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Hipra, Europe evaluates the new covid vaccine for the fourth dose – Chronicle

Bologna, 30 March 2022 – A new one protein vaccinelike Novavax, of Spanish manufacture which, according to the first analyzes, is effective against variants Omicron Of SARS-CoV-2. Is called Hipra, or rather: it is developed by the pharmaceutical company Hipra. Now, the new vaccine that started production in October last year is under review by the European drug agency Emawhich started the examination with a ‘rolling review’, that is the accelerated evaluation.

The hope is that the new preparation can be used as a booster for fourth dose, also offering cover against Omicron. The decision to move to ‘rolling review’ is based on preliminary results of laboratory studies and clinical studies. According to these studies, in short. the immune response to this vaccine (measured by the level of antibodies against Sars-CoV-2) is similar to that seen with Pfizer’s mRna vaccine.

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Hipra to Ema exam

“The EMA – the body said – will evaluate the data as soon as they are available to decide whether the benefits outweigh the risks and if the preparation proves to comply with the usual EU standards in terms of efficacy, safety and quality. Although the timing for possible approval, the EMA explains that it should be necessary less time than normal thanks to the work done during the ‘rolling review’.

What is a protein vaccine

Hipra it’s a protein vaccine, just like Novavax which was supposed to (but actually did not) convince the undecided and those who never trusted (despite the scientific evidence) mRna preparations such as Pfizer and Moderna. It is a technology used as a basis for many other vaccines (therefore extremely well-established). A protein is produced in the laboratory spike, which is then extracted, purified and compacted. They are thus obtained nanoparticles virals that contain up to 14 spikes. These particles, combined with an adjuvant molecule capable of stimulating the immune system, are ready to be injected: they will be used to stimulate the production of antibodies against protein.

Hipra, what it is and how it works

The Hipra vaccine works by preparing the body to defend itself against Covid-19. Contains two versions of a part of the Spike protein of the virus (the binding domain of the receptor) that have been produced in the laboratory: one corresponds to the part of the Spike protein of the Alpha variant and the other corresponds to that of the Beta variant. As known, the Spike protein is found on the surface of Sars-CoV-2 and is used by the virus for enter the cells.

The vaccine also contains a ‘adjuvant‘, i.e. a substance that helps strengthen the immune responses to the vaccine. When the product is administered, the immune system identifies how strangers the two proteins contained in the vaccine and produces natural defenses – antibodies and T cells – against them. If the vaccinated person subsequently comes into contact with SARS-CoV-2, the immune system will recognize the Spike protein present on the virus and will be ready to attack you.

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Hipra

Hipra is a Spanish biotechnology pharmaceutical company based in Amer, Catalonia, in the province of Girona. It employs over 2,000 people and is present in over one hundred countries, including Italy. It counts on six production plants and 11 diagnostic centers.

Production and storage

The Hipra vaccine is intended for use as recall in persons who have received a full primary vaccination course with an mRna and / or adenoviral vector product.

In addition – the Spanish company says – it can be stored at one temperature that is between +2 and +8 degrees, thus making it easy to manage even for shipments. Hipra hopes to obtain Ema authorization between the end of May and June and is said to be ready to produce, within a few days from the green light, up to 600 million doses in 2022 and able to double production in 2023.

The fourth dose, Hope speaks

The European indication on the fourth dose of the covid vaccine should arrive within a few days. “The priority is to protect the most vulnerable people, this is the basic objective”. The assessment to be made “at the European level is that of one fourth shared dose for certain more fragile generational groupswe are talking about the older age group and which, in my opinion, must be the same in all European countries “, explained the Minister of Health, Roberto Speranza, who underlines, however, that” no one speaks at world level, even at European level , by a fourth
dose for everyone“, for example, Italy has already started” with the fourth dose, for immunocompromised “.

USA authorizes Pfizer and Moderna for the fourth dose

Meanwhile, the American FDA (the Food and Drug Administration) has given the green light in the US to the fourth dose of vaccine with the mRna products of Pfizer-BioNtech and Moderna, for two categories of people: over 50 and immunosuppressed. The FDA had previously authorized a fourth dose for some immunocompromised, to be given after what is considered a 3-dose primary course for them. Today this new decision, which changes the authorizations for emergency use (Eua) for the two drugs, will ensure that the fourth dose is available for several populations at higher risk of serious illness, hospitalization and death. “The emerging evidence suggests that one second booster dose it improves protection against severe Covid and is not associated with new security problems, “explains the regulatory body in a statement.

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