Europe’s medicines regulator has given BioNTech/Pfizer’s second Omicron-targeting COVID vaccine the green light, paving the way for shipments to EU countries immediately, the companies said in a statement.
The vaccine has been designed to protect against the latest Omicron variants (BA.4 and BA.5), which are currently dominant in Europe, as well as the original virus.
The news comes just 12 days after Europe authorized the use of the first Omicron-targeting shots, from both BioNTech/Pfizer and Moderna. These vaccines target the first Omicron strain (BA.1) and the original virus first discovered in China.
BioNTech/Pfizer’s second Omicron-targeting shot is the first COVID-19 vaccine to be approved in Europe without the need for large-scale clinical trials.
Following a model that is adopted for seasonal flu jabs each year, the regulators accept that the technology is safe and effective based on animal and laboratory studies, as well as clinical trials with very similar versions of the vaccine. Subsequent efficacy trials will be carried out to confirm this.
Some have concerns that the arrival of a second type of Omicron vaccine will confuse those coming forward for vaccination. But the European Medicines Agency said a suite of shots is what’s needed to keep people safe this winter.
“The EU’s strategy is to have a broad range of adapted vaccines that target different SARS-CoV-2 variants so member states have various options to meet their needs when they design their vaccination campaigns,” the regulator said in a statement.
“This is a key element in the overall strategy to combat the pandemic as it is not possible to predict how the virus will evolve in the future and which variants will be circulating this winter.”