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AstraZeneca’s covid19 vaccine. Adverse reactions and suspension of the campaign. INFORMATION NOTE.

Update. Monday 19 April 2021

Denmark has definitively abandoned the AstraZeneca vaccine. It does so because the epidemiological situation is under control, there are other safer vaccines and there are undeniable clotting problems with the AstraZeneca vaccine.

Pharmacovigilance problems persist in the European Union that prevent a definitive answer to the association-causality and incidence of adverse effects of covid19 vaccines.

As an example, a study was published in The Lancet with data from 5 million inhabitants of Denmark, a before-after study (until 10 March 2021), which showed that there was no increase in venous thrombosis problems with AstraZeneca vaccination of the population. However, the authors note four issues that prevent them from reaching a conclusion regarding the association between clotting problems and the AstraZeneca vaccine:

1/ data on the sex and age distribution from those who received the vaccine are not yet publicly available

2/ data on the duration of the period during which the vaccinated population developed the reported thromboembolic events are also not publicly available

3/ detailed clinical descriptions of the thromboembolic events reported in relation to vaccinations are still lacking but reports are emerging of rare types of multiple thrombosis, bleeding, and thrombocytopenia

4/ as even the most efficient spontaneous reporting of adverse events is unlikely to capture all cases, the true incidence rate of thromboembolic events in relation to the vaccine is unknown

It seems therefore that it is pharmacovigilance in general that should concern us, even if this case is symbolic of its problems. We also need to move to a pro-active system of looking for adverse effects, for example from electronic medical records or close monitoring of a large population cohort.

Norway still does not vaccinate its population and the Institute of Public Health has recommended the definitive abandonment of the AstraZeneca vaccine (it should be recalled that the reported incidence of «covid19 vaccine-induced immune prothrombotic thrombocytopenia syndrome» in Norway is 1 case per 25,000 vaccinations).

An update has been published in France, with a reported incidence of 1 case per 31,000 vaccinations.

Data have been published for 23 patients in the UK, where AstraZeneca vaccine-associated clotting disorders were reported 6-24 days after the first dose was administered.

In Australia, two cases of serious haematological adverse events have been reported.

It is questionable whether this is a «class effect» of covid19 vaccines in general and of vector vaccines (AstraZeneca, Janssen, etc.) in particular. Thus, in the United States, the vaccination campaign with Janssen has been stopped because of haematological adverse effects similar to those of AstraZeneca, and its producer company, Johnson/Johnson, took the initiative not to proceed with its introduction in the European Union, where it is also authorised and purchased.

In a Norwegian study, covid19 vaccinees were closely monitored and an increase in bleeding in general could be demonstrated. Vector covid19 vaccines (AstraZeneca and Janssen) associated with bleeding skin, nose, gums more than RNA vaccines (Pfizer and Moderna) (2.8 versus 0.1%). More in women (3.1 versus 1.3%).

In addition, another adverse effect associated with AstraZeneca and Janssen, the “systemic capillary leak syndrome (SCLS or Clarkson’s disease), a leakage of blood plasma from the capillaries, is under study.

The European Union is considering not renewing the purchase contracts for the AstraZeneca and Janssen vaccines.

To avoid AstraZeneca’s second dose, both in France and Germany, the use of an RNA vaccine has been proposed, against the advice of the World Health Organisation.

A half-dose injection could also be used, which might achieve the same immunity and avoid the adverse effects, attributed in this hypothesis to excessive doses of vector (adenovirus) and adjuvant.

Johnson & Johnson privately reached out to Covid-19 vaccine rivals to ask them to join an effort to study the risks of blood clots and speak with one voice about safety, but Pfizer Inc. and Moderna Inc. declined. As concerns mounted last week over rare cases of blood clots, J&J asked AstraZeneca PLC as well as Pfizer and Moderna to join its efforts looking into the reports, people familiar with the matter said. J&J, through emails and phone calls, also sought to build an informal alliance to communicate the benefits and risks of the shots and address any concerns raised among the public by the blood-clot cases, some of the people said

As of 18 April 2020, the global situation on the use of the AstraZeneca vaccine is as follows:

  • Greece and the UK vaccinate those over 30 years old.
  • Australia vaccinates those over 50 years of age
  • Canada, Belgium and France vaccinate people over 55 years of age
  • Germany, South Korea, Ireland, Italy, the Netherlands, the Philippines, Portugal, Slovenia and South Korea vaccinate people over 60 years of age
  • Spain vaccinates older people between 60 and 69 years of age.
  • Finland and Sweden use it for those aged 65 and over.
  • Iceland uses the vaccine for those over 70 years of age
  • Austria, Costa Rica, Democratic Republic of Congo, Estonia, Malaysia and Thailand vaccinate those aged 18 and over.
  • Cameroon, Chad, Latvia, Norway and Zimbabwe do not vaccinate anyone.
  • In Denmark, the vaccine has been permanently abandoned and will not be used at all.
  • In New Zealand and Switzerland the vaccine has not yet been approved for marketing.
  • In the United States, approval has not yet been sought.
  • In South Africa the vaccine has been discontinued because of low local effectiveness.

References

Denmark Becomes First in EU to Drop AstraZeneca Vaccine

https://www.bloomberg.com/news/articles/2021-04-14/denmark-is-first-in-eu-to-drop-astra-vaccine-broadcaster-dr

Norway postpones decision on AstraZeneca vaccine.

https://www.reuters.com/business/healthcare-pharmaceuticals/norway-postpones-decision-astrazeneca-vaccine-2021-04-15/?taid=607897bf3f50910001b1c063&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter

Denmark. Thromboembolism and the Oxford–AstraZeneca COVID-19 vaccine: side-effect or coincidence?

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00762-5/fulltext?dgcid=raven_jbs_etoc_email#.YHm99kKL1MA.twitter

Laporte JR. “Las agencias del medicamento son una invención del capitalismo neoliberal de los años noventa”

https://ctxt.es/es/20210401/Politica/35653/joan-ramon-laporte-vacunas-astrazeneca-trombosis-capitalismo-mar-calpena.htm

COVID-19 vaccines and the fear of side effects.

https://culturico.com/2021/04/11/covid-19-vaccines-and-the-fear-of-side-effects/

VAXZEVRIA/COVID-19 Vaccine AstraZeneca : lien entre le vaccin et la survenue de thromboses en association avec une thrombocytopénie.

https://ansm.sante.fr/informations-de-securite/vaxzevria-covid-19-vaccine-astrazeneca-lien-entre-le-vaccin-et-la-survenue-de-thromboses-en-association-avec-une-thrombocytopenie

  1. Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination.

https://www.nejm.org/doi/full/10.1056/NEJMoa2105385?query=featured_home

Australia. AstraZeneca ChAdOx1-S COVID-19 vaccine Second case of thrombosis with thrombocytopenia.

https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine-1

The very common vaccine ingredient at the center of J&J, AstraZeneca drama.

https://arstechnica.com/science/2021/04/the-very-common-vaccine-ingredient-at-the-center-of-jj-astrazeneca-drama/

US advisers recommend J&J COVID vaccine stay on pause.

https://www.cidrap.umn.edu/news-perspective/2021/04/us-advisers-recommend-jj-covid-vaccine-stay-pause

Ny studie: Blødninger etter covid-19-vaksiner.

https://www.fhi.no/nyheter/2021/blodninger-etter-covid-19-vaksiner/

La UE no renovará contratos con AstraZeneca y Janssen.

https://www.elmundo.es/ciencia-y-salud/salud/2021/04/14/6076a1c0fc6c83b8458b4656.html?cid=BESOCYEM01&utm_source=twitter&utm_medium=social_besocy&utm_campaign=BESOCYEM01

Hard choices emerge as link between AstraZeneca vaccine and rare clotting disorder becomes clearer.

https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

New Side Effects With AstraZeneca and Janssen COVID-19 Vaccines?

https://www.medscape.com/viewarticle/949048

J&U #Janssen and @AstraZeneca #Vaxzevria were interested in joining forces to investigate the safety issue and #vaccine #covid19 benefits and risks, but @Pfizer and @Moderna_tx didn’t see the need for group action.

https://www.wsj.com/articles/j-j-privately-asked-rival-covid-19-vaccine-makers-to-probe-clotting-risks-11618570802

Covid19 vaccines suspected serious adverse events AstraZeneca follow-up.

Update. Friday April 16th.

To have an idea of the status of AstraZeneca’s covid19 vaccine, there is no better way that assess its use worldwide as of 16th April 2021:

  • Greece and the UK vaccinate those over 30 years of age.
  • Australia vaccinates those over 50 years of age.
  • Canada, Belgium and France vaccinate people over 55 years of age.
  • Germany, South Korea, Italy, the Netherlands, the Philippines, Portugal, Slovenia and South Korea vaccinate those aged 60 and over.
  • Spain vaccinates older people between 60 and 69 years of age.
  • Finland and Sweden use it for those aged 65 and over.
  • Iceland uses the vaccine for those over 70 years of age.
  • Austria, Costa Rica, Democratic Republic of Congo, Estonia, Ireland, Malaysia and Thailand vaccinate those aged 18 and over.
  • Cameroon, Chad, Latvia, Norway and Zimbabwe do not vaccinate anyone.
  • Denmark has halted rollout of the vaccine, for ever.
  • In New Zealand and Switzerland, the vaccine has not yet been approved for marketing.
  • In the United States, approval has not yet been sought.
  • South Africa does not use it because is not effective against the new variant.

 

This highly variable use is justified neither by the epidemiological situation, nor by the characteristics of the population/nation, nor by the vaccine itself.

This use expresses the confusion caused by the report of the European Medicines Agency (EMA) following its meeting on 6 and 7 April 2021 on the adverse effects of AstraZeneca’s covid19 vaccine (now called Vaxzevria), which concluded that:

  • The risk-benefit balance is very favourable and the continuation of the vaccination campaign is justified.
  • There is a «possible link» (a strong association) between the AstraZeneca vaccine and infrequent cases of clot, but it recommends continuing to use it.
  • AstraZeneca’s vaccine has a proven adverse effect of causing in rare cases severe blood clotting disorders, some fatal.
  • There are no risk factors associated with this adverse reactions.

The frequency of reported serious adverse reactions of blood clotting disorders has been one case per 25,000 people in Norway, 80,000 in the Netherlands, 87,000 in Germany, 150,000 in the European Union as a whole and 250,000 in the United Kingdom.

Overall, we can estimate that 1 case per 100,000 vaccines is reported.

This severe adverse reaction, the «covid19 vaccine-induced immune prothrombotic thrombocytopenia syndrome» (abbreviated VIPIT), has a high mortality of up to 40%.

«I can’t say that I’m happy. This is actually a day of mourning. But we’ve remained consistent in thinking that health workers and patients should be made aware of this,» said Steinar Madsen, Medical Director of the Norwegian Medicines Agency, to the Norwegian newspaper Dagbladet.

Two case series have been published, Germany-Austria (11 cases) and Norway (5 cases) but even in these publications basic data on all cases are missing. Nor has the EMA provided data in a table of the 222 cases reported up to 4 April. These basic minimum data are:

  • Age.
  • Sex.
  • Clinical picture of the adverse reaction.
  • Time since vaccination.
  • Comorbidity.
  • Medication in use.
  • Genetic changes of interest (Leiden factor V and others).

In the European Union, 169 of the blood clots were located in the brain, 53 were in the stomach. All cases had the rare combination of blood clots, bleeding and low levels of platelets.

We do not have the «denominator», i.e. we do not know the age and sex distribution/groups of the total number of vaccinated persons.

We do not have the «numerator», i.e. we do not know the age and sex distribution of those who have reported adverse effects.

The problems of adverse effects on blood clotting affect all covid19 vaccines, but there are as yet no data beyond those discussed for the AstraZeneca vaccine.

 

References

AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. News 07/04/202

https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

MHRA issues new advice, concluding a possible link between COVID-19 Vaccine AstraZeneca and extremely rare, unlikely to occur blood clots. 7 April 2021

https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots

Austria Germany Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination

https://www.nejm.org/doi/full/10.1056/NEJMoa2104840?query=recirc_curatedRelated_article 

Norway. Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination

https://www.nejm.org/doi/full/10.1056/NEJMoa2104882?query=featured_home 

From Norway. EMA: Blood clots should be listed as a very rare side effect from the AstraZeneca-vaccine

https://sciencenorway.no/covid19-vaccines/ema-blood-clots-should-be-listed-as-a-very-rare-side-effect-from-the-astrazeneca-vaccine/1840043

New questions and answers about AstraZeneca’s covid19 Vaccination

https://www.actasanitaria.com/nuevas-preguntas-y-respuestas-sobre-la-vacuna-covid19-de-astrazeneca/

 

Covid19 vaccines suspected serious adverse events AstraZeneca follow-up.

Update. Saturday April 3th.

 

AstraZeneca’s covid19 vaccine is provisionally authorised for use in Europe, like others (Pfizer-BioNTech and Moderna). It started to be used in early February 2021.

 

Since the clinical trial demonstrated its efficacy mainly in the 18-55 age group (which accounted for 84% of the sample), some countries decided to use AstraZeneca’s vaccine only in this group (including Spain). Other countries decided to use it in the whole population, such as Australia and the UK.

 

On 7 March, two suspected serious adverse events due to clotting disorders associated with the vaccine were reported in Austria. Both were in female nurses. One case, 49 years old, resulted in death due to massive and general failure and the other, 35 years old, was a pulmonary embolism with hospital admission. As a precaution, the batch with which both nurses had been vaccinated was immobilised and discontinued.

 

The situation became increasingly complicated, with similar cases in other European countries (Germany, Denmark, Norway,…) so that many decided to stop the vaccination campaign, awaiting the report of the European Medicines Agency (EMA).

 

The UK reviewed its data and was able to show that there was no association between the AstraZeneca vaccine and serious coagulation disorders. The world’s leading pharmacotherapeutic journal, the French journal Prescrire, was of the same opinion.

 

The World Health Organisation came out in favour of pursuing the AstraZeneca vaccination campaign, as did the EMA, at its first meeting on 18 March, and at a second meeting on 31 March. A final report is expected in mid-April.

 

Following the first EMA report almost all countries re-launched the AstraZeneca vaccination campaign. Some, such as Iceland, Finland, France and Sweden, only for the elderly.

 

Norway and Denmark considered that there was too much uncertainty and stopped the campaign in general, pending more data.

 

In all this it is very strange that neither the EMA nor the drug agencies of the different countries do not provide a tabulated list with basic data on the reported cases: 1/ age 2/ sex, 3/ clinical problem adverse reaction, 4/ time since vaccination, 5/ comorbidity, 6/ medication in use, and 7/ any genetic condition of interest (such as Lieden’s factor V).

 

Subsequently, the UK has reported 30 cases (previously 5). 22 reports of cerebral venous sinus thrombosis (CVST) and 8 reports of thrombosis events with low platelets. 7 died.

Canada and the Netherlands have also had cases and Canada have limited the vaccination campaign to the elderly and in the Netherlands the shot is supended. In Australia, one case in a male is under study.

 

Data from Germany and Norway have established that the AstraZeneca vaccine may initiate an auto-immune response by producing antibodies that damage the platelets.

 

As a result, thrombi and embolisms (due to platelets being «sequestered») and haemorrhages (due to a lack of platelets in the rest of the blood) occur at the same time.

 

Technically it is called “Vaccine-Induced Immune Prothrombotic Thrombocytopenia Syndrome”, and is very serious with a lethality of 40%.

 

We do not yet know whether there are risk factors or precipitating factors, nor whether causality can be attributed to the AstraZeneca vaccine, but it seems prudent to limit vaccination to the elderly.

And avoid it in young and middle-aged adults.

 

Pending a final decision, it is important for professionals and vaccinees to be aware that clotting problems usually occur between 4 and 20 days after vaccination.

 

Literally, the warning signs according to the European Medicines Agency:

 

«If after receiving the COVID-19 AstraZeneca vaccine you have any of the following symptoms:

 

Shortness of breath (difficulty breathing).        

Chest or stomach pain.        

Swelling or coldness in an arm or leg.

Severe or worsening headache or blurred vision after the vaccination.

Persistent hemorrhage (bleeding).

Multiple small bruises, red or purple spots, or blood blisters under the skin.

 

Please seek medical attention promptly and mention your recent vaccination».

 

Varied advice on the AstraZeneca vaccine:

Canada and France are restricting the vaccine to people over 55.

Germany is recommending it only to people over 60.

Finland and Sweden are using it only for those over 65.

Iceland use it for individuals older than 70.

Italy is restricting the jab to people under 80.

Australia, Austria, Belgium, Estonia, Ireland, Portugal, Slovenia, Spain and the UK have no restrictions in place.

In Norway, the Netherlands, Latvia and Denmark the shot is suspended until at least mid-April.

Switzerland has still not approved the jab at all.

 

 

References

Canada. Information for professionals.

https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/rapid-response-recommended-use-astrazeneca-covid-19-vaccine-younger-adults.html

https://covid19-sciencetable.ca/sciencebrief/vaccine-induced-prothrombotic-immune-thrombocytopenia-vipit-following-astrazeneca-covid-19-vaccination/

 

Canada’s National Advisory Committee on Immunization is recommending a pause on @AstraZeneca #COVID19 vaccine for people under 55 for safety reasons. Canadá. Por razones de seguridad, #vacuna #covid19 @AstraZeneca sólo para personas de 55 y más años.

https://www.washingtonpost.com/world/the_americas/canadian-panel-recommends-astrazeneca-pause-for-under-55/2021/03/29/cdf3f370-90b6-11eb-aadc-af78701a30ca_story.html

 

AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues. 31 march 2021.

https://www.ema.europa.eu/en/news/astrazeneca-covid-19-vaccine-review-very-rare-cases-unusual-blood-clots-continues

 

Covid-19: WHO says rollout of AstraZeneca vaccine should continue, as Europe divides over safety.

https://www.bmj.com/content/372/bmj.n728

 

Clinical and laboratory features of 9 patients in Germany and Austria who developed thrombosis and thrombocytopenia events following #covid19 #vaccine @AstraZeneca

Características clínicas y de laboratorio. 9 casos de Alemania y Austria #vacuna

https://assets.researchsquare.com/files/rs-362354/v1/ebd0055b-50ad-4a8e-9d42-b967d0d8b132.pdf

 

Joint statement on @AstraZeneca #COVID19 #vaccine. Clotting disorder. One case has been reported in Australia.

Declaración gubernamental en Australia de apoyo a #vacuna #covid19 @AstraZeneca tras un caso de problema grave de coagulación.

https://www.health.gov.au/news/joint-statement-on-astrazeneca-covid-19-vaccine

 

The Netherlands suspended use of the @AstraZeneca #COVID19 #vaccine for people under 60. 5 reports of extensive thrombosis with low platelet counts. 7 to 10 days after vaccination. Women between 25 and 65 years old. 3 patients had extensive pulmonary embolisms. One died and one also had a brain haemorrhage

https://www.reuters.com/article/health-coronavirus-netherlands-astrazene/update-2-netherlands-halts-use-of-astrazeneca-vaccine-for-people-under-60-idUSL1N2LV0OZ

 

30 cases of rare blood clot events after the use of the @AstraZeneca #COVID19 #vaccine, 25 more than the agency previously reported.

https://www.reuters.com/article/us-health-coronavirus-astrazeneca-clots-idUSKBN2BO6Y0

 

Evidence continues to accumulate that an unusual clotting disorder is a real, albeit rare, side effect. Canada and Germany joined Iceland, Sweden, Finland, and France in recommending against the #covid19 #vaccine‘s use in younger people. @AstraZeneca

https://science.sciencemag.org/content/372/6537/14?fbclid=IwAR3b5bzP2B-08Rg-NTe9IcFyeDVvyYI6As0uFLcdX6GQZ3l5L7SaB_15_wc

 

«A complicated course of #COVID19 disease is so rare in younger women that the chance of avoiding a fatal course through vaccination in women without comorbidities is of the same order of magnitude as the risk of this rare side effect.»

https://www.medscape.com/viewarticle/948560?src=WNL_mdpls_210402_mscpedit_fmed&uac=316825DY&spon=34&impID=3288118&faf=1&fbclid=IwAR00IGLBZ2lPlvBYjMtU8SZMzsJ1M84A7fHDz9D5QqoTze-GyXDN7agdAZg#vp_

 

UK The risk of developing #covid19 of sufficient severity to require hospitalisation is markedly reduced by the #vaccine ChAdOx1-S, @ AstraZeneca. Adverse effect profile as expected.

Datos Reino Unido #vacuna #covid19 @AstraZeneca efectiva y segura.

https://english.prescrire.org/en/81/168/60904/0/NewsDetails.aspx

 

Scientists hope that the #covid19 #vaccine @AstraZeneca will be judged on its merits — rather than on controversies.

¿Se acabaron las controversias sobre la #vacuna #covid19 @AstraZeneca? ¡Esperemos!

https://www.nature.com/articles/d41586-021-00836-z

 

Sobre la vacuna covid19 AstraZeneca, el Harding Center para Alfabetización Estadística.

http://www.nogracias.org/2021/04/01/que-eficacia-y-seguridad-tiene-la-vacuna-de-astrazeneca-para-la-covid19-1-de-abril-de-2021/

 

Update. Saturday 27 March.

1 Summary (from previous updates on 18, 19 and 20 March, which can be found at the end).

Starting in Austria on 7 March, and affecting several European countries, AstraZeneca’s covid19 vaccine had several reports of suspected serious adverse events. These were cases of young people, usually healthy women, who presented in the first 14 days after vaccination with unusual severe blood clotting problems. As a result, the vaccination campaign was stopped in many countries, especially in the European Union.

It is not available a list of affected persons with basic data (age, sex, clinical picture, time since vaccination, previous diseases, previous treatments, previous genetic status, etc.).

At a meeting on 18 March, the European Medicines Agency assessed the situation and concluded that the benefits «still» outweighed the risks, despite a possible link to rare embolisms accompanied by low blood platelets.

However, the European Medicines Agency recommended specific warnings, especially in the first 14 days after vaccination in women under 55 years of age.

It was immediately decided to reinstate the vaccination campaign in Bulgaria, Germany, Portugal, Spain and other countries that had temporarily suspended it. In France, the campaign was also resumed, but only for people aged 65 and over.

This is the situation with regard to AstraZeneca’s covid19 vaccine, with the peculiarities worth noting:

 

2 Norway.

It is considered that the situation is still very uncertain and that the European Medicines Agency should have gone further and indicated clotting problems in people under 55 as a proven «adverse effect».

The moratorium is maintained and a reassessment and decision will be made on 15 April.

 

3 Denmark.

The moratorium is maintained as uncertainty prevents sufficient certainty that the vaccine offers more benefit than harm.

 

4 Iceland.

Vaccination campaign has been resumed, but only for people aged 70 and over.

 

5 Finland.

The vaccination campaign will be resumed from Monday 29 March, but only for people aged 65 and over.

 

6 Sweden.

The vaccination campaign will be resumed, but only for persons aged 65 and over.

 

7 Indonesia.

In Indonesia, the vaccination campaign had been halted, both because of reports of adverse effects on blood clotting and because of concerns about contamination by pork products (thus being «non-halal»).

Both doubts were resolved and the vaccination campaign was restarted.

 

8 European Medicines Agency.

At its meeting on 25 March it reaffirmed its previous conclusion that the benefits «still» outweigh the potential harms. It will reassess the situation at its meeting on 6-9 April.

 

9 France.

In the new re-vaccination week, only for people aged 55 and over, 9 cases (two deaths) of «infrequent» vaccine-associated thrombosis have been reported.

 

10 Germany.

A group of researchers led by German clotting specialist Andreas Greinacher of the University of Greifswald says the highly unusual combination of symptoms—widespread blood clots and a low platelet count, sometimes with bleeding—resembles a rare side effect of the blood thinner heparin, called heparin-induced thrombocytopenia. He named it as syndrome vaccine-induced prothrombotic immune thrombocytopenia.

 

Referencias:

The Norwegian Institute of Public Health has decided to extend the pause until 15 April in the use of the @AstraZeneca #covid #vaccine because further investigations are necessary.

Noruega. Hasta el 15 de abril. Decisión #vacuna #covid19 @AstraZeneca

https://www.fhi.no/en/news/2021/fortsatt-pause-i-astrazeneca-vaksineringen/

 

Pausen med vaccination med COVID-19 vaccinen fra AstraZeneca forlænges med 3 uger.

https://www.sst.dk/da/Nyheder/2021/Pausen-med-vaccination-med-COVID-19-vaccinen-fra-AstraZeneca-forlaenges-med-3-uger

 

Denmark «At present, we believe that our basis for making a final decision on the further use of the #COVID19 #vaccine from @AstraZeneca is too uncertain.»

Dinamarca mantiene la pausa de #vacuna #covid19 @AstraZeneca «Hay demasiada incertidumbre».

https://www.euronews.com/2021/03/25/denmark-extends-astrazeneca-covid-19-vaccine-suspension-for-three-weeks

 

Iceland: the decision to resume vaccination and use it for individuals older than 70. #covid19 #vaccine @AstraZeneca

Islandia volverá a utilizar la #vacuna #covid19 @AstraZeneca pero sólo en mayores de 70 años.

https://www.icelandreview.com/society/covid-19-in-iceland-resume-astrazeneca-vaccinations-for-70/

 

Finland will resume administering the @AstraZeneca #covid19 #vaccine from next Monday (March 29), but only to people over the age of 65.

Finlandia. A partir del 29 marzo, #vacuna #covid19 @AstraZeneca, pero sólo para personas de 65 años y mayores.

https://yle.fi/uutiset/osasto/news/finland_set_to_resume_use_of_astrazeneca_vaccine_for_over-65s/11854136

 

Sweden is set to resume use of the Oxford/@AstraZeneca #coronavirus #vaccine, although only for people aged 65 and over.

Suecia volverá a utilizar la #vacuna #covid19 @AstraZeneca pero sólo para personas de 65 y más años.

https://www.ft.com/content/a73d6bfd-662e-4055-b9b2-f2bf5d1d670d

 

@AstraZeneca’s #COVID19 #vaccine in Indonesia despite concern and some confusion over whether the product is halal.

Tras la decisión de la @EMA_News Indonesia empieza el uso de la #vacuna #covid19 @AstraZeneca, de la que había dudas sobre si era halal.

https://www.channelnewsasia.com/news/asia/covid-19-indonesia-rollout-astrazeneca-vaccine-halal-concerns-14472760

 

@EMA_News Update review of thromboembolic events with #COVID19 #Vaccine @AstraZeneca. More, 6–9 April.

La @EMA_News se reafirma en su revisión #vacuna #covid19 @AstraZeneca Más en la reunión del 6-9 abril.

https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-update-ongoing-evaluation-blood-clot-cases

 

#Vaccin #covid19 @AstraZeneca thrombose. Neuf nouveaux cas en France, dont deux morts.

Siguen las sospechas de efectos adversos coagulación #vacuna #covid19 @AstraZeneca Francia, 9 nueve casos (2 muertes).

https://www.lemonde.fr/sante/article/2021/03/26/vaccin-astrazeneca-l-existence-d-un-risque-rare-de-thrombose-confirmee-par-l-agence-nationale-de-securite-du-medicament_6074628_1651302.html

 

#vaccine #covid19 @AstraZeneca Syndrome vaccine-induced prothrombotic immune thrombocytopenia.

Parece cierta la asociación entre #vacuna #covid19 @AstraZeneca y un síndrome inducido protrombótico con trombocitopenia.

https://www.sciencemag.org/news/2021/03/rare-clotting-disorder-may-cloud-worlds-hopes-astrazenecas-covid-19-vaccine

 

Update. Saturday, March 2021.

1 Summary.

AstraZeneca’s covid19 vaccine has had several reports of suspected serious adverse events since March 7.

These are cases of young people, usually healthy women, who presented in the first 14 days after vaccination with unusual severe blood clotting problems. We have no data on cases by age, sex, clinical picture, time after vaccination, comorbidity, drug use, genetics (Leyden factor V, etc).

Five cases of disseminated intravascular coagulation were reported when 1 case was expected, and there were 12 cases of cerebral venous sinus thrombosis when 1.35 cases were expected.

It should be noted that, in the field of vaccines, 1 in 20 serious adverse reactions are usually reported, so the cases of coagulation disorders could be many more. For this reason, the vaccination campaign was interrupted in many countries, especially in the European Union.

At a meeting on March 18, the European Medicines Agency assessed the situation and concluded that the benefits «still» outweighed the risks, despite a possible link to rare embolisms accompanied by low blood platelets [«COVID Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets» https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots ]

However, the European Medicines Agency recommended specific warnings, especially in the first 14 days after vaccination in women under 55 years of age. It was immediately decided to reinstate the vaccination campaign in Germany, Spain and other countries.

With some exceptions, which are discussed below.

2 France.

It has been decided to reinstate the use of AstraZeneca’s covid19 vaccine, but only for persons aged 55 years and older. 

The assessment of the European Medicines Agency has been taken into account in order not to expose to possible serious adverse effects those who least expect complications if they pass covid19.

3 Denmark, Norway and Sweden.

The three Nordic countries have decided not to reinstate the campaign with AstraZeneca’s covid19 vaccine.

«We need time.»

The Norwegian representative has insisted that it was the only country at the European Medicines Agency meeting that asked for severe blood clotting problems to be listed as «adverse effects». This request was rejected. 

It should be recalled that Norway is not a member of the European Union but participates in the «life» of the European Union as a member of EFTA (European Free Trade Association).

4 Finland.

Finland was the only Nordic country that did not interrupt the vaccination campaign with AstraZeneca’s covid19 vaccine. 

However, on Friday, March 19, there were two reports of probable serious adverse effect, two patients with cerebral venous sinus thrombosis.

It therefore decided to stop the vaccination campaign with AstraZeneca’s covid19 vaccine.

5 Australia and the United Kingdom.

Both Australia and the United Kingdom have reviewed the issue and decided that there is no association between the AstraZeneca vaccine and covid19. They are therefore continuing with their campaigns, without further precautions or warnings.

6 Other covid19 vaccines.

Two other vaccines (Pfizer-BioNTech and Moderna) against covid19 are also under study for reporting suspected serious adverse effects of blood clotting.

REFERENCES

-COVID-19-Impfstoff von #AstraZeneca: Das Paul-Ehrlich-Institut schließt sich der Sicherheitsbewertung der @EMA_News @PEI_Germany

El Paul Ehrlich Institut, Alemania, coincide con la @EMA_News en su evaluación de seguridad de #vacuna #covid19 @AstraZeneca

https://www.pei.de/DE/newsroom/hp-meldungen/2021/210319-covid-19-impfstoff-astrazeneca-ergebnis-sicherheitsbewertung-impfstoff-ist-sicher.html;jsessionid=87DF9CB96F475E63BE1856D88CC9CE2B.intranet231

-France. La Haute Autorité de Santé. #vaccin @AstraZeneca chez les 55 ans et plus. Possible surrisque de coagulation intravasculaire disséminée et de thrombose veineuse cérébrale. France’s National Authority for Health (HAS) took note of evidence that the clotting affected younger people mostly, whose risk of dying from COVID-19 was lower than the elderly, and departed from the EMA’s line.

Francia, #vacuna @AstraZeneca sólo para población de 55 y más años.

https://www.has-sante.fr/jcms/p_3244305/fr/covid-19-la-has-recommande-d-utiliser-le-vaccin-d-astrazeneca-chez-les-55-ans-et-plus

https://www.reuters.com/article/us-health-coronavirus-france-astrazeneca/france-recommends-astrazeneca-for-over-55s-only-departing-from-eu-guidance-idUSKBN2BB172

https://www.theguardian.com/world/2021/mar/19/france-limits-astrazeneca-covid-jab-to-over-55s-despite-ema-green-light

-Norway, Sweden and Denmark will continue a pause on @AstraZeneca #COVID19 vaccinations despite the European Medicines Agency (EMA) @EMA_News conclusion that the vaccine is «safe and effective».

Por ahora, Dinamarca, Noruega y Suecia siguen sin vacunar.

https://www.euronews.com/2021/03/18/norway-sweden-denmark-wait-before-restarting-astrazeneca-vaccinations

-Norwegian @AstraZeneca #vaccine #covid19 likely triggered a «powerful immune response». They were the only ones at the @EMA_News’s meeting on Thursday who wanted the symptoms included on the list of possible side effects for the vaccine, but to no avail.

https://medicalxpress.com/news/2021-03-nordics-safe-astrazeneca-jab.html

-I går argumenterte Norges representant i bivirkningskomiteen til EUs Legemiddeltilsyn (EMA), David Olsen – som eneste land – for at spesielle blodpropp-tilfeller skulle legges inn i listen over mulige bivirkninger i preparatomtalen.

Ayer, el representante de Noruega en el Comité de Reacciones Adversas de la Agencia Europea del Medicamento (EMA), David Olsen, como único país, defendió que los casos específicos de coágulos de sangre se añadan a la lista de posibles efectos secundarios del preparado.

https://www.nrk.no/norge/madsen-om-bivirkninger-i-europa_-_-flere-land-har-problemer-med-apenheten-1.15423812

-Finland has suspended the use of @AstraZeneca #COVID19 #vaccine while it investigates two possible cases of blood clots.

Se suspende la campaña de #vacuna #covid19 @AstraZeneca en Finlandia, por dos posibles casos de problemas coagulación.

https://www.euronews.com/2021/03/18/norway-sweden-denmark-wait-before-restarting-astrazeneca-vaccinations

-Finland. THL temporarily suspends the use of the AstraZeneca COVID-19 vaccine. The Finnish Medicines Agency Fimea has reported two cases of cerebral venous sinus thrombosis (clots in the vessels draining blood from the brain) within 4–10 days of receiving the AstraZeneca COVID-19 vaccine.

https://thl.fi/en/web/thlfi-en/-/thl-temporarily-suspends-the-use-of-the-astrazeneca-covid-19-vaccine?redirect=%2Fen%2Fweb%2Finfectious-diseases-and-vaccinations%2Fwhat-s-new

-«To 18 March 2021, the TGA has not received any reports of blood clots following administration of the @AstraZeneca #COVID19 #vaccine in Australia. We advise to get the vaccine when eligible»

Australia, sin problemas con #vacuna #covid19 @AstraZeneca

https://www.tga.gov.au/alert/astrazeneca-chadox1-s-covid-19-vaccine

-UK regulator confirms that people should continue to receive the COVID-19 vaccine AstraZeneca Following suspensions by some countries of the COVID-19 Vaccine AstraZeneca over suspected blood clots, the MHRA confirms that the benefits of the vaccine in preventing COVID-19 far outweigh the risks. People should still go and get their COVID-19 vaccine when asked to do so.

https://www.gov.uk/government/news/uk-regulator-confirms-that-people-should-continue-to-receive-the-covid-19-vaccine-astrazeneca

-Clots-thrombocytopenia, much rarer and has been linked with the #covid19 #vaccine @AstraZeneca It is also been linked with in the US with @Pfizer and @Moderna_tx vaccines and in fact other vaccines.

https://www.cambridge-news.co.uk/news/uk-world-news/oxford-astrazeneca-vaccine-covid-clots-20189776

-Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination

https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132

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