EU drugs regulator green-lights Omicron COVID-19 jabs

Europe’s medicines regulator has backed the first reworked COVID-19 vaccines to protect against Omicron in a move that opens the door for fall vaccination campaigns across the bloc.

The European Medicines Agency said on Thursday that the vaccines from BioNTech/Pfizer and Moderna are safe and effective at protecting against the latest highly transmissible variant, as well as other variants of concern. Both vaccines can be given as a booster to those aged 12 and over who have previously had at least a primary course of vaccination.

Countries throughout Europe have planned booster vaccination campaigns in anticipation of the cooling weather, a return to indoor socializing and schooling, and the possible emergence of another coronavirus variant that would fuel a new wave of infections.

The regulator, alongside the European Center for Disease Prevention and Control (ECDC), has recommended that all people aged 60 and over, those with compromised immune systems due to illness or treatment and health care workers, should be prioritized for another booster dose. They are due to issue further guidance next week following the addition of these updated COVID-19 vaccines.

The two updated vaccines “are developed to offer increased, broader protection against current and future variants,” said Health Commissioner Stella Kyriakides. “We need to be ready to face another winter with COVID-19.”

The European Commission will now accelerate its approval of the regulator’s decision, with the first deliveries of both vaccines arriving in time for immunization campaigns to begin on Monday.

At least 70 million doses of BioNTech/Pfizer’s vaccine are expected to be delivered across Europe within a month, while the same amount of Moderna’s shot will arrive within two months, according to German MEP Peter Liese, health spokesperson for the largest political grouping in the European Parliament, the European People’s Party (EPP).

The start of booster campaigns and who will be offered a shot will come down to national decisions.

Many countries including Austria have been administering second boosters to older and vulnerable people for some time with the existing vaccines. That’s because they still protect against severe disease and death from Omicron, the milder but highly transmissible variant which has caused cases to surge this summer. However, Austria said on Wednesday that, with the arrival of the updated vaccines, it will now expand its campaign to all over 12 years of age.

Germany has said it will launch its booster program next Monday for older and vulnerable people, while France has said it will wait until October to combine it with the flu shot campaign, said Liese, who is also a doctor. “I think both strategies are legitimate,” he told a news briefing on Wednesday.

Get ready

Health systems across the bloc, still struggling with the backlog of patients caused by the pandemic and gripped by chronic staff burnout, are looking for ways to roll out widespread vaccination in the most efficient way. Some countries have now dismantled their network of vaccination centers and are more heavily reliant on the health service to deliver additional boosters.

“I’m not sure we are ready for that,” said Peter Piot, former head of the London School of Hygiene & Tropical Medicine in a recent interview, adding he thought it was “too early to dismantle the COVID special, specific measures” like vaccination centers.

The World Health Organization warned this week that the northern hemisphere faces a tough winter, with the interplay of numerous respiratory viruses that have had little room to circulate over the last two years expected to cause problems. The coming flu season is likely to be atypical, based on data from Australia and Latin America, the WHO said. There, they saw an early, sharp wave of cases, putting health systems under strain. “We need to make use of the COVID-19 platform for effectively using these influenza vaccines whenever it is feasible,” said Siddhartha Datta, WHO Europe adviser on vaccine-preventable diseases and immunization.

The European Medicines Agency’s decision on the updated COVID-19 shots was based on clinical trial data that demonstrated the vaccines — which are tailored to protect against the original coronavirus strain and the first Omicron strain — generated higher antibody levels than the companies’ existing shots, against Omicron and other variants of concern. That includes the latest Omicron strain that is now dominant.

The agency is also reviewing data for a second retooled Omicron vaccine from BioNTech/Pfizer, with a decision expected by the end of the month. That version is designed to protect against today’s dominant Omicron strain and the original Wuhan strain. Moderna has also developed a similar shot, but this will not be available until later in the fall. The U.S. authorized both of these shots for use on Wednesday.

The European Commission’s COVID-19 contracts for both BioNTech/Pfizer and Moderna’s vaccines cover these two types of Omicron-targeting jabs. Once both are available, it will be up to citizens to decide which vaccine they prefer to use.