Moderna Receives Medicines And Healthcare Products Regulatory Agency (MHRA) Authorization For Updated COVID-19 Vaccine Targeting SARS-COV-2 Variant JN.1

Rhea-AI Summary

Moderna has received authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. The vaccine, Spikevax® JN.1, will be available through the NHS autumn vaccination program for eligible groups and, for the first time in the UK, can be purchased privately. This approval aligns with recommendations from global health bodies to develop JN.1-targeted vaccines, as the JN.1 subvariants currently dominate in the UK.

The updated vaccine aims to protect those at highest risk of severe COVID-19 illness and reduce strain on the NHS. It will be accessible through high street pharmacies, occupational health providers, and private healthcare companies for those not eligible for the NHS program.

Positive

• MHRA authorization for updated COVID-19 vaccine targeting JN.1 variant
• Vaccine will be available through NHS autumn vaccination program
• First-time private purchase option for COVID-19 vaccine in the UK
• Alignment with global health recommendations for JN.1-targeted vaccines

Negative

• None.

Medical Research Analyst

Moderna's new MHRA authorization for its JN.1-targeted COVID-19 vaccine is a significant development in the ongoing battle against the virus. The approval aligns with WHO recommendations and addresses the current dominant strain in the UK. This update demonstrates Moderna's ability to rapidly adapt its vaccine technology to emerging variants, potentially enhancing protection for vulnerable populations.

The dual availability through NHS and private channels is noteworthy. While prioritizing high-risk groups through the NHS program, the private option could increase overall vaccination rates. However, this may raise questions about equitable access and could potentially impact public health strategies. The effectiveness of this updated vaccine against JN.1 and its subvariants will be important to monitor in real-world settings.

Financial Analyst

This authorization represents a positive catalyst for Moderna (NASDAQ: MRNA). The approval not only secures Moderna's position in the UK's NHS autumn vaccination program but also opens up a new revenue stream through private sales. This dual-channel approach could potentially boost vaccine uptake and increase market share.

Investors should note the ongoing demand for updated COVID-19 vaccines, indicating a sustainable market. The company's ability to swiftly develop vaccines targeting new variants demonstrates its technological agility, a key competitive advantage. However, the financial impact will depend on vaccination rates, pricing strategies and potential competition. Keep an eye on Moderna's upcoming financial reports to gauge the revenue contribution from this new authorization.

Public Health Expert

The MHRA's authorization of Moderna's updated COVID-19 vaccine is a crucial step in maintaining public health defenses against evolving SARS-CoV-2 variants. Targeting the dominant JN.1 strain demonstrates a proactive approach to vaccine development and distribution. The NHS autumn vaccination program's focus on high-risk groups aligns with best practices in public health resource allocation.

However, the introduction of private sales raises ethical considerations. While it may increase overall vaccine accessibility, it could potentially exacerbate health inequities. Public health officials should monitor the impact on vaccination rates across different socioeconomic groups. Additionally, clear communication about the importance of vaccination, regardless of the distribution channel, will be vital to maintain public trust and maximize the vaccine's public health impact.

Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines

At present, the JN.1 group of subvariants remain dominant in the UK

The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time

CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2.

Following the MHRA decision, doses will be available for eligible groups as part of the NHS autumn vaccination program, which is prioritized for use in people at greatest risk of serious illness from COVID-19.

For the first time in the UK, the updated vaccine, Spikevax® JN.1, will also be available to purchase privately for those who are not eligible for the NHS Autumn vaccination program. The updated vaccine will be available from high street pharmacies, occupational health providers, and private healthcare companies.

"As the SARS-CoV-2 virus continues to evolve, COVID-19 continues to present a serious health risk. Updated vaccines targeting circulating strains play a vital role in helping to protect those most at risk from severe illness and hospitalization, alleviating strain on the NHS," said Darius Hughes, UK General Manager of Moderna. "With today's approval from the MHRA, we are pleased that our updated COVID-19 vaccine will be available to the UK public, both through the NHS autumn vaccination program, as well as being available to purchase privately for the first time."

The approval follows guidance from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), which recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024/25 vaccination campaign. At present, the JN.1 group of subvariants remain dominant in the UK.¹

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Moderna Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the availability of Moderna's updated COVID-19 vaccine to the UK public; and the ability of Moderna's updated COVID-19 vaccine to provide protection as the SARS-CoV-2 virus continues to evolve. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:

Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

¹ https://ukhsa-dashboard.data.gov.uk/topics/covid-19 - Accessed 02/09/24

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What is Moderna's new COVID-19 vaccine authorization for in the UK?

Moderna (MRNA) has received MHRA authorization for its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2 in the UK.

How will Moderna's updated COVID-19 vaccine be available in the UK?

The updated vaccine will be available through the NHS autumn vaccination program for eligible groups and, for the first time, can be purchased privately by those not eligible for the NHS program.

Which COVID-19 variant does Moderna's new vaccine target?

Moderna's newly authorized vaccine targets the JN.1 variant of SARS-CoV-2, which is currently the dominant group of subvariants in the UK.

When will Moderna's updated COVID-19 vaccine be available in the UK?

The press release doesn't specify an exact date, but states that doses will be available following the MHRA decision for the NHS autumn vaccination program and private purchase.