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 20 to 64, the company said.
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No participants have shown severe adverse reactions, it said.
Only 0.7 percent of participants who were given experimental vaccines had a fever, compared with 0.4 percent in those who received a placebo, while among those who received the vaccine 27.6 percent had muscle soreness and 36 percent felt tired, compared with 16.6 percent and 29.7 percent respectively for those who were given a placebo, it said.
“It would be the regulator that decides if our experimental vaccine has good efficacy, but I personally found the results — the seroconversion rates and the GMT figures — optimistic,” Medigen chief executive officer Charles Chen (陳燦堅) said.
“And it is very safe,” Chen added.
The company will apply to the Food and Drug Administration for emergency use authorization as soon as possible, he said.
However, asked which COVID-19 vaccine developed outside Taiwan that has been granted emergency use authorization Medigen’s experimental vaccine might be compared to, the company said it has not reached a conclusion.
“An estimate needs to be done scientifically. We can conduct an immune-bridging study to compare the antibody levels in people who are given different COVID-19 vaccines, and the WHO is also trying to establish common standards for COVID-19 vaccines,” Medigen head of development Lien Chia-en (連加恩) said.
For example, Medigen’s clinical trial result of a GMT of 662 could be converted into international units (IU) and foreign vaccine developers could do likewise to enable international comparison, Lien said.
“However, this would take some time and other companies have not disclosed their data in IU yet,” he said.
Amid discussions over whether locally developed COVID-19 vaccines would be better than foreign vaccines, Chen and Medigen spokesman Leo Lee (李思賢) said that they are confident in their product and they and their families would get Medigen’s vaccine.
Medigen is to conduct phase 3 trials for its vaccine to earn approval from foreign regulators and it aims to conduct the tests in Europe, Chen said, adding that the UK recently allowed a French company to conduct phase 3 human testing there.
It costs about US$10,000 per participant in phase 3 trials, so the costs would be enormous if Medigen recruited 30,000 participants, Chen said.
MEDIGEN: The vaccine must also be reviewed by the Advisory Committee on Immunization Practices before it is added to the national vaccination program An emergency use authorization (EUA) for Medigen Vaccine Biologics Corp’s (高端疫苗) COVID-19 vaccine — MVC-COV1901 — for people aged 20 and older was issued by the Food and Drug Administration (FDA) yesterday. Minister of Health and Welfare Chen Shih-chung (陳時中) said a specialists’ meeting was held at the FDA on Sunday to review Medigen’s application to manufacture and distribute its COVID-19 vaccine, and the panel approved it. FDA Director Wu Hsiu-mei (吳秀梅) said the meeting consisted of 21 specialists from the fields of chemistry, manufacturing and controls, pharmacy, toxicology, clinical medicine, public health, law and medical ethics. There were no major concerns over
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