Tag: Johnson & Johnson

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

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

J&J HIV Vaccine Fails in Local Trials

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

First South African-produced Vaccine Batch Shipped as Lockdown Eases

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

Second J&J Dose Needed for Delta Variant

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

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

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

US Supreme Court Snubs Johnson & Johnson Talc Lawsuit Appeal

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

Second Gen COVID Vaccine Considered for Booster Shot in SA

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

Vaccine-related Fainting Down to Anxiety, CDC Says

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

Department of Health COVID Vaccine Rollout Phase 2 Outlined

The Department of Health’s COVID vaccine rollout has been fleshed out in a presentation, including details on how the vaccines will be distributed, and the jobs earmarked for the shots.

A presentation from the department indicates that the government has secured around 51 million vaccine doses, with 20 million from Pfizer and 30 million from Johnson & Johnson (J&J). However, it is unclear how the current pause in J&J administration in South Africa due to concerns about rare blood clots will affect immunisation schedules.

However, health minister Dr Zweli Mkhize announced that South Africa has secured a further 10 million Pfizer vaccines.

“We can now guarantee that the number of people that will be vaccinated with Pfizer has increased from 10 to 15 million,” he said.

With the 30 million of the single-dose shots from J&J, the current planned rollout will cover about 45 million South Africans.

Dr Mkhize said that both the Pfizer and J&J agreements cost around $10 (R145) per vaccine, with non-refundable clauses.

“The agreements state that down-payments that have been made in advance by the department shall not be refundable by the manufacturer to us in any circumstances. This is another onerous term that we had to settle for,” Dr Mkhize told the committee.

Meanwhile, government was sent an email from J&J, which stated that the company will not sign off the 20 million doses until they receive a letter from the Trade, Industry and Competition Minister, expressing support for the local investment that they made in Aspen Pharmacare.

“We’ve been taken aback by this, as there are clauses in the agreement that express this support and acknowledge that this production will not just be limited to South Africa and the continent, but also targeted for the global market,” said Dr Mkhize.

The department indicated that the Pfizer vaccine will likely go to major metropolitans due to its larger pack size and refrigeration requirements, while the J&J vaccine with its less stringent refrigeration needs would be allocated to rural areas.

South Africa’s Phase 2 of the vaccine rollout is planned to begin in May and run until October, with essential workers over 40 and the elderly to be targeted in the programme. This is to include a focus on old age homes and care facilities, plus identifying those with co-morbidities.

The department provided an overview of occupations covered under the vaccine rollout, to include, among others, the police, army, social and municipal workers, and faith and traditional leaders. Private sectors could include mining, retail, transport, and manufacturing.

Source: BusinessTech

FDA and CDC Justify J&J Vaccine Pause

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