Leading infectious disease expert Anthony Fauci said on Monday that the progression from sequencing the coronavirus to getting Moderna’s potential vaccine into its phase three trial “is the best we, in the United States, have ever done.”
The first injection for Moderna’s vaccine in partnership with the National Institutes of Health happened at 6:45 a.m. on Monday in Savannah, Georgia. The trial aims to enroll about 30,000 people from 89 widely dispersed sites across the U.S. over the next couple of months.
Fauci called it a “truly historic event in the history of vaccinology” on a call with reporters. He said that emerging data from the trial should be available in November or December, and insisted that despite the speed of the development, “there is no compromise at all with regard to safety or scientific integrity.”
It is the first possible coronavirus vaccine to enter a phase three trial in the U.S. Phase one typically looks at a small number of people to see if the vaccine is safe. Phase two looks at an expanded group of people again to access safety and to see if the vaccine works. In the final phase three, the vaccine is tested in thousands of people to determine efficacy before seeking regulatory approval.
If the vaccine remains on track, Moderna previously said it will be able to deliver “approximately 500 million doses per year, and possibly up to 1 billion doses per year” starting in 2021.
The company announced earlier this month that healthy adults who were given the vaccine in the phase one trial tolerated it generally 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 ones from many other vaccines that have been approved, Fauci said.
Three other vaccines that are a part of the U.S. government’s Operation Warp Speed are nearing their phase three trials – one by the University of Oxford and AstraZeneca, one by Johnson & Johnson and another by Novavax. One from Pfizer and BioNTech that is not a part of Operation Warp Speed is also expected to start its phase three trial soon.[MAP: The Spread of Coronavirus]
Meanwhile, the World Health Organization on Monday said that the coronavirus pandemic is the worst global health emergency the organization has seen since its regulations came into force 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 a global health emergency has been declared under the International Health Regulations, but it is easily the most severe.”
There are nearly 16.3 million cases of the virus and close to 650,000 deaths worldwide, according to Johns Hopkins University. The virus is not showing signs of slowing, according to Tedros.
“And the pandemic continues to accelerate,” Tedros said. “In the past 6 weeks, the total number of cases has roughly doubled.”
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