European Union approves US Novavax vaccine, Nuvaxovid, to improve booster shots and expand vaccination among community citizens.
The European Medicines Agency (EMA) yesterday, 21 December, recommended the US made vaccine to the EU for use across Europe.
The European commission subsequently granted a conditional marketing authorisation for Nuvaxovid vaccine in EU countries.
Reports say the Agency also activated its earlier approval in August to purchase 200million doses from developer Novavax.
European Commission President, Ursula von der Leyen, based the decision on rapid-spreading Omicron and need to step-up vaccination and boosters.
“I am particularly pleased with today’s authorization of the Novavax vaccine,” she said in a statement.
Company clinical trials in four countries proved that Nuvaxovid is 90% effective in the prevention of Covid-19 attack.
Two of the pivotal trials featured 30,000 participants in US/Mexico, and another 14,000 from the UK.
Result of both trials are published in the New England Journal of Medicine; the second report appeared last week.
The Novavax vaccine, Nuvaxovid, is manufactured in partnership with the Serum Institute of India.
Behind the WHO endorsement
Similarly, the World Health Organisation (WHO) last week issued an emergency-use listing to Nuvaxovid.
This authorization encourages countries without sophisticated review systems to use the vaccine without local testing.
Similarly, Novavax said in a statement that it is developing an Omicron-specific version of the vaccine which is being tested.
The Company hopes to submit an application for approval of the Omicron version to US regulators by month end.
Nuvaxovid advantages
Although coming a year after other vaccines hit the market, Nuvaxovid’s potential advantages have been noted by scientists.
The WHO endorsement helps Novavax push the vaccine to countries without local capacity to independently review vaccines.
Chief Regulatory Officer at Novavax, Dr Henrietta Ukwu, said the vaccine has unique attributes that enhance its potency and acceptability.
One of these is that Nuvaxovid, which is 90 percent effective, can be easily stored. Only one other vaccine has this attribute.
“It can be preserved in a refrigerator storage ” Ukwu explained in a learning platform.
“This makes it possible to get this vaccine to so many parts of the world challenged with cold chain storage.”
Ukwu also said that being a protein-based vaccine should endear it to “vaccine hesitants.”
Over time, protein-based vaccines proved to be safer and with no or mild side effects.
“As Chief Regulatory Officer, I am especially proud of the entire Novavax Team for this exceptional contribution to humanity,” Ukwu said.
Tests and rollout
Apart from India where the vaccines are manufactured, Nuvaxovid has also passed regulatory tests in Indonesia and Philipines.
The company plans to roll out over two billion doses in the coming year.
Novavax lagged behind others in production after it won $1.7billion from the US Government to develop its vaccine.
It is the only product that follows the tradition of protein-based vaccines which guarantees mild side effects.
European Union approves US Novavax vaccine
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