Chief infectious disease expert Anthony Fauci said Monday that the progression from coronavirus sequencing to Moderna’s potential vaccine in his phase three trial “is the best thing we in the United States have done.”
© The Associated Press
The Associated Press
The first injection for the Moderna vaccine in association with the National Institutes of Health was performed at 6:45 am Monday in Savannah, Georgia. The trial aims to enroll about 30,000 people from 89 widely dispersed sites in the United States over the next two months.
Fauci called it “a truly historic event in the history of vaccination” in a call with journalists. He said the emerging data from the trial should be available in November or December, and insisted that, despite the speed of development, “there is no compromise regarding safety or scientific integrity.”
It is the first possible coronavirus vaccine to enter a phase three trial in the US Phase one generally looks at a small number of people to see if the vaccine is safe. The second phase looks again at an expanded group of people to access safety and see if the vaccine works. In final phase three, the vaccine is tested on thousands of people to determine efficacy before seeking regulatory approval.
If the vaccine continues, Moderna previously said it will be able to deliver “approximately 500 million doses per year, and possibly up to a billion doses per year” starting in 2021.
The company announced earlier this month that healthy adults who received the vaccine in the phase one trial generally tolerated it well, and all created neutralizing antibodies in response.
They developed a “robust” immune response with more than half reporting mild to moderate side effects, including fatigue, chills, headache, muscle pain, and pain at the injection site, according to Moderna.
Those side effects are similar to those of many other vaccines that have been approved, Fauci said.
Three other vaccines that are part of the US government’s Operation Warp Speed are nearing their phase three trials, one from Oxford University and AstraZeneca, one from Johnson & Johnson, and one from Novavax. One from Pfizer and BioNTech that is not part of Operation Warp Speed is also expected to start its testing phase three soon.
[[[[MAP: The spread of the coronavirus]Meanwhile, the World Health Organization said on Monday that the coronavirus pandemic is the worst global health emergency the organization has seen since its regulations went into effect in 2005.
“This Thursday marks six months since WHO declared COVID-19 a public health emergency of international concern,” WHO Director-General Tedros Adhanom Ghebreyesus said at a press conference. “This is the sixth time that a global health emergency has been declared under the International Health Regulations, but it is easily the most serious.”
There are nearly 16.3 million cases of the virus and nearly 650,000 deaths worldwide, according to Johns Hopkins University. The virus shows no signs of slowing down, according to Tedros.
“And the pandemic continues to accelerate,” said Tedros. “In the past 6 weeks, the total number of cases has roughly doubled.”
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