Modern vaccine in Italy, over 400 thousand doses on the way: leaflet

by time news

Modern vaccine in Italy, over 400,000 doses are expected to arrive this evening at the national defense vaccines hub located inside the military airport of Pratica di Mare. The lot will be distributed to the Regions starting tomorrow. The office of the extraordinary commissioner for the coronavirus emergency gives the news. But what are the characteristics of the product? From the leaflet through the necessary doses, who produces it to the side effects and informed consent to be signed, here is all the latest information available made known by the Ministry of Health and updated as of March 31, 2021.


What is it, who produces it, effectiveness

The ‘COVID-19 Vaccine Moderna’ is produced by Moderna Biotech, a US company operating in the field of biotechnology. That of the US company – reads the ministry’s website – is an mRNA (messenger RNA) vaccine against COVID-19 (modified at the level of nucleosides). Its effectiveness is 93.6% from 14 days after the administration of the second dose.

The Moderna vaccine is also more than 90% effective 6 months after the second dose. And it is 95% abundant effective in contrasting the severe form of covid. These are the data released by the US company on the basis of the clinical trials carried out in phase 3. The new data were collected on the basis of analyzes carried out up to April 9, as stated on the Nbc website.

Administration: how, how many doses and booster

The method of administration consists of two injections, usually into the muscle of the upper arm, at least 28 days apart. In subjects with severe febrile illness or acute infection, vaccination should be postponed. The presence of a minor infection and / or low-grade fever should not delay vaccination, according to the Aifa ‘leaflet’.

As with other intramuscular injections, the vaccine – it still reads – should be administered with caution to subjects receiving anticoagulation therapy or suffering from thrombocytopenia or any bleeding disorder (such as haemophilia), as bleeding can occur in these subjects o hematoma formation following intramuscular administration. The first dose administered was on January 14, 2021.

storage

Moderna vaccine can be stored in the freezer at a temperature between -25 ° C and -15 ° C, and is stable between + 2 ° C and + 8 ° C for 30 days if unopened.

Leaflet and side effects

Here the pdf of the Aifa document with the product ‘leaflet’: composition, conservation, etc. in the text. Among the contraindications reported, hypersensitivity to the active substance or to any of the excipients. These are the most commonly reported adverse reactions according to the Aifa ‘leaflet’: “Pain at the injection site (92%), fatigue (70%), headache (64.7%), myalgia (61.5%), arthralgia (46 , 4%), chills (45.4%), nausea / vomiting (23%), axillary swelling / tenderness (19.8%), fever (15.5%), swelling (14.7%) and redness ( 10%) at the injection site. Adverse reactions were usually mild or moderate in intensity and resolved within a few days. A slightly lower frequency of reactogenicity events was associated with older age. Overall, the incidence of some adverse reactions were higher in the younger age groups: the incidence of axillary swelling / tenderness, fatigue, headache, myalgia, arthralgia, chills, nausea / vomiting and fever was higher in adults aged 18 to <65 years than those aged ≥65 years. Systemic and local adverse reactions were reported more frequently after Dose 2 rather than than after Dose 1 ".

Informed consent and package leaflet

Here, however, the pdf of the informed consent that citizens must sign before administration. This, however, is the pdf of the product leaflet.

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