India: 1.6% #coronavirus vaccine breakthrough rate in study of healthcare workers

India’s largest yet data analysis of the so-called breakthrough infections after inoculation with Covishield [AstraZeneca] has found that 16 in every 1,000 fully vaccinated healthcare workers developed Covid-19 infections, about threefold the incidence observed in a US study after Pfizer or Moderna doses.

A team of doctors at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, has documented 48 Covid-19 infections among 3,000 healthcare workers who had completed two weeks after both doses of Covishield before they tested Covid-positive.

“The incidence of breakthrough infection was 1.6 per cent, the median time from receipt of the second dose to the breakthrough infection was 29.5 days,” Venkatamaha Laksmi Pinnaka and his colleagues at PGIMER wrote in their report in The New England Journal of Medicine.

TelegraphIndia.com report

 

Finland: 80% vaccine breakthrough in hospital with B16172 Delta #coronavirus variant – PPE no longer effective

 

 

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Spain: 35 year old soldier left brain dead with blood clots 17 days after AstraZeneca #coronavirus vaccination

The Spanish Health Department is investigating the death of a corporal, aged 35, assigned to the Infantry Regiment América 66 de Cazadores de Montaña, based in the Aizoáin barracks, Navarra, after suffering a “cerebral sinus thrombosis with thrombocytopenia and cerebral hemorrhage”, 17 days after receiving the AstraZeneca vaccine. The military man died this morning at the University Clinic of Navarra.

The corporal, married and expecting a child, was vaccinated with AstraZeneca on the afternoon of April 7 in his own unit. The Spanish Troop and Sailor Association (ATME) explained that in the following days he suffered “severe headaches and acute discomfort”, which forced him to go to the barracks first aid service and then to the emergency room of a health center from Pamplona. On the night of this last Wednesday, April 21, the corporal suffered a faint while he was at his home, according to the Army, to which America 66 belongs.

El Pais report

 

Update: “This Friday, the Pharmacovigilance Center of the Health Department of the Government of Navarra has received a notification of a “adverse event with fatal outcome” of a person who had been vaccinated with Vaxzevria (AstraZeneca) on April 7 against Covid-19. Despite the fact that the Provincial Government has reported that he had died after suffering a “cerebral sinus thrombosis with thrombocytopenia and cerebral hemorrhage”, the affected person has not died and is in a situation of brain death.

Source: Explica.co

 

UK: AstraZeneca #coronavirus vaccine blood clot cases double to 168 in two weeks, 32 deaths reported

The risk of a serious blood clot from AstraZeneca jab has doubled in a fortnight, new data show. Cases have gone up from 79 to 168 and deaths from 19 to 32. The chance of having a clot following vaccination has gone from one in 250,000 to one in 126,582.

The Telegraph report

 

 

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Denmark halts AstraZeneca #coronavirus vaccine – “We are dealing with a whole new syndrome. About 1 in 40,000 of those vaccinated with AstraZeneca’s vaccine are affected and many die”

“We are dealing with a whole new syndrome, called WHITE. We have identified that there is an increased risk in using the vaccine. It gives us a figure on the increased risk with the serious disease cases. About 1 in 40,000 of those vaccinated with AstraZeneca’s vaccine are affected and many die,” says Søren Brostrøm.

“We know a lot more today than we did a month ago. We know that there is a possible biological explanation why AstraZeneca’s vaccine may cause these cases. This suggests a cross-reaction. We know that there is a temporal connection – we see cases 8-10 days after the vaccination, «says Søren Brostrøm, who gradually feels on safe scientific grounds when he now puts into words the Danish decision to stop using the vaccine.

Berlingske.de report

 

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Italy: 26 yr old woman in hospital in Milan after Astrazeneca #coronavirus vaccination

A 26-year-old woman on April 13 was in fact hospitalized in a reserved prognosis at the Milan Polyclinic, after vaccination against Covid with AstraZeneca vaccine.

According to what is learned, the twenty-six year old is hospitalized at the Milan Polyclinic with cerebral thrombosis . The girl, according to the hospital, “is conscious and responds to therapies . She is in conditions considered stable, even if the prognosis remains confidential and is kept under close observation”. The hospitalization at the Milan Polyclinic was necessary because her situation was serious, also for this reason the patient was sent to the Thrombosis Center led by Flora Peyvandi, reference structure.

IlGiorno.it report

 

 

 

UK hospitals ‘swamped’ with patients seeking help for AstraZeneca side effects

People who have had the Oxford/AstraZeneca vaccine are seeking help at A&E despite having only mild side-effects such as headaches, in the wake of the controversy over whether the jab causes blood clots.

Emergency medicine doctors in England told the Health Service Journal that a growing but unspecified number of people who were anxious after having the Oxford/AstraZeneca jab were coming to A&E units, some apparently after being advised to do so by a GP.

Dr Katherine Henderson, the president of the Royal College of Emergency Medicine, confirmed the trend to the Guardian.

“It’s definitely a thing. Colleagues across England are reporting this. All A&E departments are seeing an increase in the number of people reporting concerns after having the AstraZeneca vaccine. We are seeing people with mild headaches and persistent headaches but who are otherwise alright.

The Guardian report

 

 

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Dublin woman suffers blood clot potentially linked to AstraZeneca #coronavirus vaccine

The first cases of a rare blood clot associated with the AstraZeneca vaccine in Ireland is being investigated in a Dublin hospital. A 40-year-old woman is reportedly being treated in the Mater Hospital for cerebral venous sinus thrombosis (CVST), the blood clot on the brain which the European Medicines Agency has said is possibly linked to the AstraZeneca treatment.

A spokesperson for the Health Products Regulatory Authority (HPRA) confirmed to Dublin Live it has been informed about the case.

He said: “The HPRA can confirm that it has received a case of interest, associated with the AZ vaccine, which describes CVST, an unusual clot in the brain.

DublinLive.ie report

 

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First case of thrombosis after AstraZeneca #coronavirus vaccination reported in Mexico

According to Dr. Roberto Ovilla Martínez, head of hematology and bone marrow transplants at Hospital Ángeles Lomas, the patient Francisco Aguirre, an engineer by profession, is receiving treatment based on intravenous immunoglobulin that has helped to improve the condition. This would be the first case of a thrombosis caused by the AstraZeneca vaccine registered in Mexico and in the entire American continent.

Dr. Ovilla Martínez said that on April 2, together with his colleague, Víctor Manuel Vidal, a member of the Naucalpan Satellite Hospital, they diagnosed the patient who is currently hospitalized.

According to the doctor, a graduate from the Autonomous University of Chiapas (UNACH), the 94-year-old patient was inoculated last Wednesday, March 31, with the first dose of the drug developed by the University of Oxford and the AstraZeneca laboratory.

After 42 hours, the patient began to have symptoms such as extreme fatigue and lack of appetite, so his family transferred him to the Corporate Hospital Satélite.

Vallartadaily.com report

 

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EMA: NEW investigation into capillary leak syndrome with AstraZeneca’s COVID-19 #coronavirus vaccine Vaxzevria

PRAC has started a review of a safety signal to assess reports of capillary leak syndrome in people who were vaccinated with Vaxzevria (previously COVID-19 Vaccine AstraZeneca). Five cases of this very rare disorder, characterised by leakage of fluid from blood vessels causing tissue swelling and a drop in blood pressure, were reported in the EudraVigilance database.

At this stage, it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome. These reports point to a ‘safety signal’ – information on new or changed adverse events that may potentially be associated with a medicine and that warrants further investigation.

PRAC will evaluate all the available data to decide if a causal relationship is confirmed or not. In cases where a causal relationship is confirmed or considered likely, regulatory action is necessary in order to minimise the risk. This usually takes the form of an update of the summary of product characteristics and the package leaflet. EMA will further communicate on the outcome of the PRAC’s review.

EMA.europa.eu press release

 

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France: Family of man who died a few days after AstraZeneca #coronavirus vaccination file a complaint for involuntary manslaughter

In Annecy, the family of a 63-year-old man who died on March 18, eleven days after being vaccinated against Covid-19 with a dose of AstraZeneca vaccine, confirmed they have filed a complaint against [persons unknown] for involuntary homicide. 

On March 7, 63-year-old Joël Crochet received a first dose of AstraZeneca vaccine during the mass vaccination operation organized on the Pâquier in Annecy.

“Thirty minutes after the injection, he felt quite severe joint pain and then respiratory problems”, explains his brother. The next day, the sixty-year-old went to his doctor who prescribed treatment. But a week later, this man’s health suddenly worsened.  “On Wednesday, March 17, he was hospitalized, continues Jean-Luc Crochet.  “…Doctors have detected several thromboses in the liver, kidneys and brain…” He died on Thursday March 18.

FranceBleu report

 

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UK AstraZeneca #coronavirus jab trial on children paused as regulator investigates rare blood clots in adults

A vaccine trial into the safety and efficacy of the Oxford/AstraZeneca vaccine in children has been paused while the UK medicines regulator investigates a possible link to rare blood clots in adults who had the jab.

A spokesperson from Oxford university said in a statement:  “Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial.  Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.”

 

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Ireland: HPRA has received 16 reports of blood clots occurring following vaccination with the AstraZeneca #coronavirus vaccine

Ireland’s Health Products Regulatory Authority (HPRA) has said it has received 16 reports of blood clots occurring following vaccination with the AstraZeneca Covid-19 vaccine. It said that none describe a rare blood clot. The figures are up to the end of March.

The HPRA said that none of the reports describe cerebral venous sinus thrombosis, which is a rare type of blood clot in the brain, nor the occurrence of a blood clot associated with low platelets.

RTE.ie report

 

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France: 12 cases of thromboembolic disorders following Astrazeneca #coronavirus vaccine, 4 deaths

“As part of our enhanced surveillance of thromboembolic disorders, 3 new cases of thrombosis of the large veins of atypical locations associated with thrombocytopenia and/or coagulation disorders were analyzed during the weekly monitoring committee of the ANSM with the network French CRPVs (12 cases in total since the start of vaccination, including 4 deaths).

These cases, mainly located in the brain, occurred within a median time of 9 days after vaccination, mainly in women and with no specific common history identified to date (9 vaccinated people under 55 years old, 3 people over 55 years).”

ANSM report  The seventh pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine (Vaxzevria) covers data validated from March 19 to 25, 2021

 

Information from the previous (sixth) ANSM report:

“The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021 . Since the start of vaccination with the AstraZeneca vaccine, 5,693 cases of adverse effects have been analyzed by the CRPV reporters (Amiens and Rouen). The vast majority of these cases concern flu-like syndromes, often of high intensity (high fever, body aches, headaches). More than 1,430,000 injections have been performed as of March 18, 2021.

As part of our enhanced surveillance of thromboembolic disorders, a total of 16 new cases were analyzed during the weekly ANSM monitoring committee with the French CRPV network, for a total of 29 cases since the start of vaccination. The majority of thromboembolic events have occurred within 15 days of vaccination in patients with risk factors.

Among all these cases, 9 cases of thrombosis of the large veins, atypical by their location (mainly cerebral, but also digestive), which may be associated with thrombocytopenia or coagulation disorders were reported, including 2 deaths. These cases occurred within a median of 8.5 days after vaccination in people with no specific history identified to date (7 patients under 55 years old, 2 patients over 55 years old).”

ANSM report  The sixth pharmacovigilance report on adverse reactions reported with the AstraZeneca vaccine covers data validated from March 12 to March 18, 2021

 

Australia reports first case of blood clots following AstraZeneca #coronavirus vaccination

Australia’s medical authorities are monitoring the first reported case of a rare clotting disorder following a COVID-19 jab.

A 44-year-old man was admitted to Box Hill Hospital in Melbourne’s eastern suburbs on Friday for blood clots. The man was vaccinated around March 22 and, so far, no direct link has been discovered between his condition and his vaccination. To date more than 420,000 people have received AstraZeneca vaccinations in Australia.

Sidney Morning Herald report

 

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