He covid19 It is no longer an international public health emergency. However, both the European Medicines Agency (EMA) as the European Center for Disease Control and Prevention (ECDC) consider it vital to maintain “guard up & rdquor; before the appearance of new variants of the virus. Looking ahead to the coming winter, both organizations recommend the use of monovalent vaccines, which include the dominant XBB variant, in the vaccination campaign should give priority to adults elderly, immunosuppressed peoplepeople with amedical conditions underlying disorders regardless of age, womens pregnant and health personnel.
“This virus is still circulating and there are new variants that are emerging, so the virus is and will continue to be a threat, especially for the most vulnerable,” recalled the head of the EMA’s vaccine strategy, Marco Cavaleriduring the last regular press conference organized by the organization.
A challenge that persists
Cavaleri, who accompanied the director of the EMA in the presentation, emer cookehas warned that the covid19 continues to be a challenge for European healthcare systems, particularly during the winter, when other respiratory viruses such as influenza circulate, and has asked public authorities to remain vigilant, with “the guard up & rdquor ;, and citizens, to trust vaccines because “they continue to be the best option & rdquor; against the virus.
“They have managed to save almost 20 million lives during the first year of the pandemic,” recalled Cooke, who has emphasized the 8 vaccines against covid and the 8 treatments approved during the pandemic.
diminishing protection
The authorized covid vaccines in the EU include the following strains: Wuhan and Omicron BA.1 bivalent, Wuhan and Omicron BA.4/5 bivalent, Wuhan monovalent, Beta monovalent (B.1.351) and Beta bivalent (B.1.351). and Alpha (B.1.1.7). Based on the diagnosis of both organisms, the available efficacy data show that all of them, including those based on the parent virus, continue to provide protection against serious disease. However, this decreases as the virus mutates into immunologically distant variants of the strains included in the vaccines.
And that is what is currently happening, that the virus “seems to evolve, diverging from the original & rdquor ;. Specifically, based on surveillance and sequencing data, the lineages descended from XBB.1 are currently predominant worldwide (i.e. XBB.1.5, XBB.1.16, XBB.1.9), including all 27 Member States, which means that it is necessary to update the composition of the vaccine to make it more effective next winter, as agreed with US regulators on May 8.
Adaptation
The EMA, as confirmed by Cavaleri, is already working with the pharmaceutical industry to prepare the ground. Several laboratories, those that make mRNA-based vaccines and Novavax, have shown interest in adapting their treatments. Approval may be based on manufacturing/quality and non-clinical data only, provided that the vaccine platform can demonstrate predictability of clinical immunogenicity and reactogenicity.
“The inclusion of a strain belonging to the XBB family of omicron subvariants is suitable to ensure cross-reactivity against current dominant and emerging strains, and XBB.1.5 is considered a reasonable choice to increase the breadth of immunity also against the lineages descendants of XBB& rdquor;, recommend the experts, who do not rule out considering other XBB strains in the composition (such as XBB.1.16) whenever it is adequately justified, as well as other “alternative compositions& rdquor;.
Under 5 years
The EMA shares that the monovalent vaccines could be used for the revaccination next winter and also for primary vaccination of children under 5 years, who are more likely not to be infected with the virus and never to have been vaccinated. “This age limit is conservatively based on epidemiological data indicating that children older than 5 years have been heavily exposed to SARS-CoV-2, either through infection, vaccination, or both, and therefore have already generated a specific immune response & rdquor; to the virus.
“For individuals older than 5 years, when vaccination is recommended according to national guidelines, a single dose of the newly adapted vaccine. For children under 5 years of age, with no history of vaccination or previous infection with SARS-CoV-2, a primary series consisting of 2 or 3 doses is recommended depending on the specific vaccine to be administered. Use in the pediatric population is expected to follow national guidelines,” the agency says. In the case of people with compromised immunity, however, additional doses may be necessary. “The number of doses and the intervals must be adapted to each patient depending on the severity of the condition and in accordance with national recommendations,” the agency explained.
vaccination schedule
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Regarding the period between vaccinations, revaccination will be possible at intervals of 3 months with respect to the previous dose, depending on the epidemiology and the target population. In vaccination campaigns, however, longer intervals may be considered, of at least 4 monthsbased on actual evidence of a high level of protection against severe disease that is maintained for at least 4 months after revaccination.
Regarding the groups to prioritize, the EMA recommends first inoculating people who are at risk of progressing to severe disease once infected due to risk factors, such as older adults (over 60 years of age), immunosuppressed people, those with underlying medical conditions regardless of age and pregnant women. In addition, health personnel should also be considered by public health authorities as a priority.