Tag: Johnson & Johnson

Categories : COVIDTags :

Six Different Booster Vaccines Found to be Safe and Effective

On By ModernMedia
Image by Ivan Diaz on Unsplash

The first randomised trial of COVID boosters, published in The Lancet, has shown that six are safe and provoke strong immune responses. Participants have previously received a two-dose course of ChAdOx1-nCov19 (Oxford–AstraZeneca [ChAd]) or BNT162b2 (Pfizer-BioNTech [BNT]). The announcement comes just as the Omicron variant is beginning to spread around the world.

ChAd has now been deployed in more than 180 countries and BNT in more than 145 countries. Several studies show that two doses of ChAd and BNT confer 79% and 90% protection, respectively, against hospitalisation and death after six months. However, protection against COVID infection wanes in time, which has led to the consideration of boosters. However, there are currently little data on the comparative safety of COVID vaccines, and the immune responses they stimulate, when given as a third dose.

The COV-BOOST study looked at safety, immune response (immunogenicity) and side-effects (reactogenicity) of seven vaccines when used as a third booster jab. The vaccines studied were ChAd, BNT, NVX-CoV2373 (Novavax [NVX]), Ad26.COV2.S (Janssen [Ad26]), Moderna [mRNA1273], VLA2001 (Valneva [VLA]), and CVnCov (Curevac [CVn]).

“The side effect data show all seven vaccines are safe to use as third doses, with acceptable levels of inflammatory side effects like injection site pain, muscle soreness, fatigue. Whilst all boosted spike protein immunogenicity after two doses of AstraZeneca, only AstraZeneca, Pfizer-BioNTech, Moderna, Novavax, Janssen and Curevac did so after two doses of Pfizer-BioNTech”, commented Professor Saul Faust, trial lead.

“It’s really encouraging that a wide range of vaccines, using different technologies, show benefits as a third dose to either AstraZeneca or Pfizer-BioNTech. That gives confidence and flexibility in developing booster programmes here in the UK and globally, with other factors like supply chain and logistics also in play”, added Prof Faust.

“It’s important to note that these results relate only to these vaccines as boosters to the two primary vaccinations, and to the immune response they drive at 28 days. Further work will generate data at three months and one year after people have received their boosters, which will provide insights into their impact on long-term protection and immunological memory. We are also studying two of the vaccines in people who had a later third dose after 7-8 months although results will not be available until the new year.”

A randomised, phase 2 trial of seven booster vaccines was conducted, with the third doses given 10-12 weeks after initial two-dose courses of ChAd or BNT. The trial involved 2878 healthy participants between June 1st and June 30th 2021. Participants had received their first doses of ChAd or BNT in December 2020, January or February 2021, and second doses at least 70 days before enrolment for ChAd and at least 84 days for BNT. About half of participants received two doses of ChAd and half two doses of BNT. The control vaccine used was a meningococcal conjugate vaccine (MenACWY).

Participants were aged 30 or older, roughly half of whom were 70 or older. The average age of participants who received ChAd was 53 years in the younger age group and 76 years in the older age group. Average ages for BNT were 51 and 78 years, respectively.

Thirteen experimental and control arms of the trial (seven vaccines plus three at half dose and three control arms) were split into three participant groups. Group A received NVX, half dose NVX, ChAd, or a control. Group B received BNT, VLA, half dose VLA, Ad26 or a control. Group C received Moderna, CVn (development of which was halted in October 2021), half dose BNT, or a control.

Primary outcomes were adverse effects seven days after receiving a booster, and levels of antibodies targeting the SARS-CoV-2 Spike protein after 28 days, compared to controls. Secondary outcomes included the response of T cells to wild type, Alpha, Beta, and Delta variants. 

Increases in anti-spike protein antibody levels after 28 days varied across the vaccines. After two doses of ChAd these ranged from 1.8 times higher to 32.3 times higher according to the booster vaccine used. Following two doses of BNT, the range was 1.3 times higher to 11.5 times higher. Significant T-cell responses were reported in several combinations.

At 28 days, all booster results were similar for participants aged 30-69 years and those aged 70 years or older. Boost ratios should be interpreted with caution, the authors caution, since they relate to immunogenicity rather than protection against disease, and the relationship between antibody levels at day 28 and long-term protection and immunological memory is unknown.

Reactions to all seven vaccines were similar, with fatigue, headache, and injection site pain most often reported. These were more commonly reported by those aged 30-69. 912 of the 2878 participants experienced a total of 1036 adverse events, 24 of which were severe.

Source: EurekAlert!

Categories : COVID VaccinesTags :

Mechanism Behind AstraZeneca and J&J Vaccine Blood Clots Found

On By ModernMedia
A cloud of platelet factor 4 proteins interacting with the electrostatic surface of the Oxford vaccine, as seen through the computational microscope.
Credit: Chun Kit Chan, Arizona State University

An international team of scientists believe they may have found a molecular mechanism behind the extremely rare blood clots linked to adenovirus vaccines.

Scientists led by a team from Arizona State University, Cardiff University and others worked with AstraZeneca to investigate vaccine-induced immune thrombotic thrombocytopenia (VITT), also known as thrombosis with thrombocytopenia syndrome (TTS), a life-threatening condition seen in a very small number of people after receiving the Oxford-AstraZeneca or Johnson & Johnson vaccines.

“The mechanism which results in this condition, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), was unknown,” said Abhishek Singharoy, an Arizona State University scientist and corresponding author of the study who teamed up to lead an international effort to tease out the details. 

Together, the team worked to solve the structural biology of the vaccine, and see the molecular details that may be at play, utilising state-of-the cryo-EM technology to analyse the AstraZeneca vaccine in minute detail. They sought to understand whether the ultra-rare side effect could be linked to the viral vector which is used in many vaccines, including those from Oxford/AstraZeneca and Johnson & Johnson.

Their findings suggest it is the viral vector – in this case, an adenovirus used to shuttle the coronavirus’ genetic material into cells – and the way it binds to platelet factor 4 (PF4) once injected that could be the potential mechanism.

In very rare cases, the scientists suggest, the viral vector may enter the bloodstream and bind to PF4, where the immune system then views this complex as foreign. They believe this misplaced immunity could result in the release of antibodies against PF4, which bind to and activate platelets, leading to clustering and blood clotting.

“It’s really critical to fully investigate the vector-host interactions of the vaccine at a mechanistic level,” said Singharoy. “This will assist in understanding both how the vaccine generates immunity, and how it may lead to any rare adverse events, such as VITT.”

Their findings were published in Science Advances.

Adenovirus expert Professor Alan Parker said: “VITT only happens in extremely rare cases because a chain of complex events needs to take place to trigger this ultra-rare side effect. Our data confirms PF4 can bind to adenoviruses, an important step in unravelling the mechanism underlying VITT. Establishing a mechanism could help to prevent and treat this disorder.”

“We hope our findings can be used to better understand the rare side effects of these new vaccines – and potentially to design new and improved vaccines to turn the tide on this global pandemic.”

The AstraZeneca and Johnson & Johnson vaccines both use an adenovirus to carry SARS-CoV-2 Spike proteins to trigger an immune response.

Since VITT was seen in both vaccines, scientists wondered whether the viral vector was involved. Additionally, neither the Moderna nor Pfizer vaccines, both mRNA vaccines, showed this effect.

Using cryo-EM technology to flash-freeze preparations of ChAdOx1, the adenovirus used in the AstraZeneca vaccine, they produce microscopic images of the vaccine components.

They were then able to view the viral capsid structure and other critical proteins that allow entry of the virus into the cell.

In particular, the team outlined the details for the structure and receptor of ChAdOx1, which is adapted from chimpanzee adenovirus Y25 – and how it interacts with PF4. They believe it is this specific interaction – and how it is then presented to the immune system – that could cuase the immune system to see it as foreign and release antibodies against this self-protein.

The research team also used computational models to show that one of the ways the two molecules tightly bind is via electrostatic interactions. The group showed that ChAdOx1 is mostly electronegative, attracting other positively charged molecules to its surface.

First author Dr Alexander Baker said: “We found that ChAdOx1 has a strong negative charge. This means the viral vector can act like a magnet and attract proteins with the opposite, positive charge, like PF4.” Baker is a member of ASU’s Biodesign Center for Applied Structural Discovery and an Honorary Research Fellow at Cardiff University School of Medicine.

“We then found that PF4 is just the right size and shape that when it gets close to ChAdOx1 it could bind in between the negatively charged parts of ChAdOx1’s surface, called hexons.”

The research team are hopeful that armed with a better understanding of what may be causing rare VITT they can provide further insights into how vaccines and other therapies, which rely on the same technology, might be altered in the development of the next generation vaccines and therapies.

“With a better understanding of the mechanism by which PF4 and adenoviruses interact there is an opportunity to engineer the shell of the vaccine, the capsid, to prevent this interaction with PF4. Modifying ChAdOx1 to reduce the negative charge may reduce the chance of causing thrombosis with thrombocytopenia syndrome,” said Baker.

The team likened it to the ‘two birds, one stone’ effect. The key contacts of individual amino acids that are essential to the capsid protein’s proteins interaction with PF4 can removed or substituted.

“The modification of the ChAdOx1 hexons to reduce their electronegativity may solve two problems simultaneously: reduce the propensity to cause VITT to even lower levels, and reduce the levels of pre-existing immunity, thus helping to maximize the opportunity to induce robust immune responses, said Singharoy.”

Source: EurekAlert!

Categories : COVIDTags :

Europe to Return Millions of Locally-filled J&J Vaccines

On By ModernMedia

The European Union has agreed to return millions of COVID vaccines doses partially produced in South Africa back to the African continent.

South Africa’s Aspen Pharmacare operates the plant that is partially producing Johnson & Johnson vaccines, where vaccine substance from Europe is sent to be bottled and shipped.

The plant is supposed to produce 400 million doses for the AU’s African Vaccine Acquisition Trust through 2022, to be purchased by African nations using World Bank financing. Shipments started in August, with 6.4 million doses delivered to countries, but they have been limited due to the manufacturing plant’s production capacity.

The announcement came as Africa struggles to immunise its population against COVID, partly due to a lack of supply resulting from wealthier countries buying up most vaccines, and also from widespread vaccine hesitancy. 

“All the vaccines produced at Aspen will stay in Africa and be distributed to Africa,” said Strive Masiyiwa, special African Union envoy. “This issue has been corrected and corrected in a very positive way.”

The announcement came after a meeting in Berlin between South African President Cyril Ramaphosa and European Commission President Ursula Von der Leyen, he said, adding that the first supplies were expected this month.

“In addition, the Europeans committed to give us 200 million doses before the end of December,” Masiyiwa said at the briefing by the Africa Centres for Disease Control and Prevention.

About 2.93% of people who have been fully immunised against COVID, said Africa CDC director John Nkengasong. The World Health Organization meanwhile warned that eight out of 10 African countries were likely to fall short of the “crucial” goal of vaccinating the most vulnerable 10% of their populations against COVID by the end of the month.

Source: Eyewitness News

Categories : HIV VaccinesTags :

J&J HIV Vaccine Fails in Local Trials

On By ModernMedia
HIV invading a human cell
HIV invading a human cell: Credit NIH

Johnson & Johnson and its partners announced preliminary results showing their HIV vaccine trial failed to provide sufficient protection against HIV infection in a population of young women in sub-Saharan Africa.

The vaccine had a favourable safety profile with no serious adverse events.
The Phase 2b HIV vaccine clinical trial was known as the Imbokodo study (also known as HVTN 705/HPX2008), which will now be discontinued. Further analysis of the Imbokodo study is ongoing, and the study has provided enough data to progress with key immunological correlates research.

“The high incidence of HIV among young women in sub-Saharan Africa reminds us that, despite great progress made in treatment and prevention, HIV remains a major health challenge for the region,” said Professor Glenda Gray, President and Chief Executive Officer, South African Medical Research Council (SAMRC) and Imbokodo’s Protocol Chair. “This underscores the need to apply the knowledge that will be gained from this trial to continue to advance the pursuit of a global HIV vaccine.”A parallel, ongoing Phase 3 Mosaico study (HVTN 706/HPX3002) with men who have sex with men and transgender individuals in Europe and Americas will continue due to the different HIV strains that are circulating in the trial areas and the different HIV vaccine regimen.
The HIV regimen consisted of an adenovirus vector containing four mosaic immunogens (Ad26.Mos4.HIV) at four vaccination visits over one year. The Imbokodo regimen contains a soluble protein component (Clade C gp140, adjuvanted with aluminum phosphate) which is administered at vaccination visits three and four. The ongoing Phase 3 Mosaico study is testing a different investigational vaccine regimen that involves the administration of a mosaic-based mixture of soluble proteins (Clade C/Mosaic gp140) at vaccination visits three and four.

Imbokodo participants had four vaccination visits over one year, with the primary endpoint based on new HIV infections through month 24. These data found that 63 of 1109 placebo arm participants compared to 51 of 1079 vaccine arm participants. This analysis demonstrated a vaccine efficacy point estimate of 25.2% (95% confidence interval of -10.5% to 49.3%).

HIV is prevalent in Sub-Saharan Africa, where women and girls accounted for 63 percent of all new HIV infections in 2020. The study enrolled roughly 2600 young women across Malawi, Mozambique, South Africa, Zambia and Zimbabwe. Researchers ensured that any HIV-infected participants in Imbokodo were referred to high-quality HIV treatment and care services. 

Source: PR Newswire

Categories : COVIDTags :

First South African-produced Vaccine Batch Shipped as Lockdown Eases

On By ModernMedia

The day after President Cyril Ramaphosa announced an easing of COVID restrictions to an adjusted Level 3 lockdown, Durban-based pharmaceutical company Aspen stated that it was releasing its first batch of locally-produced COVID vaccines under a licensing deal with the US giant Johnson & Johnson.

The first batch was leaving its manufacturing unit in Gqeberha, to be further distributed throughout South Africa. The company also stated that vaccines from these batches will be made available through the African Vaccine Acquisition Task Team/African Union platform.

In a statement, Aspen’s Group Chief Executive Stephen Saad, said, “Aspen is proud of the role we are playing in producing vaccines for distribution in South Africa, across Africa and the world. Our ability to produce these vaccines on behalf of Johnson & Johnson builds on our strategic vision of delivering high quality, affordable medicines that improve health outcomes for patients in our own country, continent and around the world.  Supply for Africa and South Africa is particularly rewarding, given the current global inequality in accessing vaccines. This represents a big step forward in ensuring that Africa can address its healthcare priorities. The manufacture of the Johnson & Johnson COVID vaccine builds on the global contributions we have already made in fighting the COVID-19 pandemic with both our anaesthetics portfolio and dexamethasone supply.”
Aspen has invested over R3 billion at the Gqeberha sterile manufacturing site, which contains high-technology, state-of-the-art pharmaceutical equipment and systems that will be used to manufacture advanced sterile medicines, including vaccines.

BioNTech and Pfizer last week signed a deal with South African manufacturer Biovac to help produce vaccine doses in Cape Town through what is known as a ‘fill and finish’ process. Once completed, this is expected to produce 100 million doses per year. President Cyril Ramaphosa has been vocal about global inequality in vaccine procurement, and has been pushing for an African source of vaccines to help the continent fend for itself.
With new cases falling in Gauteng, South Africa’s lockdown was lowered to an adjusted Level 3 on Sunday, with the sale of alcohol once again permitted during the week and at bars and restaurants.

Source: Aspen Holdings

Categories : COVID VaccinesTags :

Second J&J Dose Needed for Delta Variant

On By ModernMedia
Photo by Ivan Diaz on Unsplash

Johnson & Johnson’s COVID vaccine is much less effective against the Delta and Lambda variants than against the original wild-type virus, according to a new study posted on the BioRxiv preprint server on Tuesday.

Though a cause for concern, the results come from in vitro tests, and may not reflect the real world vaccine performance. However, the authors said this adds to evidence that the 13 million people inoculated with the J&J vaccine may need a second dose, preferably an mRNA vaccine, the authors said.
The findings, which are still to be peer reviewed, are however consistent with observations that a single dose of the AstraZeneca vaccine, which is similar to the J&J one, shows only about 33 percent efficacy against developing symptoms with the Delta variant.

“The message that we wanted to give was not that people shouldn’t get the J&J vaccine, but we hope that in the future, it will be boosted with either another dose of  J&J or a boost with Pfizer or Moderna,” said study leader Nathaniel Landau, a virologist at NYU’s Grossman School of Medicine.

Other experts said the results are what they would have expected, because all of the vaccines seem to work better when given in two doses. “I have always thought, and often said, that the  J&J vaccine is a two-dose vaccine,” said John Moore, a virologist at Weill Cornell Medicine in New York.

Dr Moore pointed to several studies in monkeys and people that have shown greater efficacy with two doses of the J&J vaccine, compared with one dose. The new study was particularly credible, he said, because it was published by a team not linked to any vaccine manufacturer.

But the data from the new study “do not speak to the full nature of immune protection,” said Seema Kumar, a spokeswoman for J&J. “Studies sponsored by the company indicate that the vaccine “generated strong, persistent activity against the rapidly spreading Delta variant,” she said.

The Delta variant is the most transmissible of the SARS-CoV-2 variants, and has become dominant in South Africa. 

Several studies have suggested that the mRNA vaccines made by Pfizer-BioNTech and Moderna will maintain their efficacy against the coronavirus, including all variants identified so far. One recent study showed, for example, that the vaccines trigger a persistent immune reaction in the body that may protect against the coronavirus for years. The J&J vaccine is newer, and has had fewer studies.

The J&J vaccine has had reports of rare blood clots and extremely rare neurological disorders, as well as problems with contamination at a US manufacturing plant. This is still not as bad as the disastrous news that the AstraZeneca vaccine was virtually ineffective against the Beta variant which was then the dominant strain in South Africa.

Small studies by J&J affiliated researchers suggested that the vaccine was only slightly less effective against the Delta variant than against the wild-type virus, and that antibodies stimulated by the vaccine grew in strength over eight months.

Dr Dan Barouch, a virologist at Beth Israel Deaconess Medical Center in Boston said it was important to consider the vaccine’s strength over time.

“Fundamentally I don’t see that there’s any discordance,” he said. “The question is that of kinetics, it’s not just magnitude, because immune responses are not static over time.” The new study also did not consider other components of immune defence, he added.

Dr Landau and his colleagues had compared blood samples taken from 17 people who had two doses of an mRNA vaccine and 10 who had one J&J vaccine dose.

The  J&J vaccine started out with a lower efficacy than the mRNA vaccines and showed a bigger drop in efficacy against the Delta and Lambda variants. “The lower baseline means that what’s left to counter Delta is very weak,” Dr Moore said. “That is a substantial concern.”

Very few vaccines are given as a single dose, because the second dose is needed to amp up antibody levels, noted Akiko Iwasaki, an immunologist at Yale University. People who were inoculated with the J&J vaccine “are relying on that primary response to maintain high levels of antibodies, which is difficult, especially against the variants,” she said.

Boosting immunity with a second dose should raise the antibody levels high enough to counter the variants, she said.

Source: New York Times

Categories : COVID VaccinesTags :

Millions of J&J Vaccines for South Africa Unfit for Use

On By ModernMedia

In yet another blow to South Africa’s flagging vaccination programme, millions of the Johnson & Johnson vaccine doses meant to be used have been declared unfit for use. This is due to contamination concerns at one of the group’s facilities in the US.

The US Food and Drug Administration said that the doses were not suitable for use. Upon reviewing this decision, the South African Health Products Regulatory Authority (SAHPRA) said in a statement that it had decided “not to release vaccine produced using the drug substance batches that were not suitable”.

J&J’s Emergent plant was ordered to pause production in April several weeks after it was determined that batches of a substance used to produce the vaccine were cross-contaminated with ingredients from another jab made by Anglo-Swedish pharma giant AstraZeneca. The FDA is yet to allow the factory to reopen.

Acknowledging the setback in South Africa’s vaccination programme, acting Health Minister Mmamoloko Kubayi-Ngubane said Saturday that the batches concerned were stored in a high-security laboratory in Port Elizabeth belonging to drugmaker Aspen. Aspen meanwhile promised that it is ramping up production elsewhere to meet the shortfall, and President Ramaphosa said that he discussed with President Biden the possibility of receiving US vaccine donations.

Along with other countries South Africa, is pushing for a patent waiver on COVID vaccines to allow low cost production of generics.

“If we are to save lives and end the pandemic, we need to expand and diversify manufacturing and get medical products to treat, combat and prevent the pandemic to as many people as quickly as possible,” President Cyril Ramaphosa told the G7 group of wealthy nations meeting in Britain on Sunday. The country needs 31 million doses of the J&J vaccine to help vaccinate its population of 59 million.

South Africa has secured 30 million doses of the highly effective Pfizer-BioNTech vaccine, but is a two-dose vaccine which has significant cold chain requirements.

Emergency shipment

SAHPRA stated that there is a new delivery of approximately 300 000 J&J doses “that have been cleared by the US FDA that meet the requirements and will subsequently be released and shipped to South Africa.” The expiry date of these doses have been extended, and will be ready for administration to South African teachers within days.

Vaccinations were already paused in April after reports of rare cases of blood clots. And in February, South Africa rejected over 1.5 million doses of AstraZeneca’s vaccine as it was deemed ineffective. The J&J vaccines were already facing expiry as they had been removed from long term storage.

South Africa has only vaccinated just over 1% of its population but as far as can be ascertained with limited testing in Africa is the hardest hit by COVID on the continent, with over 1.7 million recorded cases.
Source: Eyewitness News

Categories : Cancer Ethics and LawTags :

US Supreme Court Snubs Johnson & Johnson Talc Lawsuit Appeal

On By ModernMedia
Photo by Bill Oxford on Unsplash

On Tuesday, the US Supreme Court declined to hear Johnson & Johnson’s appeal challenging a $2.12 billion ruling in favour of 20 women who developed ovarian cancer which they alleged was linked to the company’s talcum powder. 

The company was appealing a 2018 court ruling in favor of 22 women who alleged asbestos-contaminated talcum powder was linked to their cases of ovarian cancer. The women had said the company did not provide adequate warning of the risks associated with using their products. The initial settlement amount had initially been over $4 billion before being cut down.

The judge in that case ruled Johnson & Johnson had “misrepresented the safety of these products for decades” and the evidence shown at the trial demonstrated “particularly reprehensible conduct on the part of Defendants.”
Johnsons & Johnson has dominated the talcum powder market for over a century.
While there is no established link between talcum powder exposure and cancer, but talcum powder is often mined close to asbestos, a known carcinogen for which there is no safe level of exposure, and which can have a long latency period between exposure and cancer development.
Some studies have shown an increase in lung cancer risk for miners working underground when exposed to raw talc, which can be contaminated with asbestos, while others have found no effect. Use of talcum powder in the genital or perineal area is thought to contribute to ovarian cancer risk, but results are also mixed.
Companies have been directed not to use asbestos in cosmetic products since the 1970s, according to the American Cancer Society. According to the National Cancer Institute, “the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.”


A 2018 investigation by Reuters uncovered documents showing that Johnson & Johnson was not only aware of the asbestos contamination problem, the company covered it up. It even tried to influence US regulatory policy over asbestos in cosmetic products. Lawyers representing the company have argued in court that the tests were unreliable, although recent independent lab tests of samples obtained from various time periods detected asbestos contamination.

In response to queries from Reuters, Johnson & Johnson’s outside litigation counsel Peter Bicks wrote: “The scientific consensus is that the talc used in talc-based body powders does not cause cancer, regardless of what is in that talc. This is true even if – and it does not – Johnson & Johnson’s cosmetic talc had ever contained minute, undetectable amounts of asbestos.”

Source: Forbes

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