REGULATORY

Shots, Symptoms And Side Effects: How Regulators Ensure The Safety Of COVID-19 Vaccines

Medicines regulators constantly monitor the safety of COVID-19 vaccines by tracking reactions among people who have gotten the jab. Each case is investigated to see if the symptoms are caused by the vaccine, in which case the response will be listed as a side effect.

Nicole Davids says she finally has closure after health officials confirmed her husband died from COVID-19 vaccine side effects.

The news comes a year after Larry Davids died after being diagnosed with Guillain-Barré syndrome.

South Africa now has two deaths connected to the Johnson and Johnson COVID-19 jab

“This is the closure I needed,” said Nicole Davids, who has been trying to get answers from Western Cape health authorities almost a year after her husband died.

Larry Davids was diagnosed with a rare autoimmune disease called Guillain-Barré syndrome (GBS) after he fell violently ill soon after getting the Johnson and Johnson COVID-19 vaccination, News24 reported.

Nicole took Larry to Victoria Hospital where he received medication, but he collapsed a day later. Larry was then taken to Groote Schuur Hospital where he was placed on a ventilator, and soon afterwards was diagnosed with GBS. He died a month later in September last year.

The South African Health Products Regulatory Authority (Sahpra) confirmed in August this year the country’s first death linked to GBS, stemming from the Johnson & Johnson COVID-19 vaccine.

News24 previously pressed the Western Cape health department for answers around Larry’s death, but the department’s spokesperson Mark van der Heever would not provide details.

Davids took her query directly to Sahpra, which, after investigations, confirmed that Larry was the country’s second death from GBS linked to the Johnson & Johnson Covid-19 vaccine.

“The events reported in the vaccine recipient were consistent with the case definition of GBS, and no other likely cause of GBS was identified at the time of illness,” said Sahpra chief executive, Dr Boitumelo Semete-Makokotlela on Monday.

She said:

As previously communicated, GBS is a very rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by some bacterial or viral infections, including SARS-CoV-2.

Speaking to News24, Davids confirmed the Sahpra report was about her husband.

She had a meeting with health officials on Monday who confirmed his death was linked to the vaccine.

“It was just a horrible day for me as I felt I had to relive all the emotions all over again almost a year later.

“It has taken them nearly 12 months. I am just glad I don’t have to carry the guilt that I didn’t do enough as a wife. That it was my fault and that I didn’t ask the right questions,” she said.

Davids said health officials apologised to her over Larry’s death, which was never reported last year.

“They said I didn’t deserve what happened to me and that I was supposed to have been treated properly.”

Davids, whose birthday is on Wednesday, said her last birthday was miserable because that was when she received the call about Larry’s health deteriorating.

She said:

This apology and confirmation feel like an early birthday present.

She said she was relieved her quest for the truth had yielded results.

“Them saying he did die from the vaccine gave me closure. I got my answers.”

GBS, which affects around 100 000 people a year globally, is characterised by muscle weakness, muscle pain, numbness, and tingling, said Semete-Makokotlela.

“In many cases, GBS resolves with no serious after-effects, but in some cases, GBS can cause serious or life-threatening problems.”

Semete-Makokotlela said regulatory authorities have previously investigated reports of GBS associated with COVID-19 vaccines.

“They concluded that COVID-19 vaccine Janssen may increase the risk of GBS. GBS is therefore listed as a rare adverse event in the professional information for COVID-19 vaccine Janssen,” she said.

Semete-Makokotlela said investigations and causality assessments of all reported severe adverse events following immunisation with the COVID-19 vaccine, Johnson & Johnson vaccine, and other COVID-19 vaccines were ongoing.

“The outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.”

She said despite the deaths, the best defence against COVID-19 was still to get vaccinated.

“COVID-19 vaccines have consistently been shown to prevent severe forms of disease, hospitalisation and death. Based on the currently available evidence, Sahpra has determined that the benefits of Covid-19 vaccination far outweigh the very low risk of severe adverse events, including GBS.

“The public are strongly advised not to delay COVID-19 vaccination if eligible in terms of the national vaccination programme.”

So far just over 50 per cent of the adult population has been vaccinated in the country.

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