Astrazeneca vaccine: efficiency, method, side effects

10/12/2022 By acomputer 414 Views

Astrazeneca vaccine: efficiency, method, side effects

The Astrazeneca vaccine is authorized in France only for those over 55.A thrombosis risk that has been confirmed below this age.According to the European Medicines Agency, 833 cases of Guillain Barré syndrome have also been reported worldwide after an injection of Vaxzevria.

  1. Is it less good than Pfizer and Moderna?
  2. Price and conservation
  3. How does it work ?
  4. Its composition
  5. What delay between the 2 doses?
  6. What efficiency?
  7. Astrazeneca vaccine: for whom?
  8. Efficiency against variants
  9. Contraindications
  10. Side effects list
  11. How to react in case of side effects?
  12. What if I am under 55 and I was vaccinated by Astrazeneca?
  13. The delay in delivery of doses in France

Latest news concerning the Astrazeneca vaccine:

The astrazeneca anti covid vaccine has undergone many criticisms and twists and turns because of the declaration of side effects after the start of its use in the European vaccination arsenal, in particular some cases of blood clots that can cause thrombosis and deaths in peoplevaccinated.

Like many countries, France had suspended from March 15 the use of the Astrazeneca vaccine following the first reports of thrombosis.The EMA therefore re-evaluated the vaccine, but confirms that these are only """"rare"""" cases.The benefit/risk balance remains advantageous and the """"safe and efficient"""" vaccine, according to them.Having followed this opinion, as well as the analysis of the HAS (French health authority)), France has again authorized the use of serum, but the latter recommended only for people over 55 years old, the risks of clotshaving been mainly noted in patients below this age group.

Some countries like Denmark have made the decision to stop its use.Norway is also thinking about following this example.

All new deliveries of Astrazeneca vaccines planned for France will now be switched to donations to developing countries, according to the announcement of the Ministry of Health Tuesday, July 20.""""About 1 million doses of astrazeneca"""" must also be delivered this week.They will be """"100% arrowed in Covax"""", the international solidarity system, informed a representative of the Ministry of Economy and Finance during an online press point.The Astrazeneca vaccine experiences disaffection in France because of its side effects.Since April France has """"sold almost 5 million doses via Covax"""".

Side effects, efficiency, composition...We take stock of what you need to know if you are going to be vaccinated by the Astrazeneca vaccine.

Is it less good than Pfizer and Moderna?

After the announcements of the results of the Alliance Pfizer/Biontech and that of Moderna tisping an efficiency of 90% for the first and 94.5% for the second (data based on the press releases of the laboratories, without publication in any scientific review for the'Instant)), Astrazeneca has less impressive results, but with detailed publication in a scientific journal.

Committed to the race for the COVVI-19 vaccine, the Astrazeneca laboratory had announced in a press release signed in collaboration with the University of Oxford, an effectiveness on average estimated at 70% for its vaccine in clinical phase III (last phase beforemarketing request)).Intermediate results obtained following large-scale clinical trials in the United Kingdom and Brazil.It is the first vaccine in the list of candidates whose level of efficiency was confirmed on Tuesday, December 8, by the journal The Lancet.

A recent American study, published by the Astrazeneca laboratory, carried out on a larger scale and real vaccination situation with the American population has revised efficiency up to 80%.

Price and conservation

The Astrazeneca vaccine is less expensive than those of Pfizer and Biontech (around 2.50 euros per dose)) and easier to store because it does not need to be kept at a very low temperature.

It can indeed be kept at the temperature of a conventional refrigerator, that is between 2 and 8 ° Celsius, unlike Moderna and Pfizer/Biontech vaccines.The latter can only be stored in the long term in very low temperature (-20 ° Celsius for the first, -70 ° C for the second)), not facilitating a large -scale vaccination.

In its recommendations the HAS also confirmed that pharmacists and midwives could participate in vaccination with the Astrazneca vaccine given its ease of conservation.

How does it work ?

Unlike the Pfizer and Moderna vaccines which both use an innovative technology called """"Messenger RNA"""" never approved on humans to date, the Astrazeneca vaccine uses a traditional process, with a viral vector called """"COVIDShield """".

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Called Chadox1, during phases I and II, then AZD1222 in phase III, the astrazeneca/oxford vaccine is made up of an adenovirus of chimpanzee (family of virus which is transmitted by fec-oral route)), modified to be harmless for theman.""""We preferred to choose an adenovirus of monkey so that the human body has not already developed an immune response,"""" explains Helen McShane, director of the Biomedical Research Center of Oxford (BRC)).In the genome of this virus, scientists injected an end of DNA of the sars-cov 2 coronavirus quipermet to reproduce the SPIKE protein.It is identified as the key which allows the virus to enter into human cells.This process allows' to cause an immune reaction both by the production of antibodies and by the implementation of a memory function of certain cells allowing the activation of the defense in the event of an attack.

Its composition

The Astrazeneca vaccine contains on a dose of 0.5 ml:

Excipients:

What delay between the 2 doses?

The Astrazeneca vaccine against COVVI-19 is administered by intramuscular injection into two doses.The second to be made between 9 and 12 weeks after the first, according to the HAS recommendations at the press conference on February 2, 2021.

According to Professor Elisabeth Bouvet, member of the Technical Vaccine Commission at HAS, studies are to come with a view to advising the administration of a single dose for people who have already had COVVI-19.Results would have shown that people who have already been affected by the coronavirus would have obtained the same efficiency from the first dose as those having received two.More research must confirm this possible immune memory.

What efficiency?

A recent phase III clinical study conducted in the United States, published by the Astrazeneca laboratory reports an efficiency, higher than the first large-scale studies.Led on more than 32,000 people who received the two doses of vaccine with 4 weeks apart, the study includes 60% of patients with comorbidities, therefore at risk and 20% of them are over 65 years old.The conclusions including:

Data concerning the over 65s that until then lacked the call and had led to recommend it for older than much later.

90 % efficiency with half a dose and 62 % with an entire dose

The Astrazeneca vaccine is based on two injections one month apart.During phase II, the Astrazeneca/Oxford vaccine had been tested on 560 volunteers.According to the second clinical preliminary study published by Astrazeneca and the University of Oxford, on November 23, in the medical journal The Lancet, the vaccine was tested on nearly 13,000 volunteers and obtained an average efficiency of 70%.Results then validated by the scientific journal on December 8.

But since their publication, these results are problematic.The vaccine first shown an efficiency of 90 % on a first sample of 3,000 people and then this efficiency dropped to 62 % during a new test in another group of almost 9,000 volunteers.

The explanations revealed in a BBC articles, explain that in the first group where the vaccine was 90%effective, the volunteers received, by mistake, only half a dose first, then a whole dose a month later.And in the group which obtained 62%, the volunteers received their two injections each with the whole dose.

A greater efficiency obtained therefore, by mistake, on which the laboratory announced that they should be leaning in order to understand why with half a dose on the two injections, the immune response was the strongest.

It is therefore on this difference in efficiency between the two tests that the laboratory must look.

During a press conference, Andrew Pollard, professor at the University of Oxford explained that the main hypothesis is that a smaller dose of the vaccine, then another greater later would allow better imitation of the'Intrusion of the virus into the body and therefore a better reaction of the immune system to defend oneself.

According to the results published in The Lancet, the immune response is the same in young and elderly subjects.A positive point because """"the oldest adults have a tenfold risk of making a serious form of COVID-19, and it is therefore essential that a vaccine intended to fight this disease is effective in this population group"""", commentscientists.But a limit to this advantage was added in the study, because among the volunteers, the oldest were 74 years old and were healthy.This does not constitute a sufficiently representative sample of the senior population.More research must be carried out on this point to expand data to people with health problems and therefore more at risk of serious form of COVID-19.

Astrazeneca vaccine: for whom?

The recommendations of the Astrazeneca vaccine do the trick of a real headache with continuous twists and turns since.The latest update of the HAS, Friday March 19 recommends the vaccine, only for those over 55, due to a risk of thrombosis possibly identified below this age, following numerous reports ofcase.

Before that: at the press conference on February 2, Professor Elisabeth Bouvet de la Has explained that the Astrazeneca vaccine was not recommended for people over 65 years old due to a lack of data.The majority of studies provided to the validation of the vaccine focused mainly on people between 18 and 65 years old and those under 65, making it possible to confirm an efficiency for these categories of people.More studies were then provided and on March 2, 2021, the HAS announced in a press release that a Scottish study in real life """"submitted to the British Medical Journal and awaiting peer reviews, bring very encouraging results on profitsIn the short term of a first dose of vaccine (Pfizer or Astrazeneca)) against COVVI-19 in those over 65.""""In this study the impact of the vaccine was analyzed on 5 million inhabitants in Scotland.Among the age groups studied: 18-64 year olds, 65-70 years and over 80s.The drop in the risk of hospitalization was beneficial to all age groups according to HAS.""""The most marked effects are observed from 28 to 34 days after the first injection: efficiency of 85% for 18-64 year olds, 79% for 65-79 year olds and 81% for those over 80 years old.""""Consequently, the HAS had redefined the place of the Astrazeneca vaccine in the vaccination strategy by expanding its use to people over 65 years old.

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Also due to lack of data, the vaccine is still not recommended for pregnant women, or immunocompromised people.

Efficiency against variants

English varying

A published preliminary study conducted on vaccinated volunteers between October 1, 2020 and January 14, 2021 (date of the flambe of the English variant in the United Kingdom)) by the Oxford University showed that the Astrazeneca vaccine was effective against the British variant B.1.1.7.

According to the director general of Astrazeneca Pascal Soriot interviewed by the Sunday Times on the British variant, """"we believe for the moment that the vaccine should remain effective.But we cannot be sure so we are going to do tests """".He assured that new versions were underway in case, while hoping not to need it: """"You have to be prepared"""".

Varying South Africa

The results are less optimistic for the variant of South Africa.During the HAS press conference, Professor Daniel Floret, explained that a study conducted in South Africa has shown more reduced efficiency, but the data remains few.The scientist affirmed that there could be no confirmation still on an effectiveness or not of the astrazeneca vaccine against the variant given the lack of study for the moment.

A few days later, South Africa announced to suspend the use of the Astrazeneca vaccine in its vaccination strategy following this study of which we know a little more details.Led by the University of Witwatersrand in Johannesburg on 2000 volunteers aged 31 on average, the research announces """"limited protection against the moderate forms of COVVI-19 linked to the South African variant in young adults"""".Only 22% efficiency is reported against moderate forms and no data is available on serious forms.This is the only study on very few people with a little -wide age range also more research must be carried out.

However, on February 10, the World Health Organization recommends using the Astrazeneca vaccine even in countries that face new variants of the coronavirus.Following the first test data in South Africa showing that the vaccine offered """"minimum protection"""", the director of WHO vaccination, Dr..Katherine O'Bien, said that the South African study """"was not conclusive"""" and that it was """"plausible"""" that the vaccine still prevents a serious illness.""""There is no reason not to recommend its use, even in countries where the variant is in circulation,"""" said Dr..Alejandro Cravioto, the president of Sage, the strategic consultative group of WHO experts on vaccination, at a press conference according to the BBC.

On the laboratory side, a new form of the vaccine containing a sequence of the South African variant would be in preparation by the Astrazeneca laboratory.

Contraindications

It is not recommended in people with an allergy to one of the active substances or one of the excipients present in the vaccine.

Side effects list

The most common

- Skin reaction in the injection zone (redness, bruising, pain)) headache- nausea- myalgia- arthralgia- fatigue- discourse- chills- chills

Frequent

- vomiting- diarrhea- fever

The least frequent

- lymphadenopathy- decrease in appetite- etoudisses- drowsiness- hyperhidrosis- prurit-

High intensity influenza syndromes

In its weekly pharmacovigilance assessment implemented since the start of vaccination, the ANSM reports that 5,693 cases of adverse effects (on more than 1,430,000 injections)) were reported to March 18, 2021.""""The vast majority of these cases concern pseudo-grapple syndromes, often of high intensity (high fever, aches, headache)).""""

On all injections this represents little declaration of side effects for the ANSM, especially since they are part of the adverse effects known and deemed little dangerous. """"Néanmoins, ces déclarations de pharmacovigilance constituent un signal potentiel et font l’objet d’une surveillance particulière par les CRPV et l’ANSM au regard notamment de l’intensité de ces effets"""", explique l'ANSM.

The Astrazeneca vaccine having been mainly made available to caregivers under the age of 64, health establishments have been warned and now have the recommendation of stagging the vaccinations of caregivers from the same service to prevent everyone from being absent at the same timeIn case of side effects.

Un risque de thromboses """"rare"""" mais qui inquiète

Just like with the Janssen vaccine, it is the most worrying side effect having declared after the start of vaccination on the population.In March 2021, several countries, including France, suspended anti -covid vaccination with the Astrazeneca vaccine following disturbing reports suggesting a risk of thrombosis.

The European Medicines Agency (EMA)) had to review the study of the benefit/risk balance.After study it confirms the link between the appearance of thrombosis and the astrazeneca vaccine. Néanmoins elle considère le vaccin toujours """"sûr et efficace"""", car cela reste un risque """"très rare"""" déclaré sur des dizaines de patients à travers toute l'Europe sur des millions de doses injectées.

After study, German researchers have found a cause, which remains to be confirmed, to these blood clots which can be declared rarely in patients vaccinated for the COVVI-19. Selon les résultats de ces scientifiques de l'université Goethe à Francfort dirigés par Rolf Marschalek, publiés dans le Financial Times en mai 2021, """"Le problème résiderait dans le vecteurs d'adénovirus que les deux vaccins utilisent pour introduire la protéine de Sars-Cov-2 dans le corps"""".

To develop, anti-virus must be introduced into cells.Parts of the virus protein, when introduced into the nucleus of the cell, would not be binding to the membrane that surrounds it.It is these protein extracts that escape from the membrane that would be responsible thrombosis in some people by causing an immune reaction.(count a patient on around 100,00)).

This could explain that this side effect is not noted as much with the Pfizer and Moderna vaccines since the latter are mesing vaccines, a technique that does not pass the protein in the cell via the famous nucleus.

Le chef de cette étude aurait déclaré être en contact avec le laboratoire Johnson&Johnson fabricants du vaccin Janssen à adénovirus afin d'optimiser le sérum pour éviter cette fuite des parties de protéines.Astrazeneca has not yet responded to her request.

""""La plupart des cas ont été observés chez des femmes âgées de moins de 60 ans dans les deux semaines après injection"""", déclare l'EMA dans un communiqué du 7 avril 2021.Nevertheless, the data is still low to define risk factors such as age, sex or medical history.Because other cases have declared themselves at several age groups.

Le nombre de cas de thrombose par rapport aux millions de doses injectées reste faibles selon les experts de la police sanitaire européenne qui souligne un vaccin """"efficace"""" qui """"sauve des vies"""".

In the United Kingdom, the British drug regulation agency prohibited the use of the vaccine in those under 30 years after 30 reports of blood clots (out of a total of 18.1 million doses administered)) following vaccination withAstrazeneca, including 7 fatal cases at home.

For its part, France has decided to resume use but taking into account the opinions of a little everyone. Dans un soucis de précaution, la HAS, qui valide les autorisations en France a tout de même tenu à rappeler que l'étude de l'EMA portant sur un nombre de signalements sur un risque possible de """"coagulation intravasculaire disséminée et de thrombophlébite cérébrale chez les personnes de moins de 55 ans"""", elle recommandait le vaccin uniquement au-delà de 55 ans, la majorité des prioritaires étant dans cette catégorie d'âge.

En France, sur la totalité des effets secondaires rapportés (5693 au 18 mars)), l'ANSM rapporte que 9 cas de thromboses des grosses veines, """"atypiques par leur localication (cérébrale, mais également digestive)), pouvant être associés à une thrombopénie ou à des troubles de coagulation ont été déclarés, dont 2 décès.""""Cases declared 8.5 days on average after vaccination in people without any particular history.7 patients under 55 and 2 over 55)).

As of May 7, 30 cases of venous thrombosis, 9 deaths of which were identified in France by the Medicines Agency on more than 3,855,000 injections carried out on April 29, 2021.

Thrombosis: what symptoms?How to react ?

Also called phlebitis, venous thrombosis corresponds to the formation of a blood clot.If this obstacle develops in a superficial vein, there is generally no need to worry.On the other hand, if it is a deep vein which is affected, the problem is much more serious with a risk of pulmonary embolism.Zoom on this mechanism.

""""Déclenchement d’une maladie inexpliquée"""" pendant les essais

Le 8 décembre la revue The Lancet a qualifié le vaccin de """"sûr"""" avec un seul patient sur les 23 754 participants ayant développé """"un effet secondaire sérieux possiblement lié"""".

Le 9 septembre 2020, Astrazeneca avait annoncé avoir suspendu volontairement les essais pour son vaccin candidat dans un communiqué suite au """"déclenchement d’une maladie inexpliquée sur l’un des volontaires durant la phase III des essais cliniques"""".No more detail has been communicated by the laboratory concerning the patient's case. """"Il s’agit d’une étape classique, avait expliqué le laboratoire dans son communiqué.During major clinical trials of side effects declare themselves and we must study them with caution and independently of the rest.The safety of our work being priority """".

Three days later, on September 12, a new press release announced the resumption of trials in Britain authorized by the doctor Health Regulatory Authority (MHRA)), English health authority having judged the security data sufficient to continue tests.In an article updated on September 17, the New York Times, explains that a source close to the file would have revealed to them that it was a transverse myelitis, a rare neurological disease caused by an inflammation touching the spinal cordwith assignment of motor functions.Nevertheless, American journalists specify that no information allowed them to know the timing of the diagnosis and whether it was linked to the vaccine or not.

""""AstraZeneca et l’université d’Oxford, en tant que commanditaire de l’essai, ne peuvent pas divulguer d’autres informations médicales"""", a déclaré le laboratoire essuyant des critiques de la communauté médicale pour son manque de transparence quant à l’évaluation du risque détecté.In a post for Forbes magazine, William has.Haseltine, doctor and former professor at the Harvard Medical School regretted that the details of the investigation have not been revealed.: ""It is good to show that the trials are suspended for patient safety, but the lack of transparency on the part of the pharmaceutical laboratory calls for caution.»

Après la validation du vaccin sur le marché, Elisabeth Bouvet, membre de la HAS a confirmé deux cas de myélite et un autre de maladie neurologique """"de type sclérose en plaques"""".A study by independent groups would have confirmed that there was no connection with the vaccine given the presence of lesions prior to vaccination.

Another reserve: no vaccine with an adenovirus of chimpanzee as a vector and not that of a human adenovirus has yet been validated.No study history allows you to inform any risks for humans.

Uncommon hematological disorder

A study conducted on 5.4 million patients by a team of doctors in Scotland revealed a very low risk of blood disorder called Purpura thrombocytopenic idiopathic (PTI)).By comparing the blood exams of people who received a first injection of Oxford/Astrazeneca vaccine with other unvaccinated people, the group of researchers identified a slightly higher risk of PTI in 1.7 million people in the group of thosehaving been vaccinated.The risk being mainly in people with chronic diseases (diabetes, cardiovascular disease, etc..)).Their results published in the scientific journal Nature DoCcin believe that there would be 11 cases of PTI for one million doses of Astrazeneca vaccine.A ratio that would be similar to the ROR vaccine (measles/mumps/rubella)).

Cases of Guillain-Barré syndrome

In India, doctors at the city of the city of Kochi, noticed 7 cases of Guillain-Barré syndrome after the injection of the Astrazeneca vaccine.Likewise in England in the Nottingham hospital.In total, 11 cases were reported (none in France)).Symptoms declared themselves 11 to 22 days after the first dose.

As the WHO indicates, this pathology is usually very rare.When a patient is affected, his immune system attacks part of the peripheral nervous system, and can reach the nerves related to muscle movements.This causes muscle weakness and loss of sensations in the lower and upper limbs.

For the time being, no cause and effect link has been established between the British vaccine and Guillain-Barré syndrome.But some patients had suffered from this pathology after having the COVVI-19. """"On a déjà eu ce genre de débat avec la grippe et la vaccination antigrippale, indique à Medisite Thomas Kassab, pharmcien.We had wrongly accused the antigripping vaccine of developing Guillain-Barré syndromes.However, several international studies later demonstrated that there was fewer Guillain-Barré in people vaccinated against flu than in those who had not received the vaccine.It would seem that the vaccine only revealed an underlying barred Guillain, but did not create it '.""""

On September 8, the European Medicines Agency identified 833 cases of Guillain Barré syndrome worldwide at July 31, 2021 for more than 592 million doses of the Vaxzevria vaccine administered on July 25, 2021. Sur la base de ces données et avec l'appui d'un expert neurologue de l'agence, le Comité d’évaluation des risques en matière de pharmacovigilance de l’EMA (PRAC)) juge qu'une """"relation causale entre Vaxzevria et le syndrome de Guillain-Barré est considérée au moins comme une possibilité raisonnable et que le syndrome de Guillain-Barré doit donc être ajouté sur les informations de ce vaccin comme un effet secondaire de Vaxzevria"""". La catégorie de fréquence désigné est """"très rare"""" (soit moins d'une personne sur 10 000)).

How to react in case of side effects?

In case of frequent side effects

Si après avoir été vacciné par Astrazeneca vous souffrez d'un des symptômes parmi les plus fréquents (voir la liste complète ci-dessus)), comme de la fatigue, des maux de tête, des frissons, des nausées, vomissements, diarrhées etc.The French Medicines Agency advises the use of paracetamol at the lowest and lowest dose as possible. Les effets se dissipent généralement """"spontanément quelques jours après la vaccination"""".

In case of anaphylactic shock

Allergic reactions are uncommon but possible. Au moindre signe de réactions cutanées sévère de type gonflement du visage (paupières, lèvres)), fortes démangeaisons, problèmes respiratoires, diarrhées, l'ANSM invite à contacter le SAMU (composer le 15)).Pending help, keeping the patient in a half-assistance position in the event of breathing disorders, in sleeping decubitus with raised legs in the event of awareness and in lateral safety position if the patient is unconscious.

In case of rare or severe side effects

If you are victims of a reaction not cited in frequent side effects, contact a health professional or the SAMU (depending on the gravity))

Concernant les risque de thrombose :si vous avez été vacciné contre la Covid avec Astrazeneca et que vous ressentez des symptômes persistants """"quelques jours après la vaccination (au delà de 3 jours)) tels que : un essoufflement, une douleur thoracique, un gonflement des jambes, une douleur abdominale, des maux de têtes sévères, une vision floue, ou des ecchymoses à distance du site d’injection"""", il est conseiller de consulter un médecin immédiatement.

What if I am under 55 and I was vaccinated by Astrazeneca?

The risks of thrombosis in those under 55 having been identified several weeks after the start of the use of the vaccine in the vaccination campaign, several people below this age had received the first injection of the vaccine. En conséquent la HAS a établi, vendredi 9 avril, que les personnes concernées doivent """"compléter le schéma vaccinal pour cette population avec un vaccin à ARNm dans un délai de 12 semaines après la première injection."""" Une dose des vaccin Pfizer/BioNtech (COMIRNATY®))ou Moderna leur sera donc inoculée puisque qu'une seule dose de vaccin ne suffit pas à être totalement protégé.

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The delay in delivery of doses in France

New delays in the delivery of doses of vaccines are to be feared in Europe on the side of the Astrazeneca group. L'entreprise a annoncé le samedi 13 mars dernier une """"des restrictions d'exportations"""" qui vont entraîner une réduction des livraisons au premier trimestre à cause de difficultés de production.100 million doses were expected in the first quarter and 70 in the second.

Alors que l'autorisation conditionnelle de mise sur le marché par l'Agence du médicament européenne a été donnée comme prévu le 29 janvier, le laboratoire Astrazeneca avait déjà été épinglé après une annonce vendredi 22 janvier à l'AFP d'un retard de livraison en raison """"d'une baisse de rendement"""" dans une usine européenne.

An announcement which immediately aroused concerns on the part of the European health authorities and the Member States while a new race against the clock is committed within the framework of the pandemic between vaccination campaign and propagation of the new English variants, South-African, Brazilian and now Californian.Especially since delays have also been announced on the side of Pfizer.

In all, 400 million doses were ordered by the European Commission.Austrian Minister of Health Rudolf Anschober deplored a delay on Twitter with a consequence resulting in February 340,000 doses instead of 650,000.The European Commission, unsatisfied with explanations from the laboratory, had the data inspection seized and requested Thursday, January 28.

Additional pressure was carried out with the publication of the contracts with the laboratory in August 2020.We can read that production is provided by 2 British and 2 European factories and all must contribute to everyone's effort.However, the world reports that Pascal Soriot, French managing president of Astrazeneca would have explained that he should keep the doses produced in the United Kingdom, for the United Kingdom only.Declarations immediately disputed by the European Union which reiterates that English factories must also participate in the effort for Europe.