TOKYO -- As clinical trials of novel coronavirus vaccines enter their final phases overseas, new problems have come to light in Japan over creating a system for their preservation and inoculation.
Managing the vaccines in extremely low temperatures of minus 70 degrees Celsius is likely to present the biggest hurdle. A new type of vaccine that is taking the lead in development overseas has yet to be approved across the globe, and must be handled differently from traditional vaccines. Some expect mass immunizations will be needed, and local governments in Japan in charge of the situation are raising concerns.
Demand for ultra-low temperature freezers for medical use is suddenly increasing around the world in anticipation of the practical use of these vaccines. "We have seen orders temporarily increase when there is an infectious disease going around, but never like this," said Nobuaki Nakamura, corporate officer of PHC Holdings Corp. -- a health and medical equipment manufacturer that boasts the second largest market share in the word and largest in Japan.
Demand from Europe began to rise from around March, and then came many inquiries from North America. PHC expects a 50% increase in sales for both Europe and North America this fiscal year compared to fiscal 2019. The company has been handling the surge in demand by operating its factory in Gunma Prefecture with a two-shift working system since August. PHC plans to increase production for domestic use going forward.
The spike in demand for ultra-low temperature freezers is caused by progress made in the development of a new type of vaccine in the United States. Flu vaccines and other vaccines distributed in Japan can be kept in refrigerators at 10 degrees C or lower, but the one being developed by major American pharmaceutical company Pfizer Inc. incorporates new technology: It is a messenger RNA (mRNA) vaccine that uses part of a virus's genetic information. It must be kept and distributed at minus 70 degrees C to maintain quality. Japan has basically agreed with Pfizer to receive about 120 million doses of the vaccine from the company and when the development succeeds, Japan must be prepared with an unprecedented number of super-low temperature freezers.
Vaccines produced overseas will be delivered to Japan on planes and distributed to local areas, where they will be stored until use. The supply will be enormous and keeping the vaccines at a temperature of minus 70 degrees C will be a difficult task.
A government source pointed out, "Not all medical institutions (in Japan) can have their own ultra-low temperature freezers, and methods used during the flu season won't work."
Japan Medical Association executive director Satoshi Kamayachi proposed, "Knowing how quick the vaccines expire after they are taken out from minus 70 degrees C freezers and defrosted, mass immunizations must be taken into consideration."
However, after the Immunization Act was amended in 1994, individuals are, as a basic rule, expected to visit medical institutions to get shots on their own, and mass immunizations, such as gathering everyone at schools for inoculations, rarely takes place. This is because the system turned inoculation into something of a choice rather than an obligation after the side effects of vaccines became a social issue.
In regard to mass immunizations, a certain amount of experience is necessary to carry out medical consultations on all individuals and to inoculate everyone in the group without any mistakes.
One municipal government official expressed concerns by telling the Mainichi Shimbun, "We haven't done (mass immunizations) for ages, so we hardly have any know-how to carry them out."
Another city government official said, "Can we conduct mass immunizations while avoiding the 'three Cs' of confined spaces, crowded places and close contact? Can we gather health care workers who are willing to inoculate large groups while conducting their daily examinations? There are countless challenges."
According to foreign media, of the vaccines with which the Japanese government is set to be supplied, the ones being developed by American biotechnology company Moderna Inc. have to be kept at a temperature of minus 20 degrees C. Although the vaccine being developed by British company AstraZeneca Plc does not need to be kept in freezers, distributing it simultaneously with other companies' vaccines without mix-ups will be a challenge.
(Japanese original by Ai Yokota, Lifestyle and Medical News Department)