New platform to monitor safety of AstraZeneca/Oxford University vaccine

Nursing officer Beverlyne Wambani (R) injects Governor Wycliffe Oparanya with AstraZeneca vaccine. [Nathan Ochunge, Standard]

The poisons board has unveiled a new platform to monitor safety of vaccines and health technologies. It is expected to play a key role in monitoring side effects.

The Pharmacovigilance Electronic Reporting System version II (PvERS II) system is an upgrade from the previous version (V.1) which is said to have gaps in quality of reports submitted and it did not include health technologies.

These include side effects from blood and blood product transfusions and adverse effects from immunisation.

Health Chief Administrative Secretary Rashid Aman said the Ministry of Health, through the Pharmacy and Poisons Board, is committed to providing Kenyans with safe, quality and efficacious health products and technologies.

“We are looking forward to great outputs from the upgraded system, especially during this time when we are still fighting the Covid-19 pandemic,” said Dr Aman.

“The country has rolled out Covid-19 vaccines through the Emergency Use Authorisation programme. This underscores the need to have a system that can quickly and effectively detect and respond to any safety concerns that may rise,” he said.

Additional forms

The new system has additional forms which have been incorporated: medical errors (blue forms), adverse events following immunisations (white forms), incidences following medical device (green form), and haemovigilance reaction due to blood and blood products (cream form).

The ongoing roll out of the AstraZeneca/Oxford University vaccine has caused anxiety among Kenyans following adverse side effect of blood clots reported in other countries.

So far 13, countries in the European Union have suspended the administration of the jab.

The World Health Organisation is monitoring the situation and is expected to give a way forward.

Poisons board chief executive officer Fred Siyoi said through the Management Sciences for Health, the pharmacovigilance electronic reporting system has collected over 14,000 reports on individual cases and 1,000 suspected quality defect reports.

“These reports have been used to inform policy change, review of treatment guidelines and various regulatory actions.

“The new system will also be more interactive and allow users at a snap shot to view summaries of what is reported to PPB,” said Siyoi.