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Moderna receives Health Canada authorization for updated COVID-19 vaccine

Moderna receives Health Canada authorization for updated COVID-19 vaccine

In a significant leap towards combating the ongoing COVID-19 threat, Moderna Biopharma Canada Corp. has received the green light from Health Canada authorization for its latest COVID-19 vaccine, SPIKEVAX XBB.1.5. This announcement, made on September 12, 2023, marks a pivotal moment in Canada’s battle against the virus. In this comprehensive guide, we delve into the key aspects of this groundbreaking development, from its importance in safeguarding Canadians to the science behind it.

The Ongoing Battle Against COVID-19

The relentless battle against COVID-19 continues to be a pressing concern globally. Canadians, like many around the world, have faced the challenges posed by this virus for far too long. As we approach the peak of the respiratory virus season, the need for robust and effective defense mechanisms is paramount.

Shehzad Iqbal’s Vision

Shehzad Iqbal, Country Medical Director at Moderna Canada, emphasizes the gravity of the situation. “COVID-19 continues to present a serious health risk,” he notes. With the authorization of SPIKEVAX XBB.1.5, Canadians now have a powerful tool to protect themselves.

NACI’s Critical Recommendation

The National Advisory Committee on Immunization (NACI) has recommended that individuals who are not vaccinated or lack a known COVID infection within the past six months should receive an updated dose. This recommendation places a strong focus on safeguarding vulnerable individuals.

Moderna receives Health Canada authorization for updated COVID-19 vaccine
Moderna’s updated COVID-19 vaccine, SPIKEVAX XBB.1.5, now approved in Canada (CNW Group/Moderna, Inc.)

The Science Behind SPIKEVAX XBB.1.5

Firstly to ensure the most robust immune response against the dominant circulating variants of COVID-19, global public health agencies and regulators recommended updating COVID-19 vaccines to a monovalent XBB.1.5 composition. Moderna’s submission to Health Canada included clinical data showcasing the vaccine’s efficacy against SARS-CoV-2 XBB sublineages, including XBB.1.5 and XBB.1.16.

Beyond Submission: Ongoing Evaluation

Secondly Moderna doesn’t stop at submission; they are committed to ongoing evaluation. Recent clinical trial data reveals SPIKEVAX XBB.1.5’s effectiveness against circulating subvariants like BA.2.86, EG.5, and FL.1.5.1. These findings underscore the vaccine’s adaptability and its ability to combat the ever-evolving virus.

Eliciting Immune Responses

In August, Moderna unveiled additional clinical trial data demonstrating that their updated COVID-19 vaccine effectively elicits an immune response in humans against EG.5 and FL.1.5.1. Furthermore, recent data confirms that the vaccine also prompts a human immune response against BA.2.86. These findings provide a promising outlook for a safer tomorrow.

Simplifying Administration and Support

In Health Canada authorization, Moderna introduces two key updates aimed at simplifying administration and supporting provincial vaccination programs. SPIKEVAX XBB.1.5 will be available in a single presentation (0.1 mg/mL 2.5mL vial), enabling healthcare providers to draw both adult and pediatric doses from the same vial. Additionally, dosing has been adjusted to streamline administration considerations, relying solely on the patient’s age and prior vaccination history to determine the appropriate dose.

Frequently Asked Questions

How does SPIKEVAX XBB.1.5 differ from previous COVID-19 vaccines?

SPIKEVAX XBB.1.5 represents the latest evolution in COVID-19 defense, but designed to target the dominant circulating variants effectively. Its clinical data demonstrates robust immunity against these variants, making it a critical tool in the fight against the virus.

Who should consider receiving an updated dose of SPIKEVAX XBB.1.5?

The National Advisory Committee on Immunization (NACI) recommends an updated dose for anyone not vaccinated or without a known COVID infection within the past six months. This recommendation is particularly important for safeguarding vulnerable individuals.

What are the advantages of the new presentation (0.1 mg/mL 2.5mL vial)?

The new presentation allows for both adult and pediatric doses to be drawn from the same vial, simplifying the vaccination process and enhancing efficiency for healthcare providers.

How has dosing been adapted for SPIKEVAX XBB.1.5?

Dosing considerations have been streamlined, requiring only the patient’s age and prior vaccination history to determine the appropriate dose. This adjustment simplifies the administration process, making vaccination more accessible.

What subvariants does SPIKEVAX XBB.1.5 protect against?

SPIKEVAX XBB.1.5 has been evaluated against subvariants i.e. BA.2.86, EG.5, and FL.1.5.1, with clinical trial data confirming its ability to elicit a robust human immune response against these strains.

How can I access SPIKEVAX XBB.1.5?

SPIKEVAX XBB.1.5 will be available through provincial and territorial vaccination campaigns, ensuring widespread access for eligible individuals.

In Conclusion

Finally The authorization of SPIKEVAX XBB.1.5 by Health Canada is a significant step towards a safer future for Canadians. With its robust immune response against dominant variants and streamlined administration, this vaccine offers hope and protection. As we continue to combat COVID-19, the innovation and dedication of organizations like Moderna bring us closer to a world free from the threat of this virus.

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