THE HAGUE, Dec 20, 2021 (BSS/AFP) - The EU's drug regulator will decide
Monday whether to approve a Covid jab by Novavax, which uses a more
conventional technology that the US biotech firm hopes will reduce vaccine
hesitancy.
Novavax's jab, a protein-based vaccine of the kind used around the world
to protect against many childhood illnesses, would be the fifth coronavirus
shot authorised for the European Union.
Approval would also be a boost for the Maryland company, whose jab has
been plagued by delays.
The European Medicines Agency (EMA) said its human medicines committee
would hold an extraordinary meeting to decide on Novavax on Monday, and "will
communicate the outcome".
The EU has already signed a deal to buy up to 200 million doses of the
two-shot vaccine pending approval by the Amsterdam-based watchdog.
Novavax says its vaccine showed 90.4 percent efficacy against Covid-19 in
a North American trial.
Chief executive Stanley Erck said the firm "looks forward to providing an
additional vaccine option in Europe, built on a proven, well-understood
technology platform".
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,
potentially 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 also said it is "evaluating its vaccine against the
Omicron variant" and working on an Omicron-specific version.