SA to halt J&J vaccines over blood clot fears

SA will suspend the rollout of the Johnson & Johnson Covid-19 vaccine over blood clot fears.

Health minister Dr Zweli Mkhize made the announcement at a media briefing  on Tuesday night after the US Food and Drug Administration advised a temporary 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 suspended 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”.

Co-principal investigator Prof Glenda Gray on Monday night said under the Sisonke implementation study, no cases of very rare blood clots have been detected in SA healthcare workers who have received the J&J Covid-19 vaccine.

By April 12, 289,787 healthcare workers had been vaccinated in the first phase of SA’s Covid-19 vaccination programme, according to Mkhize.

US federal health agencies on Tuesday recommended pausing the J&J Covid-19 vaccine after six recipients developed a rare disorder involving blood clots. The move comes a week after European regulators said they had found a possible link between AstraZeneca's Covid-19 vaccine and a rare blood clotting problem that had led to a small number of deaths.

J&J's single-dose vaccine — most Covid-19 shots are delivered over two doses — and AstraZeneca's low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

“We have noted the decision taken by the Food & Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US,” said Mkhize.

“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. It must be noted that over over 6.6 million citizens have been inoculated with the J&J vaccine in the US. In SA, we have not had any reports of clots that have formed after vaccination, and this is after having inoculated 289 787 healthcare workers under the Sisonke protocol,” he added.

An advisory committee to the US Centre for Disease Control and Prevention (CDC) will hold a meeting on Wednesday to review the cases linked to the J&J vaccine, and the US Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six recipients were women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets (thrombocytopenia). The CDC and FDA said the adverse events appeared to be extremely rare.

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the events and the Covid-19 vaccine made by its Janssen unit.

One woman died and a second has been hospitalised in Nebraska in critical condition, the New York Times reported, citing officials.

As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the US.

J&J shares were down 3% before the opening bell.

Mkhize shared what he said was good news for South Africans.

“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 another 10 million doses from Pfizer and, of these, we expect just under two million to be delivered in May. This 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 the J&J rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer.”