Daiichi Sankyo Co. and KM Biologics Co. have started clinical trials for COVID-19 vaccines, marking the third and fourth times Japanese pharmaceutical firms have taken the key step toward demonstrating the efficacy of their shots.
But despite hopes that domestically developed vaccines will be available in the near future to help curb the pandemic, the general public is unlikely to have access to them until the year starting April 2022 at the earliest, industry sources say.
Both firms started administering the two-dose vaccines Monday as part of the combined early and middle phases of their clinical trials, which involve healthy adults and people age 65 and over. Daiichi Sankyo, which is co-developing the vaccine with the University of Tokyo’s Institute of Medical Science, aims to speed up the schedule for commercialization, but the official launch is expected to be in 2022 at the earliest.
KM Biologics, a unit of Meiji Holdings Co., aims to conduct a final clinical trial for the vaccine by the end of the year, with the official launch planned for sometime between April 2023 and March 2024, its spokesman said.
Some firms including the U.S. drugmaker Pfizer Inc. have brought their COVID-19 vaccines to market in less than a year — a fraction of the four years it took to make the mumps vaccine that had previously held the record as the fastest ever developed.
But some Japanese companies are touting the advantages of their shots compared with those that have already entered the market.
Daiichi Sankyo’s messenger RNA (mRNA) shot — a kind of vaccine that makes proteins to trigger an immune response — uses a proprietary novel nucleic acid delivery technology that is expected to raise the safety and efficacy of the vaccine, a company spokesman said. This technology envelopes the genetic information in a special coating, protecting it from breaking down.
Both Daiichi Sankyo and KM Biologics said they have confirmed the safety and efficacy of their vaccine candidates in animal experiments.
KM Biologics is developing an inactivated vaccine, in which the pathogen that has been killed induces an immune response without causing severe symptoms of the disease. Currently, inactivated vaccines and live attenuated vaccines, which use a weakened form of the pathogen, make up the majority of the shots in use today to prevent various diseases. China has already authorized an inactivated COVID-19 vaccine developed by Sinovac Biotech Ltd. for use in the country.
“We believe that the vaccine has a certain efficacy when it comes to preventing severe forms of the disease from the new variants,” a KM Biologics spokesman said.
Biotech startup AnGes Inc. — Japan’s front-runner, which has teamed up with Takara Bio Inc. and Osaka University — started the early- and mid-stage clinical trials for its plasmid DNA vaccine last June, while Shionogi & Co. initiated the trial for a recombinant protein vaccine in December.
Plasmid DNA vaccines take advantage of genetically engineered DNA that gives instructions to cells to make a spike protein found on the surface of the coronavirus, which the immune system then recognizes and makes antibodies against. Recombinant protein vaccines, meanwhile, use technology based on DNA molecules called recombinant DNA to produce antigen proteins.
Daiichi Sankyo’s mRNA and AnGes’ plasmid DNA vaccines are considered safer than earlier types because the pathogen itself is not used directly in their production, while recombinant protein vaccine technology has been already well established and used in marketed vaccines.
KM Biologics has received a ¥6.1 billion grant from the health ministry to prepare a production line by the end of March 2022 that would enable the company to manufacture 35 million vaccines in six months.
Dr. Tetsuo Nakayama, a project professor at Kitasato Institute for Life Sciences and director of the Japanese Society of Clinical Virology, says that Japanese drugmakers may be forced to conduct the final stage of clinical trials overseas, as vaccinations are set to accelerate in Japan from now on — a time-consuming process that is likely to push back any approval of domestic shots to fiscal 2022.
“These domestic vaccines will not be ready in time for the response to the pandemic now, but it’s meaningful to have various types of vaccines in the pipeline for production, considering we’ll continue to see more and more people infected with the coronavirus,” he said. “It’s also important to accumulate data on two different dosing regimens to see immune responses of people who receive those new vaccines in addition to the preceding shots that are available.”
Nakayama says that he hopes for the faster rollout of domestic vaccines, as they will prove indispensable in protecting Japanese citizens.
“We should want to avoid relying on foreign manufacturers for more of their vaccines if COVID-19 is still raging next year or the year after that,” he said.
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