US AZ Vaccine Review Begins... "Approval Possible in April"

FDA Reviewing Phase 3 Clinical Data... Expected to Take 3 Weeks
NIH Director: "Thrombotic Side Effects May Be Unrelated to Vaccine"

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] As more countries in Europe temporarily suspend AstraZeneca vaccine administration due to concerns over blood clot side effects, U.S. health authorities have begun reviewing data for the emergency use authorization of the vaccine, major foreign media reported on the 15th (local time).

Francis Collins, Director of the U.S. National Institutes of Health (NIH), stated, "The Food and Drug Administration (FDA) is currently reviewing clinical trial data of the AstraZeneca vaccine conducted in the U.S. An independent monitoring body is conducting the review, and if the results are positive, the FDA may grant emergency use authorization in April."

Collins further explained, "It takes about three weeks for the FDA to analyze the clinical data, after which an advisory committee composed of experts will hold a final vote on whether to approve the vaccine."

According to FDA regulations, approval for vaccine use requires clinical trial results involving at least 30,000 participants. The AstraZeneca clinical trial currently under review in the U.S. reportedly involved approximately 32,000 participants.

An AstraZeneca spokesperson said in a statement that day, "The results of the Phase 3 clinical trial conducted in the U.S. will be released soon," adding, "We plan to apply for emergency use authorization from U.S. authorities as soon as the results are available."

Earlier, as cases of blood clot side effects from the AstraZeneca vaccine continued, Germany, France, Italy, and Spain decided to temporarily suspend AstraZeneca vaccine administration on the same day. This brings the total number of countries temporarily halting vaccinations to 19.

Director Collins emphasized that the link between the AstraZeneca vaccine and blood clots is "not clear." He noted, "(The blood clots) may be a hypersensitive reaction unrelated to the vaccine itself," showing a cautious stance regarding the vaccine side effect controversy.

The World Health Organization (WHO) also stated that there is no established causal relationship between the AstraZeneca vaccine and blood clots and that there is no reason to stop using the AstraZeneca vaccine.

The European Medicines Agency (EMA) is scheduled to announce the safety evaluation results of the AstraZeneca vaccine on the 18th.

So far, U.S. health authorities have approved three COVID-19 vaccines for use: Pfizer, Moderna, and Johnson & Johnson.

This content was produced with the assistance of AI translation services.