# EU regulator backs Novavax shot as region’s fifth COVID-19 vaccine
Author:  Pal Sinha, Barnali 
Author URL: https://financedigest.com/author/pal-sinha-barnali
Published: 2021-12-20
Category: NEWS
Category URL: https://financedigest.com/category/news
Meta Title: EU Approves Novavax COVID-19 Vaccine for 18+
Meta Description: Get the latest news on the approval of the Novavax vaccine by the EU, offering hope for additional protection against the Omicron variant.
URL: https://financedigest.com/eu-regulator-backs-novavax-shot-as-regions-fifth-covid-19-vaccinehtml

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By Pushkala Aripaka

(Reuters) – The European Union’s drug regulator on Monday approved use of the COVID-19 vaccine from U.S.-based Novavax in people 18 years and older, paving the way for a fifth coronavirus shot in the region as the Omicron coronavirus variant spreads.

Data from two large studies showed the [vaccine has an efficacy of around](https://www.financedigest.com/the-autogenous-vaccines-market-to-throw-its-innovation-based-weight-around.html "The Autogenous Vaccines Market to throw its innovation-based weight around") 90%, the European Medicines Agency (EMA) said, adding that there was currently limited data on its efficacy against some variants of concern, including Omicron.

After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the [data on the vaccine were robust](https://www.financedigest.com/dollar-buoyant-as-robust-u-s-data-keep-fed-hawks-in-control.html "Dollar buoyant as robust U.S. data keep Fed hawks in control") and met the EU criteria for efficacy, safety and quality,” the regulator said.

Novavax said it would start shipping vaccines to the EU’s 27 member states in January. Its Nasdaq-listed shares were up about 10% in U.S. pre-market trading, [following the EU approval](https://www.financedigest.com/gecko-governance-launches-compliance-solution-for-ico-market-following-approval-by-isle-of-man-regulator.html "GECKO Governance Launches Compliance Solution For ICO Market Following Approval by Isle of Man Regulator").

COVID-19 infections have broken [records in parts of Europe](https://www.financedigest.com/europe-experienced-second-warmest-winter-on-record.html "Europe experienced second-warmest winter on record") in recent weeks, with governments and researchers scrambling to bolster defences against the fast-spreading Omicron, prompting renewed curbs ahead of the Christmas holidays.

The endorsement for the two-dose vaccine, branded Nuvaxovid, comes well ahead of possible authorisation in the United States, where Novavax has had to resolve manufacturing issues and expects to file for [approval by the end](https://www.financedigest.com/eu-approves-law-to-end-sales-of-new-co2-emitting-cars-by-2035.html "EU approves law to end sales of new CO2-emitting cars by 2035") of the year.

The regulatory process in the EU has taken longer than expected too. EMA started a [real-time rolling review of the data](https://www.financedigest.com/real-time-connect-nyc-where-adtech-leaders-come-together-to-redefine-data-strategies.html "Real-Time Connect (NYC): Where AdTech leaders come together to redefine data strategies") in February.

Novavax and the EU reached a preliminary deal in December 2020 for the [supply of the vaccine](https://www.financedigest.com/gsk-expects-us-launch-of-rsv-vaccine-with-no-supply-issues.html "GSK expects US launch of RSV vaccine with no supply issues"), but due to regulatory and production issues the final contract for up to 200 million doses was only signed in August.

The shot received its first regulatory greenlight in Indonesia [last month](https://www.financedigest.com/fintech-trends-to-look-out-for-during-the-last-six-months-of-2019.html "Fintech trends to look out for during the last six months of 2019") and is awaiting approval in Japan, where it would be manufactured and distributed by Takeda Pharmaceutical.

Once EMA has endorsed or refused a product, the executive body of the [European Union](https://www.financedigest.com/lisk-announces-lsk-token-listed-on-bitflyer-the-european-unions-newest-crypto-exchange.html "Lisk announces LSK token listed on bitFlyer, the European Union’s newest crypto exchange"), the European Commission, makes the final decision, which typically matches what EMA has said.

Separately, Novavax said the Commission’s decision was expected “imminently”.

DIVERSIFICATION

Vaccines from Pfizer-BioNTech,, Moderna, AstraZeneca and J&J had already been approved for use in the EU. But faced with surging infections, EMA has been speeding up reviews of other shots and treatments.

Novavax’s protein-based [vaccine uses alternative technology to the other four shots](https://www.financedigest.com/fda-advisers-back-the-same-covid-vaccine-for-initial-shots-boosters.html "FDA advisers back the same COVID vaccine for initial shots, boosters"), which makes it more interesting to the EU as it has sought to diversify its portfolio of vaccines.

The company has about eight manufacturing locations, including those of the Serum Institute of India (SII), the world’s biggest [vaccine maker](https://www.financedigest.com/vaccine-maker-valnevas-shares-slump-after-uk-ends-covid-19-deal.html "Vaccine maker Valneva’s shares slump after UK ends COVID-19 deal").

Production of the shot in India at SII has also been approved by EMA, an EU official told Reuters.

Antigens for the vaccine, the inactivated organisms that trigger an immune response, are made at Novavax’s factory in the Czech Republic.

Earlier this month, Novavax said it could begin manufacturing of a [vaccine tailored for Omicron](https://www.financedigest.com/omicron-found-in-europe-11-days-ago-jolts-markets-on-vaccine-fears.html "Omicron, found in Europe 11 days ago, jolts markets on vaccine fears") in January, while it tests whether or not its current vaccine works against the variant.

On Friday, the [World Health Organization](https://www.financedigest.com/explainer-how-the-world-health-organization-might-fight-future-pandemics.html "Explainer-How the World Health Organization might fight future pandemics") issued an emergency use listing to SII’s version of Novavax’s vaccine.

(Reporting by Pushkala Aripaka in Bengaluru and Francesco Guarascio in Brussels; Editing by Josephine Mason and Susan Fenton)


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