Novavax’s COVID vaccine becomes the fifth jab to be approved for use in the EU

It was given the green light by the European Commission after the European Medicines Agency (EMA) recommended it for use on Monday.

“We welcome today’s European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.,” said Stanley C. Erck, Novavax’s CEO.

Called Nuvaxovid, it is the fifth vaccine authorised in the EU after Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, and Johnson & Johnson.

Its manufacturer claims it can help win over vaccine sceptics.

Nuvaxovid 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. The jab is given as two injections three weeks apart.

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.

While large numbers of people received the COVID jabs in trials, “certain side effects may only emerge when millions of people are vaccinated,” EMA said.

 

Novavax’s CEO 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 Novavax’s 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.

The World Health Organization granted emergency use listing for the vaccine late last week.

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