Tag: South Africa

Categories : COVIDTags :

AstraZenaca Ineffective Against SA Variant in Early Trial

On By ModernMedia

In a phase Ib/II trial, the AstraZeneca vaccine was ineffective against both the South African SARS-CoV-2 variant or the wild-type virus.

In this South African trial, the vaccine’s overall efficacy versus mild-to-moderate COVID was 21.9% and efficacy against the B.1.351 variant was 10.4%.

Participants’ median age was 30, about 56% were men, and 71% were black. Almost 20% of participants were obese, 42% were smokers, and about 3% of those had underlying hypertension or chronic respiratory conditions. All were HIV negative. The median time between doses was 28 days.

Overall, 19 of 750 in the vaccine group (2.5%) and 23 of 717 in the placebo group (3.2%) developed mild-to-moderate COVID. 

In regard to the secondary outcome of testing effectiveness against the B.1.351 variant, the authors note that “the trial was powered for the primary objective of a vaccine efficacy of at least 60% in preventing COVID-19 of any severity, regardless of variants.”

Exploratory analyses found about 33.5% efficacy against COVID of any severity more than 14 days after the first dose. No cases of severe COVID were reported among the participants, but with the groups’ demographics, especially their relatively young age, it was unlikely that severe COVID would be observed in such a small trial.

Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit at Wits, said in a press release that the AstraZeneca results “threw a curveball” after the initial “euphoria” over the effectiveness of the first COVID vaccines. He nevertheless stressed that the AstraZeneca vaccine was still important in preventing hospitals being overrun with COVID patients.

Despite the disappointing results, Prof Madhi said these findings “need to be made in the context of ongoing global spread and community transmission of the B.1.351 variant”.

Source: MedPage Today

Journal information: Madhi SA, et al “Efficacy of the ChAdOx1 nCOV-19 Covid-19 vaccine against the B.1.351 variant” N Engl J Med 2021; DOI: 10.1056/NEJM2102214.

Categories : COVIDTags :

How The COVID Variant Was Discovered in South Africa

On By ModernMedia

The so-called South African variant was identified by an international team of researchers, including biomedical scientists from the University of California, Riverside. They explain the process behind discovering the variants, why they are so concerning, and what the future holds.

“The new COVID variants are the next new frontier,” said Adam Godzik, a professor of biomedical sciences in the UC Riverside School of Medicine. “Of these, the SA and Brazil strains are most worrying. They have mutations that make them resistant to antibodies we generate with existing vaccines. It is commonly believed we are in a tight race: Unless we vaccinate people quickly and squash the pandemic, new variants would dominate to the point that all our COVID vaccines would be ineffective.”

Prof Godzik and Arghavan Alisoltani-Dehkordi, a postdoctoral researcher who joined his lab two years ago, helped characterise the new SA variant by providing its spike protein structure using computer simulations.  

Dr Alisoltani-Dehkordi, who was a postdoctoral fellow at the University of Cape Town before she joined UCR, mentioned that research teams at the University of KwaZulu-Natal  and UCT discovered the new SARS-CoV-2 variant from samples collected between October 15 and November 25, 2020, in three provinces. By early November, this variant rapidly became the dominant variant in samples from two provinces. The researchers suggested that this may be due to increased transmissibility or immune escape.

“Each SARS-CoV-2 variant has specific mutations defining it,” Dr Alisoltani-Dehkordi said. “Professor Godzik and I used computer modeling to suggest possible structural and functional consequences of spike protein mutations in the SA lineage. Our analysis, confirmed also by several other research groups, shows that some of the mutations potentially result in a higher transmissibility of the virus and a weaker immune response.”

The SA variant has been detected in 40 countries, and is quite likely present in more still.

“This variant is probably spreading in areas where it has not been sequenced and is, therefore, not identifiable,” Prof Godzik said. “In the US, sequencing is still a slow process. In many parts of the country, including Riverside, we have no information whatsoever about variants.”

The SA variant prompted concern among scientists because its mutations allowed it to evade antibody protection, and potentially, vaccines. Indeed, the AstraZeneca vaccine rollout was halted in South Africa due to the low level of protection against this new variant.

“That’s when it received a high level of interest,” Prof Godzik said. “Subsequent research confirmed it is resistant to vaccines and is spreading. South Africa is doing a good job, however, at controlling the variant through quarantining and other measures.”

Common mutational signatures can be seen in each of the newly emerged SARS-CoV-2 variants of concern in the UK, SA, Brazil, and California. But each of these variants also has a unique set of mutations; for example, the SA and Brazil variants have two unique mutations on spike proteins K417N and E484K, respectively. But, as Prof Godzik explains, there is no single “SA variant”, rather a branch on an evolutionary tree. And viruses can acquire mutations and escape at any time.

Prof Godzik thinks COVID will become a permanent feature of our lives. “It takes six months to develop a flu vaccine,” he said. “Models predict the evolution of the flu virus and vaccines are produced before the variants show up. If the predictions are good, the vaccines work. If they miss, a heavy flu season follows. This is how COVID will likely behave. A lot of effort will be invested in predicting what will happen the following year, vaccines would then be updated, and people will need to get a booster shot.”

Source: University of Riverdale, California

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SA to Expedite 80 000 Doses of J&J Vaccine

On By ModernMedia

South Africa will accelerate the rollout of the Johnson & Johnson vaccine, it has been reported.

SA has secured orders for 9 million doses of the vaccine, of which the first 80 000 are expected to arrive in the country next week. Since immunity with the Johnson & Johnson vaccine is achieved with a single dose, this will be enough for 9 million people in South Africa, barring some inevitable wastage. Results from clinical trials in South Africa show that the vaccine has an effectiveness of 57%, 28 days after vaccination.

Professor Linda-Gail Bekker at the Desmond Tutu HIV Centre, University of Cape Town, who was involved in a South African trial last year, explained that there is a delay between the results of a clinical trial and the licence being granted for commercial use. She has urged the need for rapid vaccine rollout, and had also tested positive for COVID herself along with her family during the festive season. As a stopgap measure, an interim vaccination plan with 80 000 doses will be put into action at 32 locations around the country.

Explaining the programme, Prof Bekker said: “Can we together bring this expedited plan forward so that we can make sure we, as quickly as possible, rollout phase one recipients – mainly healthcare workers – into a kind of emergency programme.”

Prof Bekker describes the expedited rollout as being different to a clinical trial.

She continued, “This is not clinical research in the clinical trial concept; it really is programme evaluation, and many eyes are on it at the moment to make sure that we have covered all aspects – ethical, safety and scientific. We will not move without those approvals.”

Source: Eyewitness News

Categories : COVIDTags :

Reckless to Discard AstraZeneca Vaccines, Says Prof Madhi

On By ModernMedia

Professor Shabir Madhi of Wits University says that it would be reckless to simply abandon South Africa’s stock of AstraZeneca vaccine doses, even after a small trial showed it to have minimal effect against the local variant.

One million doses of AstraZeneca vaccine had been scheduled for rollout, but that plan has been put on hold after preliminary results showed that it conferred minimal effectiveness against mild-to-moderate infections by the dominant 501Y.V2 strain in South Africa. 

Madhi said that scientists needed more time to go through the data, said Madhi.

“I think it would be highly reckless for us to discard the vaccine. We paid a high price for it and so the vaccines do have a role in protecting from severe disease. I think an important feature in all the vaccines is that generally, vaccines work much better in preventing severe disease.”

There is already a closing window of opportunity, since it was recently discovered that the first batch of one million doses received from the Serum Institute of India would be expiring in April.

Madhi said that there were other options to put the vaccine to good use.
“If we’re strategic in terms of the rollout, we might still be able to get the vaccine used, not two doses per individual but at least a single dose and we could possibly follow it up then with another vaccine and a few vaccines that might come online in the next two or three months.”

In an interview with the BBC, he said that the disappointing results of the trial had not been able to show the effectiveness against severe COVID, as the sample size was too small and too young, with an average age of 31, but that it might still have a protective effect in different age groups. “There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he said.

Source: Eyewitness News

Categories : HIVTags :

Revolutionary HIV Prophylaxis Pill Rollout in SA

On By ModernMedia

Amidst the COVID pandemic and concerns about vaccines, the South African government is rolling out a gaming-changing pill that protects against contracting HIV.

Due to delays including COVID-19, the revolutionary HIV pre-exposure prophylaxis (PrEP) pill is currently only available at 36% of public healthcare facilities – but the impact as it is rolled it will be significant.

Yogan Pillay, Deputy Director for Communicable and Non-Communicable  Diseases, Prevention, Treatment and Rehabilitation at the National Department of Health, says the PrEP pill will be available at all public healthcare providers by the end of September this year.

The pill combines two antiretrovirals, tenofovir disoproxil fumarate and emtricitabine (TDF/FTC), and gives nearly complete protection against contracting HIV. Over the past 4 years, over 50 000 people received the pill during trials. Young women and adolescent girls aged 15 to 24 are at four times higher risk of contracting HIV than males the same age, and since they may not be in a position to negotiate condom use, PrEP allows them to reduce the risk of contracting HIV through sexual activity. The TDF/FTC pill takes seven days to achieve full protection, and should be continued to be taken 28 days after the last HIV exposure. Periodic HIV and kidney function tests will be administered after the first month.

“The PrEP targets in the National Strategic Plan (NSP) for HIV, TB and STIs 2017-2022 is 85 000,” said Pillay. “We do however estimate based on the uptake trend at the current PrEP sites that approximately 10.5% of HIV negative persons offered PrEP will take up PrEP.”

The TDF/FTC pill can be taken at any point of the day, with alcohol, and is compatible with the use of birth control pills and other contraceptives. The pill will be made available through the public sector to any HIV negative person with healthy kidneys willing to take it daily. The TDF/FTC pill can only be prescribed by NIMART (Nurse Initiated Management of Antiretroviral Therapy) trained nurses, not other nurses or clinical associates at this time.

Source: Spotlight

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Ramaphosa to Take Delivery of SA’s First Vaccine Doses

On By ModernMedia

President Cyril Ramaphosa will take delivery of the first million doses arrives in South Africa at OR Tambo airport on Monday.

Ramaphosa will be accompanied by Deputy President David Mabuza, Health Minister Zweli Mkhize and the High Commissioner of India. After the vaccine has been received, it will be taken to cold storage for and undergo technical processing and quality testing.

Acting spokesperson for the Presidency, Tyrone Seale, said: “The arrival of the fist consignment at OR Tambo International Airport marks the start of the vaccine roll-out, which President Ramaphosa describes as the largest and most complex logistical vaccine undertaking in South Africa’s history.”

The AstraZeneca doses were produced by the Serum Institute of India, and healthcare workers will be the first to be vaccinated, with essential workers second on the list. However, the Department of Health has suggested that politicians (who are classified as essential workers) may be the first to receive the vaccine, in order to reassure the public and encourage vaccine uptake. An additional 500 000 doses are to be delivered in February.

There are fears that current vaccines are less effective against the B1.351 “South African” variant. The Novovax vaccine has been shown to have slightly less than 50% effectiveness in South African trials, due to the variant and the prevalence of HIV in the population. Johnson & Johnson’s vaccine, which is set to be produced locally by Aspen, is around 57% effective in South Africa. These are about what is achieved with annual flu vaccines, which are 40-60% effective. The AstraZeneca AZD1222 vaccine developed in concert with Oxford University have been shown to be 70% effective in clinical trials, although this was prior to the widespread emergence of COVID variants. However, it is possible to adjust vaccines to to deal with the new variants, with Dr Anthony Fauci saying that this reduced vaccine effectiveness against variants is a “wake-up call”.

The Azstra Zeneca vaccine uses a non replicating viral vector to deliver genetic information to cells, instructing them to produce the spike protein of the SARS-CoV-2 virus to train the immune system to recognise it and build immunity. It requires two doses administered four weeks apart, and unlike many other vaccines, does not require storage at extremely cold temperatures – only requiring normal refrigeration at 2° to 8°C.

Source: Eyewitness News

Categories : COVIDTags : 1 Comment

Ivermectin Approved to Treat COVID in SA on Limited Basis

On By ModernMedia

Ivermectin, which has some reports of high effectiveness in limited studies, has received approval from the SA government to be used under strict control for compassionate use.  

Dr Boitumelo Semete-Makokotlela, head of the South African Health Products Regulatory Authority (SAHPRA), said that practitioners applying to use the drug will be considered case-by-case.

Ivermectin has a long history of use as an antiparasitic treatment in animals, while in humans it’s used as an anthelmintic drug that is usually indicated for filarial and resistant scabies infections. While the World Health Organization has suggested the drug has encouraging effects on coronavirus, although it hasn’t been properly evaluated yet.

“We absolutely share everyone’s desperation at this point,” said Helen Rees, SAHPRA chairwoman. “So the question about ivermectin and self-medication goes back to what everyone in the scientific community is saying. And that is, we don’t know if it works and we don’t know if it doesn’t work. That’s why we need to get data.”

Physicians in Zimbabwe are reportedly treating COVID with ivermectin in combination with silver nanoparticles – normally used as an algaecide – to great success.

Rees, however, warned South Africans that people self-medicating “need to be very careful because we don’t have any information about the quality of what you’re taking.”

Dr Semete-Makokotlela said that clear guidelines for the rollout would be given tomorrow. She added that SAHPRA granted the health department permission to distribute the Oxford/AstraZeneca COVID vaccine, the first one for SA. It is also currently reviewing applications from Johnson & Johnson and Pfizer, but has yet to receive an application from Moderna, she said.

Source: BusinessTech

Categories : COVID HIVTags :

Novavax COVID Vaccine only 49.4% Effective in SA

On By ModernMedia

On Thursday, Novavax announced that its vaccine was 89% effective, according to its UK trials which had 15 000 participants. However, its SA trials showed a much lower effectiveness of 49.4%, believed to be caused by the SA COVID variant B.1.351 (aka 501.V2). 

The company conveyed the information in a press release, with a detailed journal publication still to come. The SA trial had 4400 participants, and the observed protection varied depending on HIV status. In people who were HIV negative, the vaccine conferred 60% protection. If the vaccination trial included a representative proportion of HIV positive adult South Africans, it may mean that its effectiveness for this vulnerable segment is very low.

“The higher efficacy of the vaccine in the UK than in South Africa is because the variants circulating in SA are less sensitive to vaccine induced immune responses,” said Professor Shabir Madhi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID vaccine trial in SA.

“Nevertheless, the 60% reduced risk against Covid-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the only Covid-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa.”

Novavax is pressing ahead with a trial involving 30 000 participants in the United States and Mexico, and has shared data with the UK’s pharmaceutical regulator. It is not clear whether the data from the US and Mexico trial will be required before the vaccine receives approval there. Meanwhile on Friday, the Johnson & Johnson vaccine developed by its subsidiary Janssen has been shown to be 66% effective. It is a single dose vaccine with minimal refrigeration requirements, making it very important for the logistical challenge of vaccinations in developing countries. Since Aspen would be producing some of the doses locally, the SA government had been in talks with Johnson & Johnson to secure some of those vaccines for SA use. However, there are signs that it too is less effective against the B.1.351 variant.

Source: Business Insider

Categories : COVIDTags :

Six Key Takeaways of SA’s Vaccination Programme

On By ModernMedia

From a webinar held by the Department of Health late Wednesday night, there are six key points that were learned about the government’s vaccination programme.

1: To receive a vaccine, people will need an internet connection, cellphone and an ID. The internet connection is needed for self-enrolment on the Electronic Vaccine Data System (EVDS), and the cellphone is needed to receive an SMS detailing the time and place for vaccination. An ID book is required for identification. After the second vaccination (if a two-dose vaccine), an “electronic vaccination certificate” can be accessed from the EVDS. No mention was made of alternatives for those without ID books or internet access to the EVDS.

2: Private doctors and nurses will be paid R50 to R60 per shot administered. However, the government would prefer to use public healthcare facilities wherever possible.

3: Medical aids will pay double or triple for the vaccine doses. As reported in early January, medical aid schemes will pay for some of the costs of achieving herd immunity. The single exit price (SEP) of vaccines will be higher. Whether medical aids cover the number of additional doses for uninsured people at 1:1 or 2:1 is yet to be determined.

4: Mines have significant vaccination capacity – assuming they have enough doses on hand. The head of health for the Minerals Council, Thuthula Balfour, explained: “We’ve actually worked out that the industry can administer about 60 000 to 80 000 vaccines a day, so within two months we could vaccinate between 2.5 million to 3 million people.” This would equate to some five extra people per mineworker.

5: Rural clinics without generators will not receive vaccines. The distribution will use a hub-and-spoke model with hubs that are able to guarantee security and available electricity receiving vaccine stocks.

6: The auditor-general is already involved, to forestall corruption. Health Minister Zweli Mkhize said that “all the approaches that we’re taking to make sure that at the end of it they can give us a sense of checks and balances they are going to suggest as we deal with the risks associated with this process.”

Source: Business Insider

Categories : COVIDTags :

Sceptical South Africans Want More Vaccine Info

On By ModernMedia

Professor Carin Runciman, Director of the Centre for Social Change at UJ, has said that most people who are sceptical about COVID vaccines simply want more information. 

An online survey of 10 000 South African adults conducted with the Human Sciences Research Council showed that 67% were likely to take the vaccine if it were offered to them. Runciman said that many of the participants had indicated that they wanted more information before they could decide to take it.

Government and scientists came for criticism recently for giving mixed messages about vaccines, which are a few days away from their first rollout in South Africa. With the first million doses arriving in SA from the end of January, an ambitious target of 31 000 vaccinations a day has been announced, though with few firm details. The majority (70%) of the vaccines are to be AstraZeneca, although given their delays in supplying the EU and the bloc’s subsequent restrictions on vaccine exports, that may impact on SA’s vaccination programme.

Opinions also differed according to age and race. In a very strange result, those with higher levels of education were less likely to want to take a vaccine than those with a lower level. Age and race also played a factor, although no explanation was offered for the discrepancy. “Black African adults were more likely to want to take the vaccine – 69% for black African adults, 55% for white adults – those who [are] older are more likely to want to take the vaccine compared to those that are younger. Those that have a less than matric education are much more likely to want to take the vaccine than those with a tertiary education.”

Source: Eyewitness News