Tag: COVID vaccine

Categories : COVIDTags :

Tech Transfer for Local mRNA Vaccine Production

On By ModernMedia

South Africa is planning to make vaccines locally using messenger RNA, the breakthrough technology of the global COVID vaccination effort – and once nearly consigned to the dustbin of medical research history.

The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID mRNA vaccine technology transfer hub.

This follows WHO’s global call for Expression of Interest to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. The partners will negotiate details with the South African government and public and private partners both local and international.

South African President Cyril Ramaphosa said: “The COVID pandemic has revealed the full extent of the vaccine gap between developed and developing economies, and how that gap can severely undermine global health security. This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self determination. South Africa welcomes the opportunity to host a vaccine technology transfer hub and to build on the capacity and expertise that already exists on the continent to contribute to this effort.”

“This is great news, particularly for Africa, which has the least access to vaccines,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “COVID has highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.”

The announcement follows the recent visit to South Africa by French President Emmanuel Macron, who gave his country’s commitment to aiding local vaccine production.

“Today is a great day for Africa. It is also a great day for all those who work towards a more equitable access to health products. I am proud for Biovac and our South African partners to have been selected by WHO, as France has been supporting them for years,” said President Macron. “This initiative is the first of a long list to come, that we will keep supporting, with our partners, united in the belief that acting for global public goods is the fight of the century and that it cannot wait.”

Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed. Interested manufacturers from low- and middle-income countries can receive training and any necessary licences to the technology, assisted by the WHO and partners.

Biovac is a bio-pharmaceutical company resulting from a partnership formed with the South African government in 2003 to establish local vaccine manufacturing capability for the provision of vaccines for national health management and security.

Afrigen Biologics and Vaccines is a biotechnology company focuses on product development, bulk adjuvant manufacturing and supply and distribution of key biologicals to address unmet healthcare needs.

The organisations complement one another, and can each take on different roles within the proposed collaboration: Biovac will be the developer while Afrigen is the manufacturer, with a consortium of universities as academic supporters providing mRNA know-how. Africa CDC will provide technical and regional support.

The South African consortium has existing operating facilities with available capacity and experience in technology transfers. It is also a global hub that can start training technology recipients immediately.

The WHO is speaking to a number of pharmaceutical manufacturers about establishing the hub, though the talks are so far mainly with “smaller companies,” said Soumya Swaminathan, WHO’s chief scientist. “We are having discussions with the larger companies with proven mRNA technology,” she added.

The mRNA vaccines may be produced in South Africa within 9 to 12 months, she said. WHO’s call for expressions of interest has so far generated 28 offers to either provide technology for mRNA vaccines or to host a technology hub or both. 

It is the first time that messenger RNA technology has been used to make vaccines, which has been used by Moderna and Pfizer/BioNTech. They have proven very effective against the original SARS-CoV-2 strains and even against its more recent variants.

Source: World Health Organization

Categories : COVID VaccinesTags :

ImmunityBio Vaccine Trial Expanding in Western Cape

On By ModernMedia
In addition to traditional subcutaneous administration for the vaccine candidate, the trial will measure immune responses generated by sublingual and nasal administration routes. Photo by Gustavo Fring from Pexels

The Phase I clinical trial of ImmunityBio’s experimental COVID vaccine, designed to be effective against COVID variants, is about to be expanded to include different administration routes as well as effectiveness in people who previously had COVID. 

Co-investigator Prof Graeme Meintjes, second chair in the Department of Medicine at UCT, said that the Phase I trial has started and is still ongoing at the Wellcome Centre for Infectious Diseases Research in Africa’s (CIDRI-Africa) Khayelitsha clinical research site.

He said that the first two cohorts of ten participants each both received two subcutaneous injections of the vaccine, three weeks apart, with one cohort receiving a higher dose.

“The purpose of that was to assess safety, so participants were followed up very carefully for side effects and for reactions to the vaccine. And the review of that suggests no major safety concerns,” he explained. He added that the Phase I trial design has since been adapted to include four more cohorts, which is going through the approval process.
These four additional cohorts will include people who have had COVID because the researchers want to look at the effect the vaccine will have on boosting existing immunity against COVID. Each cohort will have ten participants, bringing the expected total number of participants for Phase I to 60 people.

New administration routes

To see whether different administration routes produce a sufficient immune response, each participant in these new cohorts will receive one dose of the vaccine through one of four routes. These would be either a subcutaneous injection, a sublingual route, a combination of subcutaneous injection and sublingual method, or an intranasal route.

“We’ll be measuring the antibody responses as well as the T-cell responses to the vaccine, but we do not have results yet,” said Meintjes. He added that enrolment should be complete in the next two months, pending the outcome of the approval process.

Phase II/III trial plans

Phase II and Phase III trials in South Africa are being planned, which will be headed by the South African Medical Research Council (SAMRC), Mentjes confirmed.

Details will be made available once the trial has been approved by SAHPRA. It is unlikely that placebos will be used, now that vaccines are shown to be effective; rather different vaccines will be compared.

Broader immune response with two-pronged defence

The vaccine has been designed to potentially offer a broader, long-lasting immune response, Mentjes noted. In this way it should also provide improved protection against COVID variants.

Currently, most of the COVID vaccines are designed to produce an immune response against the spike protein of the virus, but it mutates rapidly, allowing certain variants to partially or fully escape vaccines. 

The ImmunityBio vaccine aims to offer a two-pronged or dual defence, Meintjes said, with the vaccine containing two proteins from the SARS-CoV-2 virus: the spike protein along with the more stable nucleocapsid protein. The nucleocapsid is an RNA-binding protein which is critical for viral replication and genome packaging.

He explains that targeting nucleocapsid could potentially provide more durable and long-term protection against different variants of the SARS-CoV-2 virus because the immune system will recognise the nucleocapsid even when the spike protein changes.

“The hope is that by including the nucleocapsid you would generate a vaccine response that covers emerging variants, those that have emerged and those that might emerge in the future,” he says.

Human-adenovirus based vaccine carrier

The ImmunityBio vaccine will use an adenovirus vector to deliver the antigens. Director of the Africa Health Research Institute (AHRI), Professor Willem Hanekom, explained that a vector is needed in order to stimulate the immune system’s response, and a viral vector is effective since it is foreign to the immune system, helping provoke an immune response. The virus is designed to simply carry the antigens into the body.

The AstraZeneca vaccine uses a modified chimpanzee adenovirus while Johnson & Johnson’s uses the human adenovirus Ad26, which has been used before in a number of vaccines including HIV. ImmunityBio’s vaccine uses the human adenovirus hAd5, which was initially used in failed gene therapy trials — but which proved to be an excellent vaccine delivery system. However, its development over the past two decades has been halting.

According to Prof Hanekom, if there is previous immunity against the adenovirus being used in a vaccine, the immune system will destroy it before the antigens inside are released. This has been circumvented with the ImmunityBio vaccine so that the immune system doesn’t immediately recognise the hAd5 vector. There was concern that the Johnson & Johnson vaccine would have limited efficacy in sub-Saharan Africa due to the fact that about half the population have immunity to Ad26.

“They’ve modified the adenovirus so it will still work and still be seen by the immune system even if there is pre-existing immunity because they’ve taken out the parts that the pre-existing immunity sees,” Prof Hanekom said.

Enhanced T-cell response

The vaccine is specifically designed to elicit strong T-cell responses to the nucleocapsid, and this has been seen in animal studies, Mentjes noted.

“Obviously one purpose of these studies is to see whether this design element generates those strong T-cell responses in humans as well,” he says. “All COVID vaccines elicit T and B cell responses, it’s not one or the other. But this (vaccine) is specifically designed to enhance those T-cell responses.”

B-cells and T-cells form part of the body’s adaptive immune response. B-cells form the antibodies to respond to a pathogen, and when the virus is introduced again, memory B-cells provide the antibodies to respond quickly.

Vardas says that with the ImmunityBio vaccine, B-cells and memory B-Cells will be formed that will remember the spike protein and the nucleocapsid and how to attack it. She likens this to a sniper attack. She explains that when a memory B-cell detects the spike or nucleocapsid protein, it signals for the production of B-cell antibodies. These antibodies then coat the outside of the virus, which signals the T-cells to attack and essentially “eat up” the virus-infected cells.

There are two types of T-cells, explains Vardas – CD4 cells which attack the virus, and CD8 cells, which also form a memory cell as the B-cell does. “You’ll have groups of CD4 and CD8 cells that are spike protein-specific and groups that are nucleocapsid specific, so improving that kind of attack to two sides of the war,” said Vardas.

Source: University of Cape Town

Categories : COVID VaccinesTags :

Second Gen COVID Vaccine Considered for Booster Shot in SA

On By ModernMedia
Image source: Pexels/CC0

A second generation viral vector COVID vaccine candidate from ImmunityBio Inc is being considered as a booster shot in a study involving nearly 500 000 South African health workers already innoculated with the Johnson & Johnson vaccine.

The health workers, who are the first outside of much smaller studies to receive vaccinations in South Africa, will need a booster, Glenda Gray, the co-lead of the South African studies, said in an interview Wednesday.

“It could be the universal boost that we are looking for,” she said. “Hopefully we will start in a couple of weeks.”

ImmunityBio’s second generation COVID vaccine candidate uses an hAd5 virus as vector. It induces both short term and long term immunity, and besides targeting the coronavirus’ spike proteins like first generation vaccines, it also targets the nucleocapsid protein, which has a lower rate of mutations. Additionally, this hAd5 vector virus provokes an anti-SARS-CoV-2 response, even in individuals with adenovirus immunity.

The magnitude of this T cell response was equivalent to those seen for spike and nucleocapsid T cell responses from previously infected convalescent SARS-CoV-2 patients.

The robust T cell response to both proteins could make it more effective against strains such as the B.1.351 ‘South African’ variant , ImmunityBio said in a statement earlier this year.

The vaccine is also being assessed to determine the safety and effectiveness of oral, sublingual and subcutaneous administration routes.

ImmunityBio’s vaccine is currently in phase I trials in Cape Town, and the company has signed an agreement with South Africa’s BioVac Institute to produce the inoculation in the country should it win approval.

Source: BusinessTech

Categories : COVIDTags :

Vaccine-related Fainting Down to Anxiety, CDC Says

On By ModernMedia

A brief bout of anxiety was likely the cause of possible COVID vaccine-linked symptoms that people experienced, said researchers with the US Centers for Disease Control and Prevention say.

Several reports emerged in early April that people in at least five different vaccination sites in the US, all in different states, experienced symptoms almost immediately after receiving a vaccination jab. 

These symptoms, all from people who received the Johnson & Johnson vaccine, were largely reported as being fainting, dizziness, lightheadedness, and rapid breathing. These incidents resulted in four of these sites being temporarily shut down, with pledges to investigate being made by both the CDC and local health officials.

The CDC investigation examined 64 cases documented across five vaccination sites between April 7 and 9, and interviewed providers who were at the sites when the events took place. Real-world safety data collected through the Vaccine Adverse Event Reporting System was also looked at.

While some people went to the hospital afterwards, none of the symptoms were deemed to be serious in severity, and most symptoms improved within 15 minutes. A total of 17 people experienced fainting, while more than half reported feeling lightheaded and dizzy and about a third experienced nausea and/or vomiting. Thirteen patients had also told staff members beforehand of past fainting due to a fear of needles or vaccines.

The CDC’s report on the investigation and its findings were published Friday in its Morbidity and Mortality Weekly Report (MMWR).

Fainting and similar short-term symptoms occasionally occurs following vaccination, and measures to reduce them are being investigated. In the CDC’s investigation of these cases and safety data doesn’t point to any other cause of these symptoms besides simple anxiety. In their report, the authors observed that these incidents took place before the more recent reports of a rare blood clotting condition possibly linked to the Johnson & Johnson vaccine were made known to the public. Use of the J&J vaccine has since resumed in many countries, with a warning of the risks.

Since the J&J vaccine is administered in a single dose, it’s possible that people who are more likely to be anxious about vaccines would also opt for it more often, which could then account for the higher incidence of vaccine-related fainting associated with the shot. Another possibility is that early media coverage of the first incidents on April 7 (or physically seeing someone faint) further increased people’s anxiety. However, it was widely reported that one of the first members of the public to take the Pfizer vaccine last December — a nurse — fainted right after. But the nurse pointed out at the time that she had a history of fainting.

The authors of the report summed it up in saying, “the stress of an ongoing pandemic might also increase anxiety surrounding covid-19 vaccination.”

Of course, fainting and these other symptoms can still be a scary experience, no matter the cause. And just because anxiety may be the root cause of these cases, that doesn’t mean there isn’t a real risk worth caring about. 

Since fainting is still an upsetting experience no matter the cause and the risk of it should not be dismissed, so the authors recommend that people are routinely monitored after vaccination for at least 15 minutes. This is not only the chance that fainting may occur but other rare symptoms that could appear post-vaccination, such as a strong allergic reaction.

Source: Gizmodo

Categories : COVID VaccinesTags :

New High-yield Vaccine Technology Recycles Cell Junk

On By ModernMedia

As the world struggles with COVID vaccine production bottlenecks and scaling issues, a team from Northwestern University synthetic biologists have developed a high-yield vaccine technology, increasing production of protein-based vaccines by a factor of five.

Scaling up COVID vaccine production has proved extremely challenging. Adenovirus vaccines such as AstraZeneca’s need to be cultured in 2000 litre tanks containing human cells and then extracted, while mRNA vaccines like that produced by Pfizer requires very careful mixing, as well as components and only a few companies have the skills to produce them. The promising protein subunit vaccines such as Novavax’s offering may be easier to scale up, but also require specific adjuvant, which uses saponin from the bark of a Chilean tree, Quillaja saponaria, which is also used in other vaccines.

Earlier this year, the researchers introduced a new biomanufacturing platform that can quickly make shelf-stable vaccines at the point of care, ensuring they will not go to waste due to transportation or storage problems. In this new study, the team found that enriching cell-free extracts with cellular membranes—the components needed to made conjugate vaccines—massively boosted yields of its freeze-dried platform.

The new technology can produce 40 000 doses per litre per day of antibiotics or vaccines, costing about $1 per dose. At that rate, the team could use a 1000 litre reactor to generate 40 million doses per day, reaching 1 billion doses in less than a month.

“Certainly, in the time of COVID-19, we have all realized how important it is to be able to make medicines when and where we need them,” said study leader Michael Jewett, a professor of chemical and biological engineering at Northwestern. “This work will transform how vaccines are made, including for bio-readiness and pandemic response.”

The new manufacturing platform—called in vitro conjugate vaccine expression (iVAX)—is made possible by cell-free synthetic biology, a process where a cell’s outer wall (or membrane) is removed, and its internal machinery repurposed. This repurposed machinery is then placed in a test tube and freeze-dry it. The cell-free system is activated by the addition of water, turning it into a catalyst for making usable medicine when and where it’s needed. With a shelf-life of over six months, the platform eliminates the need for complicated supply chains and extreme refrigeration, making it extremely valuable for remote or low-resource settings.

In a prior study, Jewett’s team used the iVAX platform to produce conjugate vaccines to protect against bacterial infections, repurposing molecular machinery from Escherichia coli to make a single dose of vaccine in an hour, at $5 per dose.

“It was still too expensive, and the yields were not high enough,” Prof Jewett said. “We set a goal to reach $1 per dose and reached that goal here. By increasing yields and lowering costs, we thought we might be able to facilitate greater access to lifesaving medicines.”

Prof Jewett and his team found that the cell’s membrane, which is typically discarded in cell-free synthetic biology, was key to solving this. When broken apart, membranes naturally reassemble into vesicles, spherical structures that still carry important molecular information. Studying these vesicles, the researchers discovered that increasing vesicle concentration could be useful in making components for protein therapeutics such as conjugate vaccines, which work by attaching a sugar unit—that is unique to a pathogen—to a carrier protein. 

Normally attaching the sugar unit to the protein is very complex, but the researchers found that the cell’s membrane contained machinery that enabled the sugar to more easily attach to the proteins. When they enriched vaccine extracts with this membrane-bound machinery, the researchers significantly boosted usable vaccine yields.

“For a variety of organisms, close to 30% of the genome is used to encode membrane proteins,” said study co-author Neha Kamat, who is an assistant professor of biomedical engineering at McCormick and an expert on cell membranes. “Membrane proteins are a really important part of life. By learning how to use membrane proteins effectively, we can really advance cell-free systems.”

Source: Phys.Org

Journal information: Improving cell-free glycoprotein synthesis by characterizing and enriching native membrane vesicles, Nature Communications (2021). DOI: 10.1038/s41467-021-22329-3

Categories : COVIDTags :

FDA and CDC Justify J&J Vaccine Pause

On By ModernMedia

FDA and CDC officials recommended pausing administration of the Johnson & Johnson COVID vaccine “out of an abundance of caution,” and mainly for the benefit of clinicians to respond to associated serious events.

This comes after six cases of cerebral venous sinus thrombosis (CVST) combined with thrombocytopenia were reported in the US, all among women ages 18-48. With approximately 6.8 million doses administered in the U.S., it suggests a one-in-a-million risk. 

J&J has halted distribution of its vaccine in Europe, reportedly taking officials there by surprise. South Africa has also paused the vaccine rollout.

At a media briefing, when asked whether pausing administration of the vaccine was an “overreaction,” Acting FDA Commissioner Janet Woodcock, MD, said the aim was to provide “time for the healthcare community to learn what they needed about how to diagnose, treat, and report” such events.

FDA’s director for the Center for Biologics Evaluation and Research, Peter Marks, MD, PhD, noted that the condition involves a rare blood clot for which heparin or related anticoagulants is not the standard treatment.

“The issue with these types of blood clots is if one administered standard treatment, one can actually cause tremendous harm or the outcome can be fatal,” he said. “One needs to make sure providers are aware if they see people with low blood platelets or blood clots, to inquire about recent vaccination and act accordingly.”

The background rate of CVST is 2-14 per million in the setting of a normal platelet count, but thrombocytopenia together with abnormal clotting makes it a “pattern.” CVST symptoms also include severe headache, abdominal pain, leg pain, and shortness of breath.

Marks noted that vaccination-related headaches tend to resolve within a few days, whereas CVST symptoms could manifest over a week post-vaccination, and closer to a patient presenting to the emergency department with severe headache. No such rare events have been seen more than 3 weeks post-vaccination.

Dr Marks also said that this pause is a recommendation but does not prevent healthcare providers from providing the J&J vaccine to their patients should benefits of vaccination outweigh the risks.

“We’re not going to stop a provider from administering a vaccine,” he added. “The benefit/risk will be beneficial overall to that individual in a large majority of cases.”

Dr Marks said that while they don’t have a “definitive cause” for the adverse reactions, data from AstraZeneca on similar events in Europe, it is likely a “similar mechanism” with the J&J vaccine. An autoantibody against platelet factor 4 has recently been identified as the trigger for the reaction.
“The immune response occurs rarely after some people receive the vaccine, and that immune response leads to the activation of platelets and extremely rare blood clots,” he said.

However, Marks stopped short of calling it a “class effect,” meaning it was related to the viral vector vaccine itself. He said he wasn’t ready to make a “broad statement yet,” but “obviously it’s from the same general class of viral vectors.”

The AstraZeneca, J&J and Sputnik V vaccines all use adenovirus vectors to deliver antigens. The rate CVST for AstraZeneca was estimated by European officials to be about 5 per million doses. Though Sputnik V has no confirmed CVST cases, a recent report suggests a possibility.

Besides these, the Ebola vaccines are the only other ones to use adenovirus vectors.
Woodcock said that all US cases were in women of reproductive age, with one death and one hospitalisation, but Marks said it was not clear there was any association with hormonal contraception, which also carries a small thrombosis risk. The cases did not have any preexisting conditions which could have explained the events.

The American College of Obstetricians and Gynecologists (ACOG) noted there is no “clear phenotype” for women who may experience this complication.

“Until there is a better understanding of the frequency and impact of this finding, it will be important to encourage pregnant and postpartum women who wish to be vaccinated to receive the mRNA vaccines: Pfizer or Moderna,” said Christopher Zahn, MD, vice president for practice activities at ACOG, in a statement.

“If venous thrombosis is noted in the setting of thrombocytopenia, treatment includes intravenous immunoglobulin and other supportive care,” Dr Zahn added.

Source: MedPage Today

Categories : COVIDTags :

US Hits Pause on J&J Vaccine

On By ModernMedia

Reacting to reports of potentially dangerous blood clots, the US is recommending a “pause” in immunisations with the single-dose Johnson & Johnson COVID vaccine in order to perform investigations.

The Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint statement that they were investigating blood clots in six women that occurred 6 to 13 days after vaccination. The clots, seen in the sinuses of the brain, also had lowered platelet counts. This renders the use of heparin, the standard treatment for blood clots, potentially dangerous.

Out of 183.5 million vaccine doses administered in the US, over 6.8 million doses are the J&J vaccine — the overwhelming majority without serious side effects. The rest is made up by the two other authorised vaccines, from Moderna and Pfizer.

Use of the J&J shot will be paused in US federal distribution channels, including mass vaccination sites, with states and other providers being expected to follow.

CDC’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA has also launched an investigation into the cause of the clots and low platelet counts.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Anne Schuchat, principal deputy director of the CDC, and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.

They recommend that people who received the J&J vaccine and are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the jab contact their health care provider.

Officials say that they want to bring healthcare providers up to speed on the blood clot’s “unique treatment” .

Meanwhile, Johnson & Johnson had said it was aware of the blood clot reports, but no association with its vaccine had been established.

“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines,” the company said in a statement. “At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

In late February, the FDA  granted emergency use authorisation to the J&J vaccine, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. However, only a fraction of the vaccines administered in the US are the J&J shot. The company has been beset by production delays and manufacturing errors at a contractor’s plant. 

The pharmaceutical company took over the facility to ramp up production to make good on its promise to the US government of 100 million doses by the end of May. Only about 9 million of the company’s doses have been delivered to states and are awaiting administration, according to CDC data.
Previously, concern over the blood clots was confined to AstraZeneca’s vaccine, with European regulators saying last week they found a possible link between the shots and an exceedingly rare type of blood clot presenting with low platelets, a situation found more commonly in young people.

Nevertheless, the European Medicines Agency emphasised that the benefits for the vaccine outweigh the risks. Despite this, several countries imposed restrictions on vaccine eligibility and some such as Britain and Greece recommending that people under a certain age be offered alternatives.

Unlike the Pfizer/BioNTech and Moderna vaccines which use mRNA to train the immune system to recognise the SARS-CoV-2 spike protein, the J&J and AstraZeneca vaccines use an adapted adenovirus to introduce the spike protein antigen into the body. Adenoviruses were first identified in the 1950s as a family of similar disease-causing viruses. AstraZeneca’s vaccine uses a chimpanzee adenovirus while the J&J uses a human one.

Source: Medical Xpress

Categories : COVIDTags :

South African Variant Escapes Pfizer Vaccine More Easily

On By ModernMedia

The South African variant escapes protection of the Pfizer/BioNTech vaccine better than other forms of the virus, Israeli experts said Sunday.

The study by Tel Aviv University and Clalit Health Services, Israel’s largest healthcare provider, compared patients with COVID, 400 unvaccinated patients to 400 partially or fully vaccinated ones.

Less than one percent of COVID cases in Israel were due to the South African variant. However, among the 150 people who were fully vaccinated yet had developed COVID, “the prevalence rate [of the B.1.351 variant] was eight times higher than the rate in the unvaccinated [individuals],” the authors wrote.

“This means that the Pfizer-BioNtech vaccine, though highly protective, probably does not provide the same level of protection against the South African (B.1.351) variant of the coronavirus,” the authors added.

“The South African variant is able, to some extent, to break through the vaccine’s protection,” said professor Adi Stern of Tel Aviv University’s Shmunis School of Biomedicine and Cancer Research, one of the study’s authors.

Prof Stern said that the study did not assess whether the eight people infected with the South African developed severe COVID.
“Since we found a very small number of vaccinees infected with B.1.351, it is statistically meaningless to report disease outcomes,” he said.

The possibility of reduced protection was already hinted at in two studies conducted by principal vaccine manufacturers Pfizer/BioNTech and Moderna, showing that the presence of antibodies after vaccination was less pronounced in people exposed to the B.1.351 variant. This marked the first real-world assessment of B.1.351’s ability to bypass a vaccine.

Israel’s vaccination campaign has seen 5.3 million people receive a first dose, while 4.9 million, or 53 percent of the population, have had two shots. 

Clalit’s earlier study on 1.2 million Israelis found that the Pfizer/BioNTech jab gave 94 percent protection against COVID.

Israel has eased many of its restrictions since its vaccine rollout, but various measures remain in place including mask-wearing and a “green passport” system that allows vaccinated people access to certain locations. With cases down 97% since January, Israel may have achieved “herd immunity”, according to Eran Segal, a computational biologist at the Weizmann Institute of Science.

Ran Balicer of Clalit said inoculations, plus mask-wearing and other safety measures had likely helped contain the B.1.351 variant, despite its apparent ability to break through the Pfizer/BioNTech vaccine.

A combination of all these factors “are most likely… preventing the virus strains, including the South African one, from spreading” significantly in Israel, he said.

“As we taper down the non-pharmaceutical interventions, we must do so gradually to ensure we do not cross a threshold that would enable these variants to spread.”

Source: Medical Xpress

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South African Volunteers Battle Vaccine Misinformation

On By ModernMedia
Man with LED mask reading a burning newspaper. Photo by Connor Danylenko from Pexels.

As the long-delayed vaccine rollout in South Africa has begun, the government has run a public campaign to tackle prevalent health myths. But there are also volunteers who are waging an online battle against COVID and vaccine misinformation, as reported by the BBC.

Sarah Downs, who is studying molecular biology and infectious diseases, debunks false claims under the alias Mistress of Science and is fighting a surge of misinformation in South Africa. A relatively small collection of Facebook groups and users are responsible for promoting this misinformation. When she tweeted about her grandmother’s passing, a COVID denier questioned whether an autopsy had been performed. 
“We estimate that it’s about 20 000 South Africans who are actually active on anti-vax Facebook pages,” said Prof Hannelie Meyer, a pharmacist and adviser to the South African Vaccine and Immunisation Centre (Savic).

Most anti-vaccine claims in South Africa actually originate in the United States, according to a 2015 study. Anecdotal evidence, such as the spread of false claims about vaccines and DNA by an American osteopath, show this trend still holds in the pandemic.

Prof Meyer said that while data on vaccine hesitancy in SA are limited, studies indicate that more wealthy and educated groups, particularly among whites, are less willing to be vaccinated.

Leading virologist Prof Jeffrey Mphahlele has also pushed back against rumours, such as COVID and its vaccines being a Western plot to reduce Africa’s population and control its natural resources. He called the misinformation “mind boggling” – pointing out the supposed plot would require the West to create a virus that killed millions of its own people.

Even authority figures have promulgated falsehoods: South Africa’s top judge was recently criticised after a video showed him linking vaccines to a “Satanic agenda.”

One of the most prominent groups on Facebook, with some 10 000 members, seeks to spread “awareness” about vaccines but the members’ hard-line anti-vaccine attitude is very clear, ridiculing or dismissing vaccines. One video posted in the group – originally aired on an evangelical US Christian television programme – suggested getting a jab could lead to “a lifetime of illness”.

Sarah Downs stepped in to help answer questions amidst the deluge of misinformation, and one person she helped was Sheona Lottering, a swimming teacher.

“I had a friend that forwarded me a German article,” Sheona said. “She was trying to convince me that death was one of the side-effects [of a COVID vaccination].

“And I was a little bit freaked out about that.”

Sarah explained the subtleties around adverse events to her, and now Sheona keeps in contact with Sarah over difficult vaccine-related questions.

Lisa (not her real name) spends hours lurking in Facebook groups to guide people towards trusted sources of health information.

“The claims are so bizarre I could hardly believe there are people believing these things,” she said. “I don’t like misinformation, so when I see something, I just try to correct it.”

Doing this for over a decade, she’s seen communities grow and knows their tactics. She said that young mothers are a particular target in Facebook groups, where posts are coordinated to try and convince them not to vaccinate their children., which is when Lisa steps in. She keeps her inbox open and believes gentle communication works best – asking about people’s concerns rather than shouting statistics at them.

But Sarah, Lisa and other volunteers we spoke to risk exposing themselves to online abuse, and the prospects of persuasion can often seem slim. It’s difficult, pro-health work – that isn’t paid. So do they judge success?

“I think if I can just help one person be a little bit less terrified… that’s what I aim to get out of it,” Sarah says. “And if they’re willing to take the vaccine, even more so.”

Source: BBC News

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AstraZeneca Updates its US Trial Results

On By ModernMedia

AstraZeneca issued updated phase III trial data for its COVID vaccine on Wednesday after facing questions on its accuracy of its preliminary US study.

The company now says its vaccine is 76% effective in protecting against symptomatic cases of virus. A release issued on Monday reported a symptomatic efficacy rate of 79%, but the next day, the National Institute of Allergy and Infectious Diseases said it had been informed the company may have included information from its US results that provided an “incomplete view of the efficacy data.”

The updated report still says that the vaccine is 100% effective against severe disease and hospitalisation. A number of US health officials have criticised the company for what seemed like cherry-picking of data in an effort to improve the results’ appearance.

At the time, AstraZeneca said the figures were based on a “pre-specified interim analysis” and promised it would share an updated analysis in the coming days.

Dr Anthony Fauci, White House chief medical advisor and director at the NIAID, was more supportive of the company, calling the situation “unfortunate” and said it was likely AstraZeneca would issue a modified statement.

“This is really what you call an unforced error because the fact is this is very likely a very good vaccine,” Fauci told ABC’s Robin Roberts on “Good Morning America” on Tuesday. “This kind of thing does … really cast some doubt about the vaccines and maybe contribute to the hesitancy. It was not necessary.”

The BBC’s medical editor, Fergus Walsh, was told the results may have been rushed out of a desire to address the safety concerns surrounding possible blood clots. These had resulted in AstraZeneca vaccines being withdrawn from circulation in some European countries.

The updated results include 190 symptomatic cases out of over 32 000 participants — about 50 more symptomatic cases than the data set released on Monday.

The findings suggest the vaccine is more effective in patients aged 65 and older, with a newly reported efficacy rate of 85% for that population, up from 80% stated earlier.

AstraZeneca reiterated that there were no safety concerns with the vaccine and that it was well tolerated.

Source: NBC News