Research Roundup: J&J and Novavax release vaccine efficacy data, Regeneron drug provides "passive vaccination" in trial
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Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine candidate showed 66 percent efficacy in preventing moderate to severe disease 28 days after vaccination, according to results from a phase 3 global study released Friday. The trial data differed across geographies, with the vaccine demonstrating 72 percent efficacy among participants in the United States, 66 percent efficacy in Latin America, and 57 percent efficacy in South Africa—adding to concerns about diminished vaccine efficacy against the COVID-19 variant circulating in South Africa and recently detected in the United States. The J&J vaccine also showed complete protection in preventing hospitalization and death due to COVID-19, as well as 85 percent efficacy in preventing severe forms of the disease. J&J plans to apply for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) in early February.
On Thursday, Novavax announced 90 percent efficacy of its two-dose COVID-19 vaccine candidate in preliminary results from a phase 3 clinical trial in the United Kingdom, while results from a separate trial indicated 49 percent efficacy of the vaccine in South Africa. The company has said it is already working on a new version of the vaccine designed to combat more infectious strains of the virus, which could also be used as a booster for already-inoculated individuals. The vaccine is also undergoing testing in the United States and Mexico, supported by Operation Warp Speed, which is expected to complete phase 3 enrollment in the first half of February. Novavax expects to file for emergency authorization in the United Kingdom in the coming months once it has final data from the UK trial.
In preliminary data released Tuesday, Regeneron reported that its antibody cocktail REGEN-COV was 100 percent effective at preventing symptomatic COVID-19 in participants of an ongoing phase 3 trial among people at high risk of contracting COVID-19 due to exposure to family members with the disease. The data also showed a 50 percent reduction in the overall rate of infection. REGEN-COV was granted an EUA from the FDA in November as a treatment method for patients with mild COVID-19 at high risk of progressing to severe infection, and pending a full readout expected next quarter from the phase 3 prevention trial, the company intends to file to expand the EUA for use as a “passive vaccination” method.