Benzinga | Dec 15, 2021 08:34AM EST

Johnson & Johnson Announces Positive CHMP Opinion For Booster Shot Of Its COVID-19 Vaccine

Johnson & Johnson (NYSE:JNJ) (the Company) today 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).

"We are pleased with today's Positive Opinion from the CHMP supporting the use of our COVID-19 vaccine as a booster for eligible individuals in Europe," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "There is a growing body of data showing that the Johnson & Johnson COVID-19 vaccine induces broad and durable humoral and cellular immune responses, whether administered as a single shot for an efficient response to the pandemic, or as a booster shot after at least two months to strengthen protection against symptomatic COVID-19. Cellular immune responses are showing potential to be important for both breadth of protection and durability."

The CHMP Opinion was based on a comprehensive data package that included results from the Phase 3 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%). The vaccine, when given as a booster or primary shot, was generally well-tolerated, with no new safety signals observed in the two-shot ENSEMBLE 2 trial compared with single-shot studies.

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 effectiveness estimates remained stable with no evidence of reduced effectiveness over time before the Delta variant emerged and after it became the dominant strain in the U.S. from March through August (sequencing data were not available for analysis).

The CHMP recommendation is supported by latest data for heterologous boosting with the Johnson & Johnson COVID-19 vaccine. Interim data from the National Institute of Allergy and Infectious Disease (NIAID) "MixNMatch" study demonstrated that a booster of the Johnson & Johnson COVID-19 vaccine increases immune response regardless of a person's primary vaccination. A second study by the Beth Israel Deaconess Medical Center (BIDMC), including a subset of participants from the Janssen-sponsored COV2008 study, demonstrated the potential benefits of heterologous boosting: a booster shot of the Johnson & Johnson vaccine administered at six months after a two-shot primary regimen of the Pfizer/BioNTech vaccine, increased both antibody and T-cell responses. In these participants, antibodies continued to increase for at least four weeks whereas in individuals who received a homologous boost with the BNT162b2 vaccine, antibodies declined from week two to week four post-boost, resulting in similar antibody levels in both groups.

The Company's single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an Emergency Use Authorization in the United States on 27 February 2021 and Conditional Marketing Authorisation (CMA) by the European Commission on 11 March. On 21 October 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. On 9 December 2021, the Strategic Advisory Group of Experts (SAGE) on Immunization for the World Health Organization (WHO) supported the use of the Johnson & Johnson COVID-19 vaccine as a heterologous booster shot in persons aged 18 years and above.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.