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.
Canada. Information for professionals.
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.
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues. 31 march 2021.
Covid-19: WHO says rollout of AstraZeneca vaccine should continue, as Europe divides over safety.
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
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.
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
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
«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.»
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.
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!
Sobre la vacuna covid19 AstraZeneca, el Harding Center para Alfabetización Estadística.
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:
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.
The moratorium is maintained as uncertainty prevents sufficient certainty that the vaccine offers more benefit than harm.
Vaccination campaign has been resumed, but only for people aged 70 and over.
The vaccination campaign will be resumed from Monday 29 March, but only for people aged 65 and over.
The vaccination campaign will be resumed, but only for persons aged 65 and over.
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.
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.
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.
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
Pausen med vaccination med COVID-19 vaccinen fra AstraZeneca forlænges 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».
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.
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.
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.
@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.
@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.
#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).
#vaccine #covid19 @AstraZeneca Syndrome vaccine-induced prothrombotic immune thrombocytopenia.
Parece cierta la asociación entre #vacuna #covid19 @AstraZeneca y un síndrome inducido protrombótico con trombocitopenia.
Update. Saturday, March 2021.
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.
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).
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.
-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.
Por ahora, Dinamarca, Noruega y Suecia siguen sin vacunar.
-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.
-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.
-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.
-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.
-«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
-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.
-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.
-Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination