Malta will be able to roll out COVID-19 vaccinations as from 27th December along with the rest of the European Union after the European Medicines Authority moved its planned market authorisation date forward.

The move follows the receipt of additional data requested by the EMA from the BioNTech and Pfizer, the producers of the first vaccine to hit the market.

First Vice-President of European Parliament Roberta Metsola took to Facebook to celebrate the news.

“Now it's official,” she said. “Malta, Gozo and all EU countries will start an unprecedented vaccination programme on 27 December. Every State can start at the same time.”

She praised EU Member States for working together, saying “Our European ideal of cooperation over competition has come through when it was needed the most.”

“The end of this difficult period is in sight,” she said, before warning, “but we are not out of the woods yet – keep being careful and do not let your guard down.”

In a separate post, she said, “We are only able to do this thanks to the decision for the EU to jointly procure the vaccine ensuring all EU countries got it at the same time.”

Underscoring Ms Metsola’s claim is the fact that while the EU, along with other wealthy states like the USA and Canada, has procured enough vaccines to safeguard the entire population, many countries without the financial and political clout of such global powers face remaining without a vaccine until late next year or even later.

The market authorisation of BNT162b2, the BioNTech/Pfizer COVID-19 mRNA vaccine, is reliant on a robust and complete assessment of its quality, safety and efficacy.

Market authorisation includes several safeguards, controls and obligations, including:

• full prescribing information and package leaflet with detailed instructions for safe use;
• a robust risk-management and safety monitoring plan;
• manufacturing controls including batch controls for vaccines and conditions for storage;
• an investigation plan for use in children;
• legally binding post-approval obligations (i.e. conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.

A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. It will be valid in all EU Member States at the same time, enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time.