The COVID-19 vaccine developed by Medigen has received emergency use authorization from the government, becoming the first domestic vaccine that gets green light to begin mass production. Medigen CEO Charles Chen said his firm should be able to produce 10 million doses by the end of this year, with the first batch becoming available in August at the earliest.
Medigen has become the first domestic pharmaceutical to receive emergency use authorization for its COVID-19 vaccine. While making the announcement, the Food and Drug Administration also said Medigen's average neutralizing antibody level was 375 compared to AZ's 130. Domestic experts say a conclusion on which vaccine is better overall can't be drawn from this.
Voice of Ho Mei-chin, Joint Appointment Research Fellow, Academia Sinica:”Neutralizing antibody levels are correlated positively with the levels of protection, but the ratio isn't always 1:1. In other words, just because the vaccine induces an antibody level three times higher than other products doesn't mean it is three times more effective. “
Experts say neutralizing antibody levels are only one measure of a vaccine's overall efficacy. For example, research has shown that AZ vaccines provide protection for up to eight months. They also said Medigen must continuously monitor its vaccine's side effects after it hits the market.
Voice of Huang Li-min, Honorary Chair, Infectious Diseases Society of Taiwan:”You might see a link between the AZ vaccine and thrombosis, but the thrombosis rate could be 1 in 100,000 or even lower. You won't see that in clinical trials, so vaccines must be monitored (after they hit the market).”
Experts say a conclusion has not been made regarding the ideal or minimum neutralizing antibody levels at this point and vaccines must be closely monitored after they hit the market. They also say Medigen and UBI Asia need to complete Phase 3 clinical trials overseas if they want to obtain international recognition.