EMA: “If vaccines have to be adapted to omicron, it will not be starting from scratch”

The European Medicines Agency (EMA) assured that facing the omicron variant will not mean “starting from scratch” against the pandemic and recalled: “We know more”, we have more tools and “we are prepared” to adapt vaccines, although – he clarified – ” it is not yet known ”if it is necessary.

The executive director of the EMA, Emer Cooke, stressed that “the epidemiological situation is worrying throughout Europe” with the increase in infections and the spread of the new variant, but recalled that with five vaccines and six authorized and available therapies the world it is “in a stronger position than at this time last year.”

In addition, “there is still no answer as to whether we will need a vaccine with a different composition adapted” to the new variant, he pointed out, because the scientific community around the world needs “to see more data on the impact” that omicron has on the effectiveness of the vaccines that have been used in immunization campaigns.

“My three messages now are: we have more tools than we had before; we are prepared for any change that is needed to face the omicron variant; and increasing vaccination now, both primary and booster, will help prevent deaths and hospitalizations, “summarized Cooke.

Virus mutations

EMA senior officials offered the last press conference of the year on Tuesday, coinciding with the first anniversary of the approval in the European Union (EU) of the vaccine developed by the pharmaceutical companies Pfizer and BioNTech. Vaccination campaigns in the EU began on December 27, 2020, after the arrival of the first batches of vaccines.

“We have many more tools at our disposal,” said Cooke, who recalled that vaccines “protect against death and hospitalization” beyond the appearance of new variants, so “the priority now must be to increase” the coverage of primary vaccines and administration of booster doses.

At the EMA, scientists are “well aware that viruses mutate and this is a situation for which we were already prepared” from a regulatory point of view. “But I want to insist: there is still no answer on whether we will need an adapted vaccine to address this or any other emerging variant” of SARS-CoV-2, he added.

“What we do know is that we won’t have to start from scratch thanks to our prior knowledge. Our priority now is to be prepared in case there is a need for such a change, “he explained.

The head of Vaccination Strategy at the EMA, Marco Cavaleri, also stressed about the future of the pandemic that it is not known “what the new normal will be, this virus is still in a pandemic phase and could suddenly change abruptly in the future ”, requiring or not the adaptation of available vaccines.

“We have to be prepared to see this virus change over time, until it finds a good position to live among the human community, but that can take time. Anyway, we have to be prepared and we have all the tools that will allow us to respond and offer vaccines that are effective, “he summarized.

300 million vaccines per month

Close collaboration between pharmaceutical companies and the EMA to increase vaccine manufacturing capacity has enabled the distribution of 1 billion doses of vaccines in the EU this year. Today, 300 million vaccines are produced every month in the EU, increasing the European supply and supporting global access to vaccines.

In addition to Pfizer, the EMA authorized for the European market the vaccines of Moderna, AstraZeneca, Janssen (a subsidiary of the American Johnson & Johnson) and, since yesterday, the American vaccine Nuvaxovid from Novavax, licensed for use in adults. Only Pfizer (5-17 years old) and Moderna (12-17 years old) are licensed for children under 18 years of age.

In addition, the EU has six treatments for COVID-19, including the antiviral Veklury, the immunosuppressant Kineret, and various monoclonal antibody therapies. “Neither is a magic bullet, but each one is an important addition to our COVID-19 toolbox and provides us with hope and possibility,” added Cooke.