Janssen COVID-19 vaccine use locally to continue, amid safety concerns
Namibia will continue to administer the Janssen COVID-19 vaccine, the country’s Registrar of Medicines, Fransina Nambahu said in a statement availed Wednesday evening.
This follows the decision by the U.S. FDA restrictions, to limit the authorised use of the Janssen vaccine in individuals 18 years of age and older after recording thrombocytopenia (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets that occurs approximately one to two weeks following vaccine administration cases.
“The Janssen COVID-19 vaccine was approved by the Namibia Medicines Regulatory Council (NMRC) for emergency use on Aug. 2, 2021, based on the efficacy, safety, and quality data available at the time of authorization. Following the recent regulatory announcements and emerging safety data, in line with the WHO, the European Medicines Agency, South Africa Health Products Regulatory Authority, and being cognizant of the limited vaccines approved in Namibia, the NMRC maintains its initial approval of the Janssen 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,” she stated.
NMRC, through the surveillance of advent events following immunization under the expanded programme on immunization, will continue to monitor the safety of all vaccines including TTS cases, she said.
The U.S. approved the vaccine only to be administered in cases where other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate and those who elect to receive the vaccine would otherwise not receive a COVID-19 vaccine.
Local healthcare professionals have been briefed to inform and educate the public about the TTS risks with the Janssen COVID-19 vaccine as well as the associated symptoms to look out for after receiving the vaccine, she concluded.