South China Morning Post
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Chinese authorities have not released any efficacy data – let alone held public hearings – about its approved coronavirus vaccines. Photo: AP
Opinion
My Take
by Josephine Ma
My Take
by Josephine Ma

For China’s coronavirus vaccines, public trust is in the detailed data

  • The US drug regulator has broadcast advisory committee hearings live and put questions directly to pharmaceutical executives
  • China and the WHO could take a page out of this playbook
Josephine Ma
Josephine Ma
Why you can trust SCMP
In the last two weeks, there has been intense public interest in two ordinarily dry technical meetings in the United States. The interest was in meetings of a Food and Drug Administration advisory committee vote on emergency use licensing recommendations for coronavirus vaccines from pharma firms Pfizer/BioNTech and Moderna.

The FDA released detailed documents about the vaccines before the discussions and broadcast the meetings live to shore up public confidence in the applications.

Many details were disclosed in the process, including that some clinical trial participants developed a temporary form of facial paralysis called Bell’s palsy. Scientists said the paralysis was unlikely a result of the vaccines but the cases prompted the FDA to call for further monitoring.

Moderna’s executives were also questioned about the possibility of their vaccine inducing the severe allergic reactions a nurse suffered after taking a Pfizer shot.

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The exercise is not enough to answer all questions or satisfy everyone, but it helped to manage public expectations and assure people that the regulator was being careful.

The FDA is recognised by the World Health Organization as a stringent regulatory authority (SRA) and the vaccines it approves normally have an easier path to prequalification with the WHO.

China has also approved a number of vaccines for emergency use but much less is known publicly about them. So far the authorities have not released any efficacy data – let alone held public hearings like those in the US.

But China will have to be prepared for the same level of scrutiny when it begins to export its vaccines because regulators from other countries will request to review the data. Many regulators may not be as experienced as an SRA and they would likely use the WHO approvals as a guide. The WHO prequalification is also a prerequisite for Chinese vaccines to be included in the Covax Facility, a mechanism many developing countries are relying on Covid-19 vaccines.

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Poor countries said to be left behind in Covid-19 vaccine race as rich nations get first doses

Poor countries said to be left behind in Covid-19 vaccine race as rich nations get first doses

If China wants to be an international player in the Covid-19 vaccine market, it needs to apply for

WHO prequalification. It should also be prepared to disclose data and answer questions in public.

Given the intense interest, the WHO should consider learningfrom the FDA in broadcasting some of its specialist discussions when it reviews applications from the Chinese candidates. It would improve public confidence not only in the Chinese vaccines but also in the WHO itself.

This article appeared in the South China Morning Post print edition as: Public trust in China vaccines rests on data
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