EU backs Novavax shot as area's fifth COVID

Dec 20 (Reuters) – The European Union on Monday authorised using Novavax's (NVAX.O) COVID-19 vaccine in individuals 18 years and older, giving a lift to the U.S. biotech after lengthy delays and paving the best way for a fifth shot within the EU because the Omicron variant spreads.

Knowledge from two giant research confirmed the vaccine has an efficacy of round 90%, the European Medicines Company (EMA) mentioned. learn extra

It isn’t clear but how Novavax performs towards the Omicron variant, or whether or not a booster dose might be wanted. Some early knowledge has advised that many two-dose vaccines don’t work effectively towards the variant whereas a 3rd shot improves their efficacy.

Novavax mentioned earlier this month it might start manufacturing a vaccine tailor-made for Omicron in January.

Novavax shares closed down greater than 7% on Monday.

Novavax mentioned it will begin transport vaccines to the EU's 27 member states in January as a part of its deal to provide as much as 200 million doses.

Member states have ordered round 27 million doses for the primary quarter, sufficient to inoculate about 13.5 million individuals, the Fee mentioned.

COVID-19 infections have damaged information in components of Europe in latest weeks, with governments and researchers scrambling to bolster defences towards the fast-spreading Omicron, prompting renewed curbs forward of the Christmas holidays.

"Might this authorisation provide a robust encouragement to everybody who has not but been vaccinated or boosted, that now could be the time to take action," mentioned the top of the bloc's government Fee, Ursula von der Leyen, in an announcement.

The endorsement for the two-dose vaccine, branded Nuvaxovid, comes effectively forward of doable authorisation in the US, the place Novavax has needed to resolve manufacturing points.

Chief Govt Stanley Erck mentioned he expects Novavax to file for U.S. authorization within the subsequent week to 10 days.

The regulatory course of within the EU has taken longer than anticipated too. The EMA began a real-time rolling assessment of the info in February. learn extra

The shot obtained its first regulatory inexperienced gentle in Indonesia final month and is awaiting approval in Japan, the place it will be manufactured and distributed by Takeda Pharmaceutical (4502.T).

Erck mentioned Novavax has already delivered thousands and thousands of pictures to Indonesia, which has begun administering doses.

On Friday, the World Well being Group (WHO) issued an emergency use itemizing to Novavax's vaccine made by the Serum Institute of India (SII), the world's greatest vaccine maker, paving the best way for its use in low- and middle-income nations the place rollout has been a lot slower than in Europe.

Novavax mentioned on Monday it had obtained the WHO's emergency use itemizing for the corporate's personal model of the vaccine, which it is going to distribute in Europe and different markets.

Erck mentioned Novavax is awaiting steering from COVAX on preliminary order volumes and expects to start most deliveries within the first quarter of 2021.


Vaccines from Pfizer-BioNTech (PFE.N), (22UAy.DE), Moderna (MRNA.O), AstraZeneca (AZN.L) and J&J (JNJ.N) have already been authorised to be used within the EU.

Novavax's protein-based vaccine makes use of different know-how to the opposite 4 pictures, which helps the EU diversify its portfolio of vaccines.

Nonetheless, it is going to be deployed right into a market dominated by the Pfizer-BioNTech shot. The U.S.-German companions have contracts for the availability of as much as 2.4 billion doses by means of 2023 for the EU's inhabitants of 450 million.

Virtually 70% of EU residents have obtained two vaccine doses and lots of nations are scrambling to manage third booster doses in a bid to strengthen defences towards Omicron.

With considerations about uncommon blood clotting, many EU nations have decreased their use of the AstraZeneca and J&J pictures and lots of have donated them to low-income nations instantly or by means of the COVAX programme run by the WHO.

Novavax has about eight manufacturing places, together with these of the SII. Manufacturing of the shot in India at SII has additionally been authorised by the EMA, an EU official instructed Reuters.

Antigens for the vaccine, the inactivated organisms that set off an immune response, are made at Novavax's manufacturing unit within the Czech Republic.

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