Approved By European Health Regulators, Novavax Becomes The Fifth COVID-19 Vaccine Used By Continent Blue

JAKARTA - The Novavax COVID-19 vaccine has officially received authorization for use in the European Union, after the European Drug Administration (EMA) gave the green light for its use on Monday.

"We welcome today's European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for people in the European Union," said Novavax CEO Stanley C. Erck, citing Euronews December 20.

Called Nuvaxovid, this is the fifth vaccine to be approved for use in the Birth Continent region after Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, and Johnson & Johnson.

While the manufacturer claims it can help win over vaccine skeptics, Nuvaxovid uses technology that is more conventional than that used for other vaccines already in use.

This is similar to the technology used in decades-old hepatitis B and pertussis vaccines, and does not require storage at very low temperatures.

So-called protein "subunit" vaccines contain purified fragments of the pathogen that then trigger an immune response. The vaccine is given in two doses three weeks apart.

The Pfizer and Moderna vaccines are messenger RNA (mRNA) vaccines, an innovative technology that injects strands of genetic instructions into the body, telling the patient's cells what to do to fight disease.

Meanwhile, AstraZeneca and Johnson & Johnson use viral vector technology that uses a very common type of virus called adenovirus, which has been modified to carry genetic information in the body to fight COVID.

Rare but serious side effects of cardiac inflammation have been reported with mRNA vaccines and blood clotting with viral vector vaccines.

While a large number of people received COVID shots in trials, "certain side effects can only appear when millions of people are vaccinated," the EMA said.

Novavax's CEO believes his company's vaccines "could help overcome key barriers to global vaccination, including global distribution challenges and vaccine hesitancy."

Results from clinical trials released in June demonstrated 90.4% efficacy against the disease, as well as 100 percent efficacy against severe to moderate cases.

In addition, the company also said it was "evaluating its vaccine against the Omicron variant" and working on a custom version for it.

To note, the European Commission has signed a contract with Novavax for the purchase of 200 million doses of its vaccine in advance after being approved by the EMA.

But Novavax has struggled with months of delays amid what a group of lawmakers recently called a "production problem".

Outside Europe, Indonesia and the Philippines have agreed to the Novavax vaccine, while Japan has agreed to buy 150 million doses. Novavax says. it has also applied for approvals in the UK, India, Australia, New Zealand, Canada, and with the World Health Organization.

The World Health Organization (WHO) provided a list of emergency uses for vaccines over the weekend.