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J&J COVID-19 Vaccine Neutralizes Activity Against Delta Variant
In other COVID news, Novavax's COVID-19 vaccine is 89.7% effective in a Phase 3 trial and Moderna announces Recipharm site to manufacture vaccine in France.
Johnson & Johnson recently announced that a single shot of its COVID-19 vaccine generated robust and persistent activity against the SARS-CoV-2 Delta variant and other prevalent viral variants.
For example, a recent analysis studied blood samples from participants in the company's Phase 3 ENSEMBLE trial and found that the vaccine was consistently effective across all regions studied globally, including in South Africa and Brazil.
In the trial, a single dose of the COVID-19 vaccine was 85 percent effective against severe/critical disease and demonstrated protection against hospitalization and death.
Notably, neutralizing antibody activity was even higher than what was previously seen for the South African variant.
Dan Barouch, MD, PhD, of Beth Israel Deaconess Medical Center also submitted data from the Johnson & Johnson COVID-19 vaccine sub-study. Data showed that humoral and cellular immune responses generated by the vaccine lasted for at least eight months.
Additionally, T-cell responses, including CD8+ T-cells, persisted over the eight-month timeframe.
"Today's newly announced studies reinforce the ability of the Johnson & Johnson COVID-19 vaccine to help protect the health of people globally," Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in the announcement.
"We believe that our vaccine offers durable protection against COVID-19 and elicits neutralizing activity against the Delta variant. This adds to the robust body of clinical data supporting our single-shot vaccine's ability to protect against multiple variants of concern," Stoffels continued.
Mathai Mammen, MD, PhD, global head of research and development at Johnson & Johnson, stated that with each new dataset, the company builds a solid foundation of evidence that a single shot of its COVID-19 vaccine plays a critical role in ending the pandemic.
Novavax's COVID-19 Vaccine 89.7% Effective in Phase 3 Trial
Novavax recently announced that its COVID-19 vaccine is 89.7 percent effective against the coronavirus, with over 60 percent of the cases caused by the B.1.1.7 variant.
The results published in the New England Journal of Medicine found that the vaccine was 96.4 percent effective against non-B.1.1.7 variants, which represent strains most similar to the original virus.
"We continue to be very encouraged by data showing high levels of efficacy against even mild disease, and that NVX-CoV2373 offers strong cross-protection against both the B.1.1.7 (Alpha) variant and non-B.1.1.7 (non-Alpha) variant strains which are widely circulating," Gregory M. Glenn, MD, president of research and development at Novavax, said in the announcement.
"This publication also reinforces the reassuring safety and efficacy profile shown in studies of our vaccine to date and underscores the potential for NVX-CoV2373 to play an important role in solving this ongoing global public health crisis," Glenn continued.
The randomized, placebo-controlled study enrolled over 15,000 adults at trial sites across the UK. The research showed that a two-dose regimen of Novavax's COVID-19 vaccine elicited mild to moderate side effects.
The study took place when the B.1.1.7 variant was circulating widely in the UK. Results build on an initial interim analysis conducted in January 2021 and an updated analysis in March.
Moderna Announces Recipharm Site in France for COVID-19 Vaccine
Moderna recently announced that the European Medicines Agency's (EMA) Committee for Human Medicines (CHMP) approved its Recipharm Monts site to manufacture its COVID-19 vaccine in France.
"We are proud to be working with Recipharm to build industrial production capacity in France in support of Europe's vaccination campaign," Stephane Bancel, chief executive officer of Moderna, said in the announcement.
"France is at the heart of European innovation in healthcare and will play an important role in Moderna's strategic growth plan," Bancel continued.
In May, Moderna increased its global 2022 capacity for its vaccine to up to 3 billion doses.
The company stated that its partnership with Recipharm will help to expand its global manufacturing capacity. And investments made earlier this year are expected to enable a doubling of drug substance manufacturing in Europe.
"Our collaboration with Moderna has created a strong foundation for vaccine production in France, leveraging our manufacturing excellence to ensure the timely delivery of the Moderna COVID-19 vaccine to Europe," said Marc Funk, CEO of Recipharm.
