A man adjusts the face mask of a child to protect from and prevent the spread of Coronavirus as they together move down the street in New York City on Monday. Photo by John Angelillo/UPI |
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Aug. 31 (UPI) -- Multinational pharmaceutical company AstraZeneca announced it has started Phase III clinical trials in the United States of its COVID-19 candidate vaccine as the World Health Organization warned against prematurely approving drugs to fight the pandemic.
The company said in a statement Monday that it will enroll up to 30,000 adults in the United States to assess the safety, efficacy and immunogenicity of its candidate coronavirus prevention drug, AZD1222, which it co-invented with Britain's Oxford University.
The U.S. trial centers are recruiting the tens of thousands of participants "from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from SARS-CoV-2 virus," AstraZeneca said, referring to COVID-19 by its technical name.
Participates in the trial will receive two doses of either the candidate vaccine or a placebo saline control separated by four weeks and while all will be assessed for the drug's safety and efficacy a subset of 3,000 volunteers will be checked for local and systemic reactions and immune responses, it said.
The company is also continuing with late-stage clinical trials in Britain, Brazil and South Africa with further trials planned to begin for Japan and Russia.
"These trials, together with the U.S. Phase III clinical trial, will enroll up to 50,000 participants globally," the press release said.
Results from the late-stage trial are expected later this year.
The announcement came as the World Health Organization's Dr. Soumya Swaminathan warned that authorizing a vaccine prematurely could hamper research and introduce a drug to the public that doesn't work.
"What is going to be really important, I think, is to make decisions based on science, and have a scientific group that's constituted, that's above all conflicts of interests, that's not influenced by any interests, that looks at the data and makes a recommendation on whether and when a vaccine should be licensed for use," she said Monday during a WHO briefing on the coronavirus.
The risks of releasing an understudied vaccine, she said, are not only limited to producing a drug that doesn't protect against COVID-19 but that it could be unsafe.
AstraZeneca released a second statement on Monday reiterating its core values as to "follow the science" and "put patients first."
"At the heart of AstraZeneca's core values is to 'follow the science' and adhere to the highest scientific and clinical standards, making the safety and efficacy of the vaccine of paramount importance," it said. "The company's submissions for market authorization will meet the stringent requirements established by regulators everywhere around the world."
At least two other companies -- Moderna and Pfizer/BioNtech -- have vaccine candidates in late state trials.
