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Evusheld: AstraZeneca’s preventive antibody between steps forward, doubts and hesitations

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Evusheld: AstraZeneca's preventive antibody between steps forward, doubts and hesitations

There are those who say it is effective against Omicron and those who are not yet convinced. Facts, opinions and controversy on Evusheld, AstraZeneca's first preventive antibody cocktail against Covid

On January 20, the decree of the Ministry of Health authorizing the use of the long-acting antibody Evusheld (AZD7442) by AstraZeneca in prophylaxis was published in the Official Gazette .

However, there seem to be doubts about its actual distribution in Italy and its effectiveness against the Omicron variant.

WHAT IS EVUSHELD

AstraZeneca's Evusheld is a combination of two long-acting antibodies (Laabs): tixagevimab and cilgavimab, discovered by Vanderbilt University Medical Center in Nashville, Tennessee. The Anglo-Swedish pharmaceutical company, thanks to its technology, has optimized them so as to triple the duration of action compared to conventional antibodies, in order to be able to remain in the body for months.

"Since the antibodies bind to different parts of the protein, their use in combination may be more effective than their use alone," explained the Italian Medicines Agency (Aifa).

BECAUSE IT IS REVOLUTIONARY

The real revolution of this therapy is that it is the first preventive anti Covid drug , especially useful for all those people who cannot get vaccinated or in whom the vaccine may not generate an adequate immune response.

This is the case of patients who, for example, are undergoing chemotherapy or who must take anti-rejection drugs after organ transplants, but also immunosuppressed or at risk of side effects in case of administration of the vaccine.

Thanks to this treatment, "those who get sick today, and are vaccinated, have many chances to recover quickly while those who have not responded to immunosuppression vaccines or, for example, leukemia, have a better chance of coping", explained the director. general of the Aifa Nicola Magrini.

WHAT YOU READ IN THE OFFICIAL JOURNAL

The decree states that the Technical Scientific Advisory Commission (CTS) of Aifa, after examining and evaluating the documentation available on Evusheld, considered that, "in consideration of the at least partial maintenance of the efficacy of Evusheld against the Omicron variant as well as the its long duration of action (at least six months), it may be useful to have this option in the current pandemic phase for pre-exposure prophylaxis ".

DID ITALY BUY EVUSHELD?

The Agency also announces, through the decree, that "it deemed it appropriate to proceed with the stipulation of option and / or purchase contracts in order to allow the effective availability of the association of monoclonal antibodies as soon as AstraZeneca will be able to make them available ".

However, the journalist Giovanni Rodriquez of Quotidiano Sanità tweets:

As in the case of the monoclonals and antivirals Molnupiravir and Paxlovid , its distribution will be carried out by the extraordinary Commissioner for the Covid emergency, Francesco Figliuolo, and a monitoring register will be prepared.

WHAT THE EMA SAID

The authorization of the EMA is still missing, whose head of Vaccines and Covid-19 Therapeutic Products, Marco Cavaleri, said yesterday : "We are examining the scientific evidence that is emerging, to establish whether the monoclonal cocktail called Evusheld *, which is currently in rolling review for the prevention of Covid-19, is effective against this variant. In any case, the current monoclonals are effective against Delta and other variants and remain a valid complementary tool ".

CONTRASTING OPINIONS

For Ema, therefore, the scientific evidence regarding the effectiveness against Omicron is not yet sufficient, while the president and CEO of AstraZeneca Italia, Lorenzo Wittum, on January 31st at the Health Innovation Global Forum at the Italian Pavilion of Expo 2020 Dubai assured it yes.

Wittum has, in fact, said that Evusheld "responds well to the Omicron variant". "Currently – he added – it is approved in emergency by AIFA only in prophylaxis" and for the approval of the use in treatment "it will still take some time", but "in the treatment we have seen that it responds well to the variant, is ascertained ".

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/evusheld-anticorpo-preventivo-astrazeneca-passi-avanti-dubbi-temporeggiamenti/ on Fri, 04 Feb 2022 14:31:37 +0000.