Health department insists J&J vaccine is safe and will continue with roll-out

The health department said on Friday it was confident the Johnson & Johnson (J&J) Covid-19 vaccine was safe and it would continue administering it throughout the country.

This comes after the US Centers for Disease Control said last week the Moderna and Pfizer vaccines should be used ahead of the J&J version. This is because of fears the J&J shot could, in rare instances, cause blood clots, or thrombosis.

The Moderna and Pfizer vaccines use mRNA technology.

On Friday the SA health department stood by its roll-out of the J&J vaccine, which was the first to be administered in the country under the Sisonke Trial for healthcare and related workers.

“The advisory committee on immunisation practices noted during its review that any vaccine is better than being unvaccinated, and those who are unable or unwilling to receive an mRNA vaccine would continue to have access to the J&J Covid-19 vaccine.

“The decision made in the context of rare adverse events and an abundance of mRNA vaccines in the US should not undermine the roll-out of the J&J vaccine in other parts of the world,” the department said.

It said the SA Medical Research Council (SAMRC) had analysed data from the Sisonke study, which delivered almost 500,000 doses, by monitoring adverse events (AEs).

“The frequency and incidence rate of non-serious and serious AEs were evaluated from day of first vaccination (February 17 2021) until 28 days after the final vaccination (June 15 2021). Of 477,234 participants, only 10,279 (2.2%) reported AEs. Serious side-effects were rare and occurred in only 129 healthcare workers.

“The most common side-effects were headaches and body aches, followed by injection site pain and fever, and most occurred within 48 hours of vaccination.

“In terms of rare events, the SAMRC saw two cases of thrombosis with thrombocytopenia syndrome (blood clotting) and four cases of Guillain-Barre Syndrome. There were no deaths due to the TTS or Guillain Barre Syndrome,” the department said.

Prof Glenda Gray, co-national investigator of the Sisonke study, was quoted as saying that serious adverse effects “occurred at lower than the expected population rates”.

Linda Gail Bekker, co-national lead of the study, said: “Our safety data demonstrates this vaccine was well tolerated and all the rare events associated with the J&J vaccine were well managed, demonstrating that in low and middle income countries, this single dose vaccine has great utility.” 

The health department said while the US had suspended use of the J&J vaccine, countries including France and Poland have “weighed the risks and chosen to continue to provide the J&J vaccine while this rare side effect is considered”.

“The department of health is satisfied the J&J vaccine continues to provide much hope to South Africans. This data and evidence from international data is being evaluated by the SA Health Products Authority.”

TimesLIVE