Studies have shown that the drug has an effective rate of 79%
Washington— Federal health authorities in the United States questioned the results of trials using AstraZeneca and Oxford vaccines in the country, which showed that the drug has an effective rate of 79%.
According to the United States, the data for the test was conducted on more than 30,000 volunteers and may have “outdated information”, “may not provide a complete picture of valid data.
The National Institute of Allergy and Infectious Diseases (NIAID) said in an unusual statement issued at midnight that the Data and Safety Oversight Board (DSMB) “expressed concern about whether AstraZeneca can include outdated information in the trial. Incomplete information may be provided. Picture of validity data.
In this regard, NIH urges pharmacists to check efficacy data to ensure its accuracy and update it as soon as possible.
The text states: “We urge the company to review the effectiveness data with DSMB and ensure that the most accurate and up-to-date effectiveness data is released as soon as possible.”
AstraZeneca reported on Monday that its Covid-19 vaccine provided strong protection for adults of all ages in a prospective study conducted in the United States.
This discovery may help rebuild public confidence in the drug and bring it closer to the approval of the American League.
In a trial of 30,000 people, the vaccine was 79% effective in preventing Covid-19 symptoms, including the elderly.
There were no serious cases or hospitalizations among the vaccinated volunteers, compared to 5 of the participants who received a placebo.
This number is small, but consistent with results in the United Kingdom and other countries, indicating that the vaccine can prevent the most serious effects of the disease.
AstraZeneca also said that independent safety observers found no or no serious side effects, especially the increased risk of blood clots as in Europe, prompting many countries to temporarily suspend vaccination last week.
Faced with this setback in the United States, a spokesperson for the pharmaceutical company said today that the company is “investigating” it.
The company also expects to file an application with the U.S. Food and Drug Administration (FDA) in the next few weeks, and the government’s external consultants will openly debate the test before making a decision on the agency.
After extensive analysis of the data by an independent advisory committee, the FDA and the Centers for Disease Control will be responsible for the use of the vaccine in the United States, authorization and recommendations.