Covid19 vaccines suspected events

Covid19 vaccines suspected
serious    adverse  events
AstraZeneca follow-up, by
NoGracias.
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-i
s-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_campai
gn=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_so
urce=twitter

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

https://www.thelancet.com/journals/lancet/article/PIIS0140-6
736(21)00762-5/fulltext?dgcid=raven_jbs_etoc_email#.YHm99kKL
1MA.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-laport
e-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-f
ear-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-cov
id-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=fe
atured_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-vacc
ine-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-advis
ers-recommend-jj-covid-vaccine-stay-pause

Ny studie: Blødninger etter covid-19-vaksiner.

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

La UE no renovará contratos con AstraZeneca y Janssen.

https://www.elmundo.es/ciencia-y-salud/salud/2021/04/14/6076
a1c0fc6c83b8458b4656.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-vacc
ine-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-co
ncluding-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=re
circ_curatedRelated_article

Norway. Thrombosis    and   Thrombocytopenia   after   ChAdOx1
nCoV-19 Vaccination

https://www.nejm.org/doi/full/10.1056/NEJMoa2104882?query=fe
atured_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-sh
ould-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-p
anel-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-vacci
ne-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/ebd0055
b-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-astrazenec
a-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-netherlan
ds-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-astraz
eneca-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=Iw

AR3b5bzP2B-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_21
0402_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-me
d-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-astrazen
eca-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-re
sume-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-f2bf5d1d6
70d

@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-astrazene
ca-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-astra
zeneca-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-disord
er-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-vaccin
e-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-covi
d-19-impfstoff-astrazeneca-ergebnis-sicherheitsbewertung-
impfstoff-ist-
sicher.html;jsessionid=87DF9CB96F475E63BE1856D88CC9CE2B.intr
anet231

-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-r
ecommande-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-wa
it-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-astrazen
eca-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-wa
it-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-th
e-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-tha
t-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-a
strazeneca-vaccine-covid-clots-20189776

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

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