European medicines regulator gives green light to Omicron COVID-19 shots – POLITICO

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

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

Countries across Europe have planned booster vaccination campaigns in anticipation of cold weather, a return to indoor socializing and schooling and the possible emergence of another variant of the coronavirus that will 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 weakened immune systems due to illness or treatment and healthcare workers, be prioritized for another booster dose. They are due to release new guidelines next week after adding these updated COVID-19 vaccines.

The two updated vaccines “are being developed to provide increased and broader protection against current and future variants,” said Health Commissioner Stella Kyriakides. “We have to be prepared for another winter with COVID-19.”

The European Commission will now fast-track its approval of the regulator’s decision, with the first deliveries of the two vaccines arriving in time for vaccination 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 vaccines 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 recall campaigns and who will be offered a chance will depend on national decisions.

Many countries, including Austria, have for some time given second boosters to the elderly and vulnerable with existing vaccines. That’s because they still protect against serious illness and death from Omicron, the milder but highly transmissible variant that caused an increase in cases this summer. However, Austria said on Wednesday that with the arrival of updated vaccines it would now expand its campaign to all over-12s.

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

Be ready

Health systems across the bloc, still grappling with the backlog of patients caused by the pandemic and plagued 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 reliant on health services to provide additional boosters.

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

The World Health Organization warned this week that the northern hemisphere is facing a harsh winter, with the interaction of many respiratory viruses that have had little room to circulate in the past two years and are 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 and brutal surge of cases, straining health systems. “We need to use the COVID-19 platform to effectively use these flu vaccines whenever possible,” said Siddhartha Datta, WHO’s adviser for Europe on vaccine-preventable diseases and vaccinations.

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

The agency is also reviewing data from a second revamped Omicron vaccine from BioNTech/Pfizer, with a decision expected by the end of the month. This version is designed to protect against Omicron’s current dominant strain and the original Wuhan strain. Moderna has also developed a similar blueprint, but that won’t be available until later in the fall. The United States cleared the use of those two shots on Wednesday.

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

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