Japan's Shionogi readies COVID-19 vaccine for December trial- CEO

AnGes

29/10/2020 02:11

By Rocky Swift
    TOKYO, Oct 29 (Reuters) - Shionogi & Co  4507.T  is planning
clinical trials by year-end for what may be one of Japan's first
domestically produced COVID-19 vaccines to reach the market, as
the globe races to secure enough doses to battle the pandemic.
    The company plans to put its vaccine candidate into Phase 1
clinical trials in December and shift into Phase 2 by January
and apply for tentative approval from the government, Shionogi
chief executive Isao Teshirogi told Reuters in an interview.
    But a Phase 3 trial would likely be done overseas due to the
relative lack of COVID-19 cases in Japan, he said.
    Shionogi's plan to have enough doses to inoculate 30 million
people by the end of next year means its impact will be much
larger than that of first mover Osaka-based AnGes Inc  4563.T ,
which expects to have its first doses ready by March.
 urn:newsml:reuters.com:*:nL4N2DN0GU
    "For almost national security reasons, having good capacity
in Japan makes a lot of sense," Teshirogi said.
    While Shionogi lags global front runners that are now
conducting mass final-stage clinical trials, it is betting on a
proven platform to help it become Japan's biggest home-grown
COVID-19 vaccine producer. French drugmaker Sanofi SA  SASY.PA 
and Novavax  NVAX.O  are using a similar process in their
COVID-19 candidate.
    "I think our recombinant protein vaccine, method wise, has
more accumulated data on efficacy and safety than the novel
methods," Teshirogi said. 
    Newer methodologies like mRNA vaccines may end up being the
solution, "but as of today, we don't know anything", he said.
    Prime Minister Yoshihide Suga has pledged to provide enough
vaccine for the populace by mid-2021, and Japan has struck deals
for hundreds of millions of doses with companies including
AstraZeneca Plc  AZN.L  and Pfizer Inc  PFE.N .  urn:newsml:reuters.com:*:nL4N2FU2UB
    Shionogi has received about $400 million from the Japanese
government for its COVID-19 vaccine research. 
    But the world will need several different vaccines to fight
the pandemic, given the sheer size of global demand, effects on
different populations, and possible limits of effectiveness in
the first vaccines.
    Teshirogi said holding the postponed Tokyo Summer Olympics
in 2021 is "still possible", but it will depend more on
high-rapid-diagnostic testing and logistics than vaccines.
    "Receiving the vaccine is not a so-called safe license," he
said.

 (Reporting by Rocky Swift in Tokyo; Editing by Miyoung Kim and
Michael Perry)