USA – Moderna and the European Commission (EC) have entered an agreement for amending their initially agreed contractual supply schedules for the former’s Covid-19 vaccine booster product (Spikevax, mRNA-1273) or updated booster vaccine candidate.
With the amendment, participating Member States can receive the booster vaccines later this year or earlier next year instead of the priorly scheduled supply in the second quarter.
On obtaining approval from the European Medicines Agency (EMA), they will be able to procure the anticipated updated bivalent booster candidate.
The agreement will also allow the delivery of vaccines adapted to future variants, again after approval by the European Medicines Agency, so that Member States can respond to any epidemiological developments later this year and continue to support partner countries globally.
Furthermore, Moderna continues to expect advanced purchase agreements of nearly US$21bn for this year and believes that Covid-19 market dynamics will boost sales in the second half compared to the first half.
The European Commission had granted Conditional Marketing Authorization (CMA) to Spikevax following an EMA recommendation.
Spikevax is intended for active immunization to prevent Covid-19 in people aged six years and above.
In addition, a booster vaccine can be administered a minimum of three months following the second dose in individuals of the age 18 years and above.
Last month, the company sought a variation to the CMA from the EMA for assessing 25 micrograms (µg) two-dose series of Spikevax in children aged six months to below six years in the European Union.
Currently, Moderna is seeking similar authorizations from various other regulatory authorities.
The European Commission and the vaccine developer Moderna have reached an agreement to ensure that the delivery of COVID-19 vaccines is adapted to the needs of Member States.
Meanwhile, Moderna has said up to 1.7 billion people at high risk from Covid-19 would benefit from annual booster shots, as it prioritizes developing a jab targeting the fast-spreading Omicron variant to be released in the autumn.
The bivalent prototype and Omicron booster vaccine candidate (mRNA-1273.214) of Moderna is presently being analyzed in Phase II/II clinical trial.
The company anticipates preliminary findings on this vaccine this month, which would aid in selecting the booster candidate for the Northern Hemisphere this year.
Pfizer is also pushing ahead with plans to develop an annual booster shot that can provide better protection against new variants but has acknowledged growing vaccine fatigue among the public.
Pfizer chief executive Albert Bourla told analysts this week that people were “tired of the repeated booster” and it is very important to develop an annual vaccine. “It’s not technically easy to achieve,” he added.
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