Novavax in Italy, how it works and who will be able to do it

The arrival of Nuvaxovid *, the Novavax vaccine, the first protein-based anti-Covid shield product authorized in the EU, is expected in Italy by the end of this week. How will it be used? The indications are given by a circular from the Ministry of Health, signed by the Director General of Health Prevention, Giovanni Rezza: it will be a vaccine administered to over 18s and is included in the vaccination program “currently only for the primary cycle”, specifies the document. Read also The indication for the use of this vaccine was approved on December 22, 2021 by the Technical Scientific Commission (Cts) of the Italian drug agency Aifa, which had accepted the opinion of the European medicines agency Ema. Nuvaxovid has a cycle of 2 doses (0.5 ml each, containing 5 micrograms of the Spike protein of Sars-CoV-2 with adjuvant Matrix-M), “to be administered intramuscularly (preferably in the deltoid region of the arm) “3 weeks (21 days) apart. The circular also contains the technical data sheet of the drug and the information note prepared by Aifa. The documents illustrating the product characteristics specify that “there are limited data on the use of Nuvaxovid in pregnant women” and that “animal studies do not indicate direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development “. The administration of the vaccine during pregnancy should therefore be “considered only when the potential benefits outweigh the potential risks to the mother and the fetus”. Regarding breastfeeding “it is not known whether Nuvaxovid is excreted in human breast milk”. But “it is not expected to cause effects on newborns / infants, since systemic exposure” to the shield product “of breastfeeding women is negligible.” The chapter dedicated to fertility explains that “animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity”. Each multidose vial of Nuvaxovid contains “10 doses, does not require dilution and is therefore ready to use – it is explained in the circular of the ministry – The closed vial, stored in the refrigerator at a temperature between 2 and 8 ° C, has a shelf life of 9 months. At room temperature up to 25 ° C, it can be used within 12 hours. After the first perforation, the vial can be stored at a temperature between 2 and 25 ° C and can be used within 6 hours “. The characteristics of the product also specify that at the moment” there are no data available on the interchangeability “of the Novavax vaccine with other anti-Covid vaccines for the completion of the primary vaccination course. Those who have received a first dose of Nuvaxovid should receive the second dose of Nuvaxovid to complete the vaccination course. It is then recalled that at the moment the “duration of protection offered by the vaccine is not known, as it is still being determined in ongoing clinical trials”. And that “protection may not be complete until 7 days after the second dose is administered.” One step is reserved for co-administration of Nuvaxovid with inactivated influenza vaccines, which “was evaluated in a limited number of participants”. From the available information, “the antibody response to Sars-CoV-2 was lower when Nuvaxovid was administered concomitantly with an inactivated influenza vaccine.” But “the clinical relevance of this finding is not known”.