The DPP authorities' "Infectious Disease Prevention and Control Consultation Association Vaccination Group (ACIP)" held an extraordinary meeting this morning (25th) to discuss high-end vaccination produced by Taiwan. Chen Shizhong, commander of the "Epidemic Command Center", said that first, experts agreed that high-end vaccines were included in the public-funded vaccination operation plan; second, experts agreed that vaccines could be mixed after a lot of debate and discussion. As for how to implement it, it is recommended to initially start with the first to the third type of vaccination targets, with an interval of more than 8 weeks. The second dose can be mixed with mRNA vaccine, but for the sake of integrated operation, the second dose is now planned at 10 to 12 weeks. After the high-end vaccine was delivered in mid-June, it was asked to supplement the product due to incomplete information. After completing the supplement on July 14, the Food and Drug Administration conducted an emergency authorization review and passed the authorization on July 19. "Food and Drug Administration" Wu Xiumei said that high-end vaccines will be suitable for vaccination for adults over 20 years old. The two doses must be separated by 28 days, and safety monitoring reports must be provided every month.
Chen Shizhong said that high-end production capacity is relatively low, and emergency authorization has just been approved. It will take a certain amount of time to increase production capacity. After ACIP is approved, a plan will be proposed. There should be a small supply in August.
Wu Xiumei mentioned that compared with the neutralizing antibodies of high-end vaccines with AZ vaccine, the lower limit of the 95% trust range is 3.4 times, which is far greater than the standard requirement of 0.67 times. She also claimed that the lower limit of the serum response ratio trust range in the high-end vaccine group is 95.5%, which is much larger than the standard requirement of 50%. 21 experts attended the meeting, the chairman did not participate in the voting, 18 agreed, one discussed the supplementary documents again, and one disagreed.
Wu Xiumei also said that after the Lianya vaccine was delivered, the Food and Drug Administration was actively under review. As for the antibody titers measured by AZ in Taiwan's " China Research Institute " laboratory, Chen Shizhong said that it should not be announced until the review of each brand has been completed.
However, after the high-end vaccine passed the emergency authorization, it was revealed that the quality of the expansion of production capacity was unstable, and 80% of the products were returned. Although both the high-end and the Food and Drug Administration issued a statement to defend themselves, it still aroused doubts from the outside world. Chen Shizhong was asked about this matter at a press conference a few days ago and said, "I didn't say it very clearly." However, he said that every amplification process has relevant effectiveness measures, and each company's production line has yield and defect rate, which requires batch inspection by the manufacturer and will only be released if it meets the quality requirements.
In addition, regarding vaccine scrambles, Taiwan's Linkou Chang Geng Vice President Qiu Zhengxun said yesterday that scrambles will become a trend in the future, but in order to ensure safety, I hope to provide reference data for Taiwanese people through clinical trials. NTU Hospital has conducted a mixed clinical trial of "AZ + Moderna", and Chang Gung has also proposed a plan, but it is still under the IRB review in the hospital. As for the clinical trial of "AZ + Taiwan-made vaccine" and is also being developed. (Lin Jingxian/Editor)
