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British drugmaker AstraZeneca reported on Monday that it began phase 3 trials of its experimental coronavirus vaccine in the United States, becoming the third company to begin late-phase trials of a vaccine to prevent COVID-19.
The vaccine, developed in partnership with the University of Oxford, is endorsed by the US federal government.
Rival laboratories Moderna and Pfizer / BioNTec already have Phase 3 trials underway, also with funding from the federal government.
AstraZeneca said it will "recruit up to 30,000 adults 18 years of age and older 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 SARS virus infection. -CoV-2 ».
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Participants will receive two active or placebo doses, separated by four weeks.
Phase 3 trials of the AstraZeneca vaccine are currently underway in Great Britain, Brazil and South Africa.
Trials are also planned in Japan and Russia.
The US trial is funded by the federal government's Advanced Biomedical Development Authority and the National Institute of Allergy and Infectious Diseases, part of the NIH National Institutes of Health.)
"NIH is committed to supporting multiple Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the path to recovery from this devastating pandemic," said the director of NIH, Dr. Francis Collins.
it's a statement.
"We also know that preventing this disease may require multiple vaccines and we are investing in those that we believe have the greatest potential for success."
AstraZenca says it intends to enroll more than 50,000 volunteers globally, including 30,000 in the United States, as well as participants in Latin America, Asia, Europe and Africa.
The vaccine, called by its experimental name AZD1222, combines a weakened version of a common cold virus that infects chimpanzees and a protein from the virus that causes Covid-19 to induce an immune response.
The vaccine was created by the University of Oxford before AstraZeneca was licensed for further development.
AstraZeneca said it will work with governments and other organizations to produce billions of doses and create broad and equitable access to the vaccine, once it is licensed.
"Recent supply announcements with Russia, South Korea, Japan, China, Latin America and Brazil raise global supply capacity to three billion doses of the vaccine," AstraZeneca said in a statement.
The World Health Organization on Monday warned countries not to rush to develop coronavirus vaccines and recommended extreme caution when granting emergency use authorization, a faster route to obtaining a widely used vaccine than approval. total, which can take many months.
Both China and Russia say they will begin rolling out vaccines before completing late-stage clinical trials, and US Food and Drug Administration Commissioner Dr. r.
Stephen Hahn has said that if the US gets enough data from late-stage trials, it might be possible to license a vaccine before the trials are complete.
AstraZeneca issued a statement emphasizing its commitment to science and safety.
The company also said that the vaccine will meet the strict requirements set by global regulators.
Both Moderna and Pfizer / BioNTech are still in the process of registering their stated goals of 30,000 volunteers each.
Lauren Mascarenha contributed to this story.
AstraZenecaCoronavirus Vaccine
