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.
US President Donald Trump yesterday announced sweeping "reciprocal tariffs" on US trading partners, including a 32 percent tax on goods from Taiwan that is set to take effect on Wednesday. At a Rose Garden event, Trump declared a 10 percent baseline tax on imports from all countries, with the White House saying it would take effect on Saturday. Countries with larger trade surpluses with the US would face higher duties beginning on Wednesday, including Taiwan (32 percent), China (34 percent), Japan (24 percent), South Korea (25 percent), Vietnam (46 percent) and Thailand (36 percent). Canada and Mexico, the two largest US trading
AIR SUPPORT: The Ministry of National Defense thanked the US for the delivery, adding that it was an indicator of the White House’s commitment to the Taiwan Relations Act Deputy Minister of National Defense Po Horng-huei (柏鴻輝) and Representative to the US Alexander Yui on Friday attended a delivery ceremony for the first of Taiwan’s long-awaited 66 F-16C/D Block 70 jets at a Lockheed Martin Corp factory in Greenville, South Carolina. “We are so proud to be the global home of the F-16 and to support Taiwan’s air defense capabilities,” US Representative William Timmons wrote on X, alongside a photograph of Taiwanese and US officials at the event. The F-16C/D Block 70 jets Taiwan ordered have the same capabilities as aircraft that had been upgraded to F-16Vs. The batch of Lockheed Martin
GRIDLOCK: The National Fire Agency’s Special Search and Rescue team is on standby to travel to the countries to help out with the rescue effort A powerful earthquake rocked Myanmar and neighboring Thailand yesterday, killing at least three people in Bangkok and burying dozens when a high-rise building under construction collapsed. Footage shared on social media from Myanmar’s second-largest city showed widespread destruction, raising fears that many were trapped under the rubble or killed. The magnitude 7.7 earthquake, with an epicenter near Mandalay in Myanmar, struck at midday and was followed by a strong magnitude 6.4 aftershock. The extent of death, injury and destruction — especially in Myanmar, which is embroiled in a civil war and where information is tightly controlled at the best of times —
China's military today said it began joint army, navy and rocket force exercises around Taiwan to "serve as a stern warning and powerful deterrent against Taiwanese independence," calling President William Lai (賴清德) a "parasite." The exercises come after Lai called Beijing a "foreign hostile force" last month. More than 10 Chinese military ships approached close to Taiwan's 24 nautical mile (44.4km) contiguous zone this morning and Taiwan sent its own warships to respond, two senior Taiwanese officials said. Taiwan has not yet detected any live fire by the Chinese military so far, one of the officials said. The drills took place after US Secretary
RSS