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LAST UPDATE | 20 Dec 2021
EUROPE’S MEDICINES WATCHDOG has approved a Covid jab by US-based Novavax, which uses a more conventional technology that the biotech firm hopes will reduce vaccine hesitancy.
The protein-based vaccine, of the kind used around the world to protect against many childhood illnesses, is the fifth coronavirus shot authorised for use in the European Union.
“EMA has recommended granting a conditional marketing authorisation for Novava’s Covid-19 vaccine Nuvaxovid to prevent Covid-19 in people from 18 years of age,” the European Medicines Agency (EMA) said in a statement.
“After a thorough evaluation, EMA’s human medicines committee concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality,” the Amsterdam-based agency said.
Two main clinical trials – one in Britain and the other in the US and Mexico and involving more than 45,000 people in total, showed between 89-90% efficacy in reducing the number of symptomatic Covid cases, the EMA said.
But the watchdog said the clinical studies involved the original Covid-19 strain and some variants of concern such as Alpha and Beta, which were “the most common viral strains circulating when the studies were ongoing”.
“There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron,” it said.
EU health commissioner Stella Kyriakides tweeted the Commission’s decision to authorise the Novavax shot was “to follow”.
‘Choice among vaccines’
Today’s approval is also a boost for the Maryland company, whose jab has been plagued by delays.
The EU has already signed a deal to buy up to 200 million doses of the two-shot vaccine pending the EMA’s approval.
Chief executive Stanley Erck said the Commission’s authorisation would deliver the first protein-based vaccine to the EU “during a critical time when we believe having choice among vaccines will lead to increased immunisation”.
The vaccine “may help address major obstacles to global vaccination, including global distribution challenges and vaccine hesitancy”, Erck added.
All vaccines work by teaching the body’s immune system to attack the coronavirus, but they do it in different ways.
Novavax’s so-called protein subunit technology is already tried and tested, having been used for decades to vaccinate people against diseases including hepatitis B and whooping cough.
It also means it does not have to be stored in ultra-low temperatures, giving it a logistical edge over some other jabs.
‘Production problems’
Novavax uses tiny, lab-made fragments of a protein found on the surface of the coronavirus spike.
When injected, these trigger a reaction by the immune system, so that if it later comes into contact with the Covid virus, it knows to attack it.
By contrast, the Pfizer-BioNTech and Moderna vaccines have dominated the global Covid response using pioneering, but hitherto largely untested Messenger RNA (mRNA) technology.
They use a molecule of genetic material known as RNA to deliver a message to cells to produce the spike protein themselves. The body’s immune system then learns to recognise the protein and attack it.
The viral vector approach used by AstraZeneca and Johnson & Johnson works on a similar principle, but delivers the genetic message via a version of the common cold adenovirus as a “vector”.
Rare but serious side effects of heart inflammation have been reported with the mRNA vaccines, and blood clots with the viral vector vaccines.
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.
The company has said it is “evaluating its vaccine against the Omicron variant” and working on an Omicron-specific version.
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Syrian Observatory for Human Rights? You mean the pro-Al Nusra Brit in Coventry that refuses to cite his sources, data and methadology?
@Cormac Ó Braonáin: the SOHR the shifted is stance over the course of the war as the rebels became more extreme, while initially supporting the FSA during he first few years of the war, the SOHR does not support the rebels any more. The SOHR clearly sided with the Kurds during last January’s Turkish led Operation Olive Branch (the Turkish and Syrian Rebel invasion of Kurdish region of Afrin of NW Syria). The SOHR released a lot of inaccurate news reports that supported the Kurdish YPG (false claims of Kurdish victories against the Syrian Rebels). A bit like Comical Ali, remember him?
Here’s the bomb attack (graphic), seems it was a suicide bomber wearing an explosive vest…
US backed terrorists killed by US backed terrorists?
Divide and conquer.
@paul kelly: wtf?
@paul kelly:
The US government supported the Free Syrian Army, which was not an Islamic militant organisation.
ISIS hates the Western powers. therefore, the idea that the US government would support ISIS is absurd.
@Ciarán Masterson: As absurd as them supporting the Taliban and Al Quida?
@Ciarán Masterson: LOL – America have been supporting ISIS for years in Syria,
They like to play both sides of the coin, You genuinely have blinkers on and a childlike understanding of Americas role in all of this
@paul kelly: “US backed terrorists killed by US backed terrorists?”
Eh no, 9 civilians killed and about 20 injured, including children, when an ISIS suicide bomber blew himself up in a cafe. Here’s the bomb attack (graphic)
@paul kelly: If you’re referring to the Kurds, no. The YPG doesn’t do suicide bombings and nowhere in the Journal article does it say who was responsible. And in any case, it was mostly civilians that were killed.
US-backed soldier? Who makes this shyte up? The word is Mercenary
Even thought US is leaving Syria the economic sanctions and sanctions against any ships going to Syria…By both the EU and US…..Will keep the people of Syria impoverished for years….Unable to rebuild their country….
5 US soldiers killed according to Turkish leader Erdogan in his address, He is stating that it was an attack designed to keep the us in Syria, but he thinks it won`t affect the US withdrawal as it would mean a victory for Daesh.
have your say