Study finds COVID-19 vaccination during pregnancy does not increase complications around the time of childbirth

Press Release:

Researchers have found that receiving a COVID-19 vaccine during pregnancy does not lead to increases in the frequency of complications around the time of childbirth. The findings, which are published in JAMA, provide further assurances about the safety of mRNA vaccines for this particularly unique population.

Lead author Dr. Deshayne Fell led the study of nearly 100,000 pregnancies by analyzing data from BORN Ontario (Ontario’s provincial birth registry), which is linked to the province’s COVID-19 immunization database.

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No serious health effects linked to mRNA COVID-19 vaccines

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Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 vaccines.

The study published September 2 in JAMA reports the first comprehensive findings of the Vaccine Safety Datalink (VSD), which studies patient records for 12 million people in 5 Kaiser Permanente service regions along with HealthPartners in Minneapolis, the Marshfield Clinic in Wisconsin, and Denver Health. The work is supported by the Centers for Disease Control and Prevention (CDC).

“These results from our safety surveillance are reassuring,” said lead author Nicola Klein, MD, PhD, director of the Kaiser Permanente Vaccine Study Center and principal investigator of the Vaccine Safety Datalink’s COVID-19 rapid cycle analysis.

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One shot of the Sputnik V vaccine triggers strong antibody responses

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A single dose of the Sputnik V vaccine may elicit significant antibody responses against SARS-CoV-2, finds a study published July 13 in the journal Cell Reports Medicine.

“Due to limited vaccine supply and uneven vaccine distribution in many regions of the world, health authorities urgently need data on the immune response to vaccines to optimize vaccination strategies,” says senior author Andrea Gamarnik (@GamarnikLab) of the Fundación Instituto Leloir-CONICET in Buenos Aires, Argentina. “The peer-reviewed data we present provide information for guiding public health decisions in light of the current global health emergency.”

Past research has shown that two doses of Sputnik V results in 92% efficacy against coronavirus disease 2019 (COVID-19), which is caused by SARS-CoV-2. An important question is whether a single dose would achieve greater public health benefit than two doses by allowing protection of a larger population more quickly.

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Blood clots related to AstraZeneca/Oxford vaccine can be mitigated with early detection

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New research has shown that early testing for blood clots in patients who had received the AstraZeneca/Oxford vaccine led to them being treated successfully, highlighting the need for heightened awareness of the risk among doctors.

The work, led by researchers from RCSI University of Medicine and Health Sciences and the National Coagulation Centre at St James’s Hospital, is published in the British Journal of Haematology.

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COVID-19 vaccination: Thrombosis can be prevented by prompt treatment

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A rare syndrome has been observed in people following vaccination against Covid-19. This involves thrombosis at unusual sites in the body, associated with a low thrombocyte (blood platelet) count and a clotting disorder. In medical jargon, this syndrome is referred to as VITT (vaccine-induced thrombotic thrombocytopenia). Doctors at the Department of Medicine I of MedUni Vienna and Vienna General Hospital (Division of Hematology and Hemastaseology) have now successfully treated an acute instance of this syndrome.

VITT is most probably caused by a defective immune response, whereby thrombocyte-activating antibodies are produced resulting in thrombocytopenia (low platelet count) and thrombosis. The mortality rate in VITT is high (40-50 %) and the syndrome requires immediate and appropriate treatment. However, the current recommendations are only empirical and are based on in-vitro data.

A team of doctors at the Department of Medicine I of MedUni Vienna and Vienna General Hospital, led by coagulation specialist Paul Knöbl, has now successfully treated a patient suffering from vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). The female patient was admitted to the Department with a low platelet count and low fibrinogen levels. Fibrinogen is a protein that plays a major role in blood clotting. Knöbl reports: “Apart from that, her D-dimer values, which indicate thrombosis, were very high and an ELISA assay produced a clear positive result for heparin-PF4 antibodies – all signs of incipient thrombosis.”

The doctors acted quickly, and the patient responded immediately to treatment with a high dose of intravenous immunoglobulin concentrates, cortisone and specific anticoagulants, so that thrombosis was prevented. Immunoglobulin concentrates contain antibodies that can block the misdirected immune response. The usual heparin preparations must not be used to prevent clotting, since they can trigger thrombosis, or aggravate it.

“In this case we were able to describe, for the first time, the efficacy of a potentially life-saving treatment strategy for vaccine-induced thrombosis,” says Knöbl. These new findings have been published in the Journal of Thrombosis and Haemostasis. On the one hand, the findings support the current treatment recommendations, but they also show that prompt diagnosis and immediate initiation of treatment are necessary in order to prevent a life-threatening thrombosis. “This experience could be of great help in treating other patients with similar conditions.”

Evidence for reduced antibody protection against SARS-CoV-2 variants

Testing and vaccination – these are the pillars on which humanity is trying to get a grip on the Coronavirus pandemic. Although it is taking longer than many had expected, it is believed that it is only a matter of time before we are all vaccinated and thus protected. However, time is also working for the virus, which has now mutated several times, with variants B.1.1.7 from the United Kingdom, B.1.351 from South Africa and P.1 from Brazil spreading rapidly. These viruses have mutations in the so-called spike protein, the structure on the surface of the virus that is responsible for attachment to host cells. At the same time, the spike protein is also the major target of the immune response. Antibodies generated in response to SARS-CoV-2 infection or vaccination bind to the spike protein, thereby blocking the virus. A team led by Markus Hoffmann and Stefan Pöhlmann of the German Primate Center – Leibniz Institute for Primate Research and Jan Münch of the Ulm University Medical Centre has found that the SARS-CoV-2 variants B.1.351 and P.1 are no longer inhibited by an antibody used for COVID-19 therapy. In addition, these variants are less efficiently inhibited by antibodies from recovered patients and vaccinated individuals. Thus, convalescence from COVID-19 as well as vaccination may offer only incomplete protection against these mutant viruses (Cell).

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Investigational AstraZeneca vaccine prevents COVID-19

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Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, provided funding support for the trial through the federal COVID-19 response.

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Allergists offer reassurance regarding potential allergic reactions to COVID-19 vaccines

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BOSTON – Reports of possible allergic reactions to the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both recently approved for emergency use by the U.S. Food and Drug Administration (FDA), have raised public concern. A team of experts led by allergists at Massachusetts General Hospital (MGH) has now examined all relevant information to offer reassurance that the vaccines can be administered safely even to people with food or medication allergies. The group’s review is published in the Journal of Allergy and Clinical Immunology: In Practice.

In response to accounts of potential allergic reactions in some people following COVID-19 vaccination in the United Kingdom, that country’s medical regulatory agency advised that individuals with a history of anaphylaxis to a medicine or food should avoid COVID-19 vaccination. After closer review of the data related to allergic reactions, however, the FDA recommended that the vaccines be withheld only from individuals with a history of severe allergic reactions to any component of the COVID-19 vaccine, and the Centers for Disease Control and Prevention advised that all patients be observed for 15 minutes post-vaccination by staff who can identify and manage such reactions. The U.S. agencies do not recommend that people with food or medication allergies avoid vaccination.

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Long-lasting COVID immunity gives real hope for the long-term protection of vaccines

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Australian researchers have revealed – for the first time – that people who have been infected with the COVID-19 virus have immune memory to protect against reinfection for at least eight months.

The research is the strongest evidence for the likelihood that vaccines against the virus, SARS-CoV-2, will work for long periods.  Previously, many studies have shown that the first wave of antibodies to coronavirus wane after the first few months, raising concerns that people may lose immunity quickly.  This new work allays these concerns.

The study is the result of a multi-centre collaboration led by Associate Professor Menno van Zelm, from the Monash University Department of Immunology and Pathology, with the Alfred Research Alliance between Monash University, The Alfred hospital and the Burnet Institute, and published today in the prestigious journal, Science Immunology. The publication reveals the discovery that specific cells within the immune system called memory B cells, “remembers” infection by the virus, and if challenged again, through re-exposure to the virus, triggers a protective immune response through rapid production of protective antibodies.

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New online COVID-19 mortality risk calculator could help determine who should get vaccines first

Calculator generates mortality risk estimates for individuals and communities based on sociodemographic info and medical history

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A new online calculator for estimating individual and community-level risk of dying from COVID-19 has been developed by researchers at the Johns Hopkins Bloomberg School of Public Health. The researchers who developed the calculator expect it to be useful to public health authorities for assessing mortality risks in different communities, and for prioritizing certain groups for vaccination as COVID-19 vaccines become available.

The algorithm underlying the calculator uses information from existing large studies to estimate risk of COVID-19 mortality for individuals based on age, gender, sociodemographic factors and a variety of different health conditions. The risk estimates apply to individuals in the general population who are currently uninfected, and captures factors associated with both risk of future infection and complications after infection.

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