US biotech firm Novavax started shipping their Novaxovid COVID-19 vaccines to EU member states on Wednesday (23 February). The first protein-based vaccine available in Europe is expected to raise vaccination rates, but its efficiency against omicron is yet to be determined.

Nuvaxovid is the fifth vaccine, and the first protein-based vaccine, authorised in the European Union.

The first doses, coming from a manufacturing site in India, left the distribution facility in the Netherlands on Wednesday and are on their way to Germany, Austria and France. Additional markets, such as Italy and Spain should be added over the following days.

Novavax agreed to deliver 69 million doses of vaccine to the EU in the second quarter, “and that’s exactly what we’re doing”, Silvia Taylor, senior vice president of global corporate affairs for Novavax, told a press briefing on Wednesday.

“This is extremely exciting for us, it’s exciting for the people of Europe, who are waiting for an additional option in the fight against COVID-19,” Taylor said.

She added that “we have an expectation that we’ll continue to get additional orders as the year goes on.”

As the protein-based vaccine platform has been known for around three decades, it is hoped that this will encourage those who are hesitant about the newer mRNA and vector vaccine platforms to get a jab.

Vaccine for the hesitant ones

German EU lawmaker from the centre-right EPP group, Peter Liese, said that he “got a lot of emails during the last month that people are desperately waiting for this vaccine.”

He highlighted that all vaccines authorised by Europe’s medicines agency EMA are safe but those people who did not trust new vaccine platforms “now have access to a good product”.

Novavax’s Taylor was also upbeat: “We believe that our protein-based option with its efficacy and safety profile will be an option that those who for example, are vaccine-hesitant, or haven’t wanted to take one of the other options”.

But Novavax is targeting not only primary vaccination. It is to be used as a booster, as well as a paediatric vaccine, as “vaccination rates lag” in the paediatric market, in comparison to adult vaccination. Taylor expressed hopes it could apply for marketing authorisation for adolescence “very soon”.

Another benefit is that the vaccine is “refrigerator stable” – “it does not require being frozen, which has benefits in terms of the distribution of our vaccine,” Taylor explained.

Efficiency against omicron is not known yet

Novavax’s capacity at the moment reaches two billion doses in 2022 alone.

The vaccine showed promising results from two main clinical trials that also included variants of concern, such as Alpha and Beta, where it reached 90% efficiency at preventing COVID-19 in people over 18 years of age.

“In fact, we’ve never seen a single case of severe disease or hospitalisation in the vaccine group,” said Filip Dubovsky, chief medical officer at Novavax.

The efficiency of this vaccine is yet unknown when it comes to the currently dominant COVID variant – omicron – but Liese said that “if the vaccine works against Alpha and Beta, there’s no reason to believe that it doesn’t work at all against Omicron”. 

Dubovsky said data on efficience “will likely be gathered as an effectiveness study, so postmarketing, and real-world evidence to show the vaccine works against Omicron”. He added that “those studies are planned as part of our post-licensing commitments“.

In the meantime, Novavax is “working on an omicron variant product”. “It may or may not be required,” Dubovsky said, adding that it should be known “in due course”. “All of us agreed to have one ready and we talked to the EMA they’re supportive of such an approach as well,” he said.

When it comes to adjusting the vaccine to new strains, Dubovsky stressed that the manufacturing process is going to be exactly the same and this will be similar to flu vaccination.

“We’re going to be in a good position to really leverage the last year’s worth of work we’ve done and move through a strain change process just like flu does every year to move to Omicron if needed,” he said.

With conditional market authorisation, Novavax can deliver up to 100 million of their COVID-19 vaccines to the EU starting in the first quarter of 2022. The contract allows member states to purchase an additional 100 million doses throughout 2022 and 2023.

Nuvaxovid is given as two injections, three weeks apart. Side effects reported in the studies were usually mild or moderate and cleared within a couple of days. Tenderness or pain at the injection site, tiredness, and muscle pain were among those most commonly reported.

Source: Euractiv.com