One person has died from Covid-19 jab‚ authorities say 37.5m others safe
Despite one death in SA from J&J shot‚ vaccination is still best way to prevent coronavirus infection‚ say experts
A South African has died after getting the Johnson & Johnson (J&J) Covid-19 vaccine.
About 9-million South Africans have taken the J&J vaccine and this is the first death associated with inoculations‚ SA Health Products Regulatory Authority (Sahpra) CEO Tumi Semete told a media briefing. About 37.5-million people have been vaccinated altogether‚ including the other products on offer.
The death was caused by Guillain-Barré syndrome (GBS)‚ a rare disorder where the immune system attacks the body’s nerves.
National immunisation safety expert committee chair Prof Hannelie Meyer said GBS is a known possible symptom from taking the J&J Covid-19 vaccine and is included as a contraindication in the product’s information.
“We found evidence of GBS [in the SA patient]. We know it’s a rare event but it was diagnosed in this case. Anything else could be responsible for GBS‚ but in this case there was no other cause‚” she said.
“It happened soon after the vaccination.”
She said the case involved prolonged hospitalisation‚ where the person needed mechanical ventilation. The ventilation application caused further complications and infections leading up to death.
“GBS is classified as a vaccination product reaction‚ and there was no other likely cause of GBS in this case.”
The authorities would not comment on the particulars of the person who died‚ including age‚ sex and where and when the death occurred‚ saying it violated patient confidentiality.
Minister of health Dr Joe Phaahla said though adverse events do occur after vaccinations‚ most are mild and end in a few days.
He said there had been 6‚200 adverse events reported to Sahpra‚ equating to 0.017% of the vaccinated population.
He said if links to the vaccine were found‚ there would be compensation.
Dr Nicholas Crisp‚ deputy DG of the national department of health and the person responsible for co-ordinating SA’s Covid-19 vaccine rollout‚ said from the 6‚200 adverse events after immunisation‚ “we have a fund and established 75 causally linked incidents where individuals can send in claims”.
But Semete explained the other cases were not severe and thus did not qualify for claims.
Meyer added that once an adverse event is reported‚ they need to also ensure it is the correct diagnosis. “Anaphylaxis as an example. It is a serious and rare event‚ but when we investigate the case we find the person has a bad rash but reported anaphylaxis. Thus we can’t really say [today] how many cases there have been because we are still investigating the cases.”
She said 70% of the cases reported for the J&J and the Pfizer vaccine turned out to be coincidental‚ 10% are unclassified cases where they do not know the cause‚ and about 3% of the cases were caused by stress related to the process of getting the vaccine.
Crisp said once it has been determined the vaccination caused the adverse event‚ the value and adjudication of the incident starts.
He said this process is starting for the GBS case.
Health authorities are at pains to say this is one case out of 9-million people in the country who received the J&J jab and that vaccinations are still the best way to prevent serious illness and death from the pandemic.
Prof Marc Blockman‚ chair of Sahpra pharmacovigilance‚ said GBS affects about 100‚000 people annually‚ with 1 in 100‚000 patients presenting with it globally.
“It can be mild‚ but it also has a serious element. It causes rapid aggressive ascending weakness — from lower limbs upwards — and has the potential to affect the respiratory system and brain‚ where it gets serious.”
He said the causes include viruses and bacterial infections and that some medications and vaccinations can cause or predispose patients to GBS.
He said SA was mirroring the global GBS experience in terms of Covid-19 vaccinations. “There have been a few cases reported‚ but fewer cases showed causality with vaccinations. [Despite] this tragic case‚ we are strongly convinced that the benefits of vaccination greatly outweigh the rare risk of GBS and other adverse events.”
Sahpra board chair Prof Helen Rees said: “We have lost more than 100‚000 people to Covid-19‚ [what we know is] all vaccines do well to prevent severe disease and death. We inform the public of the risk‚ but most people know someone who has died from Covid-19‚ so the benefit of vaccine outweighs the risk.”
Semete said: “We are still seeing cases of Covid-19 infection and death‚ so it is still recommended that people are vaccinated.”
Source: ARENA Holdings.