The European union’s drugs regulator will on Monday decide whether to authorise the use of Novavax’s vaccine against COVID-19 which its manufacturer claims can help win over vaccine sceptics.
If approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use, Novavax will be the fifth vaccine authorised across the bloc alongside Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, and Johnson & Johnson.
Novavax uses a more conventional technology than those used for the other vaccines already in use — it is similar to the technology used in the decades-old hepatitis B and pertussis vaccines — and does not need to be stored at ultra-low temperatures.
The so-called protein “subunit” vaccine contains purified fragments of the pathogen which then trigger an immune response.
Pfizer and Moderna’s vaccines are messenger RNA (mRNA) vaccines, an innovative technology that injects strands of genetic instructions into the body that tell the patient’s cells what to make to fight the disease.
AstraZeneca and Johnson & Johnson use viral vector technology which uses a very common type of virus called adenovirus that has been modified to carry genetic information in the body to fight COVID.
Rare but serious side effects of heart inflammation have been reported with the mRNA vaccines and blood clots with the virus vector vaccines.
Novavax’s CEO, Stanley C. Erck, has argued his company’s vaccine “could help overcome key barriers to global vaccination, including the challenges of global distribution and vaccine hesitancy”.
Results from clinical trials released in June showed 90.4% efficacy against the disease, and 100% efficacy against severe to moderate cases.
The company also said it was “evaluating its vaccine against the Omicron variant” and working on a version specific to it.
The European Commission has already signed a contract with Novavax for the advance purchase of 200 million doses of its vaccine once it has been approved by the EMA.
But Novavax has struggled with months of delays amid what a group of MEPs recently called “production problems”.
Indonesia and the Philippines have already approved the Novavax jab, while Japan has agreed to buy 150 million doses.
Novavax says it has also filed for approval in Britain, India, Australia, New Zealand, Canada, and with the World Health Organization.