South Africa’s Health Minister, Dr Zweli Mkhize, has announced the temporary and voluntary pause of the COVID-19 Johnson & Johnson (J&J) vaccine rollout in SA following reports of rare blood clots abroad.
According to the National Institute for Communicable Diseases, Dr Mkhize has made the announcement following a recommendation from the FDA in the USA, where six women reported a rare type of blood clot 6 to 13 days after the J&J vaccine was administered.
The next steps will see SAHPRA collating all the information in order to make a thorough recommendation, and hopes are high to resume the vaccine rollout soon.
A few rare blood clots have also been reported in Europe after the use of the AstraZeneca vaccine. Millions of people around the world have been successfully vaccinated.
Dr Mkhize said in a statement:
“We have noted the decision taken by the Food and Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US.
“This has occurred due to reports of six females who developed unusual blood clots with low platelets. These incidents occurred between six and 13 days after vaccination in women between the ages of 18 and 48 years old. It must be noted that over 6.6 million citizens have been inoculated with Johnson and Johnson vaccine in the US.
“In South Africa, we have not had any reports of clots that have formed after vaccination, and this is after having inoculated 289 787 health care workers under the Sisonke Protocol.
“Having said that, after this advisory came to my attention I held urgent consultations with our scientists, who have advised that we cannot take the decision made by the FDA lightly. Based on their advice, we have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson and Johnson vaccine is sufficiently interrogated. SAHPRA will collate information from Johnson and Johnson, the FDA and other regulatory bodies to make a thorough assessment of the situation and advise us as a regulatory body that has exercised its authoritative powers on the approval of the vaccine in their own right.
“I humbly call for calm and patience as we ensure that we continue to be properly guided by science in ensuring the safety of our people as we rollout the vaccine campaign.
“We hope that the deliberations will only take a few days. Given the preliminary literature on hand, our scientists are confident that the FDA’s decision is on a precautionary basis and we expect that this will not result in the complete withdrawal of the Johnson and Johnson vaccine from the vaccination armament.
“We also wish to assure citizens that these kind of reports are expected to emerge as part of a robust post market surveillance system – this should provide comfort that medical authorities keep a vigilant watch on all new products that are deployed into the market to ensure they remain safe and effective for human consumption. It is for this reason that we implemented the Sisonke Protocol and will also implement a similar post market surveillance study for Pfizer when we roll out the first batch of doses to health care workers.
“I am glad to say, however, that there is good news in the midst of this development.
“I am happy to announce that we have successfully negotiated for another 10 million doses from Pfizer and, of these, we expect just under 2 million to be delivered in May. This therefore means we have secured 30 million doses of Pfizer vaccine for this financial year.”