US Agency Questions AstraZeneca's Vaccine Data
2021-03-24
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1A United States health agency said Tuesday that drug-maker AstraZeneca might have included "outdated information" on its latest U.S. vaccine test.
2The action again raised questions about the approval of the company's COVID-19 vaccine in the United States.
3The unusual statement was released by the National Institute of Allergy and Infectious Diseases (NIAID) early on Tuesday.
4The health agency said independent experts "expressed concern that AstraZeneca might have included outdated information from that trial, which may have provided an incomplete view of the efficacy data."
5Earlier on Monday, the British-Swiss drug maker announced that its vaccine was 79 percent effective against COVID-19.
6The company added its shot was 100 percent effective against severe disease and hospitalization.
7Following the U.S. health agency's statement, AstraZeneca said Tuesday that those numbers included information from its U.S. drug trial up to February 17.
8The company said it will provide an update within 48 hours to the Data and Safety Monitoring Board (DSMB).
9The safety board is a committee of independent scientists organized by the NIAID to study drug trials and their safety in the U.S.
10The NIAID is headed by Dr. Anthony Fauci who was recently named "chief medical advisor" by U.S. President Joe Biden.
11Fauci told Statnews, "We felt we could not remain silent."
12He added: "In my mind, it's an unforced error by the company."
13Dr. Paul Hunter is a professor of medicine at the University of East Anglia.
14He told the Associated Press, "I doubt it was (U.S. officials') intention to deliberately undermine trust in the AstraZeneca vaccine."
15Hunter added, "But this will likely cause more vaccine hesitancy."
16Early in the pandemic, the AstraZeneca vaccine, developed with Britain's University of Oxford, was considered a leading candidate against the coronavirus.
17It costs much less than other vaccines.
18It also does not require extreme cold storage, making it easier to use in countries with limited resources.
19Volunteers in the early study from Britain, Brazil and South Africa produced antibodies to protect against the virus with no serious side effects.
20The company then expanded the drug trials to the United States.
21It also signed agreements to provide the vaccine at cost to nations around the world, including the United Nations COVAX program, to help poor countries.
22Last year, the company temporarily suspended the trials in September after a volunteer in Britain developed inflammation in her spine.
23It was later found to be unrelated to the vaccine but led to a long delay in the United States.
24In November, AstraZeneca and the University of Oxford reported unclear results from two different vaccine treatments in the British drug trial.
25Some volunteers received a half dose and some received a full dose.
26AstraZeneca later reported that it was a result of manufacturing problems.
27The action left many to question whether the shot was safe and effective.
28John Moore is a professor at Weill Cornell Medical College in New York.
29He told Reuters at the time, "When you get corporate and academic scientists saying different things, it doesn't give you the impression of confidence in what they're doing."
30Last week, more than 12 countries, mostly in Europe, stopped using the vaccine after reports it was linked to blood system blockages, known as blood clots.
31On Thursday, the European Medicines Agency said its investigation found the vaccine did not raise the risk of blood clots, other than very rare cases.
32AstraZeneca said Monday it would provide information to the U.S. Food and Drug Administration (FDA) in the coming weeks to apply for emergency use permission.
33Jimmy Whitworth is a professor of international public health at the London School of Hygiene and Tropical Medicine.
34He told the Associated Press, "If the U.S. regulator looks at this data and authorizes AstraZeneca, that will carry a lot of weight."
35I'm Jonathan Evans.
1A United States health agency said Tuesday that drug-maker AstraZeneca might have included "outdated information" on its latest U.S. vaccine test. The action again raised questions about the approval of the company's COVID-19 vaccine in the United States. 2The unusual statement was released by the National Institute of Allergy and Infectious Diseases (NIAID) early on Tuesday. The health agency said independent experts "expressed concern that AstraZeneca might have included outdated information from that trial, which may have provided an incomplete view of the efficacy data." 3Earlier on Monday, the British-Swiss drug maker announced that its vaccine was 79 percent effective against COVID-19. The company added its shot was 100 percent effective against severe disease and hospitalization. 4Following the U.S. health agency's statement, AstraZeneca said Tuesday that those numbers included information from its U.S. drug trial up to February 17. The company said it will provide an update within 48 hours to the Data and Safety Monitoring Board (DSMB). 5The safety board is a committee of independent scientists organized by the NIAID to study drug trials and their safety in the U.S. The NIAID is headed by Dr. Anthony Fauci who was recently named "chief medical advisor" by U.S. President Joe Biden. 6Fauci told Statnews, "We felt we could not remain silent." He added: "In my mind, it's an unforced error by the company." 7Dr. Paul Hunter is a professor of medicine at the University of East Anglia. He told the Associated Press, "I doubt it was (U.S. officials') intention to deliberately undermine trust in the AstraZeneca vaccine." Hunter added, "But this will likely cause more vaccine hesitancy." 8Trouble from the start 9Early in the pandemic, the AstraZeneca vaccine, developed with Britain's University of Oxford, was considered a leading candidate against the coronavirus. It costs much less than other vaccines. It also does not require extreme cold storage, making it easier to use in countries with limited resources. 10Volunteers in the early study from Britain, Brazil and South Africa produced antibodies to protect against the virus with no serious side effects. The company then expanded the drug trials to the United States. It also signed agreements to provide the vaccine at cost to nations around the world, including the United Nations COVAX program, to help poor countries. 11Last year, the company temporarily suspended the trials in September after a volunteer in Britain developed inflammation in her spine. It was later found to be unrelated to the vaccine but led to a long delay in the United States. 12In November, AstraZeneca and the University of Oxford reported unclear results from two different vaccine treatments in the British drug trial. Some volunteers received a half dose and some received a full dose. AstraZeneca later reported that it was a result of manufacturing problems. 13The action left many to question whether the shot was safe and effective. John Moore is a professor at Weill Cornell Medical College in New York. He told Reuters at the time, "When you get corporate and academic scientists saying different things, it doesn't give you the impression of confidence in what they're doing." 14Last week, more than 12 countries, mostly in Europe, stopped using the vaccine after reports it was linked to blood system blockages, known as blood clots. On Thursday, the European Medicines Agency said its investigation found the vaccine did not raise the risk of blood clots, other than very rare cases. 15AstraZeneca said Monday it would provide information to the U.S. Food and Drug Administration (FDA) in the coming weeks to apply for emergency use permission. 16Jimmy Whitworth is a professor of international public health at the London School of Hygiene and Tropical Medicine. He told the Associated Press, "If the U.S. regulator looks at this data and authorizes AstraZeneca, that will carry a lot of weight." 17I'm Jonathan Evans. 18Hai Do wrote this report for VOA Learning English. Mario Ritter Jr. was the editor. 19_______________________________________________________________ 20Words in This Story 21efficacy -n. the power to produce the desired result or effect 22intention -n. the thing that you plan to do; the goal or aim of some action 23deliberately -adv. done in a way that is meant or planned 24hesitancy -n. slow to act or speak especially because of being unsure 25inflammation -n. a condition when part of the body becomes red, bigger and more sensitive 26dose -n. the amount of a medicine or vaccine that is taken at one time 27impression -n. the effect or influence that something or someone has on a person's thoughts or feelings 28confidence -n. a feeling of being sure that something is true or will happen in an expected way 29authorize -v. to give legal or official approval 30We want to hear from you. Write to us in the Comments section, and visit our Facebook page.