Who will be able to receive Evusheld, the first preventive drug against Covid?
Aifa has authorized AstraZeneca's Evusheld, the first monoclonal drug to prevent Covid. Here is who will be able to receive it and how many doses has ordered Italy
A novelty in the arsenal of anti Covid treatments, but this time it is the first drug based on monoclonal antibodies designed to prevent infection. It's Evusheld from AstraZeneca and Italy is also preparing to administer it, but only to patients with certain risk factors.
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.
FOR WHO IT IS INTENDED FOR
The real revolution of this therapy is that, being a preventive drug, it can be 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.
WHO WILL IT BE ADMINISTERED
It is no coincidence that the Italian Medicines Agency (Aifa) has authorized Evusheld in high-risk patients: "adults and adolescents (aged 12 years and over) with moderate to severe immune impairment due to a medical condition or immunosuppressive drugs and who may not develop an adequate immune response to Covid-19 vaccination, and for people for whom immunization is not recommended ”.
Recipients also must not be infected or have had a recent known exposure to a Covid positive person.
DOES IT ALSO WORK AGAINST VARIATIONS?
The decree of the Ministry of Health authorizing the use of Evusheld speaks of "partial maintenance of efficacy against the Omicron variant".
Now, from the results of three independent studies carried out by University College of Oxford, Washington University School of Medicine in St. Louis and by the Food and Drug Administration (Fda), further confirmation seems to arrive about the effectiveness in neutralizing not only the previous variants but also Omicron.
According to a pre-print published in Biorxiv , in a test with 19 neutralizing antibodies, only the two antibodies that make up Evusheld were shown to be effective against Omicron.
DATA ON EFFECTIVENESS
Evusheld, says AstraZeneca , reduces the risk of developing the disease in a symptomatic form by 83% for at least six months after a single dose.
This was demonstrated by the international phase 3 study Provent on about 5,200 individuals, in which the combination of the two antibodies showed an 83% reduction in the risk of developing the disease in a symptomatic form, with long-lasting protection.
"More follow-up is needed to establish the complete duration of protection from the virus, but we could estimate it beyond 12 months after a single administration consisting of two intramuscular injections, one for each antibody, separate and consecutive, in immediate succession" explained Raffaela Fede , medical director of AstraZeneca Italia.
COULD HELP PREVENT FUTURE VARIATIONS
"Recent evidence indicates that protecting vulnerable people helps prevent viral evolution, which is an important factor in the appearance of variants", highlighted Giovanni Di Perri, director of the School of Specialization in Infectious Diseases of the University of Turin and head of the University Division of Infectious Diseases at the Amedeo di Savoia Hospital in Turin.
HOW MUCH ITALY ORDERED
According to Fede, Italy has ordered 20,000 initial doses of Evusheld: “In the US – he added – there has been a greater purchase of doses: 1.2 million. Then there are France, Spain, Germany, Israel and Italy is in this cluster with a quantity of 20,000 initial doses ”.
THE UNITED STATES ORDER
However, despite the US having placed a super order, The Atlantic writes that "these drugs are in short supply" and reports that the government "has ordered only 1.7 million doses and distributed 400,000" – a figure deemed "woefully inadequate. given that the United States has at least 7 million immunocompromised adults ”.
In fact, there will be problems in deciding who to administer Evusheld to. In the United States, the article states that "some hospitals have had to do lotteries to decide who gets the drugs."
WORK IN PROGRESS
Evusheld, says Quotidiano Sanità , “is also being tested as a potential treatment for patients already affected by Covid-19. The Phase 3 Tackle study met its primary endpoint by demonstrating a reduction in the risk of mild-moderate to severe disease progression or death compared to placebo in non-hospitalized patients with symptomatic Covid-19 for a period of 7 or less. days".
THE EMA (STILL) IS NOT PRONUNCIATED
The European Medicines Agency (EMA), however, has not yet given its opinion: "The rolling review on the Evusheld monoclonal antibody * is proceeding as expected and a more precise time frame should be defined in early March", said the head of Vaccines and Therapeutic Products of the Agency, Marco Cavaleri , during the periodic update for the press.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/chi-potra-ricevere-evusheld-il-primo-farmaco-preventivo-contro-il-covid/ on Fri, 18 Feb 2022 10:20:38 +0000.