Nuvaxovid on Monday became the fifth jab to be approved by the EU for adults in the fight against Covid-19. It’s also the first protein-based vaccine enlisted by the Europeans.Unlike the BioNTech-Pfizer and Moderna jabs that are created using mRNA technology, protein vaccines have been tried and tested for decades.“Today’s Emergency Use Listing underscores the ongoing need and potential for Novavax to help significantly increase Covid-19 vaccine access across the globe through a protein-based option built on a well-understood platform,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.“We thank the World Health Organisation for its thorough assessment and look forward to helping address major obstacles to controlling the pandemic, including practical barriers to access and vaccine hesitancy.”This is what we know about Nuvaxovid:HOW DOES IT WORK?Novavax uses a traditional vaccine technology by using purified pieces of the actual SARS-CoV-2 coronavirus spike protein to spur the production of antibodies. Two 0.5ml doses are required 21 days apart. If a person gets the jab, their immune system recognises the protein as foreign and produces natural defences. The vaccine can neither replicate, nor can it cause Covid-19.HOW EFFECTIVE IS IT?Two trials involving more than 45,000 people in the US, Mexico and the UK resulted in efficacy of around 90 per cent with only mild or moderate side effects. Novavax said its vaccine was most effective against the original Covid strain, as well as the Alpha variant first detected in the UK.The company has not conducted studies on the Delta strain.“There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” the EMA said.A phase 3 paediatric trial in the US is also testing up to 3000 adolescents aged 12-17 years.CAN IT CAUSE ADVERSE REACTIONS?Novavax has said severe reactions are “infrequent and there were no safety concerns related to vaccination”. The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise. National – 2021 – Covid Vaccination StatsHOW IS IT STORED?Novavax’ Covid-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. The vaccine is stored at 2°- 8° Celsius, meaning the shots can be stored at normal refrigerator temperatures, averting the need for the freezers required for some other Covid-19 vaccines.HOW MUCH IS EUROPE GETTING?Novavax and the European Commission announced an advance purchase agreement for up to 200 million doses of Novavax’ Covid-19 vaccine in August 2021. Initial doses are expected to arrive in Europe in January. Novavax is working with the European Medicines Agency and its partners to expedite local release testing. Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, which will supply initial doses for the EU. The vaccine has already received approval for use in Indonesia and the Philippines.WILL AUSTRALIA GET IT?The vaccine is under review by multiple regulatory agencies worldwide including Australia. If it is proven to be safe and effective by the Therapeutic Goods Administration, it will be available in Australia possibly as early as January. The government has ordered 51 million doses – enough to cover Australia’s whole population.It is unclear if it would be used for primary doses, booster shots or both. But Health Minister Greg Hunt has said it could potentially be used as a booster.“It’s always been presumed that what’s called a protein vaccine, think of it as three vaccines. Protein, Novavax; viral vector, which is AstraZeneca; and then the MRNA, Pfizer and Moderna, that the protein could make a very good booster,” Mr Hunt told Melbourne’s 3AW program this month.Doses for Australia may be manufactured in several locations across Europe. WHAT HAPPENS NOW?Novavax will continue to collect and analyse real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.The company expects to submit its complete common pre-clinical, clinical and chemistry, manufacturing and controls (CMC) package to the US FDA by the end of the year. The brand name Nuvaxovid™ has not yet been authorised for use in the US by the FDA.
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