The Covid-19 vaccine was the best tool to prevent severe disease progression during the corona pandemic. But Sars-CoV-2 will remain with the world. How best to deal with it is what the U.S. Food and Drug Administration (FDA) is having a panel of experts discuss Thursday. On the table is a proposal for an annual two-dose vaccination for infants, the elderly and the immunocompromised.
“Food and Drug Administration scientists are proposing to make Covid-19 immunization a regular, once-a-year vaccination with an adjustment for each current Sars-CoV-2 strain, say the documents, which the FDA released Monday,” wrote U.S. Pharmaceutical Information Service Stat.
Annual precaution in fall
The FDA’s Advisory Panel on Vaccines and Related Biologics meets Thursday. Experts from what remains the world’s most powerful drug agency are expected to provide feedback on whether they think such a strategy for switching from pandemic vaccination to annual preventive care – preferably in the fall – would make sense.
In the future, the FDA said in its proposal, Covid-19 vaccination could be appropriate for adults once a year at a time. Two doses of the vaccine could then be given to young children, older adults and people with weakened immune systems. Young children are likely to be largely free of any prior contact with Sars-CoV-2 until vaccination shortly. People 60 or 65 years of age and older already show a poorer response to vaccination, including immunocompromised individuals with certain pre-existing conditions or medical therapies that weaken the immune system.
This possible new vaccination scheme does not entirely convince Florian Krammer. The vaccine expert from Styria, who lives and researches in New York, wrote on Twitter that he was not a fan of this approach. Instead of coming up with a new strategy, he said, people are simply going to a regimen they know from influenza, which is not optimal there either.
Adapting vaccines to pathogen strains
For an annual vaccination, the procedure by which the vaccines are adapted to the current pathogen strains is also important. In the case of influenza, antigen selection is carried out regularly by the WHO for the southern and northern hemispheres of the world and annually for the north as early as these weeks. The drug authorities no longer need completely new approval of the adapted vaccine. The vaccine is adjusted in its antigen content. All Covid 19 vaccines in the USA will likely have a component against both the Sars-CoV-2 pathogens originally from Wuhan and against Omikron variants.
Last weekend at the Austrian Vaccination Day in Vienna, German virologist Ulrike Protzer explained that unvaccinated people in the U.S. had a 16-fold higher hospitalization rate than those adequately immunized with the first vaccine variants. Boosting with a new vaccine adapted to BA.4/5 would result in another 2.7-fold lower hospitalization rate for breakthrough infection. The positive effect was also seen in subsequent viral mutants.
According to FDA experts, an Israeli study that has not yet been subjected to the peer review process showed that the new bivalent vaccine (BA.4/5) as a booster resulted in an 81 percent lower hospitalization rate and an 86 percent lower death rate in people over 65 years of age compared with no revaccination.
The FDA has not yet taken a position on the issues to be discussed Thursday. “I assume that the agency is open to advice and that they are not quite clear yet on how to proceed,” Paul Offit, a member of the expert panel and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, was quoted by The New York Times as saying about the questions.
Based on hard information
Much is still unclear for Eric Rubin, also a member of the convened panel and editor-in-chief of the world’s most respected medical journal (New England Journal of Medicine/Boston). “I would like to see scientific data on the effect of the vaccination interval (once a year?; note), at least from observational studies,” he explained. Somehow, he said, one needs to be able to assess, based on hard information, whether one is headed in the right direction with the envisioned strategy. After all, it should be clarified whether once-a-year vaccination against Covid-19 is sufficient for sufficient protection in the future. The recommendations are also crucial for the production of vaccines.
- source: kleinezeitung.at/picture: pixabay.com
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