Sputnik V Covid-19 vaccine fails to get the green light in SA - five things you need to know about the vaccine

The SA Health Products Regulatory Authority (Sahpra) on Monday announced its decision to reject the emergency use of the Sputnik V Covid-19 vaccine, citing concerns it might lead to higher HIV infection rates among vaccinated males.

The vaccine is manufactured by the Gamaleya Centre of Epidemiology and Microbiology in Russia. 

The regulator said it has been engaged in a rolling review of the data for the Sputnik V Covid-19 vaccine since the application was submitted on February 23, 2021 by locally licensed Lamar International. 

Here are five important things you need to know:

What the vaccine is made of

According to the regulator, the Sputnik V vaccine combines two separate adenovirus-vectored constructs, one relying on the Adenovirus Type 26 (Ad26) and the other on Adenovirus Type 5 (Ad5) to produce antigens, a substance that causes the immune system to produce antibodies. 

It says the safety of Ad5 vaccines in populations at risk of HIV infection has been a concern. 

What the studies have shown

The safety of adenovirus-vaccine vectors was tested in several studies including the STEP trial, which recruited men who have sex with men in the Americas, and the local Phambili trial which recruited heterosexual men and women.

“Both clinical trials were designed to administer three doses of an Ad5-vectored vaccine encoding the HIVGag, Pol and Nef proteins. In both the STEP clinical and Phambili trials, administration of an Ad5-vectored vaccine was associated with enhanced susceptibility/acquisition of HIV in men,” said the regulator.

How did Sahpra reach its decision?

The regulator said it reviewed the outcomes of the STEP and Phambili trials and requested data from the manufacturer of Sputnik V demonstrating the safety of the vaccines in the context of men and HIV.

It said a response was not forthcoming and after consultations with health experts, it found that: “the Sputnik V Covid-19 vaccine has not received Emergency Use Listing by the World Health Organisation (WHO).”

A recent update by the organisation says the process is on hold and awaiting completion of a rolling review. 

Sahpra awaits safety data

The regulator resolved that the emergency use of the vaccine under Section 21 will not be approved until the company provides relevant data that speaks to the safety of the vaccine in the context of SA men and HIV.

“The rolling review of the Sputnik V vaccine will, however, remain open for submission of relevant safety data in support of the application.”

Manufacturers respond 

TimesLIVE reported the Gamaleya Centre of Epidemiology and Microbiology dismissed the evidence cited by the SA medicines regulator, saying there was no evidence of increased risk of HIV infection 

“All the required information confirming that possible concerns about the safety of Ad5-vectored vaccines in populations at risk for HIV infection are completely unfounded will be submitted to the SA regulator,” said the institute.