Regulators explore new methods to evaluate vaccines for latecomers

Apr 30 , 2021. 11 hours ago – 22:41 KYODO NEWS

TOKYO – A cross-border coalition of medicines regulators has begun exploring alternatives to large-scale clinical trials in evaluating the efficacy and safety of coronavirus vaccines, as it is becoming difficult for latecomers to secure enough study participants.

If the International Coalition of Medicines Regulatory Authorities finds other effective ways, drugmakers in Japan and other countries trailing the United States and European countries in COVID-19 vaccine development would be able to accelerate their development and production.

The authorization or approval of vaccines generally requires a large-scale clinical study with the involvement of tens of thousands of participants — in groups receiving a vaccine or a placebo — to assess its safety and efficacy by comparing their data.

However, since vaccination campaigns using those developed by U.S. and European makers have already been under way in a number of countries, it has become difficult for some nations to recruit a sufficient number of test subjects who hold no immunity against the novel coronavirus.

The move by the coalition came as calls have been mounting from many countries for reviewing the policy requiring large-scale clinical trials.

In Japan, for example, several companies including Shionogi & Co. have been engaging in the development of coronavirus vaccines but a large-scale clinical study becomes a major hurdle for the completion of domestic vaccines.

With highly contagious virus variants spreading in the country and elsewhere, the government is scrambling to find other ways to evaluate vaccine efficacy while not turning a blind eye to its safety, including assessment of potential side effects, at the same time.

“We are not in a stage to disclose concrete methods yet. It is essential to collect reliable data not only on efficacy but also on safety,” a Japanese health ministry official said.

The authorities are studying various ways based on data of already available vaccines developed by U.S. pharmaceutical giant Pfizer Inc. and others.

One alternative is to figure out the relationship between the amount of antibodies generated after vaccination and its effectiveness in preventing symptoms of the disease using available data.

Such a measure may allow other makers to evaluate the efficacy of their vaccine candidates by studying the amount of antibodies in small-scale clinical studies.

Other ideas include comparing data of people who received vaccines still under development and those who received authorized vaccines of U.S. and European makers. This method does not require data of those who received a placebo.

If the coalition, which plans to discuss the matter several times a month, can establish an alternative capable of evaluating COVID-19 vaccines swiftly, it would apply to the development of modified vaccines against coronavirus variants as well.

Cr. KYODO NEWS