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.
Super Typhoon Kong-rey is the largest cyclone to impact Taiwan in 27 years, the Central Weather Administration (CWA) said today. Kong-rey’s radius of maximum wind (RMW) — the distance between the center of a cyclone and its band of strongest winds — has expanded to 320km, CWA forecaster Chang Chun-yao (張竣堯) said. The last time a typhoon of comparable strength with an RMW larger than 300km made landfall in Taiwan was Typhoon Herb in 1996, he said. Herb made landfall between Keelung and Suao (蘇澳) in Yilan County with an RMW of 350km, Chang said. The weather station in Alishan (阿里山) recorded 1.09m of
NO WORK, CLASS: President William Lai urged people in the eastern, southern and northern parts of the country to be on alert, with Typhoon Kong-rey approaching Typhoon Kong-rey is expected to make landfall on Taiwan’s east coast today, with work and classes canceled nationwide. Packing gusts of nearly 300kph, the storm yesterday intensified into a typhoon and was expected to gain even more strength before hitting Taitung County, the US Navy’s Joint Typhoon Warning Center said. The storm is forecast to cross Taiwan’s south, enter the Taiwan Strait and head toward China, the Central Weather Administration (CWA) said. The CWA labeled the storm a “strong typhoon,” the most powerful on its scale. Up to 1.2m of rainfall was expected in mountainous areas of eastern Taiwan and destructive winds are likely
The Central Weather Administration (CWA) yesterday at 5:30pm issued a sea warning for Typhoon Kong-rey as the storm drew closer to the east coast. As of 8pm yesterday, the storm was 670km southeast of Oluanpi (鵝鑾鼻) and traveling northwest at 12kph to 16kph. It was packing maximum sustained winds of 162kph and gusts of up to 198kph, the CWA said. A land warning might be issued this morning for the storm, which is expected to have the strongest impact on Taiwan from tonight to early Friday morning, the agency said. Orchid Island (Lanyu, 蘭嶼) and Green Island (綠島) canceled classes and work
KONG-REY: A woman was killed in a vehicle hit by a tree, while 205 people were injured as the storm moved across the nation and entered the Taiwan Strait Typhoon Kong-rey slammed into Taiwan yesterday as one of the biggest storms to hit the nation in decades, whipping up 10m waves, triggering floods and claiming at least one life. Kong-rey made landfall in Taitung County’s Chenggong Township (成功) at 1:40pm, the Central Weather Administration (CWA) said. The typhoon — the first in Taiwan’s history to make landfall after mid-October — was moving north-northwest at 21kph when it hit land, CWA data showed. The fast-moving storm was packing maximum sustained winds of 184kph, with gusts of up to 227kph, CWA data showed. It was the same strength as Typhoon Gaemi, which was the most