SOSUKE KARINO, Nikkei staff writer
OSAKA — Japanese drugmaker Shionogi’s COVID-19 vaccine candidate was found to be as effective as Pfizer shots as a booster in a late-stage clinical trial, the company announced Friday.
“We saw extremely positive results, and we hope to accelerate development,” President and CEO Isao Teshirogi told reporters.
The Phase 2/3 trial, conducted at Tokyo Shinagawa Hospital, targeted roughly 200 adults aged 20 or older who had received two doses of the Pfizer-BioNTech coronavirus vaccine at least six months before the booster.
Subjects that received a Shionogi booster showed similar levels of neutralizing antibodies as those with a Pfizer booster, while a similar percentage of subjects in each group reported significantly higher antibodies than before the trial, the company said.
Similar or fewer instances of fever, headaches and other negative side effects were reported among recipients of the Shionogi booster, according to the company.
Shionogi’s shots use recombinant protein instead of messenger RNA technology used in the Pfizer and Moderna vaccines.
“We are preparing to be able to start commercial deliveries in May and beyond,” Teshirogi said. Shionogi plans to expand capacity at its Gifu Prefecture plant to up to an annual 120 million doses by the end of this year, enough for a single booster shot for a million people. They will initially only be delivered within Japan.
Shionogi is seeking government authorization to use its vaccine as a booster initially. But Teshirogi did not say when the company expects to receive the green light. Shionogi has been in preconsultation with relevant agencies since February, sharing preliminary data to ensure a quick screening process once it formally submits its application. It will continue discussions with the health ministry and other agencies as additional data becomes available.
Japan so far has authorized vaccines developed by Pfizer, Moderna and AstraZeneca. Though several Japanese players are working on alternatives, none have received authorization so far.
Mitsubishi Tanabe Pharma is conducting a clinical trial for a plant-based vaccine cleared for use in Canada, with the goal of receiving authorization in Japan between July and September. Daiichi Sankyo and KM Biologics aim to bring their shots to market by the end of this year.
Shionogi last month applied for approval to manufacture and sell an oral COVID-19 treatment designed for patients with mild or moderate symptoms.
