CHMP Issues Positive Opinion of J&J’s COVID-19 Vaccine Booster

December 17, 2021 - The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued positive opinion of Johnson & Johnson’s COVID-19 vaccine booster for adults.

The CHMP recommended the use of the booster for individuals 18 years of age and older at least two months after primary vaccination with the single-shot Johnson & Johnson vaccine, and as a mix-and-match booster following primary vaccination with an approved mRNA vaccine.

“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,” Mathai Mammen, MD, PhD, global head of Janssen research & development, Johnson & Johnson, said in the announcement.

“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,” Mammen continued.

The CHMP based its opinion on the Phase 3 ENSEMBLE 2 study results and multiple real-world evidence studies.

First, the ENSEMBLE trial found Johnson & Johnson’s COVID-19 vaccine booster 75 percent effective against symptomatic coronavirus globally and 94 percent effective against symptomatic virus in the US.

Additionally, the booster was 100 percent effective against severe COVID-19 at least 14-days post-booster vaccination.

And Johnson & Johnson’s real-world evidence study showed that a booster shot of its COVID-19 vaccine at two months provided 100 percent protection at least 14 days post-final vaccination and 75 percent protection against symptomatic COVID-19 globally.

Pfizer Re-Confirms Efficacy of COVID-19 Vaccine Booster Shot

Pfizer’s recently announced additional Phase 2 study results confirming the efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, high-risk adult patients.

Final data available from all high-risk patients enrolled in the EPIC-HR trial found that Paxlovid reduced the risk of hospitalization or death for any cause by 89 percent compared to placebo.

This data is consistent with November findings.

The trial enrolled 2,246 unvaccinated adults. About 0.7 percent of patients who received Paxlovid were hospitalized through Day 28 following randomization, compared to 6.5 percent of patients who received placebo and were hospitalized or died.

In a secondary endpoint, Paxlovid reduced the risk of hospitalization or death for any cause by 88 percent compared to placebo in patients treated within five days of symptom onset.

Additionally, 0.8 percent of patients who received the drug were hospitalized or died through Day 28 following randomization, compared to 6.3 percent of patients who received placebo.

In a separate interim analysis of an ongoing study in standard-risk adults, researchers noted a 70 percent reduction in hospitalization and no deaths in the treated population compared to placebo.

Pfizer shared this data with FDA as part of an ongoing rolling submission for Emergency Use Authorization (EUA).

“This data further supports the efficacy of PAXLOVID in reducing hospitalization and death and show a substantial decrease in viral load,” Albert Bourla, chairman and CEO Pfizer, said in the announcement.

“Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic,” Bourla concluded.

GSK, Sanofi’s COVID-19 Vaccine Booster Elicits Strong Immune Responses

GSK and Sanofi recently announced that a single booster dose of their COVID-19 vaccine candidate delivered consistently strong immune responses.

Preliminary results from the VAT0002 clinical trial found that the booster neutralized antibodies nine to 43 fold, regardless of the primary vaccine received, for all age groups tested.

Overall, the booster was well tolerated and the safety profile was similar to currently approved vaccines, including Johnson & Johnson, Moderna, and Pfizer/BioNTech.

Additionally, an independent Data Safety Monitoring Board (DSMB) identified no safety concerns in an ongoing Phase 3 trial, VAT0008, and recommended the trial to continue into early 2022 to accrue more data.

“As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time,” Roger Connor, president of GSK, said in the announcement.

“The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available,” Connor continued.