AstraZeneca expecting FDA approval soon, despite reported death

AstraZeneca found out to be only vaccine causes seven deaths, result and true cause yet to be known


COVID-19 Vaccine safe or not arguably becomes hot topic since the UK confirmed seven death due jab of Astrazeneca, resulted in blood clotting. The U.K.’s Medicines and Healthcare Products Regulatory Agency said Saturday that of 30 cases of clotting and low blood platelets identified in people in the U.K. who had received the shot through March 24, seven had died. More than 18 million doses have been administered in the country and the regulator insists the shot is safe.

Earlier this week, the EU drugs regulator said a link between the AstraZeneca vaccine and a rare type of blood clot is possible, identifying at least 62 cases of the condition. The European Medicines Agency said its safety committee will probably issue an updated recommendation next week.

Although more research is needed to examine possible links, “the key thing to remember is how rare these brain clots are, and how powerful the proven benefit of vaccination is against Covid,” said David Werring, professor of clinical neurology at University College London’s Institute of Neurology.

It has not yet been approved in the U.S. because the Food and Drug Administration (FDA) asked the company to provide results from a large-scale trial, Umair Irfan reports for Vox. Experts have expected the data to show that the vaccine is safe and effective but worry how AstraZeneca’s recent hurdles might impact its reputation around the world.

“The benefits of Covid-19 Vaccine AstraZeneca in preventing Covid-19 infection and its complications continue to outweigh any risks and the public should continue to get their vaccine when invited to do so,” June Raine, the MHRA chief executive, said Saturday in an emailed statement.

The AstraZeneca vaccine may not have a large role in vaccinating people in the United States because the three companies already approved to supply vaccines in the country agreed to provide enough doses for anyone who wants one this year. But AstraZeneca is participating in the COVAX program to provide doses in low and middle-income countries for no profit, and FDA approval is a global gold standard for the safety of medications. “At the end of the day, the FDA looks at the data, not the press releases,” says the FDA’s former chief scientist Jesse Goodman to Vox. “Looking at that data and doing their analysis is what’s going to determine whether this vaccine gets an [emergency use authorization], whether the benefits outweigh the risk.”