Novavax’s COVID-19 vaccine has achieved 893% effectiveness in a Phase 3 clinical trial that included subjects exposed to the B117 variant found in the UK However, the vaccine fared far worse on a smaller Phase 2b match against another variant first identified in South Africa, adding to concerns that updated prophylactic drugs will be needed to protect against the evolving virus

Clinical studies from Pfizer, Moderna, and the University of Oxford have been completed before the emerging B117 and B1351 variants accounted for a significant proportion of COVID-19 cases in any of the countries where subjects were enrolled, but Moderna recently presented in vitro data suggesting that its vaccine against B117 is as effective as previous variants, but suffers a six-fold reduction in the neutralization titre with B1351

Novavax’s clinical trials represent the first major controlled clinical trials of how a COVID-19 vaccine works against B117 and B.1351 variants Overall, the results suggest that the Novavax vaccine could be just as effective as all prophylaxis against older variants studied so far

In the 15th000 times UK In the Phase 3 clinical trial, Novavax saw 56 cases of COVID-19 in the placebo arm and six cases in the NVX-CoV2373 group at the interim analysis, resulting in an overall efficacy of 89.3% All cases in the vaccine cohort were mild or moderate 27 percent of the subjects were over 65 years old

Novavax said 32 of the COVID-19 cases were infected with the B117 variant A post-hoc analysis showed the effectiveness against B.117 in 856%, compared with 956% effectiveness over older variants The effectiveness of other vaccines against B117 is unclear because the phase 3 studies mainly included people at certain times and locations where the variant had not yet arrived and where it predominantly prevailed

Based on the data available, Novavax appears well positioned to successfully complete the rolling filing it filed with the Medicines and Health Products regulator earlier this month and ship the 60 million doses purchased by the UK Government The final analysis of the UK The process is still a few weeks away, and Novavax expects more weeks to prepare a filing

The biggest gap in the data made available so far concerns security Novavax only stated that “serious, serious and medically treated adverse events occurred in low levels and were balanced between vaccine and placebo groups”

NVX-CoV2373 performed worse against B1351, possibly because all vaccines based on the virus identified in China earlier last year will fight the variant in South African phase 2b with 4In 400 subjects, NVX-CoV2373 achieved an effectiveness of 494%. This population comprised HIV-positive subjects. In the subgroup of HIV-negative participants, the effectiveness was 60%

Novavax has preliminary sequencing data for 27 of the 44 COVID-19 cases identified at the time of the cutoff, the analysis showed 926% of the cases involved B infection1351

One-third of the subjects were seropositive at baseline, suggesting they were previously infected with SARS-CoV-2, Novavax believes most of these people were infected with the original strain of COVID-19 based on this evidence, it said Novavax that the data suggest that “a previous infection with COVID-19 may not fully protect against a subsequent infection” with B1351, but “vaccination with NVX-CoV2373 provided significant protection”

Factors other than B are possible1351 contributed to lower effectiveness in South Africa. Phase 2b was relatively small and other differences between studies – such as the definition of symptomatic disease – may have played a role

However, more and more clinical data are suggesting that existing COVID-19 vaccines may be less effective against B.1351 Vaccine developers act accordingly Novavax began work on new constructs against emerging strains earlier this month, Moderna takes a version of its vaccine to protect against B1351 in preclinical studies and phase 1

Novavax believes its approach of delivering adjuvant fragments of the spike protein produced in insect cells is well suited to the developing situation. “A major advantage of our adjuvant platform is that it contains a very small amount of antigen which enables the rapid creation and large-scale production of combination vaccine candidates that could potentially target multiple circulating COVID-19 strains, “said Gregory Glenn, MD., President of R&D at Novavax, said in a statement

Inclusion in a phase 3 clinical study with NVX-CoV2373 in the USAS and Mexico is still ongoing Novavax has more than 16 so far000 subjects were randomized and thus more than half of his 30th000 target achieved The company is speaking to the FDA but has yet to say whether it will be able to get approval in front of the US-Mexico test is complete Novavax expects the UK to be the first country to approve the vaccine

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World news – FI – Novavax COVID-19 vaccine 90% effective in phase 3, but protection against one variant drops

Source: https://www.fiercebiotech.com/biotech/novavax-covid-19-vaccine-90-efficacious-phase-3-but-protection-plummets-against-one-variant