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Product Development

J&J adds to emerging patchwork of COVID variant data, positions single-dose vaccine as bulwark against severe disease

J&J plans to seek EUA in days, on track with manufacturing goals

The pharma plans to seek emergency authorization from FDA and says it’s on track to meet its manufacturing commitments.

Jan 30, 2021 | 2:55 AM GMT

The second company to share vaccine efficacy data in the age of escape variants, J&J argues its candidate cannot be compared to those that read out in November, and points to the public health benefit of the single dose vaccine’s impact on severe disease. 

Phase III data from Johnson & Johnson (NYSE:JNJ), announced Friday, comes a day after Novavax Inc. (NASDAQ:NVAX) presented the first glimpse of how the SARS-CoV-2 variants that have become dominant in the U.K. and South Africa fare against vaccines aimed at the virus’ spike protein. 

The prevalence of these variants across the two companies’ trial populations is not yet fully known. But the matrix of data available so far indicates the efficacy of both vaccines is limited by the South African variant, and suggests the >90% protection reported for vaccines from Moderna Inc. (NASDAQ:MRNA), partners Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) and N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology could be difficult to replicate from here on out.

“Our data are not comparable apples to apples to data generated earlier,” said Mathai Mammen, global head of R&D for J&J’s Janssen Pharmaceutical Cos. unit, in an investor presentation. “You really cannot compare our 72% in the United States to a 94% done at a different time.”

J&J and Novavax reported their vaccines induced 57% and 49.4% protection, respectively, in South African participants; in both cases, the B.1.351 (501Y.V2) variant traced to that country caused more than 90% of the reported cases. J&J said it did not see a difference across HIV-positive and  HIV-negative cohorts; in contrast, Novavax saw a superior efficacy of 60% for HIV-negative participants. 

Both companies reported higher efficacy in other countries. J&J’s adenoviral vector vaccine Ad26.COV2.S was 72% and 66% protective for trial participants in the U.S. and Latin America, respectively, and Novavax’s recombinant protein nanoparticle vaccine NVX-CoV2373 had an overall efficacy of 89.3% across its U.K. trial, which rose to 95.6% when considering only those infected with the original SARS-CoV-2 strain.

J&J has not yet disclosed how many of the 468 symptomatic cases in its interim analysis belong to vaccine versus placebo groups, or how many represent cases of severe disease, hospitalization or death.

But the company reported the vaccine was 85% effective at preventing severe disease and 100% effective at preventing hospitalization and death across all the geographies in its analysis, including South Africa.

Mammen said this readout, along with the vaccine’s single-dose regimen and stability under typical freezing and refrigeration conditions, make Ad26.COV2.S a strong candidate for the pandemic response. “Success against severe illness is by far the most important feature, from a public health standpoint, for any COVID-19 vaccine,” he said.

Severe case counts reported by other companies with authorized or late-stage products suggests that despite variable efficacy against milder cases, the product cohort is broadly effective at preventing severe COVID-19 and keeping people out of the hospital.

Mammen said J&J plans to seek emergency use authorization (EUA) in early February, and will be ready to ship its product immediately after authorization. He said the company is on track to meet its 2021 supply commitments, which includes 100 million doses for the U.S. by June.

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