Europe’s Medicines Agency approves Pfizer/BioNtech vaccine

Nurse Administers a Vaccine
Photo by National Cancer Institute on Unsplash

Tista' taqra bil- Malti.

The European Union geared up to start mass vaccinations against COVID-19 just after Christmas after the shot developed by Pfizer and its German partner BioNTech cleared regulatory hurdles on Monday.

Commission President Ursula von der Leyen said doses would be available for all EU countries, at the same time and on the same conditions.

“Today we add an important chapter to a European success story. We approved the first safe and effective vaccine against COVID-19. More vaccines will come soon,” she said.

The EMA said that once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks, it will recommend a marketing authorisation. 

In a statement, the EMA said that the rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.

Once the authorisation is given, the European Commission is expected to fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States. The meeting is scheduled to be taking place on Wednesday. 

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.

A number of countries, including Malta, announced that they will be starting vaccination on December 27th. 

The UK and USA started the vaccination earlier this month.

90-year-old woman first to take vaccine in UK
90-year old woman first to take vaccine in the UK

Meanwhile, the EMA said that the Moderna vaccine will be reviewed on January 6th. This testing was brought forward from January 21st. 

EMA brings forward the Moderna vaccine meeting
EMA moves forward meeting on Moderna COVID-19 vaccine

The role of EMA is the independent regulatory assessment of evidence generated for COVID-19 vaccines and to make recommendations on their authorisation and use in EU citizens.

The process is being eclipsed by the concerns on a variation of the Covid-19 strain reported in the UK.