Special fast-track review to be applied to vaccine

An application for a COVID-19 vaccine filed by U.S. pharmaceutical giant Pfizer Inc. has begun undergoing the review process in Japan. The health ministry plans to apply a special fast-track system for approval, which will significantly reduce the time required for the review compared with that for ordinary drugs, but many issues need to be addressed before the vaccine can be offered to the public.

FOR SWIFT APPROVAL

Health, Labor and Welfare Minister Norihisa Tamura on Friday indicated his willingness to apply a special fast-track system, saying: “We will swiftly examine the application, along with the results of clinical trials in Japan. We’d like to send out information to the public after analyzing the side effects and other issues.”

Although it normally takes over 10 years to develop a vaccine, Pfizer’s latest vaccine became available in Britain and the United States less than a year after development started. This was the result of a successful strategy of using messenger RNA (mRNA), a genetic material that can be synthesized in large quantities in a short period of time, as the main ingredient.

As the technology is new, there were initially some concerns about its efficacy, but the vaccine showed a surprising 95% efficacy in the final stage of clinical trials.

U. S. biotech company Moderna Inc. is taking a similar approach. After an expert panel of the U.S. Food and Drug Administration decided on Thursday that the vaccine’s benefits outweigh the risks, the FDA authorized the vaccine on Friday.

University of Tokyo Prof. Ken Ishii, an expert on vaccine science, said: “We could not have predicted such high efficacy in a drug developed at an unprecedented speed. There is no doubt that this will be a historic achievement.”

THREE WEEKS IN THE U. S.

Pfizer’s vaccine was tested on a large scale in the United States, given to more than 40,000 people. It was approved for use in the United States within three weeks after the application was filed.

However, the clinical trials in Japan were on a smaller scale, involving 160 people. Because novel coronavirus infections are less prevalent in Japan than in Europe and North America, it is more difficult to test the effectiveness of the vaccine.

The review process for the special fasttrack approval will refer to overseas data used for approval in those countries, which is deemed reliable. Pfizer had already submitted overseas data to the ministry before filing the application.

There are about 560 doctors, pharmacists and other specialists at the relevant divisions of the Pharmaceuticals and Medical Devices Agency, which will undertake the review of the application. It is likely that “a number of experts will be gathered to review [Pfizer’s] application,” according to a senior ministry official, with the aim of shortening the review period.

As the side effects of a vaccine can vary by racial group, some experts say that overseas data alone is insufficient to verify the safety of the vaccine. The agency said that data from clinical trials in Japan is important for approval, and Pfizer plans to submit the data to the ministry in February.

CONCERN OVER SIDE EFFECTS

No mRNA vaccine had been in practical use before Pfizer’s new product. Although there were no reports of serious side effects in clinical trials conducted by Pfizer and Moderna, it should not be ignored that very rare side effects could occur when millions of healthy citizens are vaccinated.

In the United States, a woman who was inoculated with Pfizer’s vaccine on Tuesday suffered a severe allergic reaction and was hospitalized. Two medical professionals in Britain showed allergic reactions as well.

Side effects, including relatively mild ones, reported in the clinical trials included 59% of those aged 16 to 55 experiencing fatigue after being vaccinated twice, 52% experiencing headaches and 16% developing fevers of 38 C or higher.

“Hopes are high, but there seem to be some side effects,” said Tetsuya Matsumoto, a professor of infectious diseases at the International University of Health and Welfare.

“I hope the government will not make a hasty decision on whether or not to approve the vaccine and proceed with the procedure carefully, while watching overseas cases as well. If any cases of serious side effects are reported, the assessment may have to change,” he said. (Dec. 20)