Written by Jahnavi Sarma |Published : March 24, 2021 9:51 AM IST
AstraZeneca has been at the centre of controversy for some time now. Many nations stopped the rollout of this vaccine after reports of blood clots. Now, US-based National Institute of Allergy and Infectious Diseases (NIAID) expressed concern on Tuesday that British-Swedish pharmaceutical major AstraZeneca may have provided outdated information on the efficacy data related to the clinical trial of its COVID-19 vaccine, which may have provided an incomplete view of the efficacy data. On Monday, the drug maker showed that its vaccine's efficacy is 79 per cent in preventing symptomatic illness in a large trial in the US. However, in an unusual statement, the independent Data and Safety Monitoring Board (DSMB), which reviewed the trial results, notified NIAID, Biomedical Advanced Research and Development Authority (BARDA), and AstraZeneca that it is concerned over the information released by AstraZeneca on the initial data from the clinical trial of its COVID-19 vaccine.
The Agency urged AstraZeneca to work with the DSMB to review the efficacy data and ensure that the most accurate, up-to-date efficacy clinical trial data is made public as quickly as possible. Authorisation and guidelines for use of the vaccine in the US will be determined by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) after a thorough review of the data by independent advisory committees.
Following the snub, AstraZeneca said that it will share primary analysis of its vaccine with the most up-to-date data, with the independent Data and Safety Monitoring Board (DSMB), which reviewed the trial results. The drug maker, which showed that its COVID-19 vaccine's efficacy is 79 per cent in preventing symptomatic illness in a large trial in the US on Monday, said that the data published were based on a pre-specified interim analysis with a data cut-off of 17 February.
In a statement, the drugmaker said that they have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. They are now completing the validation of the statistical analysis. They said that they will immediately engage with the independent data safety monitoring board (DSMB) to share the primary analysis with the most up-to-date efficacy data and also added that they intend to issue results of the primary analysis within 48 hours.
Earlier, the Phase III AstraZeneca trials in the US showed an efficacy of 80 per cent in people over the age of 65, the most vulnerable group for contracting COVID-19 with deadly consequences. Twenty per cent of the trial participants were over the age of 65. The vaccine, known by the scientific name 'AZD1222', was 100 per cent effective in preventing hospitalisation, the company had said in a statement. It means that even those who contracted COVID-19 after vaccination had only less severe symptoms and did not need intensive treatment in a hospital.
Initially, the DSMB conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST), which refers to the presence of a blood clot in the dural venous sinuses, with the assistance of an independent neurologist. The board found no increased risk of thrombosis or events characterised by thrombosis among the 21,583 participants receiving at least one dose of the vaccine. The specific search for cerebral venous sinus thrombosis found no events in this trial, AstraZeneca said, adding that vaccine efficacy was consistent across ethnicity and age.
(With inputs from IANS)
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