FDA to come up with new guidance on use of AstraZeneca vaccines this week


The Food and Drug Administration (FDA) is expected to come up this week with a “new guidance”  for the resumption of the use of AstraZeneca coronavirus disease (COVID-19) vaccines.

(Photo by Christof STACHE / AFP)

FDA Director General Eric Domingo said this in a radio interview Sunday, April 11.

"The National Adverse Events Following Immunization Committee already had their emergency meeting. The Vaccine Experts Panel is already set to submit their recommendations. The World Health Organization has also sent their recommendations. We just need to merge everything and come out with the guidance," he said.

"We will not stop using it. We will just have a new guidance so that we will know how to better use it," added Domingo.

Last week, the Department of Health (DOH) adopted the recommendation of the FDA to temporarily suspend the use of AstraZeneca vaccines for individuals aged below 60 years old, following recent reports of rare cases of blood clots with low platelets detected in some individuals inoculated with the vaccine.

“We are aware of the recommendation of the European Medicines Agency (EMA) to list blood clots as very rare side effects of the AstraZeneca vaccine. While we have not seen such incidents in the country, the FDA has recommended to temporarily suspend the use of the vaccine for persons below 60 years old as we await results of the review being done by our local experts, as well as the official guidance of the WHO,” Domingo said.

The DOH and FDA assured the public that experts are carefully reviewing information pertinent to this new development in order to craft appropriate recommendations on the vaccine’s use. 

“I want to emphasize that this temporary suspension does mot mean that the vaccine is unsafe or ineffective—it just means that we are taking precautionary measures to ensure the safety of every Filipino. We continue to underscore that the benefits of vaccination continue to outweigh the risks and we urge everyone to get vaccinated when it's their turn,” he added.