Johnson & Johnson (JNJ) announced Wednesday 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 recommendation is based on data from the Phase 3 ENSEMBLE 2 study showing a booster (second shot) of the Johnson & Johnson COVID-19 vaccine increased protection to 75 percent against symptomatic COVID-19 infection globally and 94 percent protection against symptomatic (moderate to severe) COVID-19 in the U.S. The data also demonstrated 100 percent protection against severe COVID-19, at least 14 days post-booster vaccination.
Also included in the data package reviewed by the CHMP were results from multiple real-world evidence (RWE) studies, including the Company’s previously announced RWE study that demonstrated similar estimates of single-shot vaccine effectiveness as observed in our randomized clinical trials.
The Company’s single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an Emergency Use Authorization in the U.S. on February 27, 2021 and Conditional Marketing Authorization (CMA) by the European Commission on March 11.
On October 21, 2021, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) authorized for emergency use a booster shot of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older.
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