Tag: covid vaccination

Should Unvaccinated-by-choice COVID Patients Get Less Priority?

Credit: ATS

A new opinion piece provides an exhaustive examination of the ethics of using hospital resources on unvaccinated-by-choice COVID patients with pneumonia, versus patients with other serious but slower illnesses.

In his article published online in the Annals of the American Thoracic Society, William F. Parker, MD, PhD, looked at cases in which hospitals delayed time-sensitive and medically necessary procedures for vaccinated adults when they were overwhelmed with unvaccinated patients who had severe, life-threatening COVID pneumonia and suggested an ethical framework for triaging these patients.

“These vaccinated patients are directly harmed when hospitals use all their resources to care for the many unvaccinated patients with COVID,” he wrote.  “For example, delaying breast cancer surgery by just four weeks increases the relative risk of death from the disease by 8%.”

Dr Parker argues for a contingency care standard prioritising emergency life-support, regardless of vaccination status, in order to save the most lives.  “Simply rejecting the use of vaccination in prioritisation of medical resources without analysis ignores the very real tradeoffs at play during a pandemic.  The pain and suffering of the vaccinated from deferred medical care require a deeper defense of caring for the unvaccinated.”

Eliminating double standards
He stated: “Even though the vast majority of patients who develop life-threatening COVID pneumonia are unvaccinated, hospitals still have ethical obligations to expand capacity and focus operations on caring for them—even if it means making vaccinated patients wait for important but less urgent care like cancer and heart surgeries.”

“If tertiary care centers turn inward and stop taking transfers of COVID patients from overwhelmed community hospitals, this will result in de facto triage in favor of lower benefit care and cause systematic harm to both the vaccinated and unvaccinated in vulnerable communities,” he adds.  “Hospitals must justify their nonprofit status by accepting transfers and prioritizing life-saving care during a pandemic surge.”

He cited the example of a surge in Los Angeles, when the public health department had to issue an order forcing elite hospitals to stop doing financially lucrative elective procedures and accept patient transfers from community hospitals with ICUs overwhelmed by COVID.

Reciprocity and proportionality
The principle of reciprocity supports a possible tiebreaker role for vaccination status when two patients have equivalent survival benefit from a scarce health care resource. However, a universal exclusion of the unvaccinated from life support during a pandemic surge fails the test of proportionality for reciprocity, according to Dr Parker.

Reciprocity is rewarding one positive action with another. One example of this principle is giving vaccinated people access to sporting or entertainment events that are off limits to the unvaccinated (even if negative for COVID). Proportionality is the principle that ‘payback’ should be proportional to the magnitude of the act.  For example, living kidney donors get moved way up the waitlist- the equivalent of four years of waiting time on dialysis.  This satisfies the proportionality principle.

Dr Parker points out that while the increased relative risk of death of 8% from deferring breast cancer surgery is awful, the absolute increase in risk is only one per 100, and perhaps only one per 200 for a two-week deferral.
“After the surge is over, the hospital can catch up on deferred elective surgeries,” he wrote. “The harm from a coronary artery bypass or cancer surgery delayed two weeks is real, but tiny in comparison to certain death from denying life support for respiratory failure.”

He concluded that: “There is a defensible role for vaccination status in triage as a limited tiebreaker, not as a categorical exclusion, but only in the context of a well-defined and transparent triage algorithm.  Despite the enormous financial pressure to do otherwise, elite academic centres are obligated to prioritise life support for emergency conditions to save as many lives as possible during COVID surges.”    

Source: EurekAlert!

South Africa Faces Vaccine Glut as Uptake Slows

Photo by Mat Napo on Unsplash

South Africa has asked Johnson & Johnson and Pfizer to delay delivery of COVID vaccines as it has too much stock now, health ministry officials said, as vaccine hesitancy continues to slow the immunisation campaign.

About 35% of South Africans are fully vaccinated, still only half the government’s target of 70% by year end. In the past 15 days, an average of 106 000 doses a day have been administered. At the beginning of the year, the programme had been beset by a lack of doses for a wide range of reasons, from AstraZeneca’s ineffectiveness against the Beta variant to overseas production delays. 

Deputy director-general of the Health Department, Nicholas Crisp, told Reuters that South Africa had 16.8 million doses in stock and said that deliveries had been deferred.

A spokesman for the Health Ministry said: “We have 158 days’ stock in the country at current use. We have deferred some deliveries.”

Stavros Nicolaou, chief executive of Aspen Pharmacare, which is packaging 25 million doses a month of J&J vaccines in South Africa, said most of the vaccines bound for South Africa would now be diverted to the rest of Africa, and deliveries would likely be deferred until the first quarter of next year.

A Pfizer spokesperson said: “We remain adaptable to individual country’s vaccine requirements whilst continuing to meet our quarterly commitments as per the South Africa supply agreement.”

The government has been trying to boost the rate of daily administered doses, such as with R100 ‘Vooma vouchers’ for registering to vaccinate, but even these have failed to sufficiently stoke uptake.

“There is a fair amount of apathy and hesitancy,” said Wits University’s Professor Shabir Madhi.

On Twitter, he further suggested using the excess stock for booster shots, which would “provide all single dose JJ adult recipients a JJ or Pfizer boost, and  those > 65 or immunosuppressive conditions an additional Pfizer dose if received 2 doses > 5 months ago.” 

Source: U.S. News

Immune Cells Persist 6 Months after COVID Vaccination

Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

A recent study shows that T helper cells produced by people who received either of the two available messenger RNA (mRNA) vaccines for COVID persist six months after vaccination, at only slightly reduced levels from two weeks after vaccination. They are also at significantly higher levels than in unvaccinated individuals.

In the study, published in Clinical Infectious Diseases, the researchers also found that the T cells they studied recognise and help protect against the highly infectious delta variant of SARS-CoV-2.

“Previous research has suggested that humoral immune response – where the immune system circulates virus-neutralising antibodies – can drop off at six months after vaccination, whereas our study indicates that cellular immunity – where the immune system directly attacks infected cells – remains strong,” said Professor Joel Blankson, MD, PhD, study senior author. “The persistence of these vaccine-elicited T cells, along with the fact that they’re active against the delta variant, has important implications for guiding COVID vaccine development and determining the need for COVID boosters in the future.”

The researchers sampled blood from 15 study participants at three times: prior to vaccination, between seven and 14 days after their second Pfizer/BioNTech or Moderna vaccine dose, and six months after vaccination. The median age of the participants was 41 and none had evidence of prior SARS-CoV-2 infection.

CD4+ T lymphocytes are nicknamed helper T cells because they assist another type of immune system cell, the B lymphocyte (B cell), to respond to antigens on viruses such as SARS-CoV-2. Activated by the CD4+ T cells, immature B cells become either plasma cells that produce antibodies to mark infected cells for disposal from the body or memory cells that ‘remember’ the antigen’s biochemical structure for a faster response to future infections. Therefore, a CD4+ T cell response can serve as a measure of how well the immune system responds to a vaccine and yields humoral immunity.

The researchers found that the number of helper T cells recognising SARS-CoV-2 spike proteins was very low pre-vaccination, with a median of 2.7 spot-forming units (SFUs, the level of which is a measure of T cell frequency) per million peripheral blood mononuclear cells (PBMCs, identified as any blood cell with a round nucleus, including lymphocytes). Between 7 and 14 days after vaccination, the T cell frequency rose to a median of 237 SFUs per million PBMCs. At six months after vaccination, the level dropped slightly to a median of 122 SFUs per million PBMCs – a T cell frequency still significantly higher than before vaccination.

Six months after vaccination, the number of T cells recognising the delta variant spike protein was not significantly different from that of T cells attuned to the original virus strain’s protein.

“The robust expansion of T cells in response to stimulation with spike proteins is certainly indicated, supporting the need for more study to show booster shots do successfully increase the frequency of SARS-CoV-2-specific T cells circulating in the blood,” said Prof Blankson. “The added bonus is finding that this response also is likely strong for the delta variant.”

Source: John Hopkins Medicine

WHO Predicts Shortfall in Syringe Production

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The World Health Organization has said that with the goal of two COVID vaccine doses for seven billion people between now and 2023, a shortage of at least one billion syringes “could occur”, if manufacturing does not increase. This could endanger other immunisation programmes.

Lisa Hedman, WHO Senior Advisor, from the Access to Medicines and Health Products division, warned that there could be a generation of children who miss scheduled immunisation jabs unless manufacturers come up with a way to make more single-use disposable syringes.

“When you think about the magnitude of the number of injections being given to respond to the pandemic, this is not a place where we can afford shortcuts, shortages or anything short of full safety for patients and healthcare staff,” said the WHO expert.

She told media that more than 6.8 billion doses of COVID vaccines are being administered globally per year – nearly twice the yearly number for routine inoculations.

“A shortage of syringes is unfortunately a real possibility and here’s some more numbers. That [given] the global manufacturing capacity of around six billion a year for immunisation syringes it’s pretty clear that a deficit in 2022 of over a billion could happen if we continue with business as usual.”

Reuse of syringes was inadvisable, also noting that syringes were particularly prone to transport delays because they took up 10 times the space of a vaccine.

Meanwhile, the heads of the International Monetary Fund (IMF), World Bank Group, WHO and the World Trade Organization (WTO) held a follow up session of High-Level Consultations with the CEOs of leading COVID vaccine manufacturing companies on Tuesday.

All participants at the meeting agreed on the urgency of increased vaccine dose delivery to low-income countries, where less than 2.5% of the population has been fully vaccinated.

The meeting’s aim was to identify how to ensure more equitable distribution of vaccines and all participants pledged to continue working together to clarify donations, vaccine swaps and delivery schedules, so that distribution of the life-saving vaccines can be more effectively targeted towards needy countries.

The meeting of the Multilateral Leaders Task Force on COVID-19 built on technical work undertaken by multidisciplinary teams during the months of September and October.

During the consultations, the leaders of the four organisations and the CEOs also examined how best to tackle trade-related bottlenecks; how to improve the donation process; what additional steps are needed to reach the vaccination target of 40% of people in all countries by the end of the year; and how to improve transparency and data sharing with the IMF-WHO Vaccine Supply Forecast Dashboard and the Multilateral Leaders Task Force.

The effort will require close collaboration between manufacturers, governments and the international COVAX initiative, on enhanced delivery schedules, especially for doses that are being donated.

Source: UN News

No Finding of Early Miscarriage Risk from COVID Vaccinations

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A new study has found no association between COVID vaccinations and risk of first-trimester miscarriages, providing further evidence of the safety of COVID vaccination during pregnancy. The findings were published in the New England Journal of Medicine.

Study co-author Dr Deshayne Fell said, “The study analysed several national health registries in Norway to compare the proportion of vaccinated women who experienced a miscarriage during the first trimester and women who were still pregnant at the end of the first trimester.”  Dr Fell, is Associate Professor in the School of Epidemiology and Public Health in the University of Ottawa’s Faculty of Medicine and a Scientist at the Children’s Hospital of Eastern Ontario (CHEO) Research Institute.

“Our study found no evidence of an increased risk for early pregnancy loss after COVID vaccination and adds to the findings from other reports supporting COVID vaccination during pregnancy,” the study authors wrote. 

“The findings are reassuring for women who were vaccinated early in pregnancy and support the growing evidence that COVID vaccination during pregnancy is safe.”

Dr Fell and colleagues found no relationship between the type of vaccine received and miscarriage. In Norway, the vaccines used included Pfizer, Moderna and AstraZeneca.

“It is important that pregnant women are vaccinated since they have a higher risk of hospitalisations and COVID-complications, and their infants are at higher risk of being born too early. Also, vaccination during pregnancy is likely to provide protection to the newborn infant against COVID infection in the first months after birth,” the study authors stressed.

Source: University of Ottawa

Gauteng Vaccination Goals Under Threat

Image by Quicknews

Gauteng Premier David Makhura has stated that the province is not vaccinating enough people, which he acknowledged jeopardises its ambitious plans of having 70% of the population vaccinated by year end.

In a media briefing on Monday regarding the province’s vaccination rollout, he revealed that of Sunday, 5.3 million vaccines have been administered. More than 2.6 million people in Gauteng have been fully vaccinated. Gauteng’s infection rate has stabilised, with the number of active cases having fallen to approximately 1000. 

The Premier said that as things currently stand, there are still 4.4 million people in Gauteng that have to be vaccinated by the end of December. Makhura said that while they are still focussed on the target, it is becoming difficult to achieve, given the low numbers of people coming in for vaccinations.

“We are not retreating on our target of 70%, but the idea that we will meet 70% by mid-December is becoming a target that is elusive. The vaccination rate per day in Gauteng, on average during the week we are just between 52 and 58 000. We have fallen below the mid 60 000 daily vaccination rate. In September, we were doing extremely well. We were getting around 65-75 000.”

Based on last week’s total of 313 790 vaccinations, with 11 weeks in the year that would mean only about 3.5 million vaccinations administered – let alone persons fully vaccinated with a second dose. Concerns had been voiced at the end of September about flagging vaccination rates in South Africa as a whole.

Makhura also highlighted the low turnout of people in the province’s townships.

“Our townships are lagging behind. The substantial vaccinations are happening in more suburban areas, and the townships are lagging behind. Those townships in the south, Orange Farm and Palestine, we have the lowest number of vaccinations in the south of Johannesburg, that’s where we have 11% vaccination in terms of just single doses,” he said. 

Professor Bruce Mellado, of the Gauteng Provincial Command Council, said that, there was still a need to be cautious, especially with big events on the horizon, such as the municipal elections, saying:

“While the situation in the Gauteng Province remains stable and low risk, the risk of a fourth wave is very, very high. In fact, we predict that the fourth wave will hit sometime between November and January as we expect a number of super-spreader events to follow in a row. That’s something we have to have in mind.”

“We should not be confused or misled by the fact that we are currently in a situation of low risk, but that can change quite rapidly,” Prof Mellado cautioned.

Source: The South African

Post-COVID Vaccination Menstrual Changes Investigated

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A paper awaiting peer review on the MedRxiv preprint server shows that menstrual changes in women receiving after the COVID vaccine are quite common.

Many people began sharing that they experienced unexpected menstrual bleeding after being vaccinated for COVID, an emerging phenomenon which was undeniable yet understudied.

Unfortunately, dismissal by medical experts fueled greater concerns, as both vaccine hesitant and anti-vaccine individuals and organisations began to conflate the possibility of short-term menstrual changes with long-term harms to fertility. Many influencers used this well-used framing of protecting women as a means of further anti-vaccine messages.

There are many plausible biological mechanisms that could explain a relationship between an acute immune challenge such as a vaccine, its corresponding and well-known systemic effects on haemostasis and inflammation, and menstrual repair mechanisms of the uterus. The uterine reproductive system is flexible and adaptable in the face of stressors. Examples include marathon running having short term influence on hormone concentrations in the short term; short-term calorie restriction that results in a loss of menstrual cycling can be overcome by resuming normal feeding; that inflammation influences ovarian hormones; and that psychosocial stressors can correspond to cycle irregularity and yet resilience can buffer one from these harms. Typhoid, Hepatitis B, HPV vaccines have all had menstrual irregularity associated with them.  

While sustained early stressors can influence adult hormone concentrations, short-term stressors resolve and do not produce long-term effects. This is quite different from the sustained immune assault of COVID itself: studies and anecdotal reports are already demonstrating that menstrual function may be disrupted long-term, particularly in those with long COVID.

In this sample, 42% of people with regular menstrual cycles bled more heavily than usual, while 44% reported no change, after being vaccinated. Among people who typically do not menstruate, 71% of people on long-acting reversible contraceptives, 39% of people on gender-affirming hormones, and 66% of post-menopausal people reported breakthrough bleeding. We found increased/breakthrough bleeding was significantly associated with age, other vaccine side effects such as fever or fatigue, history of pregnancy or birth, and ethnicity.

Many respondents who had post-vaccine changes did not have them until fourteen days or longer post-inoculation, which extends beyond the typical seven days of adverse symptom reporting in vaccine trials.

Source: MedRxiv

Vaccinated Individuals Reduce COVID Risk for Nonimmune People

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As the number of family members with COVID immunity from prior infection or vaccination increased, there was a decrease in infection and hospitalisation risk for nonimmune people. 

This is shown in a Swedish study conducted by researchers at Umeå University and published in JAMA Internal Medicine.

“The results strongly suggest that vaccination is important not only for individual protection, but also for reducing transmission, especially within families, which is a high-risk environment for transmission,” said Peter Nordström, professor of geriatric medicine at Umeå University.

Evidence shows that vaccines greatly reduce the severity of COVID including the Delta variant but there less is known how vaccination affects transmission of the virus in high-risk environments, eg within families.

The researchers found that there was a dose-response association between the number of immune individuals in each family and the risk of infection and hospitalisation in non-immune family members. Specifically, non-immune family members had a 45 to 97% reduced risk of infection and hospitalisation, as the number of immune family members increased.

The study is a nationwide, registry-based study of more than 1.8 million individuals from more than 800 000 families, drawing on various databases. In the analysis, the researchers quantified the association between the number of family members with immunity against COVID and the risk of infection and hospitalisation in nonimmune individuals. The researchers accounted for factors such as differences in age, socioeconomic status, clustering within families, and several diagnoses previously identified as risk factors for COVID in the Swedish population.

“It seems as if vaccination helps not only to reduce the individual’s risk of becoming infected, but also to reduce transmission, which in turn minimises not only the risk that more people become critically il, but also that new problematic variants emerge and start to take over. Consequently, ensuring that many people are vaccinated has implications on a local, national, and global scale,” said study co-author Marcel Ballin, doctoral student in geriatric medicine at Umeå University.

Source: Umeå University

Digital COVID Vaccination Certificates for South Africa are Here

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People vaccinated in South Africa can now download their digital COVID vaccination certificates. The service officially went live on Friday, and was announced by the Minister of Health, Dr Joe Phaahla.

Addressing a media briefing, Dr Phaahla said the certificate could be used for travel and tourism, sport and recreation events, music festivals, shops that are providing discounts and prizes for people who are vaccinated.

“Our role is to make this tool available to the nation to provide people with the proof of vaccination so they can have access to the many amenities and activities that some have been missing…

“The vaccination certificate was introduced over the last three days while it was in the testing phase but some people have been able to upload it to their cell phones.

“We are launching the first phase of the certificate – there’s going to be a lot more improvements in the next two months [with regards to] the safety and security of the certificate but it is ready for use,” said the Minister.

The certificate was developed by the Department of Health and the Council for Scientific and Industrial Research (CSIR) and can be found at https://vaccine.certificate.health.gov.za.

The project manager for the National Electronic Vaccination Data System (EVDS), Milani Wolmarans, said the certificate can be downloaded through a web portal by anyone who has received the COVID vaccine in South Africa.

“You’ll need your vaccination code from the SMS you received after your vaccination, South African ID or Foreign Passport number or Asylum or Refugee number. This should be the same document that you presented when you got vaccinated and the cell phone you included on your registration,” she said.

Vaccination codes will be sent via SMS over the next four day, and also be accessed from the COVID call centre on 0800 029 999.

“With regards to the recognition of the digital certificate, most countries around the globe would accept the certificate. It is, however, dependent on the policy of the country that you would be visiting and also what their verification requirements would be.

“Towards the end of the next two months, there will be an app that you can use to download the certificate,” Wolmarans said.

The Minister also welcomed South Africa’s removal from the UK’s red list, which will take effect on Monday 11 October.

“We are also pleased with the UK government announcement that it is taking our country from the red list – meaning more easy travel between people from South Africa and the UK. The UK will be recognising the certificate that we are launching,” Dr Phaahla said.

Importantly, the UK will also now recognise South African COVID vaccination certificates.

Source: SA News.Gov

COVID Vaccines less Effective in Patients Undergoing Chemotherapy

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New research has found that patients undergoing active chemotherapy had a lower immune response to two doses of the COVID vaccine, although a third dose increased response.

“We wanted to make sure we understand the level of protection the COVID vaccines are offering our cancer patients, especially as restrictions were being eased and more contagious variants were starting to spread,” said Rachna Shroff, MD, MS, University of Arizona Health Sciences.

To find out, Dr Shroff and colleagues looked at 53 Cancer Center patients on immunosuppressive active cancer therapy, such as chemotherapy. They compared the immune response following the first and second dose of the Pfizer-BioNTech COVID vaccine with that of 50 healthy adults. 

After two vaccine doses, most of the cancer patients showed some immune response to the vaccine in that they had produced antibodies for SARS-CoV-2.

“We were pleasantly surprised,” said Deepta Bhattacharya, PhD, professor of immunobiology in the College of Medicine – Tucson. “We looked at antibodies, B cells and T cells, which make up the body’s defense system, and found the vaccine is likely to be at least partially protective for most people on chemotherapy.”

However, this  immune response was much lower than in healthy adults, and a few of the patients had no response to the COVID  vaccine. This translates to less protection against SARS-CoV-2, especially the now-dominant Delta variant.

Twenty patients returned for a third shot, which boosted the immune response for most. The overall group immune response after the third shot reached levels similar to those of people who were not on chemotherapy after two doses.

The results were published in Nature Medicine.

Source: University of Arizona Health Sciences