J&J’s Covid-19 Vaccine Booster Dose Receives Positive CHMP Opinion

Gulf Time

• 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 -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)

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 v vaccine regimen (known as heterologous boosting).
“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, MD, 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.