RETIRADA POR LA COMISIÓN EUROPEA DE LA AUTORIZACIÓN DE LA VACUNA Vaxzevria - COVID-19 (AstraZeneca) (II)

 Astra Zeneca withdrew their Covid vaccine Vaxzevria, from the global market. 

We were told it was due "to the application submitted by AstraZeneca AB on 5 March 2024 with a view to the withdrawal of the marketing authorisation for the medicinal product "Vaxzevria - COVID-19 Vaccine (ChAdOx1-S [recombinant])", . 

Just prior to its withdrawal the European Medicine's Agency received the data from the 2 year follow up Astra Zeneca safety and efficacy trial.

 

Clinical Trial Results:
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19

Alguna información significativa de la prueba y de los resultados :

Recipientes vacuna: 21.587

Recipientes "placebo": 10.793

Efectos adversos serios:

Vacuna: 621 (1 de cada 34,76 participantes); "Placebo": 136 (1 de cada 39,68)

Efectos adversos atendidos médicamente:

Vacuna: 4.750 (1 de cada 4,54 participantes); "Placebo": 1256 ( 1 de cada 4,29)

Efectos adversos de especial interés:

Vacuna: 2.516 (1 de cada 8,57 participantes); "Placebo":  591 (1 de cada 9,13)

Total efectos adversos

Vacuna: 7.887 ( 1 de cada 2,73 participantes); Placebo: 1.983 ( 1 de cada 2,72 participantes)

La incidencia es superior en la vacuna al "placebo"

La incidencia de la infección Covid en el grupo de vacuna y en el de "placebo" es también similar y más favorable en el grupo del "placebo":

¿Tiene sentido la autorización de la EMA después de los resultados publicados?

 

 

 

 

 

Global Advisory Committee on Vaccine Safety (GACVS) review of latest evidence of rare adverse blood coagulation events with AstraZeneca COVID-19 Vaccine (Vaxzevria and Covishield) 

16 April 2021

Statement

Reading time: 2 min (665 words)

AstraZeneca formally admits that its COVID-19 vaccine can cause rare side effect In court documents, AstraZeneca has admitted for the first time that its covid vaccine can cause a rare side-effect. 

 Posted on 30 April 2024 

The admission is confirmed by AstraZeneca in legal documents responding to a group action claim launched by Leigh Day partner Sarah Moore under section 2 of the Consumer Protection Act 1987 against the pharmaceutical giant, AstraZeneca. It is expected that the claims could be worth millions of pounds.

Fifty-one claimants represented by Sarah are pursuing the claim due to injuries allegedly caused by the Vaxzevria Astra Zeneca COVID-19 Vaccine manufactured by AstraZeneca UK Limited (AZUK). Twelve of the claimants are acting on the behalf of a loved one who died following a complication allegedly caused by the vaccine.

All twelve of the bereaved claimants have received death certificates or medical evidence that confirms that the AZUK vaccine caused the deaths and injuries suffered by their loved ones.

The claimants say that they, or their loved one, suffered Vaccine Induced Immune Thrombosis with Thrombocytopenia (VITT) which is a form of Thrombosis with Thrombocytopenia Syndrome (TTS) as a direct result of the AZUK vaccine. This is a rare syndrome characterised by blood clotting and insufficiency of platelets.

TTS can have life-threatening consequences including strokes, brain damage, heart attacks, pulmonary embolism (a blockage of an artery in the lungs) and amputation.

Although AstraZeneca has disputed the claims, a legal document submitted to the Court to clarify their defence in February this year stated that its vaccine “can, in very rare cases, cause TTS.”