United States (US) federal health officials said Tuesday morning the results of the US trial of AstraZeneca’s COVID-19 vaccine may use “outdated information.”
The Data and Safety Monitoring Board said in a statement that it is concerned that AstraZeneca may provide an incomplete view of its vaccine efficacy data.
Associated Press reported AstraZeneca reported on Monday (22/3) that its COVID-19 vaccine provides strong protection against adults of all ages in a long-awaited US study. The findings could help rebuild public confidence in the AstraZeneca vaccine around the world and take a step towards getting licensed for use in the US.
In a study of 30,000 people, the vaccine was 79 percent effective in preventing cases of COVID-19 with symptoms – including in the elderly. None of the volunteers became seriously ill or hospitalized after being vaccinated, compared to five similar cases in participants who received dummy injections – a small number, but consistent with findings from the UK and other countries that the vaccine protects against the most severe disease.
AstraZeneca also said the study’s independent safety monitors found no serious side effects, including no increased risk of blood clots as identified in Europe. The case sparked fears that prompted many countries to briefly halt use of the vaccine last week.
The company is targeting to submit a proposal to the US Food and Drug Administration (Food and Drug Administration/ FDA) in the coming weeks. The government’s independent advisers will publicly debate the evidence before the agency makes a decision.
Authorizations and guidelines for vaccine use in the US will be determined by the FDA and the Centers for Disease Control and Prevention (Centers for Disease Control and Prevention/ CDC) after a thorough data review by an independent advisory committee. [ah/au/ft]
–
– .
