On Tuesday, American Federal health officials accused AstraZeneca of including “outdated information” and providing misleading data in touting the effectiveness of its COVID-19 vaccine in a U.S. study.
In response AstraZeneca said, it’s working on recent findings and updated information. It also promised an update within 48 hours.
On Monday, AstraZeneca announced that its vaccine worked well in the US study. It announced that a study of 32,000 volunteers showed that vaccinated volunteers did not suffer hospitalizations and severe illness and it was 79% effective in preventing Covid-19 symptoms.
Soon after this announcement, an independent panel that supervises the study rebuked the company for outdated data, as per a senior administration official.
A statement was issued by the National Institutes of Health few hours after this announcement by AstraZeneca that says the study may have included outdated data from that trial and it may have provided incomplete view of the efficiency data.
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The NIH urged the company to “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
The panel wrote to US health leaders and AstraZeneca that it was concerned that AstraZeneca used outdated data instead of complete and recent findings as per administration official who discussed it on the condition of anonymity.
The letter goes on to say, “Decisions like this are what erode public trust in the scientific process.”
The US study was supposed to assist settle prolonged doubts about the vaccine’s effectiveness. This vaccine is used in many parts of the world along with Europe and now it is about to be used in America too.
Experts are confused by this spat and ultimately FDA will inspect data before deciding whether this vaccine can be rolled out in the USA.
“It would seem that whatever this communication misstep is, at the end of the day the data will have to stand for itself,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
The NIH’s Dr. Anthony Fauci told ABC’s “Good Morning America” that the incident “really is what you call an unforced error” and that he expects the discrepancy to be straightened out.
Fauci also said the episode shows the U.S. regulatory system is working: “The data and safety monitoring board picking up this discrepancy was an example of a safeguard.”
Every vaccine trial is supervised by DSMB that include statisticians and scientists and DSMB watches for the safety concerns.
In AstraZeneca study, some volunteers got dummy shots, while others got real vaccines and nobody knows which is which. Only DSMB can unlock the code of who got which.
Concerns about vaccine data were raised by NIH-appointed DSMB.
This vaccine is widely used in Europe and Britain, but it’s rollout was troubled by inconsistent study reports about the vaccine’s effectiveness.
Earlier, the European Union called for an Emergency Vaccine Summit after more than a dozen European nations decided to stop using the AstraZeneca COVID-19 vaccine due to serious blood clot incidents reported in many countries.
However, as reported by GreatGameIndia, the Chief Norwegian Investigator and Physician Pal Andre Holme who examined the three hospitalized health workers confirmed that it was indeed the AstraZeneca COVID-19 vaccine which caused the rare blood clots due to unexpected immune reaction.
Recently, the U.S. NIAID (National Institute of Allergy and Infectious Diseases) claimed that AstraZeneca provided incomplete and outdated efficacy data from latest COVID-19 trial.
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