Tag: covid vaccination

SAHPRA Reports 3rd Fatal Case of Guillain-Barré Syndrome Following Janssen Vaccination

Gloved hand holding vial of Janssen COVID vaccine
Photo by Spencer Davis on Unsplash

The South African Health Products Regulatory Authority (SAHPRA) issued media statements on 4 August 2022 and 12 September 2022, relating to two fatal cases of Guillain-Barré syndrome (GBS) following vaccination with COVID-19 Vaccine Janssen. SAHPRA has been informed of a third fatal case of GBS following vaccination with the same vaccine.

A causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organization’s (WHO) methodology. Following investigations, the case was classified as a vaccine product-related event. The events reported in the vaccine recipient were consistent with the case definition of GBS and no other likely cause of GBS was identified at the time of illness.

As previously communicated, GBS is a very rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by some bacterial or viral infections, including SARS-CoV-2. Symptoms of GBS range from mild to severe, and may include muscle weakness, muscle pain, numbness, and tingling. In many cases, GBS resolves with no serious after-effects, but in some cases GBS can cause serious or life-threatening problems.

Regulatory authorities have previously investigated reports of GBS associated with COVID-19 vaccines. They concluded that COVID-19 Vaccine Janssen may increase the risk of GBS. GBS is therefore listed as a rare adverse event in the professional information (PI) for COVID-19 Vaccine Janssen.

Investigations and causality assessment of all reported severe adverse events following immunisation (AEFI) with all COVID-19 vaccines are ongoing. The outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.

Important points to note

  • COVID-19 vaccines have consistently been shown to prevent severe forms of disease, hospitalisation and death. Based on the currently available evidence, SAHPRA has determined that the benefits of COVID- 19 vaccination far outweigh the very low risk of severe adverse events, including GBS. The public are strongly advised not to delay COVID-19 vaccination if eligible in terms of the national vaccination programme.
  • SAHPRA urges the public to report any suspected adverse events following the use of all medicines and vaccines. Reporting can be done at a health facility or by downloading the Med Safety App (https://medsafety.sahpra.org.za/), which is available for Android and iOS phones, or by calling the COVID-19 hotline at 0800 029 999. More information regarding AEFIs reported for the COVID-19 vaccines and how to report an AEFI is available from the SAHPRA website: https://aefi-reporting.sahpra.org.za/.
  • More information regarding AEFIs reported for the COVID-19 vaccines and how to report an AEFI is available from the SAHPRA website: https://aefi-reporting.sahpra.org.za/.

Source: SAHPRA

Hybrid Immunity Offers Greatest Protection against COVID

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

Analysing data from controlled studies throughout the world, researchers discovered that people with hybrid immunity – from both full vaccination and prior infection – are the most protected against severe illness and reinfection. The study, published in The Lancet Infectious Diseases, will aid public policy-makers in planning the optimal timing of vaccinations.

Researchers from University of Calgary teamed up with World Health Organization (WHO) experts to answer the question of how well protected people are from combinations of vaccinations, boosters and prior infection.

“The results reinforce the global imperative for vaccination,” says Dr Niklas Bobrovitz, first author on the study. “A common question throughout the pandemic was whether previously infected people should also get vaccinated. Our results clearly indicate the need for vaccination, even among people that have had COVID.”

The global emergence and rapid spread of the Omicron variant required scientists and policy-makers to reassess population protection against Omicron infection and severe disease. In the study, investigators were able to look at immune protection against Omicron after a prior SARS-CoV-2 infection, vaccination or hybrid immunity.

“Protection against hospitalisation and severe disease remained above 95 per cent for 12 months for individuals with hybrid immunity,” says Dr Lorenzo Subissi, PhD, a technical officer with WHO and senior author on the study. “We know more variants are going to emerge. The study shows, to reduce infection waves, vaccinations could be timed for rollout just prior to expected periods of higher infection spread, such as the winter season.”

The systematic review and meta-analysis found that protection against Omicron infection declines substantially by 12 months, regardless of prior infection, vaccinations or both, which means vaccination is the best way to periodically boost protection and to keep down levels of infection in the population. In total, 4268 articles were screened and 895 underwent full-text review – a difficult task before the assistance of experts in health informatics.

“This study demonstrates the power of machine translation. We were able to break through language barriers; most of the time, systematic reviews aren’t done in every language, they are limited to one or two,” says Dr Tyler Williamson “These former BHSc classmates, along with the large diverse team they brought together, have emerged as global leaders in SARS-CoV-2 research and delivered decision-grade evidence to the world.”

While the findings demonstrate that vaccination along with a prior infection carries the most protection, the scientists warn against intentional exposure to the virus.

“You should never try to get COVID,” says Bobrovitz. “The virus is unpredictable in how it will affect your system. For some, it can be fatal or send you to hospital. Even if you have a mild infection, you risk developing long COVID.”

The group says the next phase of this research would be to investigate how the bivalent vaccine performs against severe disease.

Findings from the study complement data on the SeroTracker dashboard which monitors studies and news reports to track seroprevalence data – the percentage of people in a population who have antibodies against the novel coronavirus. The website aggregates serology data from studies and news reports in different populations, and built-in filters allow users to compare seroprevalence levels between countries, occupations, and demographic groups.

Source: University of Calgary

Getting a COVID Booster Shot is not as Easy as it Should be

Photo by Spencer Davis on Unsplash

By Daniel Steyn for GroundUp

As COVID cases rise again around the world and the more infectious XBB.1.5 variant spreads rapidly, health minister Joe Paahla has emphasised the importance of getting vaccinated and boosted.

About 19 million people in South Africa (just over 30% of the population) are fully vaccinated and four million booster shots have been administered. The country is administering just over 40 000 jabs a week.

At the moment only people over 50 are eligible for a second booster. But according to Dr Nicholas Crisp, Deputy Director-General for the National Department of Health, all adults will be eligible in February. “As soon as the systems are all in place and staff orientated, the department will announce,” Crisp told GroundUp.

But finding a booster shot has become difficult. Privately-owned facilities have mostly discontinued their rollout of the vaccine, although a handful of Dis-Chem pharmacies still do vaccinations. Public sector health facilities are the only alternative.

Active vaccination sites can be found on the government’s Find My Jab website. Some are “visiting” sites only, open once or twice a week, and others are permanently open, but it is advised to call ahead to confirm availability.

“The department is trying to find a more efficient way of updating which vaccination sites are active and those are being reflected and changed weekly on Find My Jab,” says Crisp.

The Western Cape Health Department makes weekly updates to this list of vaccination sites in the province.

One concerned reader from Pennington in KwaZulu-Natal, who is over the age of 50 and HIV-positive (meaning COVID poses a higher risk for him) told GroundUp that his local clinic no longer offered vaccines. It had been ten months since his previous booster. He went to the nearest hospital but was refused a jab and told to wait for an SMS.

He called the vaccination hotline and was told to send a copy of his ID and vaccination card to be registered on the system and receive an SMS, despite already having received jabs in the past.

Without a device to send the documents, and 60km of flood-damaged road between him and and his nearest PostNet, he has still not received his booster shot.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Increase in Global Willingness to Accept COVID Vaccines

Vaccine injection
Image source: NCI on Unsplash

Global COVID vaccine acceptance increased from 75.2% in 2021 to 79.1% in 2022, according to a new survey of 23 countries accounting for more than 60% of the world’s population, published today in Nature Medicine. It was not all good news, though: vaccine hesitancy increased in eight countries including South Africa, and nearly one in eight vaccinated respondents were hesitant about receiving a booster dose.

This third annual study reveals a wide variability between countries and suggests a need to tailor communication strategies to effectively address vaccine hesitancy.

“The pandemic is not over, and authorities must urgently address vaccine hesitancy and resistance as part of their COVID prevention and mitigation strategy,” says CUNY Graduate School of Public Health and Health Policy (CUNY SPH) Senior Scholar Jeffrey V. Lazarus. “But to do so effectively, policymakers need solid data on vaccine hesitancy trends and drivers.”

To provide these data, an international collaboration led by Lazarus and CUNY SPH Dean Ayman El-Mohandes performed a series of surveys starting in 2020 in 23 countries which were impacted significantly by the pandemic, including the United States as well as South Africa and Brazil.

Of the 23 000 respondents (1000 per country surveyed), 79.1% were willing to accept vaccination, up 5.2% from June 2021. The willingness of parents to vaccinate their children also increased slightly, from 67.6% in 2021 to 69.5% in 2022. However, eight countries saw an increase in hesitancy (from 1.0% in the UK to 21.1% in South Africa). Worryingly, almost one in eight (12.1%) vaccinated respondents were hesitant about booster doses, and booster hesitancy was higher among the 18–29 age groups.

“We must remain vigilant in tracking this data, containing COVID variants and addressing hesitancy, which may challenge future routine COVID immunisation programs,” says Dean El-Mohandes, the study’s senior author.

The survey also provides new information on COVID treatments received. Globally, ivermectin was used as frequently as other approved medications, despite the fact that it is not recommended by the WHO or other agencies to prevent or treat COVID  

Also of note, almost 40% of respondents reported paying less attention to new COVID information than before, and there was less support for vaccine mandates. 

In some countries, vaccine hesitancy was associated with being female (for example in China, Poland, Russia), having no university degree (in France, Poland, South Africa, Sweden, or the US), or lower income (in Canada, Germany, Turkey or the UK). Also, the profile of people paying less attention to the pandemic varied between countries.

“Our results show that public health strategies to enhance booster coverage will need to be more sophisticated and adaptable for each setting and target population,” says Lazarus, also head of the Health Systems Research Group at ISGlobal. “Strategies to enhance vaccine acceptance should include messages that emphasise compassion over fear and use trusted messengers, particularly healthcare workers.”

The data provided by these surveys may offer insight to policymakers and public health officials in addressing COVID vaccine hesitancy. The study follows on the heels of a global consensus statement on ending COVID as a public health threat that Lazarus, El-Mohandes and 364 co-authors from 112 countries published in Nature in November.

Source: CUNY SPH

Review Finds Little, if Any, Difference in Safety among COVID Vaccines

Covid vaccines
Photo by Mat Napo on Unsplash

A Cochrane review of all the evidence available from randomised controlled trials of COVID vaccines up to November 2021 has concluded that most protect against infection and severe or critical illness caused by the virus. In addition, the Johnson and Johnson vaccine and the Cuban Soberana 2 vaccine “probably” reduced all-cause mortality.

The independent, international expert reviewers also found that there was little or no difference between the number of people experiencing serious side effects after vaccination compared to those who were unvaccinated.

The researchers, led by Isabelle Boutron, Professor of Epidemiology at Université Paris Cité and Director of Cochrane France, analysed published data from 41 randomised controlled trials of 12 different COVID vaccines, involving 433 838 people in various countries around the world. They assessed the certainty of the evidence and the risk of bias in the different studies.

The trials compared COVID vaccines with placebo, no vaccine, or each other, and were published before 5 November 2021. Most trials were no longer than two months in length.

The review found that the following vaccines reduced or probably reduced the risk of COVID infection compared to placebo: Pfizer/BioNTech, Moderna, CureVac COVID-19, Oxford-AstraZeneca, J&J, Sputnik V (Gam-COVID-Vac), Sinopharm (WIBP CorV and BBIBP-CorV), Bharat (Covaxin), Novavax and Soberana 2 (Finlay-FR-2). The following reduced or probably reduced the risk of severe or critical disease: Pfizer/BioNTech, Moderna, Janssen, Sputnik V, Bharat and Novavax. In addition, the J&J and Soberana 2 vaccines probably decreased the all-cause mortality risk. There were very few deaths recorded in all the trials and so evidence on mortality for the other vaccines is uncertain.

For most of the vaccines, vaccinated individuals reported more localised or temporary side effects compared no-treatment or placebo groups. These included tiredness, headache, muscle pains, chills, fever and nausea. With respect to the very rare side effects associated with some vaccines such as thrombosis, the team found that the reporting of these events was inconsistent, and the number of events reported in the trials was very low.

Given the evidence of efficacy of these vaccines, the researchers question whether further placebo-controlled trials are ethical. They suggest that further research compares new vaccines with those already in use.

Source: Wiley

GroundUp: Vaccine drive is Running out of Steam

Covid vaccines
Photo by Mat Napo on Unsplash

By Daniel Steyn

Daily COVID vaccinations have more or less plateaued since July. At the peak of the vaccination drive, South Africa was administering up to 240 000 vaccine doses a day. But this number has dropped to just over 5000 a day. Less than half of these are first doses and a third are booster shots.

The government still hasn’t reached its target of 67% adult vaccination, which it wanted to achieve by the end of 2021. Half of the adult population in South Africa is currently vaccinated. Among adults 60 years or older, nearly 73% have been fully vaccinated.

GroundUp visited the District Six Community Day Centre, a government clinic, in Cape Town. We asked for a COVID vaccine and were directed to a small room on the first floor, where one of us waited over 1.5 hours to get a vaccine (though two of us were vaccinated considerably quicker – about 30 minutes). This wasn’t because there was a long queue.

The nurse administering the vaccines was busy treating patients elsewhere in the clinic. The person logging the vaccines on the computer system told GroundUp that on average, 12 people a day come to the clinic for vaccines.

GroundUp visited a Clicks store in Cape Town where, three months ago, vaccines were still being administered. But they no longer do COVID vaccines.

The government’s dedicated Coronavirus website has a list of “active vaccination sites”, many of which are no longer active, and the “Find My Jab” page has completely different information.

Meanwhile, people are still getting ill from the virus. About 2000 new cases are reported each week, but according to the National Institute for Communicable Diseases (NICD) only 16% of cases are being detected. Testing sites are also few and far between.

Professor Glenda Gray says that the vaccine has done a good job at reducing deaths, serious illness and hospitalisations. Official daily deaths and hospitalisation rates are low in relation to previous waves. In the past four weeks, 125 deaths from COVID were reported.

The real number of deaths is likely much more than this. A weekly report published by the Medical Research Council and the University of Cape Town calculates the number of excess deaths – the deaths above the historical average before COVID: there have been close to 50 000 excess deaths so far this year. While in earlier waves the researchers were able to estimate that 85% to 95% of these excess deaths were due to COVID, the changing nature of the epidemic has made it much harder to estimate how many of this year’s excess deaths are due to COVID.

More than 85% of COVID infections in the country are from the Omicron BA.5 variant, which is widespread and infectious but usually causes very mild illness.

To prevent serious illness and death, getting the vaccine and booster shots are still recommended. Gray says that it is especially important for immunocompromised people, such as people living with HIV, to get vaccinated.

“Sadly, the virus has done a far better job of generating immunity than our government, which continues to be maddeningly slow at getting the vaccine out,” says Professor Francois Venter, infectious diseases clinician and head of Ezintsha at Wits University.

Although being infected by and recovering from the virus does provide a level of immunity, getting a vaccine still greatly improves one’s protection against the virus.

“I think we were all hoping once we had immunity from either infection or a vaccine or two, it would be enough. But from what we are seeing internationally, new waves of COVID, while not killing people in the numbers we saw in 2020 and 2021, are still making people very sick,” Venter says.

Dr Nicholas Crisp, Deputy Director-General of the National Department of Health, is the coordinator of the national vaccination drive. He agrees the current status of the vaccination drive is “very disappointing”.

He says the vaccination program is being integrated into primary health care, targeting areas geographically where communities or segments of a community are not vaccinated.

To monitor and manage the pandemic, Crisp says the government is continuing with daily testing, gene sequencing and wastewater sampling. Crisp says that the government is preparing for the future of COVID as well as other potential pandemics.

Future variants of the virus could be more dangerous. “As long as there is transmission, there is going to be mutation,” Gray told GroundUp. How the virus mutates in the future is yet to be seen.

In the US, new bivalent vaccines designed to target the Omicron variant are already available. But, Gray says, there is not yet sufficient evidence that these work better than the current vaccines.

According to Crisp, the government is not considering any new vaccines. “We are not buying vaccines this year and may not buy vaccines next year,” he says.

South Africa still has 8 million doses of the Pfizer vaccine and 10 million doses of the Johnson and Johnson vaccine. He says paediatric Pfizer vaccines will be purchased with some of the credit that South Africa has with the Covax facility. These will be given to children who are immunocompromised.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Distressed Individuals were Strong on COVID Vaccination but Lax on Social Distancing

COVID heat map. Photo by Giacomo Carra on Unsplash

During the COVID pandemic, individuals who were distressed, showing signs of anxiety or depression, were less likely to follow recommendations from the Centers for Disease Control and Prevention, yet they were more likely to get vaccinated than non-distressed peers.

The authors refer to this as differential distress: when people act safely in one aspect while disregarding safety in another, both in response to the same psychological distress. This creates a conundrum for those trying to determine how best to communicate risks and best practices to the public.

Their study of 810 people revealed that distress was less likely to affect older people either way, despite their higher risk for severe outcomes if infected with SARS-CoV-2. Reported in Frontiers in Psychology, the findings suggest that fear messaging, which is intended to scare people and can increase their levels of distress, may not be the most effective way to encourage people to change behaviours.

“These findings do not point to a straightforward public health messaging campaign,” said Professor Joel Myerson, study leader. “Instead, officials may have to consider more finely tailored messages for different populations in order to achieve best outcomes: more attention to CDC recommendations as well as more people getting vaccinated.”

In a previous study, the researchers looked at social distancing and hygiene behaviours across a range of demographics. The results suggested that distress was closely tied to the way people responded to recommendations about social distancing. People who were more distressed were less likely to observe social distancing recommendations, perhaps as a way to maintain social connections that can ease anxiety and depression.

In the latest work, researchers again asked people about their adherence to the latest CDC recommendations, including newer recommendations outlining when to wear a mask and suggesting that people avoid spending lots of time inside with others. The results showed similar correlations to the previous study among age, distress and behaviour changes.

In terms of public health and effective messaging, one of the most pressing issues to arise after publication of the first study was the introduction of vaccines and the perceptions around them. Looking at four categories, fully vaccinated; partially vaccinated; unvaccinated but likely to get one; unvaccinated and unlikely to get one, researchers found:

  • People who had been fully vaccinated were more likely than those who were partially vaccinated to have close interactions with others following their shots.
  • Relative to those who said they were unlikely to get vaccinated, those who said they were likely to do so thought their chance of infection was higher.
  • Depending on the person’s age, they responded differently to the same level of stress. Overall, for example, the higher level of distress someone had, the less likely they were to social distance, but the more likely they were to get vaccinated. Both of these correlations became weaker, however, as people aged.

Fear messaging that tries to scare people into following guidelines tends to be useful only for a one-time event, Green said. “Ostensibly, getting vaccinated should count as such an event.” But as breakthrough cases increase and boosters add up, vaccinations are no longer one and done; they are instead a series of events, spread out over more than a year.

Although fear-based messaging may encourage younger people to get vaccinated, it also weakens their resolve to mitigation behaviours like social distancing. Not doing both poses a greater breakthrough infection risk.

Messaging also becomes less effective as people age, just as they become more vulnerable to severe illness.

“Part of the solution to the problem of differential distress may be to avoid the distress altogether,” said Professor Leonard Green, study co-lead. This would entail forgoing the fear campaign. Instead, a gentler approach may be warranted. “Our previous work suggests that what really motivates many people to change behaviours for the better is considering how their actions can benefit, or harm, other people.”

Source: Washington University in St. Louis

COVID Vaccine Response in Blood Cancer Patients Only after Booster

Patients with blood cancers have an impaired immune system due to their disease and its treatment, putting them at risk of severe COVID infection and a reduced COVID vaccination response. In a recent study published in CANCER, less than half of patients with haematologic malignancies including leukaemia, lymphoma, and multiple myeloma mounted detectable antibodies after initial COVID vaccination, but 56% of ‘nonresponders’ produced antibodies after receiving a booster dose.

For the study, Thomas Ollila, MD, and colleagues retrospectively analysed antibody responses to initial and booster COVID vaccination in 378 patients with hematologic malignancies.

Anti-SARS-CoV-2 antibodies were detected in the blood of 181 patients (48%) after initial vaccination with one of three FDA-authorised or approved COVID vaccines, and patients with active cancer or those recently treated with an immune cell–depleting therapy were least likely to produce these antibodies. Among patients who did not mount an antibody response following initial vaccination, responses were observed after a booster dose in 48 of 85 (56%) patients who were assessed.

By the end of February 2022, 33 patients (8.8%) developed a COVID infection, with three COVID-related deaths (0.8%). Although there was no significant link between post-vaccination antibody response and incidence of COVID infection, no patient with antibody responses died from COVID

Also, no patient who received tixagevimab plus cilgavimab was diagnosed with a COVID infection. Tixagevimab and cilgavimab are antibody therapies that bind to non-overlapping portions of the SARS-CoV-2 spike protein, preventing the virus from binding to and infecting cells. The FDA authorised the combination therapy for emergency use during the COVID pandemic as a way to help prevent COVID infection in certain individuals.

“Our findings build on the wealth of literature showing that patients with hematologic malignancies have an impaired response to COVID vaccination. Importantly, we show that many of these patients who did not respond initially will in fact have a response to booster vaccination,” said Dr Ollila. “Moreover, when we looked at outcomes, we found that deaths from COVID in the patient population we reviewed only occurred in those with undetectable antibodies, and nobody who received prophylactic antibody therapy was diagnosed with COVID. This suggests to us the importance of checking antibody levels in these patients and arranging prophylactic antibody therapy.”

Dr. Ollila encourages providing booster vaccines for patients and prioritising prophylactic antibody therapy when indicated. “This is real world evidence that these actions can save lives,” he said.

Source: Wiley

Menstrual Changes after COVID Vaccine

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A new analysis of offers the most comprehensive assessment so far of menstrual changes experienced by pre- and post-menopausal individuals in the first two weeks after being vaccinated against COVID. Published in the journal Science Advances, the study adds to the growing body of evidence that significant numbers of people experience this unexpected side effect.

“Menstruating and formerly menstruating people began sharing that they experienced unexpected bleeding after being administered a COVID vaccine in early 2021,” the scientists who led the study wrote. Because vaccine trials typically do not ask about menstrual cycles or bleeding, this side effect was largely ignored or dismissed.

Early reports about post-vaccination menstrual changes were largely brushed aside, said Kathryn Clancy, a professor of anthropology who led the research with Katharine Lee, another anthropology professor. Some clinicians said it was unclear how a vaccine could trigger such changes.

However, it is known that other vaccines – including those for typhoid, Hepatitis B and HPV – are sometimes associated with changes in menstruation, Prof Clancy said. The changes are more likely to be associated with an increase in immune-related inflammatory pathways, as opposed to any hormonal changes.

“We suspect that for most people the changes associated with COVID vaccination are short-term, and we encourage anyone who is worried to contact their doctor for further care,” Lee said. “We want to reiterate that getting the vaccine is one of the best ways to prevent getting very sick with COVID, and we know that having COVID itself can lead not only to changes in periods, but also hospitalisation, long COVID and death.”

The researchers used a survey to query people about their experiences after vaccination. Launched in April 2021, the survey asked for demographic and other information but focused on respondents’ reproductive history and experiences regarding menstrual bleeding. The team downloaded the data from the surveys on June 29, 2021. Only those who had not been diagnosed with COVID were included in the analysis, as COVID itself is sometimes associated with menstrual changes. Data from people aged 45–55 years was excluded to avoid the confounding of effect menstrual changes associated with perimenopause.

“We focused our analysis on those who regularly menstruate and those who do not currently menstruate but have in the past,” Prof Clancy said. “The latter group included postmenopausal individuals and those on hormonal therapies that suppress menstruation, for whom bleeding is especially surprising.”

A statistical analysis revealed that 42.1% of menstruating survey respondents reported a heavier menstrual flow after receiving the COVID-19 vaccine. Some experienced this in the first seven days but many others saw changes 8–14 days after vaccination. Roughly the same proportion, 43.6%, reported no alteration of their menstrual flow after the vaccine, and a smaller percentage, 14.3%, saw a mix of no change or lighter flow, the researchers report.

Because the study relied on self-reported experiences logged more than 14 days after vaccination, it cannot establish causality or be seen as predictive of people in the general population, Lee said. But it can point to potential associations between a person’s reproductive history, hormonal status, demographics and changes in menstruation following COVID vaccination.

For example, the analysis revealed that respondents who had experienced a pregnancy were most likely to report heavier bleeding after vaccination, with a slight increase among those who had not given birth. A majority of non-menstruating premenopausal respondents on hormonal treatment experienced breakthrough bleeding after receiving the vaccine. This side effect was common in respondents using long-acting reversible contraception and 38.5% of those undergoing gender-affirming hormone treatments reported this side effect.

Those who were older, and those who experienced fever or fatigue as a side effect of vaccination were also more likely than other groups to report heavier menstrual flow after vaccination. White respondents were slightly less likely to report heavier menstrual flow.

Those who had experienced endometriosis, menorrhagia, fibroids or other reproductive problems also were more likely to report a heavier menstrual flow post-vaccination, the team found. The largest single increase was in those who have been pregnant without a delivery.

While the uptick in menstrual flow for some people may be transitory and quickly resolve, unexpected changes in menstruation can still cause concern, Prof Lee said.

“Unexpected breakthrough bleeding is one of the early signs of some cancers in post-menopausal people and in those who use gender-affirming hormones, so experiencing it can make people worry and require expensive and invasive cancer-screening procedures,” Prof Lee said.

“This screening is very important so we can catch cancers early,” Prof Clancy said. “For diagnostic purposes, it would be helpful to know whether there are other causes for the bleeding.”

“We’d love to see future vaccine testing protocols incorporate questions about menstruation that go beyond screening for pregnancy,” Prof Lee said. “Menstruation is a regular process that responds to all kinds of immune and energetic stressors, and people notice changes to their bleeding patterns, yet we don’t tend to talk about it publicly.”

Source: University of Illinois at Urbana-Champaign

Long COVID Risk only Slightly Lower after Vaccination

Man wearing mask with headache
Source: Usman Yousaf on Unsplash

Vaccination only reduces the risk of long COVID after infection by only about 15%, according to a study of more than 13 million people published in Nature Medicine. That’s the largest cohort that has yet been used to examine how much vaccines protect against the condition, but it is unlikely to end the uncertainty as other studies have produced conflicting results.

Studying long COVID has been challenging not least because of how hard it is to define from its constellation of symptoms. Even its prevalence has been hard to determine, with some studies suggesting it occurs in 30% of people after COVID infections. But nephrologist Ziyad Al-Aly and colleagues conducted a study of about 4.5 million people treated at US Department of Veterans Affairs (VA) hospitals, and the findings suggested that the number is 7% overall and lower than that for those who were not hospitalised.

Another mystery has been whether long COVID is less likely to occur after a breakthrough infection. But Al-Aly’s team now looked at VA health records from January to December 2021, including those of about 34 000 vaccinated people who had breakthrough SARS-CoV-2 infections, 113 000 people who had been infected but not vaccinated and more than 13 million people who had not been infected.

These results indicated only 15% a reduction of Long COVID in vaccinated individuals, a marked contrast to previous, smaller studies which suggested much higher protection rates. It’s also a departure from another large study, which used self-reported data from 1.2 million UK smartphone users and found that vaccination halved the risk of long COVID.

The authors of the latest study also compared symptoms such as brain fog and fatigue in vaccinated and unvaccinated people for up to six months after they tested positive for SARS-CoV-2. The team found no difference in type or severity of symptoms between those who had been vaccinated and those who had not. “Those same fingerprints we see in people who have breakthrough infections,” Al-Aly said.

In the US alone there have been over 83 million COVID infections, he noted. If even a small percentage of those turn into long COVID, “that’s a staggeringly high number of people affected by a disease that remains mysterious”.

Such limited protection means putting vulnerable people such as the immunocompromised at risk if measures such as masking are withdrawn. “We’re literally solely reliant, now almost exclusively, on the vaccine to protect us and to protect the public,” said Al-Aly. “Now we’re saying it’s only going to protect you 15%. You remain vulnerable, and extraordinarily so.”

“Generally speaking, this is horrifying,” said David Putrino, a physical therapist at Mount Sinai Health System in New York City who studies long COVID. While he praises the study, he notes that it is limited because it does not break the data down by key factors, such as medical history. “These are very important questions we need answers to,” Putrino says. “We don’t have any really well constructed studies just yet.”

Steven Deeks, an HIV researcher at the University of California, San Francisco, points out that the study includes no data from people infected during the period when the Omicron variant was causing the majority of infections. “We have no data on whether Omicron causes long COVID,” he says. The findings, he adds, “apply to a pandemic that has changed dramatically”.

Deeks added, that the results do highlight the need for more research on long COVID, and for accelerated development of therapies. “We don’t have a definition, we don’t have a biomarker, we don’t have an imaging test, a mechanism or a treatment,” he said. “We just have questions.”

Source: Nature