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Large Canadian study suggests COVID-19 mRNA vaccines are safe to use in pregnancy – News-Medical.Net

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COVID-19 mRNA vaccines are safe to use in pregnancy and pregnant women experienced lower rates of health events post vaccination than similarly aged, non-pregnant vaccinated people, suggests a large Canadian study published in The Lancet Infectious Diseases journal.

The COVID-19 pandemic has disproportionately affected pregnant women, who are at higher risk of severe COVID-19 disease compared with similarly aged non-pregnant individuals. COVID-19 vaccines were recommended for use in pregnancy in many countries early on in vaccine deployment, based on established prior safety of inactivated vaccines in pregnancy and reassuring data from the small number of pregnancies occurring during pre-authorization vaccine trials.

This study is one of the first to look at vaccine side effects in a group of vaccinated pregnant women at the same time as both an unvaccinated pregnant group and a vaccinated non-pregnant group to enable comparisons between the three.

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In the early stages of the COVID-19 vaccine rollout there was low vaccine uptake among pregnant people due to concerns about data availability and vaccine safety. There still is lower than average uptake among non-pregnant women of reproductive age. Large, observational studies like ours are crucial for proper understanding of the rates of adverse health events in pregnant women after different doses of COVID-19 vaccination. This information should be used to inform pregnant women about the side effects they may experience in the week following vaccination.”

Dr Manish Sadarangani from the British Columbia Children’s Hospital Research Institute and first author on the study

This new study, from The Canadian National Vaccine Safety (CANVAS) Network, looked at data from participants across seven Canadian provinces and territories between December 2020 and November 2021. All vaccinated participants were asked to self-report any health events during the seven days following each dose of COVID-19 vaccine. The unvaccinated pregnant control group was asked to record any health problems over the seven days before they filled out the survey. In total, 191,360 women aged 15-49 years with known pregnancy status completed the first dose survey and 94,937 completed the second dose survey.

A ‘significant health event’ was defined as a new or worse health event which was enough to cause the participant to miss school/work, require medical consultation and/or prevent daily activities in the previous seven days. ‘Serious health event’ was defined as any event resulting in an emergency department visit and/or hospitalization in the previous seven days.

The researchers found that 4.0% (226/5,597) of mRNA-vaccinated pregnant females reported a significant health event within seven days after dose one of an mRNA vaccine, and 7.3% (227/3,108) after dose two. The most common significant health events after dose two in pregnant females were a general feeling of being unwell, headache/migraine, and respiratory tract infection.

In comparison, 3.2% (11/339) of pregnant unvaccinated participants reported similar events in the seven days prior to survey completion. In the vaccinated non-pregnant control group, 6.3% (10,950/174,765) reported a significant health event in the week after dose one and 11.3% (10,254/91,131) after dose two. Serious health events were rare in all groups (fewer than 1%) and occurred at similar rates in vaccinated pregnant individuals, vaccinated non-pregnant people and unvaccinated controls after dose one and dose two.

Miscarriage/stillbirth was the most frequently reported adverse pregnancy outcome with no significant difference between the rates in vaccinated and unvaccinated women; 2.1% (7/339) of unvaccinated pregnant women and 1.5% (83/5,597) of vaccinated pregnant women experienced a miscarriage or stillbirth within seven days after dose one of any mRNA vaccine.

“The lower rate of significant health events amongst vaccinated pregnant people, compared with vaccinated non-pregnant individuals, is unexpected and requires more research. Previous studies on other vaccines in pregnant women have mostly reported no significant differences in health events between pregnant and non-pregnant women or have found higher rates in pregnancy. Further studies of non-COVID-19 mRNA vaccines are required to identify if the reduced side effects observed in pregnant people in this study is a feature of the mRNA vaccine platform, or of these specific vaccines.” says Dr Julie Bettinger, senior author on this paper and also from the British Columbia Children’s Hospital Research Institute.

The authors caution that most participants who reported ethnicity in this study were white and these data may therefore not be fully generalizable to other populations. Additionally, this study focused on health events occurring within the first seven days following vaccination and so cannot conclude anything about longer term reactions. However, longer-term follow-up of this cohort is ongoing. A further limitation of this study is that data are based on self-reports from study participants, without verification by medical records.

Writing in a linked comment, Dr Sascha Ellington and Dr Christine Olson from the Centers for Disease Control and Prevention in the USA (who were not involved in the study) note, “These findings are consistent with and add to the growing body of evidence that COVID-19 mRNA vaccines are safe during pregnancy. […] COVID-19 vaccination among pregnant people continues to be lower than among non-pregnant females of reproductive age. Given the risks of significant illness and adverse pregnancy outcomes, it is imperative that we continue to collect and disseminate data on the safety and effectiveness of COVID-19 vaccination in pregnancy and to encourage healthcare providers to promote vaccination during all trimesters of pregnancy.”

Journal reference:

Sadarangani, M., et al. (2022) Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study. The Lancet Infectious Diseases. doi.org/10.1016/S1473-3099(22)00426-1.

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New technology to advance women’s cancer care at Southlake

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NEWS RELEASE
SOUTHLAKE REGIONAL HEALTH CENTRE
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This Cancer Awareness Month, Southlake is adding advanced technologies to detect and treat breast cancer and other women’s cancers thanks to generous community donor support, most recently through the HERE is Where Cancer Meets its Match campaign. New cancer care technology, including new mammography machines, the MyoSure System and the MOLLI 2® System will make a measurable impact in diagnosing and treating women’s cancers in the communities Southlake serves.

Southlake is installing three new mammography machines to expand its breast cancer screening program to 1,500 more women each year. Two of these machines have new biopsy capabilities that will reduce the number of cancelled exams due to equipment failure, ensuring timely care for women. Women ages 40 to 49 years old will be able to self-refer for publicly funded mammograms through the Ontario Breast Screening Program starting this fall.

“Early detection is critical when treating breast cancer and other women’s cancers,” said Lorrie Reynolds, Director, Regional Cancer Program at Southlake. “We treat more than 1,700 breast cancer patients at Southlake every year. By adding advanced technology, like the new mammography machines, we’re ensuring women have the best experience at Southlake.”

Southlake is also introducing the MyoSure System, an innovative technology that can help detect female reproductive cancers. Damaged tissue in a woman’s uterus such as fibroids and polyps can now be removed in a precise, minimally invasive procedure that leaves the rest of the uterus intact. This will improve the overall patient experience by supporting faster recovery, reducing the risk of infection and giving more women the option to have children. An estimated 200 women per year will benefit from the MyoSure System.

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The new mammography machines and the MyoSure System build on Southlake’s recent investment in the MOLLI 2® System, a made-in-Canada wire-free breast localization technology.  This technology is considerably less invasive and more accurate when compared to wire-guided localization, resulting in a better patient experience and improved cosmetic outcomes.  More than 200 women each year will benefit from this innovative medical device as they are treated for breast cancer at Southlake.

“As a clinician caring for women with cancer in our community, I’m incredibly proud of the work Southlake is doing to advance women’s health and improve patient experiences,” said Sara Temple, MD, Surgical Oncologist and Chief of Surgery at Southlake. “Women who visit Southlake can be confident that they are receiving leading edge care, close to home when they need it most.”

The World Health Organization anticipates a 77 per cent increase in cancer diagnoses by 2050.  Southlake serves some of the fastest growing communities in Canada and anticipates that the number of patients requiring cancer care will grow. By investing in new technology, Southlake is ensuring that women in the communities it serves have access to leading edge cancer care. All of these investments were funded with support from community donors who generously gave to Southlake to support investments into women’s health at the hospital.

“The generosity of our donor community and the impact they have made for women receiving cancer diagnosis and treatment at Southlake is something we can all take great pride in,” said Jennifer Ritter, President and CEO of Southlake Foundation. “From our Women’s Health Initiative donors supporting new mammography machines, to the Ladies in Philanthropy for Southlake funding the MOLLI 2 System, to our long-standing partners The Edge Benefits and Pheasant Run Golf Club enabling the introduction of MyoSure System through their joint annual charity golf tournament, we are incredibly lucky to share a vision of access to exceptional care for everyone who depends on Southlake when they need us most. Thank you, to every donor who contributed to these important upgrades to care for women.”

Southlake Foundation’s HERE is Where Cancer Meets its Match campaign supports the Stronach Regional Cancer Centre at Southlake. For more information or to make a donation, visit: southlake.ca/HERE.

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Pasteurized milk includes remnants of H5N1 bird flu, U.S. officials say

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The U.S. Food and Drug Administration says that samples of pasteurized milk have tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement on Tuesday.

The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department (USDA) says 33 herds have been affected to date.

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FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”

WATCH | Bird flu spread in U.S. cows:

 

Bird flu is spreading in cows. Are humans at risk? | About That

15 days ago

Duration 8:54

For the first time ever, avian influenza, or H5N1 bird flu, was detected in roughly a dozen dairy cow herds across the U.S. About That producer Lauren Bird explores why scientists and public health officials are concerned about the cross-species transmission and whether humans are now at higher risk.

The polymerase chain reaction (PCR) lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University

“There is no evidence to date that this is infectious virus, and the FDA is following up on that,” Jaykus said.

Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.

Tests for viable virus underway, agency says

Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.

The agency said it has been evaluating milk from affected animals, in the processing system and on the shelves. It said it is completing a large, representative national sample to understand the extent of the findings.

The FDA said it is further assessing any positive findings through egg inoculation tests, which it described as a gold standard for determining viable virus.

Matt Herrick, a spokesperson for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.

Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.

To date, two people in the U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.


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Remnants of bird flu virus found in pasteurized milk, FDA says

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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.

The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.

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