SAHPRA approves J&J booster shot

Thursday, December 23, 2021

The South African Health Products Authority (SAHPRA) has approved the Johnson & Johnson (J&J) booster shot to be taken at least two months after the original dose for adults over the age of 18.

In addition, the local drug watchdog has also authorised the heterologous booster, also known as mix-and-match jabs, for those who had the Pfizer jab at least after six months after the second dose.

“The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination,” said SAHPRA.

SAHPRA initially registered the J&J vaccine with conditions on 30 March 2021, in terms of section 15 of the Medicines and Related Substance Act (Act 101 of 1965).

On 10 December 2021, SAHPRA received an application to amend the dosing schedule for the J&J vaccine, allowing for a second dose at least two months after primary vaccination, and the use of heterologous booster immunisation following completion of primary vaccination with an approved mRNA COVID-19 vaccine.

“SAHPRA reviewed the safety and efficacy data provided, and has subsequently approved the COVID-19 vaccines Janssen second dose/booster dose,” SAHPRA said.

This comes after SAHPRA approved the administering of the third dose of the Pfizer COVID-19 vaccine for adults and children with a weak immune system.

This means all adults in South Africa are now eligible for an additional shot six months after the second dose, and it may be given at any point after that time.

The Health Department’s Deputy Director-General, Dr Nicholas Crisp, told media earlier this month that the first qualifiers for the booster shot will be eligible on 28 December.

“That is a couple of days before New Year's, so we do not envisage introducing a major new programme on New Year's Day or thereabout.

“So, from January, once the Ministerial Advisory Committee on Vaccines (VMAC) has aligned with this approval, we will get the recommendation and plan the appropriate rollout of boosters at that time,” he said.

According to the department’s data, since the start of the Sisonke programme, 230 488 second doses of the J&J vaccines have been distributed to healthcare workers who took part in the original study. – SAnews.gov.za