Day: September 13, 2021

The South African Health Products Authority (SAHPRA) has given the green light for children aged 12 and older to receive the Pfizer COVID-19 vaccine.

According to the local drug watchdog, the approval is in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965, also known as the Medicine Act.

“This was as a consequence of the review of updated safety and efficacy information submitted as conditions of Section 21 initially authorised on 16 March 2021,” SAHPRA said.

In addition, the watchdog said, Section 21 of the Medicines Act is a mechanism that enables emergency use access and allows it to authorise the use of medicine, subject to certain conditions.

“The regulatory decisions of SAHPRA do not translate into a procurement decision, as SAHPRA’s mandate is limited to safety, quality and efficacy of health products.”

In March, SAHPRA has approved the Section 21 application for the Pfizer vaccine for adults.

University of KwaZulu-Natal Acting Deputy Vice-Chancellor for Research and Innovation, Professor Mosa Moshabela, told the SABC that there is now a strong case for vaccinating children.

“Initially, we thought COVID-19 doesn’t affect children very much from the first wave but that has changed over time. We now know that the Delta variant, the burden on children was quite high, where they can suffer from long COVID,” he said.

Meanwhile, he said the burden has shifted to children now that more adults are getting vaccinated and are protected.

“We’ve seen outbreaks in South Africa in schools and this has limited the possibility of children catching up in terms of learning. I think, therefore, there’s a strong case to be made for children to be vaccinated, especially because schools are daily gatherings and social gatherings, and can contribute to reinfections in the households, as well as most from schools to households through these children.”

Moshable has also welcomed the launch of the main phase of a global COVID-19 vaccine study on children and teenagers, led by Chinese Coronavirus-vaccine maker, Sinovac Biotech.

The trials will be conducted on 2 000 children aged six months to 17 years, based on international data.

According to reports, the trials will enrol 14 000 children from South Africa, Chile, the Philippines, Malaysia and Kenya.

“I think SAHPRA should engage the public on the data that they have used to make this decision because it’s not something that originated in South Africa, and there’s a lot more effort on the side of SAHRPA to actually convince the South African public why they made that decision and how safe it is for the kids.”

Moshabela believes that the country needs to show that the data is there and it is compelling.

Source: South African Government News Agency

KwaZulu-Natal Premier Sihle Zikalala has encouraged citizens in the province to get vaccinated in order to get the country to reach herd immunity quicker.

He was speaking at the launch of the province’s first drive-through vaccination site at the UMhlathuze Sports Complex in Richards Bay on Friday.

Zikala said the site will provide for quicker turnaround times for those who are willing to get vaccinated but don’t want to stand in line to do so.

“We are… here to launch the drive-through [vaccination site] where people will be able to vaccinate while still in their cars and without standing in a queue for a long time.

“Vaccination will help us to get life back to normal. So it’s important for all of us to take the jab,” he said.

The drive-through vaccination site also boasts a walk-in site for those not using vehicles.

Zikalala encouraged people – especially those who are calling for the return of fans to sports stadiums – to go out and get vaccinated.

“Today there is a big [football] game that is taking place… Surely the supporters would have loved to go there but they can’t because they have not vaccinated and the country… has not reached a point of herd immunity. People want to go back to their normal lives but that can only happen if we all go out and vaccinate.

“In some areas, numbers are increasing but we would like to encourage the youth, men and women to get vaccinated, and not hesitate to do so,” Zikalala said.

Source: South African Government News Agency

Agriculture, Land Reform and Rural Development Minister Thoko Didiza, has announced the reduction of the size of the disease management area (DMA) affected by foot-and-mouth diseases (FMD) in KwaZulu-Natal.

This follows the conclusion of the second round of serological surveillance, where it was established that the disease, within the DMA, is still confined to two clusters of diptanks in Mtubatuba and Nongoma.

This shows that the restriction on the movement of animals out of, within, through, and into the DMA was sufficient to prevent the disease from spreading.

“Since the disease did not spread within or outside of the DMA, the size of the KZN DMA can now be decreased. This will release areas that remained free of the disease from movement restrictions, while still maintaining restrictions on those areas where the disease is still present,” Didiza said in a statement.

The Minister declared in the Gazette the new KZN DMA, which includes the following areas:

The portions of the Pongola local municipality east of the R66, and south and west of the N2;

The whole of the Nongoma local municipality;

The portions of the Big Five Hlabisa local municipality west of the N2;

The whole of the Mtubatuba local municipality;

The whole of the Mfolozi local municipality;

The portions of the uMhlathuze local municipality north of the R34; and

The whole of Hluhluwe uMfolozi Park.

In total, FMD was detected and confirmed in 29 locations, including two clusters of diptanks in communal grazing land.

The local municipalities of Umhlabuyalingana, Jozini, eDumbe, Abaqulusi, Ulundi, Nkandla, Mthonjaneni and uMlalazi, are now released from movement restrictions.

The Minister has commended the farmers and communities that have adhered to the movement restrictions imposed upon them, saying this has now made it possible to reduce the area under restrictions.

Movement of cloven-hoofed animals allowed on permit

The Minister added that there are still signs of circulating FMD virus within the two clusters, and the movement protocol and permit system for movement of cloven-hoofed animals remains in place in the revised DMA.

“Movement of cloven-hoofed animals and their products into, out of, through, or within the DMA is still only allowed on authority of a permit issued by the Veterinary Services of the area. The movement protocol can be obtained from KZN Veterinary Services.

“Visible Veterinary Patrols and roadblocks will remain in place in the reduced DMA to control the movement of livestock and to monitor adherence to the movement protocol. Livestock owners are encouraged to submit all applications for movement to the Provincial Veterinary Movement Control Officers for evaluation and risk assessment. Applications and queries can be submitted to [email protected],” Didiza explained.

She reminded all stakeholders to continue abiding by the movement restrictions still in place in the reduced DMA, as “these restrictions are deemed necessary to prevent the escape of the virus out of the affected areas.”

“As soon as it is clear that there is no longer circulating virus in these areas, the remaining movement restrictions can also be reconsidered.”

Source: South African Government News Agency

No South African has died from the COVID-19 jab, as the South African Health Products Regulatory Authority (SAHRPA) continues to investigate the safety of vaccines.

This is according to the National Immunisation Safety Expert Committee (NISEC) Chairperson, Professor Hannelie Meyer, who was speaking during a webinar on self-reporting of side effects or adverse events.

Meyer said SAHPRA and NISEC received 88 reports of death among those who have received a COVID-19 vaccine between 17 May and 31 August this year.

According to Meyer, this accounts for 0.0007% out of the 12 166 043 that had been administered as of the end of August.

Meanwhile, she said 46 are still under investigation, while 40 have been examined and causality assessed.

“Amongst the 40 that have been causality assessed, none of those were related to any of the COVID-19 vaccines we are using in South Africa.”

Causality assessment is defined as a procedure to determine if there is a cause-and-effect relationship between medicine and the occurrence of an adverse event, with no other factor intervening in the process.

However, she said 13 of them died due to COVID-19 disease.

“So, these people died because of COVID-19. They had already incubated COVID-19 at the time of vaccination or contracted COVID-19 shortly after being vaccinated before they could mount an adequate immune response.”

Meanwhile, Meyer told the public that the non-COVID-19 related deaths happened “coincidentally” after being jabbed.

According to the Professor, the majority of them had multiple comorbidities including hypertension, heart disease, tuberculosis, obesity and so on.

“So, they die coincidentally through vaccination because of comorbidities.”

She has assured citizens that all the data is considered before the experts before any conclusion, adding that there are six unclassified cases due to insufficient information.

“So, as you’ve seen, all this data are being considered before we conclude to say this is just coincidental to vaccination or not and there must be adequate evidence for that,” she explained, adding that there are six unclassified cases due to insufficient information.

“If we don’t have sufficient scientific evidence, then the case will end up being unclassifiable, so we can’t say it was not the vaccine causing the event or something else causing the event.”

The Professor has also reminded citizens that government has been inoculating the elderly population, of which most of them suffer from chronic conditions.

“And what we also need to remember is that the main goal is to protect these people from severe illness to protect everybody from severe illness, especially the elderly population. However, they are at a higher risk of dying from COVID-19.”

She said if senior citizens are vaccinated on time, the jab could protect them.

“Still, it cannot protect them or prevent them from dying from a chronic illness.”

SAHRPA’s Pharmacovigilance Manager, Mafora Matlala, said communicating the information received about the adverse events following immunisation (AEFI) was important, particularly because of the use of the new vaccines to fight COVID-19.

An adverse event following immunisation (AEFI) is any “untoward” health event that happens after a person receives treatment but which does not necessarily have a causal relationship with the treatment.

“Monitoring the safety of medicines and vaccines, and communicating any risks is a critical priority for SAHPRA,” Motlala said.

In addition, she said the local drug watchdog would continue to monitor and inform health professionals and the public about the updated safety profiles of medicines and vaccines.

Matlala has encouraged citizens to report any AEFI by downloading the Med Safety App, designed to simplify and promote reporting of suspected adverse drug reactions (ADRs) or AEFIs.

Meanwhile, vaccinees can also visit their nearest health facility, which usually uses a paper-based format or go to the SAHPRA website.

Source: South African Government News Agency