covid vaccines

Second J&J vaccine death in SA a potential indication of tragic events to come

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Horrific statistics in respect of Covid-19 vaccine deaths are surfacing. The Office for National Statistics (ONS), the UK’s largest independent producer of official statistics and the recognised national statistical institute of the UK, released a dataset showing that between 1 January 2021 and 31 May 2022, a total of 14,103 people died with Covid-19 within 60 days of vaccination, and a total of 166,556 people died of any other cause within 60 days of vaccination. In total, 180,659 people died within 60 days of Covid-19 vaccination between January 2021 and May 2022 in England. In Germany, an analysis by two German university professors of government data has implicated Covid-19 vaccination as a factor in excess deaths. SAHPRA’s recent announcement of the second Johnson & Johnson Covid-19 vaccine death in the country may, if the prevailing data in the developed world is any indication, be the beginning of very tragic events to come. – Nadya Swart

Covid-19 Vaccine Janssen Update – Second Fatal Case Of Guillain-Barré Syndrome

On the 04th of August 2022, SAHPRA issued a media statement relating to the first fatal case of GBS following vaccination with COVID-19 Vaccine Janssen. Recently, SAHPRA has been informed of a second fatal case of Guillain-Barré syndrome (GBS) following vaccination with the COVID-19 Vaccine Janssen. Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organisation’s (WHO) methodology. The case was classified as a vaccine product-related event following investigations conducted and causality assessment. 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.

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. Symptoms of GBS range from mild to severe, and may include muscle weakness, muscle pain, numbness, and tingling. In many cases, GBS resolves with no serious after-effects, but in some cases GBS can cause serious or life-threatening problems.

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 (PI) for COVID-19 Vaccine Janssen.

Investigations and causality assessment of all reported severe AEFI with the COVID-19 Vaccine Janssen and other COVID-19 vaccines are ongoing. The outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.

Important points to note

  • 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.
  • SAHPRA urges the public to report any suspected adverse events following the use of all medicines and vaccines. Reporting can be done at a health facility or by downloading the Med Safety App (https://medsafety.sahpra.org.za/), which is available for Android and iOS phones, or by calling the COVID-19 hotline at 0800 029 999. More information regarding AEFIs reported for the COVID-19 vaccines and how to report an AEFI is available from the SAHPRA website: https://aefi-reporting.sahpra.org.za/.

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