The US-developed NOVAVAX vaccine against COVID-19 has been approved Monday by the European Medicines Agency (EMA), thus becoming the fifth drug of its kind to become available at a continental level.
NOVAVAX is recommended for adults 18 years of age or older and it must be administered in two doses, 21 days apart. It can be stored, handled, and distributed at refrigerator temperature. Traded under the brand Nuvaxovid, it is the fifth vaccine authorized in the EU after Pfizer/BioNTech, AstraZeneca/Oxford, Moderna, and Johnson & Johnson.
The EMA ruling is the first step before the European Commission grants the conditional marketing authorization (CMA), subject to the pharmaceutical company researching, studying, and sharing emerging data on the vaccine over the next few years.
The committee for human medicines (CHMP), which convened Monday especially to discuss NOVAVAX, reached a consensus in that the data gathered thus far was ”robust and met the EU criteria for efficacy, safety and quality.”
When the vaccine studies were carried out, the circulating variants of SARS-CoV-2 were the original, as well as Alpha and Beta, so EMA warned that “there is limited data on the efficacy of Nuvaxovid (trade name of the vaccine) against other variants, including Omicron.”
The CHMP analyzed the results of two clinical trials involving more than 45,000 people. In the first study, conducted in Mexico and the United States, there was a 90.4% reduction in the number of symptomatic cases since seven days after the second dose. In the second study, carried out in the United Kingdom, a similar reduction was observed in symptomatic patients who received the vaccine, putting its efficacy at 89.7%. Together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%, said EMA.
The most common side effects were “mild or moderate” and disappeared within a couple of days after vaccination, and included injection site tenderness and pain, tiredness, in addition to joint, headache and muscle pain, malaise, nausea or vomiting.
This vaccine, also known as NVX-CoV2373, is based on a stabilized form of protein S (Spike) of the virus, for which a recombinant protein nanoparticle technology has been used. The antigens of the purified protein in the vaccine cannot replicate or cause COVID-19, it was explained.
It is the first protein-based vaccine endorsed by EMA, which will support vaccination campaigns in EU member states during a crucial phase of the pandemic.
We welcome today's European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U., said Novavax's CEO Stanley C. Erck.
Nuvaxovid uses a more conventional technology than other vaccines already in use — it is similar to the technology used in the decades-old hepatitis B and pertussis vaccines — and does not need to be stored at ultra-low temperatures. Pfizer and Moderna's vaccines are messenger RNA (mRNA) vaccines, an innovative technology that injects strands of genetic instructions into the body that tell the patient's cells what to make to fight the disease.
AstraZeneca and Johnson & Johnson use viral vector technology which uses a very common type of virus called adenovirus that has been modified to carry genetic information in the body to fight COVID. Rare but serious side effects of heart inflammation have been reported with the mRNA vaccines and blood clots with the virus vector vaccines.
Erck insists his company's vaccine could help overcome key barriers to global vaccination, including the challenges of global distribution and vaccination hesitancy. The company also said it was evaluating its vaccine against the Omicron variant and working on a version specific to it.
The European Commission has already signed a contract with Novavax for the advance purchase of 200 million doses of its vaccine now it has been approved by EMA.
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 Novavax's 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, which has granted emergency use listing for the vaccine last Friday.
Hence, Novavax can now be distributed to poorer countries as part of the Covax initiative as soon as the Serum Institute of India has produced enough doses for the first delivery. Because as part of the Covax Alliance, which is committed to a fairer global vaccine distribution, low-income countries get the Novavax vaccine not only at a significantly reduced price or even for free.
How well the Novavax vaccine will work against Omicron is yet unknown and specialists still favor a booster dose of either Moderna's or Pfizer's drug.