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WHO and EU Nod off on Novavax Covid Vaccine

22.12.2021 - Following a recommendation by the European Medicines Agency (EMA), the European Commission has granted conditional marketing authorization to the protein-based Covid-19 vaccine made by US biotech Novavax. It is the fifth shot to be made available in all 27 member states and the first protein-based.

The EU move closely followed the vaccine’s approval by the World Health Organization (WHO), the ninth authorized by that body. With its nod to Novavax, the WHO is hoping to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate even 10% of their populations, said Mariângela Simão, the organization’s assistant director general for access to medicines.

The EU said its approval was based on the totality of preclinical, manufacturing and clinical trial data submitted by Novavax for review. This includes two separate pivotal Phase 3 clinical trials, one in the US and Mexico, the other in the UK. Commenting on the green light, Commission president Ursula von der Leyen said the decision is especially expedient at a time where the Omicron variant is rapidly spreading, and the bloc needs to step up vaccination and the administration of boosters.

Novavax said most recently that it plans to begin deliveries to the EU in January. Earlier, the company had said it hoped to start with small shipments toward the end of 2021 and deliver the bulk in 2022. In August, the Commission ordered 100 million doses of the recombinant protein shot, with an option to order 100 million more. Supplies for the EU will be produced by the Serum Institute of India, with which Novavax has a partnership.

According to the Gaithersburg, Maryland-based firm, the Phase 3 trials showed an efficacy rate of 90% against the alpha form of Covid-19 and 100% efficacy against moderate to severe disease. As yet it has not tested the shot against the omicron variant but said it is stepping up plans to do so.

After months in a rolling review, Novavax submitted a formal application to the EU for the vaccine, now branded as Nuvaxov, in November. Just prior to that, the UK’s Medicines and Health Regulatory Agency (MHRA) accepted the biotech’s data submission but to date has not formally granted approval. The company’s plans for an application to the US Food and Drug Administration (FDA) have been in limbo for several months, due to disputes with the health regulator over the quality of trial data.

The US has approved only three Covid vaccines, those of Pfizer-BioNTech, Moderna and Johnson & Johnson. Due to issues with blood clots, the country’s Centers for Disease Control (CDC) is no longer recommending J&J’s shot except in extreme cases, so that only the mRNA doses are currently being administrated.

AstraZeneca has held back on applying for an Emergency Use Authorization (EUA) in the US for reasons similar to those of Novavax. While Novavax has said several times that it expects to seek FDA approval in the ongoing fourth quarter, this is looking increasingly unlikely. The development of all the Covid-19 vaccines approved in the EU was funded by the US government, with the exception of Pfizer-BioNTech’s Comirnaty. Novavax won $1.7 billion.

In November, Nuvaxov won its first authorization – from Indonesia – and was subsequently approved for use in the Philippines.

Author: Dede Williams, Freelance Journalist

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