Daiichi Sankyo is apologizing to the Japanese people. The drugmaker is sorry for again missing a deadline to be able to quickly manufacture enough bird flu vaccine to help protect the country in case of an epidemic. It is still coming up far short of the goal to produce within six months enough doses to vaccinate 40 million people.
The drugmaker recently said as penalty for having failed to be able to achieve the goal by the March 31 deadline, it is returning part of the government grant provided as backing for the effort and will pay a delinquency charge.
It says it will continue to work to improve its manufacturing so that it can eventually hit the needed yield, but it acknowledged its efforts so far have resulted in the ability to produce only enough vaccine in six months to vaccinate 23 million of the promised 40 million people.
“Daiichi Sankyo sincerely apologizes for having been unable to build the required scheme in the time frame allotted,” the company said in an announcement.
Daiichi’s vaccine operation was selected in 2011 to take on the so-called “scheme,” with the idea that it would get the project done by 2014. But when that deadline hit, it indicated more time would be needed. The deadline was extended for five years and other drugmakers, like Takeda, were added to the program.
The problem, Daiichi said, is that it was discovered in the development phase that higher doses are needed than expected when it first designing the production facilities. It says it worked to improve the facilities to increase the vaccination yield but have yet to be able to produce enough. It says it will keep trying.
The company didn’t say how much the grant was worth, but in 2014, Japan’s Takeda received a supplemental subsidy of ¥7.2 billion ($70.2 million) to help expand production of its cell-cultured influenza vaccine for H5N1 by an additional 8 million people.
As outbreaks of the highly contagious H5N1 and H7N9 strains have increased in recent years, the U.S. and other countries have been working to find an effective vaccine and produce supplies for protection. Last year, two phase 2 trials sponsored by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases started enrolling participants in the U.S. to test a candidate against H7N9 developed by Sanofi Pasteur.