The US National Institute of Allergy and Infectious Diseases (NIAID) on Tuesday, 23 March, said that AstraZeneca may have given out outdated information about its COVID-19 vaccine trial.
The Data and Safety Monitoring Board, which is responsible for ensuring the safety and accuracy of the vaccine trial, expressed their concern that AstraZeneca may have included outdated information from that vaccine trial, which may have provided an “incomplete view’’ of the efficacy of the shot.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” National Institute for Allergy and Infectious Diseases said in their statement.
“Authorisation and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees,” the statement further said.
Meanwhile, AstraZeneca on Tuesday said that it will release more data on US COVID-19 vaccine trials "within 48 hours".
AstraZeneca Vaccine Found to Have 79 Percent Efficacy in US Trial
The unusual statement from the US agency comes as a major setback to AstraZeneca, who, on Monday, said that its vaccine was found 79 percent effective in preventing COVID-19 in a large US clinical trial.
The company said that the vaccine was well tolerated in the US trial, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine.
The DSMB, with the assistance of an independent neurologist, conducted a specific review of thrombotic events, as well as cerebral venous sinus thrombosis (CVST) which refers to presence of a blood clot in the dural venous sinuses.
No increased risk of thrombosis or events characterised by thrombosis were found among the 21,583 participants receiving at least one dose of the vaccine.
The company also added that there were no cases of cerebral venous sinus thrombosis found in the trial.
Reports of Blood Clotting in Some Vaccine Recipients
AstraZeneca also recently found itself in the midst of controversy after reports of blood clotting in some vaccine recipients surfaced, with Norway, Denmark and some other European countries suspending the use of the Oxford-AstraZeneca COVID-19 vaccine.
There were also reports that a 50-year-old man had died in Italy after developing deep vein thrombosis (DVT) following a dose of the jab.
However, the EU's medicines regulator later said that there is no indication that the vaccine is linked to an increased risk of blood clots. It also said that the number of cases in vaccinated people was no higher than in the general population.
“There is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine. The vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered while investigation of cases of thromboembolic events is ongoing,” the European Medicines Agency (EMA) said.
Several European nations then said that they would resume vaccinations with the AstraZeneca shot after the agency cleared the vaccine, saying that it is “safe and effective" and not linked with a higher blood clot risk.