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FDA tables AZ jab but insists it is still safe

Republika

Amid reports of blood clots after inoculation in Europe, the Philippine Food and Drug Administration recently recommended the Department of Health to temporarily discontinue use of the AstraZeneca vaccine to people below 60.


This “temporary suspension”, according to FDA director general Eric Domingo, was merely a precautionary measure to “ensure safety of every Filipino.”


Meanwhile, presidential adviser for entrepreneurship Joey Concepcion appealed to Filipinos to focus on the benefits of the jab, instead of blood clotting reports.


Some 525,600 individuals have received the AstraZeneca shot, and the adviser pointed out that “if there are any extreme adverse effects, we should know it by now.”


In a statement, AstraZeneca said: “Patient safety remains to be the highest priority for AstraZeneca. Tens of millions of people have now received our vaccine across the globe. The extensive body of data from two large clinical datasets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.”


It added: “We will continue to work with the Philippine Food and Drug Administration to answer any questions they may have.”


European Union drug regulator, European Medicines Agency, likewise echoed that these shots are still safe and added that blood clotting events are “very rare.”


There were no risk factors, including age, which had been found to be associated with blood clotting, leading the EMA to declare that there was no causal link between the vaccines and the blood clots.


“A plausible explanation for these rare side effects is an immune response to the vaccine,” said EMA chief Emer Cooke.


The 2.6 million doses procured by a first batch of donors is slated to arrive by next month or in June, while the second batch, consisting of 14.5 million doses donated by the private sector and local government units, are to arrive in the third or fourth quarter.


Meanwhile, the FDA has approved Sinovac for the elderly. To date, it has been given to more than 700 HCWs over 60, with no reported severe side effects. Although the Chinese vaccine’s efficacy rate stands at somewhere between 51 to 52%, it falls under the acceptable rate under World Health Organization standards.


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