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Novavax COVID-19 vaccine 90% efficacious in phase 3, but protection plummets against one variant - FierceBiotech

3 weeks ago 16

Novavax’s COVID-19 vaccine has achieved 89.3% efficacy successful a signifier 3 objective proceedings that enrolled subjects exposed to the B.1.1.7 variant recovered successful the U.K. However, the vaccine performed acold worse successful a smaller signifier 2b that pitted it against different variant archetypal identified successful South Africa, intensifying concerns that updated prophylactics volition beryllium needed to support against the evolving virus.

Clinical trials tally by Pfizer, Moderna and the University of Oxford wrapped up earlier the emerging B.1.1.7 and B.1.351 variants began to relationship for a important proportionality of COVID-19 cases successful immoderate of the countries wherever subjects were enrolled. Moderna precocious presented successful vitro information suggesting its  vaccine is arsenic effectual against B.1.1.7 arsenic anterior variants but suffers a sixfold simplification successful neutralizing titers with B.1.351. 

The Novavax objective trials correspond the archetypal large controlled objective tests of however a COVID-19 vaccine performs against the B.1.1.7 and B.1.351 variants. Overall, the results suggest Novavax’s vaccine whitethorn beryllium arsenic effectual arsenic immoderate prophylactic studied to day against older variants.

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In the 15,000-subject U.K. signifier 3 objective trial, Novavax saw 56 cases of COVID-19 successful the placebo limb and six cases successful the NVX-CoV2373 radical astatine the interim analysis, resulting successful an wide efficacy of 89.3%. All the cases successful the vaccine cohort were mild oregon moderate. Twenty-seven percent of subjects were aged implicit 65 years. 

Novavax said 32 of the COVID-19 cases were infected with the B.1.1.7 variant. A station hoc investigation enactment the efficacy against B.1.1.7 astatine 85.6%, compared to an efficacy of 95.6% versus older variants. The efficacy of different vaccines against B.1.1.7 is unclear, due to the fact that the signifier 3 trials mostly enrolled radical astatine times and successful places wherever the variant was yet to get and go predominant. 

Based connected the disposable data, Novavax looks good acceptable to successfully reason the rolling submission it filed with the Medicines and Healthcare products Regulatory Agency earlier this period and spell connected to commencement shipping the 60 cardinal doses bought by the U.K. government. The last investigation of the U.K. proceedings is inactive a fewer weeks away, and Novavax past expects to request different fewer weeks to hole a filing. 

The large spread successful the information made disposable truthful acold relates to safety, with Novavax lone stating “severe, superior and medically attended adverse events occurred astatine debased levels and were balanced betwixt vaccine and placebo groups.”

NVX-CoV2373 performed worse against B.1.351, perchance due to the fact that each vaccines based connected the microorganism identified successful China aboriginal past twelvemonth volition conflict against the variant. In the 4,400-subject South African signifier 2b, NVX-CoV2373 achieved efficacy of 49.4%. That colonisation included HIV-positive subjects. In the subset of HIV-negative participants, efficacy was 60%.

Novavax has preliminary sequencing information connected 27 of the 44 COVID-19 cases seen arsenic of the cutoff. The investigation showed 92.6% of the cases progressive corruption with B.1.351.

One-third of the subjects were seropositive astatine baseline, indicating they had antecedently been infected with SARS-CoV-2. Novavax thinks astir of those radical were infected with the archetypal COVID-19 strain. Based connected that evidence, Novavax said the information suggest “prior corruption with COVID-19 whitethorn not wholly support against consequent infection” with B.1.351, but “vaccination with NVX-CoV2373 provided important protection.”

It is imaginable factors different than B.1.351 contributed to the little efficacy seen successful South Africa. The signifier 2b was comparatively small, and different differences betwixt the studies—such arsenic their definitions of symptomatic disease—may person played a role. 

Yet, the objective information inactive adhd to a increasing assemblage of grounds that existing COVID-19 vaccines whitethorn beryllium little effectual against B.1.351. Vaccine developers are acting accordingly. Novavax began moving connected caller constructs against emerging strains aboriginal this month. Moderna is taking a mentation of its vaccine designed to support against B.1.351 into preclinical studies and signifier 1.  

Novavax thinks its approach, which entails delivering adjuvanted fragments of the spike macromolecule made successful insect cells, is good suited to the evolving situation. “A superior payment of our adjuvanted level is that it uses a precise tiny magnitude of antigen, enabling the accelerated instauration and large-scale accumulation of operation vaccine candidates that could perchance code aggregate circulating strains of COVID-19,” Gregory Glenn, M.D., president of R&D astatine Novavax, said successful a statement.

Enrollment successful a signifier 3 objective proceedings of NVX-CoV2373 successful the U.S. and Mexico is ongoing. Novavax has randomized much than 16,000 subjects truthful far, putting it much than halfway to its 30,000 target. The institution is talking to the FDA but is yet to accidental whether it volition beryllium imaginable to question support earlier the U.S.-Mexico proceedings is complete. Novavax expects the U.K. to beryllium the archetypal state to o.k. the vaccine. 

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