Source : 'The Pink Sheet'
As China’s state-owned Sinopharm Group Co. Ltd. starts its Phase III study in Abu Dhabi and Beijing-based Sinovac Biotech Ltd. commences its study with partner Butantan in Brazil, the race to approve and launch the first coronavirus vaccines is heating up fast. However, a lack of guidance on how to handle data obtained outside China could become a challenge for a program even with strong clinical results.
So far, China’s regulatory agency, the National Medical Products Administration (NMPA), has yet to issue guidance over the use of such data towards approving the vaccines in China, and regulatory experts say that absence could be a significant stumbling block for sponsors, especially since the government has traditionally required ethic difference studies when using clinical data obtained from non-Chinese populations.
A former FDA China official told the Pink Sheet that the relevance of foreign data may limited not only because of potential “ethical differences” in the studies, but because the “virus itself potentially varies due to different time and locations.”
As developers around the world continue their race to develop the vaccines, many stakeholders have voiced concerns over a the potential risks from a focus on speed and lack of independence of regulatory agencies. In what could be seen as a response to those concerns, the US FDA, for one, has publicly set a bar for sponsors to meet in developing COVID-19 vaccines: an efficacy rate of at least 50%.
The US FDA recommendation is intended to ensure quality and value but also public confidence to encourage uptake and help achieve herd immunity. ("COVID19 Vaccine Should Demonstrate At Least 50 Effectiveness US FDA Says" "Pink Sheet" )
In the past, made-in-China vaccines such as Hecolin, the hepatitis E product developed by Xiamen-based InnoVax, have been used outside the country via the World Health Organization’s pre-qualification (Pre-Q) program. But logistical disruptions from the global coronavirus pandemic, not just the need to have a vaccine ready fast, has made the regular inspections and vetting process difficult to undertake.
China also said the government will provide the vaccines, if approved, as a “global public good,” though the pledge raises several questions. First, whether China will approve the vaccines if the efficacy data is from a population outside China, and second, whether China would seek approvals from other national regulatory agencies to make the products available for use.
Furthermore, without the WHO’s prequalified vetting, the use of the vaccines outside China could be a hard sell. So far, NMPA has provided no clarifications about the pathways.
Some say the urgency of the pandemic could give the vaccines a leeway to gain faster approvals and wider use. “Coronavirus vaccines could potentially open doors to some rule bending,” noted a clinical study professional, who cited surging cases and urgency to prevent the second wave, especially in Latin American countries where cold weather may worsen the virus spread.
But Chinese regulators say they won’t relax rules over the vaccines. In 2019, China issued the first-ever Vaccines Administration Law, explicitly requiring vaccines makers to ensure product quality and safety and monitor any quality-related issues post-market launches. Several vaccines makers, including Changchun Changsheng, have received harsh punishment due to quality violations, and the new law will likely to deter further potential violators, insiders say.
By Brian Yang