A supplement to the anti-covid vaccine for those most at risk.

The High Authority for Health (HAS) gave the green light on Friday so that "immunocompromised patients who are not protected despite a full vaccination" benefit from "early access authorization" to Ronapreve (casirivimab and imdevimab), a preventive treatment against Covid-19 with monoclonal antibodies.

If health specialists assure that the vaccines approved and currently available on the market are effective against the coronavirus, they are not necessarily so for people with immunosuppression.

For her, the risk of developing a severe form of Covid remains high, despite a full vaccination schedule.

“About 25% of people who are immunocompromised following a transplant or chronic lymphoid leukemia still do not have detectable antibodies (seronegative) after the third dose,” points out the HAS.

When will they be able to access treatment?

In the event of contact with an infected person, the treatment may be administered to patients 12 years of age and over who are “non-responders or weakly responders” to vaccination when they are at high risk of contracting a severe form of Covid.

The treatment could also be offered in "pre-exposure", that is to say in pure prevention, "every 4 weeks as long as there is a risk of being exposed to the virus", but only to "patients not. responders ”, that is, not having developed antibodies at all despite vaccination.

"It is estimated that in France, 130,000 immunocompromised patients are non-responders to a complete vaccination schedule and thus concerned by this treatment", specifies the authority.

1,700 people continue to live in "self-containment"

The preventive treatment with Ronapreve has not yet received marketing authorization for the indication concerned. “Early access” is a procedure that allows some patients to still benefit from a drug in this kind of situation. In the case of Ronapreve, this authorization is granted for five months, specifies the HAS, which will reassess its interest "within a maximum period of two months".

It is granted by the HAS, based on scientific advice from the National Medicines Safety Agency (ANSM). This had given an opinion in favor of a wider access to this preventive use, for all "patients with low response to a complete vaccination", because of the "therapeutic impasse" in which these patients find themselves. "We hope" that this partial authorization "will make it possible to collect efficacy data and then to open" access "to those who have weak responses" to vaccination, commented Yvanie Caillé, one of the managers. of the association of renaloo kidney patients.

According to a survey of 1,700 kidney patients, dialysis patients and kidney transplant recipients, more than three-quarters (77%) continue to live in "self-containment" for fear of the virus, underlines the association Renaloo, which had sent a letter opened to the President of the Republic two weeks ago to speed up access to monoclonal antibodies.

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