The Supreme Court of Appeal has dismissed an application for leave to appeal by Solidarity and Afriforum over a 2021 court case where they challenged a condition by South African Health Products Regulatory Authority (SAHPRA) that the Johnson & Johnson vaccine be restricted to the government. SAHPRA said that this was not a condition that they had imposed.
On 26 July 2023, the Supreme Court of Appeal (SCA) dismissed an application for leave to appeal filed by Solidarity and Afriforum (the Applicants) on the grounds that there is no reasonable prospect of success.
The Pretoria High Court struck Solidarity and AfriForum’s application from the court roll on the grounds of an alleged lack of urgency, and the court also ordered them to pay SAHPRA’s legal costs which was filed in June 2021 by the Applicants, wherein they alleged that when SAHPRA approved and registered the J&J vaccine, SAHPRA imposed a condition that the sale of the J&J vaccine is restricted to the National Government. The applicants argued that SAHPRA was not mandated to stipulate the condition that only the government may purchase the J&J vaccine and questioned the legality of such a condition.
SAHPRA refuted this claim because this is not a condition that SAHPRA had imposed. Subsequently, the applicants proceeded to lodge an application for leave to appeal with the SCA . SAHPRA CEO, Dr Boitumelo Semete-Makokotlela said, “This court ruling indicates that SAHPRA is judicious in adhering to its mandate responsibly. We welcome the outcome of this judgement.”
The South African Health Products Regulatory Authority (SAHPRA) issued media statements on 4 August 2022 and 12 September 2022, relating to two fatal cases of Guillain-Barré syndrome (GBS) following vaccination with COVID-19 Vaccine Janssen. SAHPRA has been informed of a third fatal case of GBS following vaccination with the same vaccine.
A causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology. Following investigations, the case was classified as a vaccine product-related event. 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 adverse events following immunisation (AEFI) with all 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/.
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/.
The investigational HIV ‘Mosaico’ vaccine regimen was safe but did not provide protection against HIV acquisition, an independent data and safety monitoring board (DSMB) has determined. Based on the DSMB’s recommendation, the study will be discontinued. This follows the failure of the similar ‘Imbokodo’ vaccine in sub-Saharan Africa.
The HPX3002/HVTN 706, or ‘Mosaico’ Phase 3 clinical trial began in 2019 and involved 3900 volunteers in Europe, North America and South America. The participants were men who have sex with men (MSM) or transgender people.
The Janssen-developed vaccine was based on ‘mosaic’ immunogens, which are vaccine components featuring elements of multiple HIV subtypes, in order to induce immune responses against a wide variety of global HIV strains. The investigational vaccine regimen consisted of four injections over a year of Ad26.Mos4.HIV, with the mosaic immunogens delivered by a common-cold virus (adenovirus serotype 26, or Ad26). The final two vaccinations were accompanied by a bivalent (two-component) HIV envelope protein formulation, combining clade C gp140 and mosaic gp140 envelope proteins, adjuvanted by aluminium phosphate to boost immune responses. All study vaccinations were completed in October 2022.
In early studies, this vaccine combination induced strong antibody and T-cell responses and protected monkeys exposed to SIV, the simian cousin of HIV. The vaccines however failed to stimulate production of broadly neutralising antibodies (bNAbs) that disable multiple HIV variants, according to aidsmap. In that study, the vaccine conferred a 25.2% effectiveness in protection, but not the 50% necessary for an effective vaccine.
In its scheduled data review, the DSMB determined there were no safety issues with the experimental vaccine regimen. However, the number of HIV infections were equivalent between the vaccine and placebo arms of the study. During the clinical trial, all participants were offered comprehensive HIV prevention tools, including pre-exposure prophylaxis, or PrEP. Study staff ensured that participants who acquired HIV during the trial were promptly referred for medical care and treatment. Participants are being notified of the findings, and further analyses of the study data are planned.
The Mosaico findings track with developments in the Phase 2b ‘Imbokodo’ (HPX2008/HVTN 705) clinical trial, which was testing a similar HIV vaccine regimen in young women in sub-Saharan Africa. A DSMB determined in 2021 that the experimental vaccine regimen in that study was also safe but ineffective in protecting against HIV acquisition.
A Cochrane review of all the evidence available from randomised controlled trials of COVID vaccines up to November 2021 has concluded that most protect against infection and severe or critical illness caused by the virus. In addition, the Johnson and Johnson vaccine and the Cuban Soberana 2 vaccine “probably” reduced all-cause mortality.
The independent, international expert reviewers also found that there was little or no difference between the number of people experiencing serious side effects after vaccination compared to those who were unvaccinated.
The researchers, led by Isabelle Boutron, Professor of Epidemiology at Université Paris Cité and Director of Cochrane France, analysed published data from 41 randomised controlled trials of 12 different COVID vaccines, involving 433 838 people in various countries around the world. They assessed the certainty of the evidence and the risk of bias in the different studies.
The trials compared COVID vaccines with placebo, no vaccine, or each other, and were published before 5 November 2021. Most trials were no longer than two months in length.
The review found that the following vaccines reduced or probably reduced the risk of COVID infection compared to placebo: Pfizer/BioNTech, Moderna, CureVac COVID-19, Oxford-AstraZeneca, J&J, Sputnik V (Gam-COVID-Vac), Sinopharm (WIBP CorV and BBIBP-CorV), Bharat (Covaxin), Novavax and Soberana 2 (Finlay-FR-2). The following reduced or probably reduced the risk of severe or critical disease: Pfizer/BioNTech, Moderna, Janssen, Sputnik V, Bharat and Novavax. In addition, the J&J and Soberana 2 vaccines probably decreased the all-cause mortality risk. There were very few deaths recorded in all the trials and so evidence on mortality for the other vaccines is uncertain.
For most of the vaccines, vaccinated individuals reported more localised or temporary side effects compared no-treatment or placebo groups. These included tiredness, headache, muscle pains, chills, fever and nausea. With respect to the very rare side effects associated with some vaccines such as thrombosis, the team found that the reporting of these events was inconsistent, and the number of events reported in the trials was very low.
Given the evidence of efficacy of these vaccines, the researchers question whether further placebo-controlled trials are ethical. They suggest that further research compares new vaccines with those already in use.
A comparison of vaccinations has demonstrated that mRNA vaccines perform better against variants of concern (VOCs) than viral vector vaccines. Although they all effectively prevent severe disease by VOCs, the research published in PLOS Medicine suggests that people receiving a viral vector vaccine are more vulnerable to infection by new variants.
The Pfizer-BioNTech and Moderna are mRNA vaccines, which deliver genetic code to the bodies’ cells, whereas Oxford/AstraZeneca and J&J are viral vector vaccines which uses a modified virus to deliver instructions. J&J is delivered as a single dose while the rest are administered two weeks apart.
Marit J. van Gils at the University of Amsterdam, Netherlands, and colleagues, took blood samples from 165 healthcare workers, three and four weeks after first and second vaccination respectively, and for J&J at four to five and eight weeks after vaccination. Samples were collected before, and four weeks after a Pfizer-BioNTech booster.
Four weeks after the initial two doses, antibody responses to the original SARS-CoV-2 viral strain were highest in recipients of Moderna, followed closely by Pfizer-BioNTech, and were substantially lower in those who received viral vector vaccines. Tested against the VOCs Alpha, Beta, Gamma, Delta and Omicron, neutralising antibodies were higher in the mRNA recipients than the viral vector recipients. Neutralisation ability against VOCs was reduced in all vaccine groups, with the greatest reduction against Omicron. The Pfizer-BioNTech booster increased antibody responses in all groups with substantial improvement against VOCs, including Omicron.
The researchers caution that their AstraZeneca group was significantly older, because of safety concerns for the vaccine in younger age groups. As immune responses tend to weaken with age, this could affect the results. This group was also smaller because the Dutch government halted use for a period.
South Africa’s COVID vaccine production plant, the first of its kind in Africa is at risk of closure after failing to secure a single according to a report from Reuters. President Cyril Ramaphosa is reported to be in talks with three other African nations in effort to save the venture.
The World Health Organization had called the licensing deal between Johnson & Johnson and Aspen Pharmacare to manufacture the Aspenovax COVID vaccine, a “transformative moment” in the pursuit of equitable access to vaccines. The vaccine is the J&J adenovirus vector vaccine sold under the Aspen brand.
However, after initial vaccine delivery shortfalls, the African continent is now well stocked with vaccines, while the poor infrastructure hampers vaccine distribution.
“There’ve been no orders received for Aspenovax,” Reuters reported, citing a phone conversation with Aspen senior director Stavros Nicolaou.
“If we don’t get orders, we would have to repurpose these lines back into other things that we were previously doing,” he told CapeTalk.
There are several other such vaccine plants in various stages, as the African Union aims at 60% of locally produced vaccines for continent locally by 2040, up from the current 1%.
“If Aspen doesn’t get production, what chance is there for any of the other initiatives?” Nicolaou remarked.
Regarding possible options, he said: “We are exploring various options. It is our medium-to-long-term objective to look at providing a sterile [processing] platform and solutions for the continent but the short-term needs to be sorted out.”
Moderna announced an agreement with Kenya to set up its first mRNA manufacturing facility in Africa with the aim of producing up to 500 million doses a year.
A South African-led study published in the New England Journal of Medicine has shown that two doses of the Pfizer or the Johnson and Johnson (J&J) vaccine are equally effective against severe COVID caused by the omicron variant.
The omicron variant has been shown to escape antibody neutralisation by both the Pfizer/BioNTech mRNA and the Johnson & Johnson adenovirus viral vector vaccine, the only two COVID vaccines available in South Africa. As of May 1, 44.8% of adults in South Africa had been fully vaccinated. Assessing vaccine effectiveness is critical for national vaccine programs.
Starting in October 2021, health care workers who were participating in phase 3b of the Sisonke study of the early vaccine access program were eligible to receive a second dose of the J&J vaccine. Discovery Health data was accessed for Pfizer vaccine effectiveness. Severe COVID was defined as hospitalisation or admission to an intensive care unit (ICU) or to high care.
Vaccine effectiveness was compared between the two vaccine groups according to the number of days since the second vaccine dose had been administered. However longer follow-ups were not available for the J&J group as booster had been initiated later for them.
PCR results were analysed from participants who had received two doses of the Pfizer vaccine given at least 42 days apart or two doses of the J&J vaccine given 4 to 6 months apart. Among these participants, the test positivity rate was 34%; of those with a positive PCR test, 1.6% had been admitted to a hospital and 0.5% to an ICU or to high care.
Effectiveness against hospitalisation in the J&J group, was found to be 55% within 13 days after the second dose, 74% at 14 to 27 days, and 72% at 1 to 2 months. For the Pfizer group, the vaccine’s effectiveness was 81% within 13 days after the second dose, 88% at 14 to 27 days, 70% at 1 to 2 months, 71% at 3 to 4 months, and 67% at > 5 months. Among J&J vaccine recipients, the vaccine effectiveness against ICU admission or high care was 69% at 14 to 27 days and 82% at 1 to 2 months after the second dose; among the Pfizer recipients, effectiveness against ICU admission or high care was 70% at 1 to 2 months, 73% at 3 to 4 months, and 71% at > 5 months.
Gray et al concluded, “After two doses, both vaccines were equally effective against severe disease caused by the omicron variant. These estimates of vaccine effectiveness were calculated in a South African population with a high background prevalence of SARS-CoV-2 exposure during the Covid-19 pandemic. These data provide reassurance about the continued value of the national Covid-19 vaccine program during a surge in the omicron variant.”
In a news release, pharma giant Aspen has announced that it has concluded an agreement with Johnson & Johnson to manufacture an Aspen-branded COVID vaccine, Aspenovax, and to make it available throughout Africa.
This follows on from the November 2021 announcement of an agreement of terms between the two companies. This new agreement will expand the existing technical transfer and manufacturing agreements between the companies.
The agreement will grant Aspen’s South African subsidiary the rights to manufacture finished Aspenovax product from drug substance supplied by J&J. It will also make Aspenovax available to markets in Africa through transactions with designated multilateral organisations and with national governments of member states of the African Union.
Under the agreement, Aspen has secured the necessary intellectual property from Johnson & Johnson for production. There is also a good faith undertaking between the companies to expand the agreement to cover any new versions of the drug substance, such as those developed for new variants or a different formulation for administration as a booster.
The agreement will last through to the end of 2026.
Commenting on this agreement, Dr Matshidiso Moeti, World Health Organization Regional Director for Africa said: “This important agreement on sharing know-how and technologies for the production of COVID vaccines is a huge leap forward towards realising our shared vision for medicines and vaccines to be manufactured on the African soil for the African people. Vaccines are our best way out of this pandemic and local production is an essential recipe for our success.”
Stephen Saad, Aspen Group Chief Executive said: “Even with all the support in the world, none of this would be possible without the competence of our teams at Gqeberha. They knew the weight of a continent’s ambitions rested on their shoulders. They persevered and succeeded in becoming a significant supplier within the Johnson & Johnson network. Aspenovax has become a reality due to the confidence placed in their abilities. They are our African heroes.”
Scientists have found that four COVID vaccines (Pfizer-BioNTech, Moderna, J&J/Janssen, and Novavax) prompt the body to make effective, long-lasting T cells against SARS-CoV-2. These T cells can recognise SARS-CoV-2 Variants of Concern, including Delta and Omicron.
The new study, published in Cell, showed that the vast majority of T cell responses are also still effective against Omicron, reducing the odds of illness for up to six months, regardless of vaccine.
These data come from adults who were fully vaccinated, but not yet boosted. The researchers are now investigating T cell responses in boosted individuals and people who have experienced “breakthrough” COVID cases.
The study also shows that fully vaccinated people have fewer memory B cells and neutralising antibodies against the Omicron variant. This finding is in line with initial reports of waning immunity from laboratories around the world.
Without enough neutralising antibodies, Omicron is more likely to cause a breakthrough infection, and fewer memory B cells means a slower production of more neutralising antibodies.
Co-first author Camila Coelho, PhD, said: “Our study revealed that the 15 mutations present in Omicron RBD can considerably reduce the binding capacity of memory B cells.”
Neutralising antibodies and memory B cells are only two arms of the body’s adaptive immune response. , T cells do not prevent infection, rather they patrol the body and destroy cells that are already infected, which prevents a virus from multiplying and causing severe disease.
The team believes the “second line of defence” from T cells helps explain Omicron’s reduced severity in vaccinated people. The variant also appears to infect different tissues.
To know whether the vaccine-induced T cells they detected in their study were actually effective against variants such as Delta and Omicron, the scientists took a close look at how the T cells responded to different viral “epitopes.”
Every virus is made up of proteins that form a certain shape or architecture. A viral epitope is a specific landmark on this architecture that T cells have been trained to recognise. Current COVID vaccines were designed to teach the immune system to recognise specific epitopes on the initial variant of SARS-CoV-2, specifically targeting the Spike protein which the virus uses to access human cells. As the virus has mutated, its architecture has changed, and the concern is that immune cells will no longer recognise their targets.
The new study shows that while the architecture of Omicron is different enough to evade some neutralising antibodies and memory B cells, memory T cells still do a good job of recognising their targets, even on the highly mutated Omicron variant. Overall, at least 83 percent of the CD4+ (helper) T cell responses and 85 percent of the CD8+ T cell responses stayed the same, no matter the vaccine or the variant.
The memory B cells that do bind Omicron are likely to also contribute to protection against severe disease, forming multiple lines of defence.
Researchers are now focusing on measuring T cells, B cells and antibody responses after COVID booster shots, and also characterising immune responses after a breakthrough infection.
Administering a booster shot of Johnson & Johnson’s COVID vaccine was found to be 85% effective in preventing serious illness in Omicron-dominated areas, preliminary results from a South African trial study show.
The South African Medical Research Council performed the study on health workers from 15 November to 20 December, but has not yet been peer-reviewed. It found the booster was effective in largely protecting staff as Omicron came to dominate the country.
“The increase in CD8+ T-cells generated by the Johnson & Johnson vaccine may be key to explaining the high levels of effectiveness against severe COVID disease and hospitalisation in the Sisonke 2 study, as the Omicron variant has been shown to escape neutralising antibodies,” Johnson & Johnson reported in a statement. That data showed that the booster jab “provides 85 percent effectiveness against hospitalisation in areas where Omicron is dominant/”
“This adds to our growing body of evidence which shows that the effectiveness of the Johnson & Johnson Covid vaccine remains strong and stable over time, including against circulating variants such as Omicron and Delta,” it continued.
Around half a million South African health staff have received Johnson jabs as part of clinical trials. South Africa has recorded more than 3.5 million cases and 94 000 deaths since the start of the pandemic.
An earlier South African study in December found the Pfizer/BioNTech vaccine to be less effective overall against Omicron, but still reduced hospital admissions by up to 70%.
