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.
Photo: Screen grab from the Internet
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.
SOLIDARITY: A group of European lawmakers condemned China’s aggressive moves, while the foreign minister of Lithuania said Taiwan ‘cannot become a second Ukraine’ A German parliamentary delegation would visit Taiwan in the first week of October, German lawmaker Holger Becker on Monday told visiting Democratic Progressive Party legislators Fan Yun (范雲) and Lin I-chin (林宜瑾) at the Bundestag in Berlin. Asked by Fan whether he is worried about possible reprisals from Beijing, such as banning him and his family from entering China, Becker said he is more interested in visiting Taiwan, as “now is the time for democracies to stand together.” Fan and Lin also met with German officials to exchange views on digital education and governance. Investing in digital infrastructure and protecting equal rights to
As China waged extensive military exercises off Taiwan, a group of US defense experts in Washington was focused on their own simulation of an eventual — but for now entirely hypothetical — US-China war over the nation. The unofficial what-if game is being conducted on the fifth floor of an office building not far from the White House, and it posits a US military response to a Chinese invasion in 2026. Even though the participants bring a US perspective, they are finding that a US-Taiwan victory, if there is one, could come at a huge cost. “The results are showing that under
WRONG TIMING: The delegation’s trip has not only disappointed Taiwanese, but could send a wrong message to the global community, Tsai Ing-wen said Chinese Nationalist Party (KMT) Vice Chairman Andrew Hsia (夏立言) yesterday left with a delegation for a trip to China, drawing fire for visiting at a time when Beijing has been conducting intensive military drills to pressure Taiwan. Before boarding, he told reporters that the delegation would be visiting Taiwanese communities and students in China, and possibly meet with Chinese officials. The Mainland Affairs Council on Tuesday night said that it was not the right time for political party members to visit China, as Beijing has been conducting military exercises since Thursday last week. President Tsai Ing- wen (蔡英文), chairperson of the Democratic
‘MILITARY PLAYBOOK’: It would have taken far longer for the PLA to put together the drills had they actually been in response to Nancy Pelosi’s visit, Joseph Wu said China is using military drills to prepare for an invasion of Taiwan, and its anger over US House of Representatives Speaker Nancy Pelosi’s visit is just an excuse, Minister of Foreign Affairs Joseph Wu (吳釗燮) said yesterday. Speaking in English at a news conference in Taipei, Wu accused China of “gross violations of international law.” “China has used the drills in its military playbook to prepare for the invasion of Taiwan,” he said. “It is conducting large-scale military exercises and missile launches, as well as cyberattacks, disinformation and economic coercion, in an attempt to weaken public morale in Taiwan.” He said the Chinese