Staff Reporter
THE Namibia Medicines Regulatory Council (NMRC) has stated that it maintains its initial approval of the use of the Johnson & Johnson’s vaccine, despite recent announcement’s that the US will restrict its use, after health concerns raised by the US Food and Drug Administration (USFDA).
On 13 April 2021, the (USFDA) announced a 10—day pause in the administration of the Johnson and Johnson COVID—19 vaccine to allow investigations of six reported cases of thrombocytopenia syndrome (TTS).
Thrombocytopenia syndrome is a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets that occurs approximately 1-2 weeks following vaccine administration. Symptoms include shortness of breath, chest pain, leg swelling, persistent stomach pain, neurological symptoms (including severe ‘or persistent headaches or blurred vision), or petechiae beyond site of injection site.
By 22 March 2022, there were sixty (60) TTS confirmed cases in the United States of America (USA), nine of which were fatal.
“Following the recent regulatory announcements and emerging safety data, in line with the WHO, the EMA, SAHPRA, and being cognizant of the limited vaccines approved in Namibia, the NMRC maintains its initial approval of the Johnson and Johnson COVID—19 vaccine for individuals 18 years of age and older as the known and potential benefits outweigh the known and potential risks of receiving the Janssen COVID-19 vaccine,” Fransina Nambahu, registrar of medicines at the NMRC stated.
She added that the NMRC, through the surveillance of adverse event following immunization (AEFI) under the expanded program on immunization (EPI), will continue to monitor the safety of all vaccines including the TTS cases.
“Any significant changes to the safety profile and regulatory actions taken regarding the Johnson and Johnson COVID-19 vaccine will be communicated,” Nambahu said.
As it stands currently, the reporting rate of TTS is 3.23 per million doses of vaccine administered and the reporting rate of TTS related deaths is 0.48 per million doses of vaccine administered.
In addition to cases reported in the US, so far, there have been four cases of TTS reported in South Africa following administration of 8.5 million doses of the Janssen COVID-19 vaccine.
Investigations of these cases are currently underway. Nonetheless, the Johnson and Johnson COVID- 19 vaccine remains in use in South Africa, in line with the World Health Organization (WHO), as well as the European Medicines Agency (EMA) and because the known benefits of the vaccine for the prevention of COVID—19 greatly outweigh the known and potential risks of receiving the vaccine.
Namibia has administered a total of 160,849 doses of the Janssen COVID—19 vaccine (149,428 of 1St doses and 11,421 of booster doses). No cases of TTS have been reported through the adverse event following immunization (AEFI) surveillance system to the NMRC thus far.
Nambahu however encouraged healthcare professionals to inform and educate the public of the TTS risk with the Janssen COVID—19 vaccine as well as the TTS associated symptoms to look out for when vaccinated with the Janssen COVlD—19 vaccine.
“The Janssen COVID-19 vaccine should be avoided in individuals with known history or risk factors for thrombosis or thrombocytopenia including previous thrombotic events after COVID—19 vaccination. Furthermore, healthcare professionals should report all AEFI with COVID—19 vaccines, including the Janssen COVID-19 vaccine using the AEFI reporting form, and forwarding the completed forms to the EPI via the Regional Chief Health Programme Officer or District Primary Healthcare Supervisor,” Nambahu said.
The public is also encouraged to report any adverse event that have occurred following vaccination with COVID-19 vaccines, including the Janssen COVID-19 vaccine to the healthcare professionals at vaccination points or any health facility.
