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COVID-19

EU approves use of Pfizer-BioNTech vaccine in children 12 and over in Europe

The European Commission authorised the use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds on Friday, following the European Medicines Agency's approval of administering the jabs to adolescents earlier in the day.

EU approves use of Pfizer-BioNTech vaccine in children 12 and over in Europe
A nurse prepares a syringe with saline solution before it is diluted with the Pfizer/BioNTech vaccine at the Evonik vaccination in Hanau, western Germany (Photo by THOMAS LOHNES / AFP)

This vaccine is already approved for people aged 16 and over in the EU.

Earlier this month, US regulators authorised the vaccine for children in the 12-to-15 age group, and it is now widely available.

The European Medicines Agency said that two doses of the vaccine would be needed in adolescents and should be given at least three weeks apart, which is the same guidance as for adult use.

Individual EU states would be able to decide whether or not they wanted to offer the vaccine to the 12 to 15-year-olds.

READ ALSO: Vaccines to be made available to children 12 and over in Germany starting June

Germany said on Thursday that it would start giving the vaccine to children from 12 to 15 from June 7th, which is when vaccine prioritisation for all adults is set to end in Germany.

READ ALSO: Covid jabs for children in Germany will be an ‘individual decision’, says Health Minister

Italy has also said it would extend its vaccination campaign to the over-12s, with approval from Italy’s regulator expected by Monday.

READ ALSO: Italy to open Covid jab appointments to all over-16s from June 3rd

And Austrian capital Vienna was waiting for the EMA approval before opening up Covid-19 vaccination registrations to parents of 12- to 15-year-olds.

In Switzerland, meanwhile, children may be able to get vaccinated at the age of 10, even without their parents’ approval.

The EMA approval may help reassure parents when children go back to face-to-face teaching, but the issue is not without controversy.

A few figures in the medical community have said there is not yet enough evidence to support vaccines and their potential side effects in younger people, while others believe older and vulnerable people in less wealthy countries should be prioritised over children.

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COVID-19

‘Serious malfunctions’ at French research unit headed by Didier Raoult

A criminal investigation is set to begin into the Marseille research unit headed by controversial scientist Didier Raoult, after a report found "serious malfunctions".

'Serious malfunctions' at French research unit headed by Didier Raoult

The findings of the joint investigation into the IHU at Marseille by the Inspection générale des affaires sociales (IGAS) and the  l’Inspection générale de l’éducation, du sport et de la recherche (IGESR) prompted Health Minister François Braun and Research Minister Sylvie Retailleau to refer the unit to the city’s public prosecutor, urging it to investigate “serious malfunctions” at the institution.

Raoult was head of the unit from its foundation in 2011 until his retirement this summer.

The controversial microbiologist gained significant worldwide attention during the Covid-19 pandemic for his vociferous promotion of hydroxychloroquine as a treatment, despite a lack of evidence on its effectiveness.

READ ALSO Five minutes to understand: Whatever happened to French professor Didier Raoult?

He was succeeded as director by Pierre-Edouard Fournier.

The ministers said that a number of issues highlighted in the latest report are “likely to constitute offences or serious breaches of health or research regulations”.

Fournier, and the institute’s seven founding members – including the University of Aix-Marseille, Assistance Publique-Hospitals de Marseille, the Research Institute for Development or the army health service – will now be summoned by their supervisory bodies to “implement a proactive action plan as soon as possible” which “will condition the continuation of the activity of the IHU-MI and its funding by the State”, according to the joint communiqué of the ministers.

The IHU was already under judicial investigation for “forgery in writing”, “use of forgery in writing”, and “interventional research involving a human person not justified by his usual care without obtaining the opinion of the committee for the protection of persons and the authorisation of the Agence nationale de sécurité du médicament et des produits de santé (ANSM),” the Marseille prosecutor’s office said on Tuesday.

In an earlier report, the ANSM had noted “serious breaches of the regulations for research involving humans”, during some clinical trials.

READ ALSO Maverick French Covid doctor reprimanded over ‘breaches’ in clinical trials

François Crémieux, the director of Marseille public hospitals, told local newspaper La Provence on Tuesday that the establishment “shares the observation of managerial excesses of certain hospital-university managers occupying key functions within the infectious diseases division”.

“The legitimacy of the IHU has been affected. It has lost its scientific credibility. It must now be regained. 800 highly skilled professionals work there every day,” he added.

Raoult bit back at the report in a tweet, saying: “I regret that the IGAS/IGAENR mission does not take into account the detailed legal and scientific response that I have provided”.

Separately, Raoult will be in court on Friday as his defamation case against Karine Lacombe, Professor of Infectious Diseases at Sorbonne University Faculty of Medicine, comes before judges.

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