Today, the Western Cape Government hosted the weekly digital press conference, where we were joined by the CEO of South African Health Products Regulatory Authority (SAHPRA), Dr Boitumelo Semete-Makokotlela, and the Chair of the Board of SAHPRA, Professor Helen Rees.
It was explained that the work done by SAHPRA is conducted in line with the International Coalition of Medicines Regulatory Authorities and the World Health Organisation. This is done alongside regulatory authorities in the USA, Australia, Canada, Europe, Nigeria and Brazil. It also shows us that the work conducted by SAHPRA to ensure vaccine safety is in line with international norms and standards and rooted in best practice.
The presentation provided by SAHPRA spoke to the rigorous process followed by SAHPRA on authorization and ensuring the safety of the COVID-19 vaccine. This process includes:
Verifying the applicant is licensed, SAHPRA compliant and can oversee the necessary processes;
Ensuring that each production site complies with good manufacturing process and conducting the necessary evaluations;
Ensuring that the production process adheres to best practice and ensuring the necessary assessments are conducted;
Evaluating pre-clinical data to ensure that the vaccine trial meets all regulatory requirements for vaccines;
Assessing clinical trials in terms of safety data and providing evidence of the vaccine’s ability to prevent COVID-19;
Ensuring that the vaccine schedule is aligned to the clinical data, product labelling and patient information leaflet;
Assisting rejected applicants to appeal to the CEO of SAHPRA within 20 days. They can further appeal to the health minister; and
Verifying lot release requirements to ensure easy accessibility of rest reports, lot summary protocol, transportation and cold chain verification.
In a period where there is so much misinformation being spread on social media, it was encouraging to hear the extensive efforts undertaken by SAHPRA to ensure that vaccines are safe to use.
“Adverse side effects related to vaccines are still extremely rare.”
The COVID-19 vaccine is safe to administer and there are very, very rare instances in which people experience serious side effects.
As of 10 September 2021, the Provincial Department of Health found that the most common adverse side effects reported were mostly mild, including:
Headaches in 18.1% of cases;
General body pain in 15.1% of cases; and
Fever over 38ºC in 9.9% of cases.
Of the reported side effects, most cases are mild and serious side effects remain extremely rare.
At a recent briefing by SAHPRA it was highlighted that while there have been reports of common adverse side-effects from COVID-19 vaccines, there have been no confirmed cases of deaths linked to the vaccine.
Between May and August 2021, following an extensive investigation by SAHPRA’s experts in their field, 40 deaths required investigation and the findings by the experts confirmed 34 cases were unrelated to the vaccine and 6 cases had insufficient information to conclude.
The benefits of getting vaccinated, far outweigh the potential risks of side effects. In an analysis conducted by the Provincial Department of Health between 14 – 20 August, when the Western Cape was in its peak of the third wave, 96% of those over 60 years who were hospitalized were not fully vaccinated and 98.3% of those who died were not fully vaccinated.
To ensure that our vaccine programme continues to operate at the highest standards and that it ensures the safety of all, the Provincial Department of Health will continue to conduct its intensive safety monitoring practices.
“We are on track to exit the third wave by 27 September 2021”
We have now passed the peak of the third wave with infections, admissions and deaths continuing to decline, and we are on track to exit the third wave by 27 September 2021, according to SAMRC projections.
The province will have officially exited the third wave once we reach a daily caseload of approximately 530 cases a day or 15% of cases compared to the peak of the third wave.
While this is welcomed, we must continue to practice the lifesaving behaviours that we have learnt throughout the pandemic to prevent spikes or outbreaks, particularly as we approach the summer season.
Our healthcare platform shows us that across the province:
Case numbers continue to decline, with approximately 1000 new diagnoses daily.
The proportion of positive COVID-19 tests have decreased to 16.3%.
Admissions and deaths have started to decrease more steadily, with an average of 170 new admissions to hospitals a day and approximately 52 deaths a day.
There has been a steady decline in excess deaths both in the Cape Metro and across the province.
The Reproduction or “R” number, which is based on cases and deaths, is now firmly below 1 indicating that we are continuing to exit the third wave.
“Pressure on the healthcare platform continues to decline”
We have tailored our response to the third wave in line with clearly identified trigger points to ensure that we protect our healthcare system so that we can respond throughout the pandemic.
I am pleased to note that we have exited the current third wave warning indicator and we can now begin de-escalating the triggered response in line with the decreased pressure placed on the healthcare platform.
Insofar as our acute service platform is concerned:
Currently, there are 2 466 COVID-19 patients in our acute hospitals (1399 in public hospitals and 1067 in private hospitals). This excludes persons under investigation and cases in specialised hospital settings.
The Metro hospitals have an average bed occupancy rate of 92%; George drainage area hospitals at 64%; Paarl drainage area hospitals at 77% and Worcester drainage area hospitals at 69%. The critical care bed occupancy rate for the province at 78%.
COVID-19 and persons under investigation cases currently make up 19%, compared to 22% last week, of all available acute general hospital capacity in both Metro and Rural Regional Hospital drainage areas.
COVID inter-mediate care: the Brackengate Hospital of Hope currently has 151 patients or 44.9% bed occupancy rate, Mitchells Plain Hospital of Hope has 46 clients or a 29.8% bed occupancy rate, and Sonstraal currently has 42 clients or a 70% bed occupancy rate. We have not had to bring online Freesia and Ward 99 throughout the third wave.
The Metro mass fatality centre has the capacity for 240 bodies and 8 decedents have been admitted. The overall capacity has been successfully managed across the province and the TMFC will close on 30 September.
“Western Cape has vaccinated more people, as a percentage of total adult population, than any other province”
The Western Cape has vaccinated (with at least one dose) approximately 36.6% of its adult population and is the leading province in the percentage of the 18+ population vaccinated to date.
By 15 September 2021, the total number of individuals vaccinated who have received at least one dose is 1 821 815. Of which, the total number of individuals fully vaccinated was 1 133 038 or 22.75% of the adult population.
By 15 September 2021, the public sector has received 2 671 240 vaccine doses which include 2 346 510 single doses of Pfizer and 324 730 doses Johnson & Johnson.
We consistently scaled up our vaccination capacity and we now can vaccinate over 50 000 people a day, ensuring that we administer up to 200 000 vaccines a week. This has been supported by the additional vaccine supply received.
“Premier Winde calls to play their part in saving our summer”
As we approach the summer season and exit the third wave, we must continue to be vigilant and practice the lifesaving behaviours that we learnt over the pandemic.
Please:
Get vaccinated when it is your turn.
Wear your mask properly, covering your nose and mouth.
Wash and sanitise your hands regularly.
Keep your gatherings short, small and outdoors – with lots of ventilation.
Stay home if you feel sick. If you have any difficulty breathing, seek urgent medical treatment.
Together, we can save both lives and livelihoods and reduce the impact of later waves so that we can begin to move forward.
Source: Government of South Africa