SA will suspend the rollout of the Johnson & Johnson Covid-19 vaccine over blood clot fears, health minister Dr Zweli Mkhize said on Tuesday.
Mkhize was speaking at a media briefing on Tuesday night after the US Food and Drug Administration advised a temporarily suspension of its rollout of the J&J vaccine after six women developed “unusual blood clots” within two weeks of receiving the shot.
“We cannot take the decision of the FDA lightly. We've voluntarily suspend the rollout until the causal relationship between the blood clot and the vaccine is sufficiently interrogated,” he said.
Mkhize hoped this would be done within “a few days”.
Mkhize emphasised that there were no reports of blood clots after vaccination in SA and that the decision to halt the J&J vaccine was just a “precautionary decision”.
“In SA, 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 & Johnson vaccine is sufficiently interrogated. SAHPRA [the SA Health Products Regulatory Authority] will collate information from Johnson & 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,” he said.
Mkhize was confident that there would be more answers “over the next few days”, before additional supplies of the vaccines arrived on SA shores next week.
“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 roll out 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,” he said.
He insisted that it was not a knee-jerk decision and that it would not have a significant affect on the vaccine roll out in SA.
Mkhize said that towards the end of last year, the government was attacked for not securing vaccines early enough and was now being questioned on why it had moved so fast with Johnson and Johnson.
“We went for a vaccine that showed efficacy. We have secured the vaccines. We have not got a link that has proved there is a link between the vaccine and the clotting.”
Mkhize said there wasn’t a need to discuss a refund or contractual issues as he was confident that the matter would be cleared up in a few days.
He also had good news in the midst of the latest 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 two million to be delivered in May. This therefore means we have secured 30 million doses of Pfizer vaccine for this financial year. This also reassures us that, in the extremely unlikely event that Johnson & Johnson rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer.
“We are confident that the rollout of Johnson & Johnson will resume and so, with 30 million doses of Johnson & Johnson and 30 million doses of Pfizer secured, we now have enough doses to exceed the 40 million we were targeting this year. This is in line with our commitment to vaccinate as many people as possible in this financial year — in the ideal scenario we would vaccinate every single adult in SA,” the minister said.
He said the latest development was an example of how the government made commitments and worked to the best of its ability to honour those commitments. However, he said, science must be respected at all times, which sometimes meant a disruption in plans.
“Though we are operating in dynamic and ever-changing environment, the government is constantly seeking to secure vaccines that will protect us from the 501Y.V2 variant. We therefore urge South Africans to be supportive of our experts and scientists as they work under enormous pressure to give us answers on this worrying development so that we may proceed safely with the global vaccination programme.
“We commit to keeping the public informed of all developments,” he said.
Mkhize added that he did not have concrete evidence on when the third wave would hit SA.