The European Union’s medicines regulator on Tuesday said it had found a “possible link” between Johnson & Johnson’s (J&J) COVID-19 vaccine and the development of rare blood clots in a small number of recipients, but concluded the shot’s overall benefits outweigh any risks associated with its use.

The European Medicines Agency (EMA) said its safety committee decided that a warning about unusual blood clots with low blood platelets must be added to the vaccine’s labels, just as the regulator has also required of rival vaccine maker AstraZeneca, whose own jab was found by the agency last month to also have a “possible link” with rare blood clots.

The EMA found that all instances of clotting had occurred in adults under 60 years, mostly women, within three weeks of vaccination with J&J’s single-shot vaccine. The agency said these rare blood disorders should be considered as “very rare side effects of the vaccine”.

It said all available evidence, including eight cases that were reported in adults who had received the jab in the United States, including one death, had formed part of its assessment.

The watchdog also said that most clots among recipients had occurred in the brain and abdomen, as was the case with AstraZeneca’s shot, which is also being studied for similar rare clotting problems.

Rare US blood clot cases

The EMA’s update came after J&J last week halted the European rollout of its one-dose shot in response to a recommendation by the US Food and Drug Administration (FDA) that officials pause its use while the rare blood clot cases were examined.

The cases were reported out of more than seven million doses administered in the US as of April 13, the EMA said.

J&J had advised European governments to store their doses until the EMA issued guidance on their use, and the US-based pharmaceutical giant is reportedly prepared to resume the deployment of its vaccine following the agency’s review.

The company has said it would aim to deliver 55 million doses to the European Union, as contracted, by the end of June. It is one of four COVID-19 vaccines authorised for use in the bloc.

European Medicines Agency backs use of single-dose COVID-19 shot, saying its overall benefits outweigh risks.

But widespread use of the shot among its 27-member states has not yet started, with the recent delay posing a fresh setback to already faltering vaccination efforts in the union, in particular, and global efforts to tackle the coronavirus pandemic.

The EU’s choppy vaccine rollout has been plagued by problems including poor coordination between national and regional authorities, supply shortages, concerns over the AstraZeneca shot and a damaging contractual row with the Anglo-Swedish company.

‘Suspicion is rising’

With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.

It is not yet clear if there might be a similar mechanism with the J&J shot.

But both the J&J and AstraZeneca vaccines, as well as a Russian-made COVID-19 vaccine and one from China, are made with the same technology.

They train the immune system to recognise the spike protein that coats the coronavirus. To do that, they use a cold virus, called an adenovirus, to carry the spike gene into the body.

“Suspicion is rising that these rare cases may be triggered by the adenovirus component of the AstraZeneca and J&J vaccines,” Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh, told the Associated Press news agency.

Riley said that while more data was needed, “it remains the case that for the vast majority of adults in Europe and the US, the risks associated with contracting COVID-19 far, far outweigh any risk of being vaccinated”.

SOURCE: NEWS AGENCIES

L’article EU regulator finds J&J vaccine has ‘possible link’ to blood clots est apparu en premier sur زوايا ميادين | Mayadin Columns.

Suspensions follow reports that some people developed blood clots after receiving the shot, but the WHO and the EMA say they have seen no evidence of a link.

Germany, France, Italy and Spain have suspended the use of AstraZeneca’s COVID-19 vaccine after several reports of blood clots in people who received the shot in Europe.

The flurry of suspensions on Monday came after a number of other countries, mostly in Europe, halted their rollouts late last week.

The World Health Organization (WHO) has backed the use of the vaccine and said it has seen no evidence that the shot had caused clotting.

The UN health agency is reviewing the reports related to shot and urged countries not to suspend vaccinations, as its top scientist said people should not panic.

The European Medicines Agency (EMA) said in a statement that it has not found any evidence of links between reported thrombosis cases and the AstraZeneca shot, saying that the shot’s benefits outweigh the risks and was safe to use. The regulator is reviewing the shot and will issue a decision on any further action on Thursday, it said.

EU members halt shots

German Health Minister Jens Spahn said the country suspended the use of the shot on the advice of the national vaccine regulator, the Paul Ehrlich Institute.

The institute had called for further investigation into seven reported cases of clots in the brains of people who had received this vaccination.

“Today’s decision is a purely precautionary measure,” Spahn said.

France and Italy announced similar moves shortly afterwards.

French President Emmanuel Macron said the use of the AstraZeneca shot would be suspended as a precautionary measure until at least Tuesday afternoon when the European Union’s medicines regulator – the EMA – will issue its recommendation over the vaccine.

Macron did not elaborate on the reasoning behind the decision, but told a news conference he hoped France would be able to vaccinate with AstraZeneca shots again “soon”.

Italy’s medicines authority AIFA meanwhile said it was implementing its own suspension as a “precautionary and temporary measure” pending rulings by the EMA.

The announcement followed the seizure of hundreds of thousands of doses of the vaccine by Italian prosecutors in the northern region of Piedmont, where a teacher died following his vaccination.

Experts are investigating whether there is a connection between his death and the vaccination.

Late on Monday, Spain’s Health Minister Carolina Darias said the country was suspending its use of the vaccine for two weeks as a “precaution”.

She said the decision would remain in place until the EMA “analyses the recent incidences of blood clots, notably over the weekend”.

AstraZeneca has said there is no cause for concern with its vaccine, which is jointly produced with the United Kingdom’s University of Oxford, and that there were fewer reported thrombosis cases in those who received the shot than in the general population.

Peter Drobac of Oxford University told Al Jazeera the AstraZeneca vaccine went through “rigorous clinical trials” and blood clots were not identified as a problem.

“The safety pause, I think it is certainly the prerogative of the regulators in these countries. However we have heard from the World Health Organization, the European Medicines Agency and others, that at this point the benefits of vaccination clearly outweigh the risks,” Drobac said.

WHO urges calm

The EMA and the WHO also said available data does not suggest the vaccine caused the clots and people should continue to be immunised with the shot.

The WHO on Monday called on countries not to suspend vaccinations against a disease that has caused more than 2.7 million deaths worldwide. The UN health agency’s top scientist reiterated that there have been no documented deaths linked to COVID-19 vaccines.

“We do not want people to panic,” Soumya Swaminathan said, adding there has been no association, so far, pinpointed between so-called “thromboembolic events” reported in some countries and COVID-19 shots.

The reassurances appear to have done little to calm doubts, however, with several countries having now temporarily halted the use of the AstraZeneca vaccine in recent days.

Denmark, Norway, Ireland, the Netherlands, Iceland, Bulgaria, Portugal and Slovenia were among those to suspend the use of the shot.

SOURCE : AL JAZEERA AND NEWS AGENCIES

L’article Germany, France, Italy and Spain halt use of AstraZeneca vaccine est apparu en premier sur زوايا ميادين | Mayadin Columns.

L’Agence européenne des médicaments (EMA) a recommandé, vendredi, d’accorder une autorisation de mise sur le marché du vaccin d’AstraZeneca contre le Covid-19 pour les personnes âgées de 18 ans et plus. Il s’agit du troisième vaccin contre le Covid-19 dont l’EMA a recommandé l’autorisation.

Le régulateur européen en matière de vaccins et antibiotiques, l’Agence européenne des médicaments (AME), a autorisé vendredi 29 janvier le vaccin anti-Covid produit par AstraZeneca et Oxford pour les plus de 18 ans.

L’autorité vaccinale allemande a toutefois pris le contre-pied de l’AME en réitérant vendredi sa recommandation de ne pas autoriser ce vaccin AstraZeneca pour les personnes âgées de 65 ans et plus.

Il s’agit du troisième vaccin contre le Covid-19 dont l’EMA a recommandé l’autorisation, après les vaccins Pfizer/BioNTech et Moderna.  L’agence a par ailleurs indiqué vendredi s’attendre à recevoir “prochainement” une demande d’autorisation de mise sur le marché conditionnelle dans l’UE du vaccin contre le Covid-19 développé par Johnson & Johnson.

Pour autant, l’Union européenne (UE) reste en litige avec le laboratoire britannique, coupable selon elle de ne pas respecter les termes du contrat passé avec Bruxelles.

L’UE a ainsi publié, vendredi, le contrat signé avec AstraZeneca pour son vaccin anti-Covid, dans le but affiché de renforcer la pression sur le laboratoire, appelé à respecter ses engagements, alors qu’il a fait état d’importants retards de production.

Bruxelles réclamait au groupe suédo-britannique la publication du contrat signé en août sur la précommande de 400 millions de doses, après l’annonce d’une réduction de trois-quarts au premier trimestre des livraisons promises à l’UE.

Le contrat d’une quarantaine de pages, mis en ligne par la Commission, est amputé de nombreux passages jugés “confidentiels” ou relevant du “secret des affaires” – qui incluent le prix, les modalités de paiement et le calendrier exact de livraisons.

“Un objectif légal classique”

L’accord assure qu’AstraZeneca fera “de son mieux” pour augmenter ses capacités de production, tout en rappelant que le respect du contrat constitue pour lui “une obligation légale, valide et contraignante”.

L’entreprise “s’est engagée à faire tous les efforts raisonnables en vue de mettre sur pied des capacités pour produire 300 millions de doses du vaccin, sans en tirer de bénéfices ni essuyer de pertes”, indique le texte, mentionnant l’option pour l’UE de commander 100 millions de doses supplémentaires.

Le PDG d’AstraZeneca avait suggéré, dans un entretien à plusieurs médias, que son groupe n’avait pas d’engagement formel en termes de livraisons en raison de la formule “faire de son mieux”.

“Il semble dire que c’est une notion subjective : ce n’est pas vrai sur le plan juridique (…) Le ‘meilleur effort raisonnable’ est un objectif légal classique, habituellement utilisé dans ce type d’accord quand vous achetez quelque chose qui n’existe pas encore”, a expliqué sous couvert d’anonymat un responsable de la Commission.

Si des facteurs (autorisation du vaccin par exemple) ne dépendent pas de l’entreprise, “la montée en puissance des capacités de production est, elle, entièrement aux mains du groupe”, a-t-il affirmé.

Débat sur la production faite au Royaume-Uni

AstraZeneca a argué d’une “baisse de rendement” sur un site de fabrication européen pour expliquer ses retards de livraisons à l’UE. Une explication jugée “insatisfaisante” par la Commission, qui a réclamé une inspection du site industriel belge concerné, géré par un sous-traitant du groupe.

Selon l’exécutif européen, le contrat prévoit que la production aurait lieu dans quatre usines, deux dans l’UE et deux au Royaume-Uni – des indications masquées dans le texte rendu public vendredi – et des baisses de rendement en Belgique devraient donc être compensées ailleurs.

Dans un entretien à certains médias, le PDG d’AstraZeneca, le Français Pascal Soriot, avait cependant assuré devoir réserver aux Britanniques la production des usines au Royaume-Uni.

Un argument fermement contesté par Bruxelles : le recours aux usines britanniques pour approvisionner l’UE “n’est pas une option, c’est une obligation contractuelle”, a insisté le responsable européen. “On est quelque peu embarrassé par le fait que plusieurs usines sont manifestement censées nous fournir les vaccins commandés, et pourtant nous ne recevons des doses que d’une seule d’entre elles”, a-t-il critiqué.

World Opinions News – AFP – France 24

L’article Le régulateur européen approuve le vaccin AstraZeneca pour les plus de 18 ans est apparu en premier sur زوايا ميادين | Mayadin Columns.