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July 2, 2021
New Data for Johnson & Johnson Single-Shot COVID-19 Vaccine demonstrates Strong Neutralizing Antibody Activity against the Delta Variant
NEW BRUNSWICK, N.J., July 1, 2021 — Johnson & Johnson today announced data demonstrating its single-shot COVID-19 vaccine’s robust and persistent activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. In addition, the data showed that the durability of the immune response lasted through at least eight months, the length of time evaluated to date. The two preprint study summaries have been submitted today to bioRxiv.
“Today’s newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine to help protect the health of people globally,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee, and Chief Scientific Officer at Johnson & Johnson. “We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant. In addition, it adds to the robust body of clinical data supporting our single-shot vaccine’s ability to protect against multiple variants of concern.”
“Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time. In addition, we observe a persistent and particularly robust, durable cellular immune response,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “With each new dataset, we build on our solid foundation of evidence that our single-shot COVID-19 vaccine plays a critical role in ending the pandemic, which continues to evolve and pose new challenges to global health.”
• Demonstrated neutralizing solid antibody activity against the Delta (B.1.617.2) variant
A preprint submitted by the Company today to bioRxiv contains a new analysis in the Phase 3 ENSEMBLE study. These data showed that the Johnson & Johnson single-shot COVID-19 Vaccine elicited neutralizing antibody activity against the Delta variant at an even higher level than what it did for the Beta (B.1.351) variant.
A single dose of the Johnson & Johnson COVID-19 vaccine generated neutralizing antibodies against a range of SARS-CoV-2 variants of concern, which increased over time. For example, the average neutralizing titer at eight months exceeded that average at 29 days, including against the increasingly prevalent and more transmissible Delta (B.1.617.2) variant, the partially neutralization-resistant Beta (B.1.351), the Gamma (P.1) variants, and others, including the Alpha (B.1.1.7), Epsilon (B.1.429), Kappa (B.1.617.1), D614G, as well as the original SARS-CoV-2 strain (WA1/2020).
Johnson & Johnson’s single-dose COVID-19 vaccine is now available in many regions and countries on a not-for-profit basis during the emergency pandemic period.
The vaccine received Emergency Use Authorization (EUA) in the United States on February 27 and Conditional Marketing Authorization (CMA) by the European Commission on March 11, 2021. The World Health Organization (WHO) issued Emergency Use Listing on March 12, 2021. In addition, the Company received an interim recommendation by the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO on March 17, 2021. Many more authorizations have been granted in countries worldwide, and regulatory submissions are ongoing.
• Storage and Distribution
The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas. The vaccine is estimated to remain stable for two years at -4°F (-20°C) and a maximum of 4.5 months at average refrigeration temperatures. The Company will ship the vaccine using the same cold chain technologies it uses today to transport other medicines.
• Important Safety Information
• WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE YOU GET THE COVID-19 VACCINE?
Tell the vaccination provider about all of your medical conditions, including if you:
have any allergies
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine
Source: Johnson & Johnson
|GlobalGiants.Com|
Edited & Posted by the Editor | 6:57 AM | Link to this Post
