Johnson & Johnson Submits Application to EMA for Conditional Marketing Authorization of Single-Dose Janssen COVID-19 Vaccine

February 18, 2021 /Bio ValleyBIOON/ -- Johnson & Johnson (JNJ) recently announced that its subsidiary, Janssen-Cilag International, has submitted a Conditional Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval for its single-dose Janssen COVID-19 vaccine. This MAA is based on Phase 3 ENSEMBLEClinical Trialtop-line efficacy and safety data. Once conditional marketing authorization is granted, Johnson & Johnson must fulfill specific obligations within a specified timeframe, including the provision of additional data.

The Janssen COVID-19 vaccine is compatible with standard vaccine distribution channels. If approved, the Janssen COVID-19 vaccine is expected to remain stable for two years at -20°C (-4°F), including at least three months at 2–8°C (36–46°F). The company will utilize existing cold-chain technologies currently employed for transporting other innovative medicines to deliver the vaccine. Subject to regulatory approval, Johnson & Johnson is committed to providing an affordable COVID-19 vaccine on a not-for-profit basis for use during the pandemic emergency.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated: “There remains an urgent need for additional COVID-19 vaccines across Europe, and today’s submission represents a critical step toward ensuring that the European Union has another option to help mitigate the impact of this pandemic in Europe and around the world. We are prepared to begin distributing our vaccine in the EU in the second quarter of 2021.”

In December 2020, Johnson & Johnson announced that it had begun submitting a rolling application for the Janssen COVID-19 vaccine to the European Medicines Agency (EMA), enabling the EMA to review the data as it became available. Additionally, Johnson & Johnson initiated rolling submissions for its single-dose COVID-19 vaccine in several countries worldwide and to the World Health Organization (WHO). In the United States, Johnson & Johnson submitted an Emergency Use Authorization (EUA) request on February 4, 2021.

In late January 2021, Johnson & Johnson announced the top-line efficacy and safety data from the Phase 3 ENSEMBLE study, demonstrating that the Janssen COVID-19 Vaccine met all primary and key secondary endpoints. The top-line safety and efficacy data were based on 43,783 participants, among whom a total of 468 symptomatic COVID-19 cases occurred.

Vaccine (Image source: nasdaq.com)

The Phase 3 ENSEMBLE study aimed to evaluate the efficacy and safety of the Janssen COVID-19 candidate vaccine in protecting against moderate to severe COVID-19, with co-primary endpoints assessed at 14 and 28 days post-vaccination. Among all participants from diverse regions, including those infected with emerging viral variants, the overall efficacy of the Janssen COVID-19 candidate vaccine in preventing moderate to severe COVID-19 was 66% at 28 days post-vaccination. Notably, the onset of protection was observed as early as 14 days post-vaccination. At 28 days post-vaccination, the efficacy against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America, and 57% in South Africa.

These results from a single-dose COVID-19 candidate vaccine represent a promising milestone. By providing an effective and well-tolerated vaccine that requires only one immunization, it is possible to significantly reduce the burden of severe disease, which is a key component of global public health responses. The World Health Organization considers a single-dose vaccine the optimal choice in a pandemic setting, as it enhances access, distribution, and compliance. With an efficacy rate of 85% in preventing severe COVID-19 disease and reducing the need for COVID-19-related medical interventions, this vaccine has the potential to protect hundreds of millions of people from the severe and fatal consequences of COVID-19. It also offers hope for alleviating the tremendous strain on healthcare systems and communities. (Bioon.com)

Original Source: Johnson & Johnson Announces Submission of European Conditional Marketing Authorisationapplication to the EMA for its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate