A Taiwanese Covid-19 vaccine developer said on Thursday that it would apply for emergency use authorisation to roll out its vaccine locally, as the island continues to grapple with an outbreak of the coronavirus and a limited supply of doses.
Announcing the results of its phase 2 clinical trials, Medigen Vaccine Biologics said the vaccine met the safety and efficacy thresholds and the review standards of the Taiwan Food and Drug Administration.
The company said it would apply to the European Medicines Agency and other international health authorities to start large-scale phase 3 clinical trials. Its target is to gain international recognition for the vaccine, it added.
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If successful, the shot would be the first locally developed jab to be included in Taiwan’s vaccine portfolio, which is dominated by products that have been approved by the World Health Organization.
“We are very confident,” Medigen executive vice-president Leo Lee said. “The recombinant spike protein vaccine is the most traditional and safest.”
Medigen signed an agreement last May with the US National Institutes of Health, which designed the recombinant spike protein platform. It has the right to develop and commercialise the vaccine worldwide.
The announcement came as the island’s Central Epidemic Command Centre reported 263 new local cases of Covid-19, three imported cases and 28 deaths.
“The number of cases shows a slight downward trend overall from both the onset and testing date. But it is not significant and we need to keep paying attention,” Health Minister Chen Shih-chung said.
One of the imported cases was a patient who had received two doses of the Pfizer-BioNTech vaccine in the United States in April.
Lo Yi-chun, deputy director general of Taiwan’s Centres for Disease Control and Prevention, said it was possible for people who had had both doses to be infected and have mild symptoms.
“But severe disease and death are unlikely,” Lo said. “The viral load and the transmission ability of those vaccinated will be lower than those who have not had it.
“We encourage people to get vaccinated and continue to wear masks and wash their hands to avoid infecting others.”
The island started administering its first batch of 150,000 doses of US-made Moderna vaccine on Wednesday. It has received 1.24 million doses of AstraZeneca’s vaccine donated by the Japanese government, with the US promising to give another 750,000 doses.
Separately, a Taipei clinic was fined NT$2 million (US$72,200) for administering more than 1,000 doses to people who were not on the official priority list, Taipei deputy mayor Vivian Huang Shan-shan said on Wednesday.
The command centre said the incident “seriously affected the rights and interests of medical staff who have not yet been vaccinated” and an investigation had been ordered.
Taiwanese President Tsai Ing-wen said “the order of vaccination set by the central government is the result of expert discussions on public health and social stability”.
“[I] hope local governments and other units will follow the order and administer vaccines efficiently,” she said on Facebook. “Get vaccinated when it’s your turn.”
With Monday’s Dragon Boat Festival public holiday just a few days away, the government has been encouraging people to stay put for the long weekend to prevent further spread of the virus.
Chen Tsung-yen, deputy commander of the Central Epidemic Command Centre, said highway traffic would be limited to about half, and about 6,000 train tickets were refunded on Wednesday after people heeded advice and cancelled travel plans.
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This article Coronavirus: Taiwan vaccine maker confident of success after phase 2 trials first appeared on South China Morning Post