The Food and Drug Administration (FDA) yesterday announced emergency use authorization (EUA) standards for locally developed COVID-19 vaccines, just hours before Medigen Vaccine Biologics Corp (高端) announced its phase 2 trial results.
The standards include safety data from at least 3,000 subjects and efficacy test results at least on par with the AstraZeneca vaccine, the FDA said.
The standards were determined after a year of discussions with experts in the clinical, statistical, pharmaceutical, manufacturing, public health and other related fields, it added.
Photo: Huang Mei-chu, Taipei Times
The EUA review is to focus on two main points: safety and efficacy, Medical Products Division deputy head Wu Ming-mei (吳明美) told reporters.
Efficacy would be difficult to assess, as clinical trials were held while Taiwan did not have any community transmission, Wu said.
This means the subjects did not have contact with the virus, making it less clear whether the vaccine had the intended effect compared with the control group, she added.
The review would therefore refer to a criteria the WHO began discussing earlier this year called immunogenicity, which measures the type of immune responses triggered by a vaccine and their magnitude over time, she said.
This would involve measuring the level, or titer, of neutralizing antibodies in the body after vaccination to determine efficacy, she added.
To determine the appropriate level, the FDA is to commission Ministry of Health and Welfare hospitals to conduct studies comparing the effect of domestic vaccines with that of foreign vaccines, Wu said.
Researchers are to put together a control group of 200 Taiwanese who have received both doses of the AstraZeneca vaccine since rollout began in March, she said.
If the neutralizing antibody titer among subjects who received the domestic vaccine are at least as high as that of the control group, then the vaccine would be considered effective, she added.
As for the safety part of the evaluation, the FDA would require researchers to follow up with 3,000 or more clinical trial participants for at least one month after receiving their last dose, Wu said.
The report must then compile safety data from the subjects followed for a median of at least two months, she said, adding that it must include a population study for people older than 65.
Medigen was yesterday set to unblind participants of the second stage of clinical trials for its COVID-19 vaccine, leading some to speculate over potential insights into its efficacy.
The unblinding would only reveal if there were differences between the subjects who received a vaccine and those who received a placebo, Wu said.
The results must still be sent to the FDA before it can begin EUA procedures, she added.
PRIORITY GROUPS: A line of people were waiting at the Good Liver Clinic, apparently to get shots, while the CECC announced more priority groups for jabs The Taipei-based Good Liver Clinic is to be fined NT$2 million (US$72,028) after giving free COVID-19 vaccine shots to people not in groups eligible to receive them, Taipei Deputy Mayor Vivian Huang (黃珊珊) said yesterday. The Zhongshan District (中山)-based clinic was removed from the city’s list of vaccination venues and health officials would be investigated for giving 1,113 doses to the clinic, Huang told an afternoon news conference at Taipei City Hall. The Chinese-language Liberty Times (the Taipei Times’ sister paper) on Tuesday in an exclusive story citing an anonymous tip reported that a Taipei clinic was doling out unused vaccines. People in
PHASE 2: The firm’s CEO said that the results were good and the experimental vaccine safe, but added that hoped-for phase 3 trials would be expensive Medigen Vaccine Biologics Corp (高端疫苗) yesterday reported positive results from an interim analysis of phase 2 trials for its COVID-19 vaccine, saying that the vaccine demonstrated high seroconversion rates and geometric mean titer (GMT) figures. A seroconversion rate is the percentage of participants in a trial displaying virus-specific immune memory after being given a vaccine, while the GMT measures the level of neutralizing antibody response, Medigen said. The experimental vaccine has a seroconversion rate of 99.8 percent and its GMT was 662 among the participants aged 20 to 89, while the gauges rose to 99.9 percent and 733 respectively in participants aged
NUMBERS HAVE FALLEN: Minister of Health and Welfare Chen Shih-chung said there are good signs, but ‘we cannot afford to let our guard down now’ The Central Epidemic Command Center (CECC) yesterday reported 219 new locally transmitted COVID-19 infections and 22 deaths. Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the center, said that the 219 local infections — 117 male and 102 female — were aged from under five to over 100 years old, and they began having symptoms between May 22 and Monday. New Taipei City reported 123 cases, followed by Taipei with 54, Miaoli County with 16, Taoyuan with 13, Keelung with eight, Changhua County with two, and one each in Hsinchu City, Taichung and Tainan. The 22 deaths were 15 men and
ROLLING OUT DOSES: The expansion aims to speed up Taiwan’s vaccination drive by making more Moderna jabs available to workers at hospitals, the CECC said The Central Epidemic Command Center (CECC) yesterday expanded the eligibility for the Moderna COVID-19 vaccine to all healthcare workers and non-healthcare workers in the highest vaccine priority group. The center said that 75,000 doses of the vaccine — half of the first batch Taiwan has received — were on Wednesday distributed to hospitals across the nation with specialized COVID-19 rooms, negative pressure wards and testing services. Thus far, they had only been offered to frontline healthcare workers and non-healthcare workers at the designated hospitals, it said. Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the center, said that the eligibility was