Domestic vaccine maker Medigen Vaccine Biologics Corp’s (高端疫苗) shot has already been used by President Tsai Ing-wen (蔡英文) over better-known, more established inoculations.
Now the company is aiming to sell 100 million doses next year by gaining clearance from three to five additional countries, Medigen chief executive officer Charles Chen (陳燦堅) said in an interview.
The ambitious target comes even as Medigen has not yet started the final trials typically required for approval. About 660,000 doses have been given locally thus far based on early study results.
Photo: Sam Yeh, AFP
The company, which is developing vaccines for dengue fever and hand, foot and mouth disease, is targeting neighboring countries in Asia and Taiwan’s 15 diplomatic allies, mainly nations in Latin America, the Caribbean and the Pacific, as potential purchasers, he said.
“You must focus on the countries that believe in your medical quality,” Chen said in Taipei on Friday. “There are certain countries that believe that any clinical data, government endorsement from Taiwan is reliable. Those are the countries that we focus on.”
Medigen joined an elite group of fewer than two dozen companies, including industry behemoths Pfizer Inc and AstraZeneca PLC, when it won authorization to sell its shot in Taiwan last month.
It will have to overcome numerous hurdles, including its price, to meet its lofty sales target. Chief among them will be persuading health authorities overseas to approve an immunization from a little-known company with sparse data and no track record of bringing immunizations to market.
Shares of Medigen have risen 169 percent this year, compared to the 17 percent gain of the Taipei Exchange Index, where it is listed.
The company has a lot of competition, with nearly 100 rival vaccines in development. More than a dozen have started the third and final phase of study needed to reach the market.
Medigen plans to start its phase 3 trial, a head-to-head comparison with AstraZeneca’s vaccine in Paraguay, later this month with 1,000 participants. That compares with other companies that plan to enroll thousands more in their pivotal trials, as well as the initial studies, which typically have a higher bar, that included 30,000 or more volunteers each.
It might be challenging to enroll enough participants to persuade regulatory authorities outside of Taiwan, said Mia He, an analyst with Bloomberg Intelligence who tracks the industry.
Vaccinations are already being offered in many places and rival clinical trials have recruited many of those willing to participate, she said.
Chen said he hopes data from the company’s studies that show the vaccine’s effect on the immune system compared to proven shots will be sufficient to win international backing.
He acknowledged that securing approval from US or European drug regulators might be crucial to the company’s chances of selling its COVID-19 shots overseas.
Pricing is another issue. The government placed an order for 5 million doses with an option for 5 million more at a price of up to NT$880 (US$31.8) per dose, according to a report by Taipei-based Mirror Media. That makes it among the most expensive vaccines.
Although prices vary widely, estimates are that Moderna Inc’s vaccine costs at least US$31, whereas AstraZeneca is typically the cheapest, coming in at about US$5 per dose after the company pledged to sell at cost.
Chen said the price per dose would come down as Medigen ramps up production.
The rollout of Medigen’s vaccine is a boost for Taiwan amid a struggle to secure shots from overseas.
Although its outbreaks have been small compared with most other places, Taiwan has fallen behind when it comes to vaccination. Only about 4 percent of the population was fully vaccinated as of Sunday, one of the lowest rates among developed economies.
Almost 45 percent of people have had one dose.
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