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UK approves Novavax vaccine

The UK has authorised the Novavax Covid-19 vaccine for use as a two-dose primary shot in adults, boosting the fortunes of the US drugmaker after it encountered significant delays in submitting data to regulators.

The Medicines and Healthcare products Regulatory Agency’s chief June Raine said on Thursday the approval followed “a rigorous review of the safety, quality and effectiveness of this vaccine”. It will be the UK’s fifth vaccine.

Novavax’s Covid-19 vaccine, also known as Nuvaxovid, already approved by the European Medicines Agency and the World Health Organization last year, was shown in trials to be up to 90.4 per cent effective against Covid. The New Jersey-based biotech has been in business for over three decades, but its Covid vaccine the first drug it has brought to market.

The company suffered problems in its manufacturing processes that led to delays in seeking regulatory approval for the vaccine and prompted significant volatility in its share price. On Thursday shares ticked 2.2 per cent higher before market open in New York but are down 37 per cent for the year date.

In its discussions with the EMA and WHO to secure approval, Novavax had acknowledged concerns about the manufacturer’s ability to ensure the product is the same everywhere.

Chief executive Stanley Erck said at the time “all the manufacturing issues that we went through have been resolved”.

Novavax’s regulatory filings so far have been for the primary two doses. More than 91 per cent of those aged 12 or over in the UK have received at least one vaccine dose, according to government data, and mRNA vaccines such as Pfizer’s and Moderna’s are used for third and, in limited instances, fourth doses.

On boosters, Novavax said it was “prioritising updates to our label in the first half of 2022”, and that research was under way to assess the shot as a booster.

The vaccine, of which the UK has ordered up to 60mn doses, is protein-based and uses a traditional type of technology that some health observers have said could convince those who are hesitant about shots currently in use. It is kept at fridge temperature and given in two doses 21 days apart. It has shown broad cross-reactivity against variants, including Omicron.

Novavax’s vaccine could also play a significant role in raising coverage rates in poorer countries. Vaccine access scheme Covax has an order for more than 1bn doses made in partnership with India’s Serum Institute.

The shot’s price is tiered into three ranges based countries’ income, from about $4 to $5 for the poorest ones to about $20 a dose for the richest ones, the FT has reported.

Novavax submitted its application to the US Food and Drug Administration last month. It has targeted production of 2bn doses in 2022.

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