Novavax, protein vaccine in Italy: the ok is coming

The Novavax protein vaccine is about to receive the first ok in Italy. “In all likelihood today it will be approved by the AIFA CTS. It is another powerful weapon, with an efficacy of over 89% to protect against symptomatic Covid”, says Professor Giorgio Palù, president of the Italian Agency of the Aifa drug, on Sky Tg24. The first doses will be purchased by the European Union at the beginning of 2022 and Read also The Novavax vaccine, the fifth to arrive in Italy, received the go-ahead 2 days ago by EMA, the European drug agency. It differs from the mRna vaccines (Pfizer and Moderna) and the viral vector vaccines (AstraZeneca and Johnson & Johnson) and for this reason it could break between skeptics and ‘soft’ no vaxes that so far have not come close to immunization against the coronavirus. In Italy it is estimated that there are at least 6 million unvaccinated adults. NOVAVAX VACCINE IN ITALY, HOW IT WORKS How does the drug that is about to arrive work? The vaccine of the American giant uses proteins and therefore a more traditional technology: for this reason it is believed that it can convince many hesitant to get vaccinated against covid. The ‘ingredients’ of Nuvaxovid, the vaccine that is given in 2 doses 3 weeks apart, are a laboratory-made version of the Spike protein found on the surface of the virus, and an ‘adjuvant’, a substance which helps strengthen the immune response to the vaccine. The immune system identifies the protein as foreign and makes natural defenses – antibodies and T cells – against it. If the vaccinated person later comes into contact with the coronavirus, the immune system will recognize the Spike protein on the virus and be ready to attack it. Antibodies and immune cells can protect against Covid by working together to kill the virus, prevent its entry into cells and destroy infected cells.The results of two main clinical studies reviewed by EMA experts show that Nuvaxovid has been shown to be effective in prevent Covid-19 in people from 18 years of age. The trials involved a total of over 45,000 people. In the first study, about two-thirds of the participants received the vaccine and the others were given a placebo injection; in the other, the participants were evenly split between Nuvaxovid and placebo. The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic cases of Covid-19 from 7 days after the second. dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared to those who received placebo (63 out of 8,140) .This means, the EMA notes in a note, that the vaccine was 90% effective , 4% in this study. The second study conducted in the UK also showed a similar reduction in the number of symptomatic cases of Covid-19 in people who received Nuvaxovid (10 cases out of 7,020 people) compared to the group that was given placebo (96 out of 7,019). with an efficacy of 89.7%. Taken together, therefore, the results of the two studies show an efficacy of the Nuvaxovid vaccine of approximately 90%. The original Sars-CoV-2 strain and some disturbing variants such as Alpha and Beta were the most common viral strains circulating during the trials. Currently, EMA points out, limited data are available on the efficacy of Nuvaxovid against other worrying variants, including Omicron NOVAVAX, FIRST DOSES IN ITALY: WHEN? The first doses of Novavax’s anti-Covid vaccine should reach the member countries of the EU “in the first months of 2022”, since the capitals have ordered “for the first quarter of 2022 about 27 million doses”, specifies the European commission. The preliminary purchase contract with Novavax was signed by the Commission on 4 August 2021 and concerns the supply to EU member countries of 100 million doses of the vaccine, starting from the first quarter of next year. The contract then allows the States to purchase an additional 100 million doses, to be delivered in the course of 2022 and 2023. The Novavax vials are added to the 2.4 billion doses purchased or booked by Pfizer / BioNtech, to the 460 million of Moderna , 400 million of Astrazeneca and 400 million of Janssen’s (Johnson & Johnson) drug. VACCINE SIDE EFFECTS The side effects seen with Nuvaxovid in studies, Ema explains, were generally mild or moderate and disappeared within a couple of days after vaccination. The most common were sensitivity or pain at the injection site, fatigue, muscle aches, headache, general feeling of discomfort, joint pain, and nausea or vomiting. The safety and efficacy of the vaccine will continue to be monitored as it comes. used across the EU, through the EU pharmacovigilance system and further studies by the company and the European authorities.