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Positive CHMP Opinion for a booster shot of JNJ 78436735 COVID-19 vaccine.- Johnson & Johnson

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Published:18th Dec 2021
Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a Positive Opinion for use of the Company’s COVID-19 vaccine as a booster for adults aged 18 and older at least two months after primary vaccination with a single-shot of the Johnson & Johnson COVID-19 vaccine, and as a ‘mix and match’ booster following primary vaccination with an approved two-shot mRNA COVID-19 vaccine regimen (known as heterologous boosting).

The CHMP Opinion was based on a comprehensive data package that included results from the Phase III ENSEMBLE 2 study, which found a booster of the Johnson & Johnson COVID-19 vaccine given two months after the primary shot provided 75 percent protection against symptomatic (moderate to severe) COVID-19 globally (CI, 55%-87%) and 94 percent protection against symptomatic (moderate to severe) COVID-19 in the U.S. (CI, 59%-100%). It also demonstrated 100 percent protection against severe COVID-19, at least 14 days post-booster vaccination (CI, 33%-100%).

Condition: Coronavirus/COVID-19 Infection
Type: drug

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