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.
NO HUMAN ERROR: After the incident, the Coast Guard Administration said it would obtain uncrewed aerial vehicles and vessels to boost its detection capacity Authorities would improve border control to prevent unlawful entry into Taiwan’s waters and safeguard national security, the Mainland Affairs Council (MAC) said yesterday after a Chinese man reached the nation’s coast on an inflatable boat, saying he “defected to freedom.” The man was found on a rubber boat when he was about to set foot on Taiwan at the estuary of Houkeng River (後坑溪) near Taiping Borough (太平) in New Taipei City’s Linkou District (林口), authorities said. The Coast Guard Administration’s (CGA) northern branch said it received a report at 6:30am yesterday morning from the New Taipei City Fire Department about a
IN BEIJING’S FAVOR: A China Coast Guard spokesperson said that the Chinese maritime police would continue to carry out law enforcement activities in waters it claims The Philippines withdrew its coast guard vessel from a South China Sea shoal that has recently been at the center of tensions with Beijing. BRP Teresa Magbanua “was compelled to return to port” from Sabina Shoal (Xianbin Shoal, 仙濱暗沙) due to bad weather, depleted supplies and the need to evacuate personnel requiring medical care, the Philippine Coast Guard (PCG) spokesman Jay Tarriela said yesterday in a post on X. The Philippine vessel “will be in tiptop shape to resume her mission” after it has been resupplied and repaired, Philippine Executive Secretary Lucas Bersamin, who heads the nation’s maritime council, said
CHINA POLICY: At the seventh US-EU Dialogue on China, the two sides issued strong support for Taiwan and condemned China’s actions in the South China Sea The US and EU issued a joint statement on Wednesday supporting Taiwan’s international participation, notably omitting the “one China” policy in a departure from previous similar statements, following high-level talks on China and the Indo-Pacific region. The statement also urged China to show restraint in the Taiwan Strait. US Deputy Secretary of State Kurt Campbell and European External Action Service Secretary-General Stefano Sannino cochaired the seventh US-EU Dialogue on China and the sixth US-EU Indo-Pacific Consultations from Monday to Tuesday. Since the Indo-Pacific consultations were launched in 2021, references to the “one China” policy have appeared in every statement apart from the
More than 500 people on Saturday marched in New York in support of Taiwan’s entry to the UN, significantly more people than previous years. The march, coinciding with the ongoing 79th session of the UN General Assembly, comes close on the heels of growing international discourse regarding the meaning of UN Resolution 2758. Resolution 2758, adopted by the UN General Assembly in 1971, recognizes the People’s Republic of China (PRC) as the “only lawful representative of China.” It resulted in the Republic of China (ROC) losing its seat at the UN to the PRC. Taiwan has since been excluded from