Moderna Begins First U.S. Late-Stage Vaccine Trial

0
125


Earlier tests of Moderna’s vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.

In a statement, Dr. Collins said, “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people.” He said that despite the unprecedented speed in bringing this experimental vaccine to human testing, “the most stringent safety measures” were being maintained.

Moderna said in a statement that it would be able to deliver about 500 million doses a year, and possibly up to a billion doses per year, starting in 2021. The Massachusetts-based company, which has received nearly $1 billion dollars from the federal government to develop a coronavirus vaccine, has said it will not sell the vaccine at cost, but for profit.

Moderna has not said what it will charge. “We will price it responsibly during the pandemic, to make sure it is broadly accessible,” a spokesman, Ray Jordan, said in an email. The company may change the price later, when the virus becomes endemic, “but that is not something we have settled at this time,” Mr. Jordan said.

Moderna shares were up 8 percent at $79 in midday trading on Monday.

The company’s vaccine uses a synthetic version of genetic material from part of the coronavirus, encased in tiny particles made of fat that help it get into human cells. The genetic material, called messenger RNA or mRNA, then prompts the cells to churn out a tiny piece of the virus, which the immune system sees as foreign and learns to recognize. If the person is later exposed to the real virus, the immune system will attack it.

Messenger RNA has not yet produced any approved vaccines, but other companies have also invested in the approach, because of its potential to produce vaccine quickly. The government announced last week that it had reached a $1.95 billion deal to buy 100 million doses of an mRNA vaccine made by Pfizer, in partnership with the German company BioNTech, by the year’s end. That vaccine is also expected to begin Phase 3 trials soon, and the government will buy it only if the trial proves it safe and effective. CureVac and Sanofi are also working on mRNA vaccines.



Source : Nytimes