Regulatory The UK first to approve bivalent COVID-19 vaccine

The UK first to approve bivalent COVID-19 vaccine

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U.S. pharmaceutical company Moderna has developed a bivalent vaccine to target both the original strain of the virus and the Omicron variant. The UK government has become the first to approve its use after the Omicron BA.1 variant wreaked havoc in the region last year.

The booster shot named  “Spikevax bivalent Original/Omicron” has been approved for use in adults over the age of 18 by UK regulatory authorities.  The Joint Committee on Vaccination and Immunisation (JCVI) stated that the vaccine will be used in autumn for UK’s booster program, which is planned to start next month. 

The bivalent booster contains equal portions of both the original COVID strain vaccine and the newer Omicron strain vaccine- 25 micrograms each. 

Bivalent vaccines are those vaccines that target two infections at the same time and with the multiple strains of the Coronavirus, the use of bivalent vaccines is underway to target 2 strains at the same time. Moderna is the first pharma company to successfully have such a vaccine approved by regulatory authorities in the UK. 

The original COVID-19 vaccines were able to provide protection and possibly save the lives of thousands but as the virus continues to evolve, the defenses against the disease must also continue to evolve as well. The bivalent vaccine is a step in this direction. 

Agreeing with the regulatory authority’s decision to approve the use of Spikevax bivalent, the chair of the Commission on Human Medicines stated that the COVID virus continues to evolve and counter the immunity provided by current vaccines in the market. In order to ensure immunity from the virus is retained, booster shots are needed and the Omicron-specific booster is a definite need to develop a broad immune response.

Moderna revealed that during the clinical trial of Spikevax, the trial partciants had antibody levels that were almost 1.7 times higher when compared to those that had been administered the original booster. The MHRA also said that after conducting an exploratory analysis, the bivalent vaccine showed promising results and produced a good antibody response against the Omicron strain of COVID.  

The Omicron variant caused a spike in cases and a significant number of infections, reinfections and deaths in the UK, as well as the rest of the world. 

Not everyone holds the view that this bivalent vaccine will offer sufficient protection against the Omicron strain, especially against its variant BA.5 as it has proven to be quite difficult to control. A professor of immunology at Imperial College London stated: “We lack the certainties we had in early 2020 of which way to go with the vaccines, not least, how to keep up with evolution of the variants. BA.5 is highly immune evasive so that even boosted people have highly impaired protection. Even exposure to the original Omicron sequence – as used in this, new, bivalent vaccine booster – only gives a rather marginal advantage to the antibody response.”

However, he clarified that this bivalent booster program was certainly better than having no vaccine, and did provide an improvement when compared to the first-generation shots. 

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