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.
Photo courtesy of the Central Epidemic Command Center
There were no major concerns over the safety of the vaccine, she said, adding that it also met the standards that the FDA had previously published for the manufacture or importation of COVID-19 vaccines.
One of the two most important standards was that the geometric mean titer of neutralizing antibodies produced in individuals who received the Medigen vaccine must be at least 0.67 times that prodcued in those who received the AstraZeneca vaccine, using the 95 percent lower confidence limit, she said.
The geometric mean titer of neutralizing antibodies of Medigen vaccine recipients was 3.4 times that of those who received the AstraZeneca vaccine, Wu said.
The AstraZeneca vaccine was chosen for comparison because it is being administered in more than 100 nations and it was the only vaccine available in Taiwan at the time of the testing, she said.
The other important standard was that the sero-response rate of Medigen vaccine recipients be higher that 50 percent, using the 95 percent lower confidence limit, Wu said, adding that the sero-response rate was 95.5 percent, exceeding the requirement.
At the specialists’ meeting, 18 members voted to approve the vaccine, one voted for further discussion after asking for more information and one voted to not approve the vaccine, she said, adding that the convener of the meeting was not allowed to vote.
The Medigen vaccine is only suitable for people who are aged 20 or older, and each person should get two doses at least 28 days apart, Wu said.
Under the EUA, the company must provide a safety report every month, she said.
A report on the effectiveness of the vaccine, from administering it in Taiwan and other nations, must be provided after one year, she added.
The vaccine would also be reviewed by the Advisory Committee on Immunization Practices before it is added to the national COVID-19 vaccination program, Chen said, adding that if it gains approval, a small number of doses could be available as soon as next month.
Meanwhile, about 1.7 million people in the sixth, eight, ninth and 10th priority groups for vaccination, and people born before 1974 who selected the AstraZeneca vaccine using the national online vaccination booking system before noon yesterday, would begin receiving text messages from the center today, Chen said.
After receiving a text message, they can book an appointment for a vaccination between Friday and Thursday next week, he said.
The vaccination booking system has been temporarily closed and it would be reopened for new registrations when more vaccine doses become available, he added.
People who edit their preference and select the AstraZeneca vaccine when the system is reopened would be eligible for vaccination after the approximately 4.95 million people who had chosen the AstraZeneca vaccine before midday yesterday, Chen said.
Two US House of Representatives committees yesterday condemned China’s attempt to orchestrate a crash involving Vice President Hsiao Bi-khim’s (蕭美琴) car when she visited the Czech Republic last year as vice president-elect. Czech local media in March last year reported that a Chinese diplomat had run a red light while following Hsiao’s car from the airport, and Czech intelligence last week told local media that Chinese diplomats and agents had also planned to stage a demonstrative car collision. Hsiao on Saturday shared a Reuters news report on the incident through her account on social media platform X and wrote: “I
SHIFT PRIORITIES: The US should first help Taiwan respond to actions China is already taking, instead of focusing too heavily on deterring a large-scale invasion, an expert said US Air Force leaders on Thursday voiced concerns about the Chinese People’s Liberation Army’s (PLA) missile capabilities and its development of a “kill web,” and said that the US Department of Defense’s budget request for next year prioritizes bolstering defenses in the Indo-Pacific region due to the increasing threat posed by China. US experts said that a full-scale Chinese invasion of Taiwan is risky and unlikely, with Beijing more likely to pursue coercive tactics such as political warfare or blockades to achieve its goals. Senior air force and US Space Force leaders, including US Secretary of the Air Force Troy Meink and
‘BUILDING PARTNERSHIPS’: The US military’s aim is to continue to make any potential Chinese invasion more difficult than it already is, US General Ronald Clark said The likelihood of China invading Taiwan without contest is “very, very small” because the Taiwan Strait is under constant surveillance by multiple countries, a US general has said. General Ronald Clark, commanding officer of US Army Pacific (USARPAC), the US Army’s largest service component command, made the remarks during a dialogue hosted on Friday by Washington-based think tank the Center for Strategic and International Studies. Asked by the event host what the Chinese military has learned from its US counterpart over the years, Clark said that the first lesson is that the skill and will of US service members are “unmatched.” The second
Czech officials have confirmed that Chinese agents surveilled Vice President Hsiao Bi-khim (蕭美琴) during her visit to Prague in March 2024 and planned a collision with her car as part of an “unprecedented” provocation by Beijing in Europe. Czech Military Intelligence learned that their Chinese counterparts attempted to create conditions to carry out a demonstrative incident involving Hsiao, which “did not go beyond the preparation stage,” agency director Petr Bartovsky told Czech Radio in a report yesterday. In addition, a Chinese diplomat ran a red light to maintain surveillance of the Taiwanese
RSS