Monday, August 15, 2022

MHRA: First Bivalent COVID-19 Booster Approved For UK



#16,945

Six weeks ago the FDA Recommended Adding BA.4/5 Spike Protein To Create A Bivalent COVID Booster Shot for this fall in the United States.  Plans are to offer this booster shot - at least to the most vulnerable members of the population - as early as September or October. 

With COVID variants continuing to evolve away from the original strain - and the original vaccine - the inclusion of a second strain is expected to extend the life, and effectiveness, of the booster.  

This addition only involves the booster shot, as the primary vaccine remains unchanged. 

Today the UK announced that they have approved a bivalent vaccine as well.  This from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).  I'll have a brief postscript after the break. 



First bivalent COVID-19 booster vaccine approved by UK medicines regulator

The adapted COVID-19 vaccine made by Moderna targets two different coronavirus variants – the original virus from 2020 and the Omicron variant
 
An updated version of the COVID-19 vaccine made by Moderna that targets two coronavirus variants (known as a “bivalent” vaccine) has today been approved for adult booster doses by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The decision to grant approval for this booster vaccine in the UK was endorsed by the government’s independent expert scientific advisory body, the Commission on Human Medicines, after carefully reviewing the evidence.

In each dose of the booster vaccine, ‘Spikevax bivalent Original/Omicron’, half of the vaccine (25 micrograms) targets the original virus strain from 2020 and the other half (25 micrograms) targets Omicron.

The MHRA’s decision is based on data from a clinical trial which showed that a booster with the bivalent Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain. In an exploratory analysis the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

Safety monitoring showed that the side effects observed were the same as those seen for the original Moderna booster dose and were typically mild and self-resolving, and no serious safety concerns were identified.

Dr June Raine, MHRA Chief Executive said:

“I am pleased to announce the approval of the Moderna bivalent booster vaccine, which was found in the clinical trial to provide a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved today.”
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said:

“The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality and effectiveness and agrees with the MHRA’s decision.”

“The virus, SARS-CoV-2, is continually evolving in order to evade the immunity provided by vaccines. This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine.”

The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme.
Notes to editors
  • The  Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
  • The MHRA’s Conditional Marketing Authorisation for the Moderna bivalent booster vaccine is valid in Great Britain only. An emergency use authorisation has been granted for Northern Ireland to ensure access across the whole of the United Kingdom. Both authorisations were made on the basis of the same rigorous evaluation of data.
  • More information can be found in the product information
  • A recent paper in a Lancet journal suggested that COVID-19 vaccines have prevented up to 20 million deaths in the first year of use

 

A month ago (Jul 15th), the UKHSA announced - in anticipation of a fall wave of COVID and a potentially severe flu season - that Over 50s to be offered COVID-19 booster and flu jab this autumn.
Since a timeline for delivery is not mentioned in this announcement, it isn't clear when - and initially for whom - this bivalent booster will be offered, although media reports suggest it will be available for the `autumn-winter booster campaign'.

While both COVID and influenza are notoriously unpredictable, having an `enhanced' booster as part of our armamentarium against the pandemic virus could significantly reduce its impact.  Assuming, of course, that COVID doesn't make another abrupt evolutionary leap like it did with Omicron. 

Stay tuned. 


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