View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
August 30, 2022

Moderna’s omicron-targeting Covid-19 booster gets Swissmedic approval

The approval is based on findings from the Phase II/III clinical trial of the mRNA-1273.214 vaccine.

Moderna has obtained temporary authorisation from Swissmedic for its Omicron-targeting bivalent booster vaccine for Covid-19, Spikevax Bivalent Original/Omicron (mRNA-1273.214), for individuals aged 18 years and above. 

The vaccine is indicated for active immunisation for the prevention of Covid-19.

It comprises 25µg mRNA-1273 (Spikevax) and 25µg of a vaccine candidate that acts on the Omicron variant of concern (BA.1).

The approval is based on findings from the Phase II/III clinical trial of the mRNA-1273.214 vaccine.

According to the study data, the trial met all primary endpoints. 

In previously uninfected subjects, the bivalent vaccine showed a greater neutralising antibody response against Omicron (BA.1) versus the 50µg booster dose of Spikevax authorised presently. 

In the trial, mRNA-1273.214 was found to be well tolerated with a reactogenicity and safety profile in line with the booster authorised presently.

With the latest authorisation, Switzerland became one of the first countries globally to approve this next-generation bivalent booster vaccine for Covid-19.

The company is collaborating with Swissmedic and the Government of Switzerland to supply the mRNA-1273.214 vaccine to people in the country by early September this year. 

Moderna chief commercial officer Arpa Garay said: “We are delighted to receive authorization from Swissmedic for our next-generation bivalent vaccine, mRNA-1273.214. 

“This is another example of Switzerland’s continued leadership in helping to end the Covid-19 pandemic.

“Moderna is proud to play a key role in helping to protect the people of Switzerland from the ongoing threat that Covid-19 represents to global public health.”

Before this development, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional authorisation for this vaccine to adults aged 18 years and older.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Free Whitepaper
img

Optimise your cell therapy process: a guide to cell thawing

Typically carried out at the point of care, errors in cell therapy thawing could compromise treatment efficacy, leading to significant patient impact as well as high costs and a compromised reputation for the product’s developer. This guide addresses how cell thawing has historically developed into the new techniques used today, along with the physical and biological implications of key metrics and components such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.
by Cytiva Thematic

By clicking the Download Free Whitepaper button, you accept the terms and conditions and acknowledge that your data will be used as described in the Cytiva Thematic privacy policy By downloading this Whitepaper, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our privacy policy for more information about our services, how we may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology