Benefits of Covid-19 vaccination ‘far outweigh the very low risks

Cape Town - Health experts maintain that the benefits of vaccines outweigh the risks, after the South African Health Products Regulatory Authority (Sahpra) confirmed the country’s first death linked to receiving the Johnson & Johnson Covid-19 vaccine.

Sahpra confirmed the person had died of Guillain-Barré syndrome (GBS) following vaccination.

To date over 20 million South Africans have been vaccinated against Covid-19 with 7 780 115 being jabbed with a Johnson & Johnson vaccine.

The National Immunisation Safety Expert Committee (NISEC) - who review and assess severe adverse events reported after immunisation - conducted a causality assessment of the reported case using the World Health Organisation’s (WHO) methodology.

“We identified the person presented with symptoms shortly after vaccination and this resulted in prolonged hospitalisation, which required mechanical ventilation and that in itself led to further complications and infections and eventually in death,” NISE’s Professor Hannelie Meyer said during a briefing yesterday.

Authorities would not reveal any details about the person, including age or province, citing patient confidentiality.

The events reported in the vaccine recipient were consistent with GBS and no other likely cause of GBS was identified at the time of illness, Sahpra said.

GBS is a very rare but severe adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by infections such as Covid-19. It affects the body’s immune system. Symptoms of GBS can vary from being mild to severe, and include muscle weakness, muscle pain, numbness, and tingling. In many cases, GBS gets better but in some cases it can become serious and cause paralysis or life threatening problems, such as breathing problems and abnormal blood pressure or heart rate.

“Regulatory authorities have previously investigated reports of GBS associated with Covid-19 vaccines. In July 2021, the European Medicine Agency conducted a review of 108 suspected cases of GBS reported worldwide after 21 million people had received the Covid-19 Vaccine Johnson. They concluded that there is a possible increased risk and causal relationship between GBS occurrence and the Covid-19 Vaccine Johnson. GBS is therefore listed as a rare adverse event in the professional information (PI) for Covid-19 Vaccine Johnson,” Sahpra chief executive Dr Boitumelo Semete-Makokotlela said.

She added that based on the currently available evidence, the regulatory body determined that the benefits of Covid-19 vaccination “far outweigh the very low risk of severe adverse events, including GBS”.

So far the Health Department’s compensation fund for Covid-19 vaccination side-effects are dealing with 75 potential claims.

South African National Bioinformatics Institute researcher Peter van Heusden said with excess death well over 300 000 during the pandemic, the “ vast majority of these people died unvaccinated”.

“They died in the waves before we had vaccines available. Every calculation by authorities around the world shows the risk of not having a vaccine is higher. Vaccines in general are the biggest public health game changer of the twentieth century. We’ve seen the influence of lack of vaccination across the world.”

He added that he understood the reason why some would be hesitant to get the jab.

“Normally you get medicine when you are sick. Now you are perfectly healthy, going to a healthcare facility where someone is going to give you something that’s going to make you feel tired and sore for a day, I understand how that can feel strange. However in terms of overall impact so many people died because we got vaccines late. If we got them at the same time they were available in America and the UK, many South African lives would have been saved,” added Van Heusden.

The South African Medical Association’s Dr Akhtar Hussain said with GBS it was very difficult to pinpoint the cause as it is very rare.

“I will advise people to take the vaccine that will prevent many other problems, millions and millions… if not vaccinated end up in the ICU. There is more risk when you are not vaccinated. People who lost their lives were mostly unvaccinated. It still has a lot of benefits protecting us. Complication is there, but that’s the case with any medicine, even paracetamol, any injection has the possibility of complication. However the benefit far outweighs the disadvantage,” he said.

Meanwhile Free the Children - Save the Nation’s John Taylor, who have taken health department and Sahpra to court to halt the vaccinating of children against the virus said: “Despite the public interest and necessity for open disclosure and public debate, Sahpra are disingenuous and not revealing all the information they should be making public.”

Cape Times