South Korea’s food and drug ministry said on Tuesday it had begun a preliminary review of a COVID-19 vaccine being developed by AstraZeneca PLC for potential fast-track approval. The Ministry of Food and Drug Safety said in a statement that it had formed a screening team to review the vaccine candidate, with an application for formal approval expected in 90 days under its rapid approval program for COVID-19 treatments and vaccines.
The team is reviewing the vaccine’s non-clinical test data, the ministry said. The ministry added that it had given a green light to some 26 clinical trials for COVID-19 treatments and vaccines as of Monday, by entities such as pharmaceutical companies Celltrion Inc and Genexine Inc, with seven completed and 19 ongoing.
Doctors Question FDA Approval of Gilead’s COVID-19 Treatment and Say it has Limited Benefits
The Food and Drug Administration’s decision to grant a full approval to Gilead Sciences Inc.’s remdesivir is raising questions about the broader value of a drug that has been praised for being “first” but may only provide limited clinical benefits. It’s the first COVID-19 treatment to receive an FDA approval during the pandemic.
“The balance of the data shows that it is providing a benefit,” Dr. Scott Gottlieb, a former FDA commissioner, told Squawk Box Friday morning. “We have to be comfortable with singles and doubles when it comes to developing drugs against COVID right now. We rushed a lot of medicines into clinical development, not necessarily optimizing them. This is sort of the first generation of medicines. Nothing, probably, is going to be a home run.”