Tag: covid vaccination

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

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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

SA Daily COVID Vaccination Rate Plummets

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The daily COVID vaccination rate in South Africa plunged this week, prompting fears that the vaccination drive may be losing steam. This comes amid criticism around insufficient  information about vaccinations in more remote and impoverished communities.

Just 159 542 doses were administered on 20 September, the lowest weekday total since 13 August, when 147 307 jabs were given, according to government statistics.

That falls short of its target of 300 000 daily doses (which is yet to be obtained), and also the lowest since 18-to-35 year-olds became eligible for vaccines on 1 September.

As of Wednesday, 22 September South Africa has administered 16.56 million doses, but only 8.23 million of the country’s almost 40 million adults are fully vaccinated. Of those fully vaccinated, about 44% are the single-dose Johnson & Johnson vaccines.

To achieve 70% coverage of the adult population by December, a further 18 million adults will need to be vaccinated, noted health minister Dr Joe Phaahla.

In an address to the media on Friday, 17 September, Dr Phaahla said that the government is still focused on adult vaccinations, with the main priority being the 50 and older age group ahead of a possible year-end fourth wave. Dr Phaahla also noted the South African health regulator’s approval of Pfizer’s COVID vaccine for use for children 12 years and older, saying that the policy of vaccination of under 18s would be revisited based on the total number of adults vaccinated by the end of October.

“Even though we know the Pfizer vaccine has been approved [for children], we want to remain focused on the high-risk people as of now.

“If we can reach 70% of the 50+ age group when the next wave comes, our hospitals will not be as overwhelmed as they have been.”

Dr Phaahla added that the government is aware of pressure from schools for vaccinations of children. Other factors to be taken into account are the local government elections on 1 November — a possible super-spreader event — and a surplus vaccine supply to enable targeting under 18s.

“We think it will be very risky to be all over and start just vaccinating people everywhere. Let’s manage the schools,  and keep on pushing the elderly to get vaccinated.”

On Wednesday, 22 September, there were 2967 new COVID cases, with a case positivity rate of 7%. The total number of vaccinations on that day was slightly higher, but only stood at 187 003, short of the government’s goal of 300 000 per day. Of these, 110 847 were fully vaccinated, 45.3% from J&J doses.

Source: BusinessTech

Stockpiling Could Cause 241 Million Vaccine Doses to be Wasted

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Analytics company Airfinity estimates the G7 and EU will have an excess of 1 billion vaccine doses by the end of 2021, of which 10% are expected to expire. 

When factoring the time taken to distribute and administer the doses in Lower Income Countries (LICs) and Lower Middle Income Countries (LMICs), the proportion rises. Many of these countries will refuse vaccines that don’t have at least a two month shelf life. Taking into account this two month shelf, 241 million doses could be wasted by the end of 2021, amounting to a quarter of the G7 and EU surplus stock. 

The available vaccines in the G7 and EU, together with already purchased doses and COVAX deliveries, are sufficient for LICs and LMICs to vaccinate 70% of their populations by May 2022. Airfinity estimates that total global COVID cases are likely to exceed 400 million by mid-2022 and immediately redistributing vaccines could potentially avert nearly 1 million deaths from the virus in that time frame. 

“Currently doses tend to get shared in low volumes, at short notice, and with shorter than ideal expiry dates – making it a huge logistical lift to allocate and deliver these to countries able to absorb them,” says Aurélia Nguyen, managing director of the COVAX facility.

Vaccine manufacturers are now making 1.5bn doses every month.

“They’re producing a huge number of doses. It has scaled up immensely over the last three or four months,” Dr Matt Linley, lead researcher at Airfinity, told BBC News.

“I don’t think it was necessarily rich countries being greedy, it’s more that they didn’t know which vaccines would work,” says Dr Linley. “So they had to purchase several of them.”

Airfinity hopes to show governments that there are enough vaccines to fulfil their needs, and thanks to this secure supply they can donate without stockpiling.

“They don’t want to be caught off guard,” said Agathe Demarais. “It’s also about domestic political pressure because part of the electorate would probably be very unhappy to see vaccines being donated, if there is a feeling that they’re still needed at home.”

Co-founder and CEO of Airfinity, Rasmus Bech Hansen said: “The world has witnessed two extraordinary scientific achievements in the pandemic: The fast development of highly effective vaccines and the unprecedented scale up of production.For the world to get the full benefit of this, our data shows, we need a third equally unprecedented achievement: A large scale, rapid, globally coordinated, science driven vaccination campaign.” 

Source: Airfinity

Menstrual Changes After COVID Vaccinations

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In an article in the BMJ, authors argue that menstrual changes after COVID vaccination are plausible and should be investigated. 

Listed common side effects of COVID vaccination include a sore arm, fever, fatigue, and myalgia. However, changes to periods and unexpected vaginal bleeding are not listed, and primary care clinicians and those in the reproductive health field are seeing more and more people who have experienced these events shortly after vaccination.

More than 30 000 reports of these events had been made to the UK;s surveillance scheme for adverse drug reactions by 2 September 2021, across all COVID vaccines currently offered.

Most post-vaccination changes to periods return to normal, and there is no evidence that COVID vaccination adversely affects fertility. In clinical trials, there were similar rates for unintended pregnancies in vaccinated and unvaccinated groups. In fertility clinics, fertility measures and pregnancy rates are similar in vaccinated and unvaccinated patients. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) says that there are few reported that 

Menstrual changes have been reported after both mRNA and adenovirus vectored COVID vaccines, suggesting that, if there is a connection, it is likely to be a result of the immune response to vaccination rather than a specific vaccine component. Human papillomavirus (HPV) vaccinations have also been associated with menstrual changes. Indeed, the menstrual cycle can be affected by immune activation from various stimuli, including viral infection: one study found about a quarter of menstruating women with COVID experienced menstrual disruption.

Biologically plausible mechanisms linking immune stimulation with menstrual changes include immunological influences on the hormones driving the menstrual cycle or effects mediated by immune cells in the lining of the uterus, which are involved in the cyclical build-up and breakdown of this tissue. Research may also help understand the mechanism.

Though the period changes are short lived, there is need for adequate research. Vaccine hesitancy among young women is largely driven by false claims that COVID vaccines could harm their chances of future pregnancy. Failing to thoroughly investigate reports of menstrual changes after vaccination is likely to fuel these fears. If a link between vaccination and menstrual changes is confirmed, this information will allow people to plan for potentially altered cycles. Clear and trusted information is particularly important for those who rely on being able to predict their menstrual cycles to either achieve or avoid pregnancy.

In terms of management, the Royal College of Obstetricians and Gynaecologists and the MHRA recommend that anyone reporting a change in periods persisting over several cycles, or new vaginal bleeding after the menopause, should be managed according to the usual clinical guidelines for these conditions.

The authors conclude by stating there is an important lesson in that the effects of medical interventions on menstruation should not be an afterthought in future research. In clinical trials, participants are unlikely to report changes to periods unless specifically asked, so in future trials, information about menstrual cycles and other vaginal bleeding should be actively solicited.

Source: The BMJ