The European Union’s health body has authorised the Novavax COVID vaccine. The European Medicines Agency authorised a COVID vaccine by US biotech firm Novavax on Monday, hoping to lessen vaccination reluctance.
The protein-based vaccination is the fifth coronavirus injection approved for use in the European Union.
“EMA has proposed issuing a conditional marketing authorisation for Novavax’s Covid-19 vaccine Nuvaxovid,” the European Medicines Agency announced.
The EMA’s human pharmaceuticals committee agreed that the vaccine’s effectiveness, safety, and quality satisfied EU standards.
The EMA claimed two major clinical studies involving over 45,000 patients in total demonstrated between 89-90 percent effectiveness in lowering the incidence of symptomatic COVID-19 cases.
Concerning viral variations such as Alpha and Beta were “the most frequent viral strains circulating during the studies,” according to the watchdog.
“Data on the effectiveness of Nuvaxovid against other worrisome variants, particularly Omicron, are limited,” it noted.
‘Understood framework’
The Maryland firm’s jab has been dogged with delays, and Monday’s clearance helps.
The EU has already agreed to buy up to 200 million doses of the two-shot vaccination.
A new vaccination alternative for Europeans based on an established, well-understood technological platform is welcomed by CEO Stanley Erck.
Erck stated that the vaccine might assist overcome key worldwide immunisation difficulties including vaccine reluctance.
To instruct the body’s immune system to target the coronavirus, all vaccinations act differently.
Novavax’s so-called protein subunit technology has been used for decades to protect against illnesses including hepatitis B and whooping cough.
It also doesn’t require ultra-low storage temperatures, providing it a logistical advantage over other jabs.
‘Problems’
Novavax employs microscopic lab-made protein fragments from the coronavirus spike surface.
When injected, they cause an immunological response, alerting the body to combat the COVID virus.
Pfizer-BioNTech and Moderna vaccines, on the other hand, have dominated the global COVID response utilising novel, but unproven, Messenger RNA technology.
They employ RNA to tell cells to make spike proteins. The immune system then learns to recognise and fight the protein.
The AstraZeneca and Johnson & Johnson approaches utilise adenoviruses as “vectors” to convey the genetic information.
The mRNA vaccinations have caused cardiac inflammation and the viral vector vaccines have caused blood clots.
But Novavax has been plagued by months of delays due to “production issues”, according to MEPs.
Indonesia and the Philippines have already authorised the Novavax vaccine, and Japan has committed to purchase 150 million doses from Japan.
New Zealand, Australia, Canada, and the World Health Organization have all approved Novavax.
Omicron has also said that it is testing its vaccine against the Omicron variety.
