- Booster applicable with a single-dose of J&J’s COVID-19 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-dose mRNA COVID vaccine regimen (known as heterologous boosting)
Dubai: Janssen, one of the companies of Johnson & Johnson, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion for the use of Johnson & Johnson’s COVID-19 vaccine as a booster dose.
This is applicable for adults aged 18 and older at least two months after primary vaccination with a single-dose of Johnson & Johnson’s COVID-19 vaccine, and as a ‘mix-and-match’ booster following primary vaccination with an approved two-dose mRNA COVID-19 vaccine regimen (known as heterologous boosting).[1]
“We are pleased with the 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 dose for an efficient response to the pandemic, or as a booster dose 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 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.
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 dose provided 75% protection against symptomatic (moderate to severe) and 94% protection against symptomatic (moderate to severe).1 It also demonstrated 100% protection against severe COVID-19, at least 14 days post-booster vaccination.1 The vaccine, when given as a booster or primary dose, was generally well-tolerated, with no new safety signals observed in the two dose ENSEMBLE 2 trial compared with single-dose studies.
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 dose of the Johnson & Johnson vaccine administered at six months after a two-dose 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.
About the Janssen Pharmaceutical Companies of Johnson & Johnson:
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
