The vaccines that could stop Covid-19

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No mRNA vaccine for any disease has yet won approval, but the technique has tantalized public health experts because churning out doses using this technology would be cheaper and easier than making traditional vaccines. The U.S. government’s Biomedical Advanced Research and Development Authority has pledged up to $483 million to accelerate the Moderna vaccine’s path to FDA approval. BARDA in July added another $472 million to that initial investment.

Scientists at the Kaiser Permanente Washington Health Research Institute in Seattle and Emory University in Atlanta began a 45-person Phase I safety trial in March. Nearly all showed an immune response to the vaccine without major side effects, according to results published in July in the New England Journal of Medicine. Participants, who received two shots of the experimental vaccine approximately one month apart, will be followed for about a year.

The company won “fast track” designation from the FDA to speed its development and began a Phase II trial aimed at determining whether the vaccine works. Six hundred participants have received either a 50 or 100 microgram dose of the vaccine or a placebo.

A Phase III trial began on July 27, and is expected to include about 30,000 participants in the U.S. The aim is to prevent symptomatic Covid-19. Trial participants will receive two vaccine doses 29 days apart. Beginning 14 days after the second dose, the company will evaluate how many people have developed Covid-19. Moderna said the enrollment for the trial is likely to be completed in September. If the early data is promising, the company says it could churn out enough doses by fall to vaccinate health care workers and other priority groups, and then 500 million doses per year beginning in 2021.

Government dose purchases: The U.S. agreed to purchase 100 million doses for $1.5 billion (but if the vaccine comes after January 31, 2021, Moderna loses $300,000), with an option to acquire 400 million more. When manufacturing begins for Moderna, they will receive $600 million of the government funds, according to an SEC filing.

The Canadian government said in early August that it was striking a deal with the company for shots, without disclosing the value of the agreement or the number of doses involved. Switzerland also announced an agreement in August for 4.5 million doses to vaccinate 2.25 million citizens, since it is expected that two doses will be needed. Moderna said in August that for some smaller volume agreements, it has sold its vaccine at $32-37 per dose. It has received approximately $400 million in deposits for vaccine doses, it said in August.



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