear when a COVID-19 vaccine will be available.
"Sometime in December, companies with enough data and safety committees will review the results," he said during a question and answer hosted Wednesday by the Journal of the American Medical Association.
He added that the first green light of a vaccine could be January, could be later. We do not know it. & # 39;
(tagsToTranslate) Dailymail (t) Gesundheit (t) Coronavirus