EFF calls for immediate halt in roll out of J&J vaccine
13 April 2021
The EFF unequivocally calls for an immediate halt of the Johnson & Johnson Vaccine that is being administered in South Africa as part of the Phase 1 of the Vaccine Rollout Plan. Phase 1 of the Vaccine Rollout Plan is set to focus on healthcare workers, who were initially a part of the vaccine trial in the Phase 3b of the Johnson & Johnson vaccine trial.
The call by the EFF is guided by the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention recommendation that the Johnson & Johnson vaccine be halted in the United States of America following severe adverse reaction in six cases of women aged between the ages 18 — 45 after having received the single dose vaccine.
As part of the regulations that saw the successful registration of the Johnson & Johnson vaccine by the South African Health Products Regulatory Authority (SAHPRA), the registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965 and furthermore, as per the assertion of SAHPRA CEO, Boitumelo Semete-Makokotlela, "the authorisation [of Johnson & Johnson Vaccine] is subject to a number of conditions... further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan including the submission of periodic safety updates."
Part and parcel of the vaccine rollout in the fight against Covid-19 is the global monitoring of the research generated in countries rolling out the Johnson & Johnson vaccine in the interest of risk management and consistent safety updates. Primary side effects noted by the FDA and the CDC that should be distinctly monitored and
be halted, include muscle pain and nausea. These side effects have already been noted in the South African Sisonke study and thus the urgency to halt the Johnson & Johnson vaccine.
The EFF emphasises the call to President Cyril Ramaphosa and Minister Zwelini Mkhize to not abandon their duty to protect our people from a possible health related threat in regards to the Johnson & Johnson Vaccine in favour of their business associates. The decision to halt the Johnson & Johnson Vaccine rollout should not rely on domestic evidence and life being lost in our country first when health bodies that they initially relied on to motivate the extended study/trial of the Johnson & Johnson vaccine cite a concern related to the J&J Vaccine.
The EFF thus calls for an immediate halt to the Johnson & Johnson vaccine rollout pending a completion of the investigation to the severe adverse effects in six cases cited by the FDA and CDC and an immediate replacement of other available vaccines.
Finally, we urge the South African government to consider the Russian and Chinese vaccines, which up to this point, have proven to be of better efficacy than EuroAmerican vaccines.
Issued by Vuyani Pambo, National Spokesperson, EFF, 13 April 2021
