The mRna preparations can be updated in 100 days, but the manufacturers Moderna and Pfizer BioNTech evaluate if the dose boosters are enough
Is it Possible to Update a Vaccine Against Omicron?
S, mRNA vaccines, quindin Modern e Pfizer-BioNTech they are built with a technology that should allow a rapid modification capable of intercepting the variant. There great flexibility this is the strong point of this category of vaccines: it is enough change only the mRNA molecule which contains the information for the production of the Spike protein and instruct the immune system to fight against the virus, without further changes to the platform used.
What are the steps to follow?
Based on the knowledge acquired so far, once the gene sequence of the new variant (that of Omicron was published on 23 November) is known, it takes about two months to synthesize and test the new mRNA for the updated vaccine in the laboratory. Between clinical trials and production, 3-4 months should elapse.
What are the times announced?
Shortly after Omicron’s discovery, when the World Health Organization called it a concern variant, both drug companies announced that they had already started work on updating the vaccine, after general testing with other variants such as Delta and Beta. The two companies have talked about 90-100 days to be able to update the Omicron vaccine
, announcing that the new product may be ready for distribution by March. However, the days necessary for clinical trials and practices for approval by regulatory bodies must be added to the actual times for creating the update, and therefore it is likely that the vaccine can be actually available for use starting in June.
How will regulatory agencies behave for approval?
It is assumed that they will be less stringent because the product is very similar to the original vaccine and the procedures should be leaner, with an even faster path than that which led to the approval of the vaccine for children. They might be enough a few hundred people on which to test whether the levels of antibodies produced are sufficient and effective against Omicron or perhaps it will be sufficient to have used the same technique as the current vaccines without further additional clinical tests. However, it is not yet clear what information the regulatory authorities will ask for, which could also be different depending on the country, and consequently the timing for the approval of the vaccine adapted to Omicron could vary.
Will the new vaccine actually be produced?
Not said, one decision not yet made and reflections on this point are underway. The pharmaceutical companies involved are evaluating through studies whether one is really needed new version of the vaccine or is it enough a booster of the existing product. In any case, the decision rests with the companies.
Not enough booster dose against Omicron?
That might be enough. The third dose of Pfizer indicates a significant increase in antibody response: one month after the third dose iantibody levels were increased 25 times
compared to those identified three weeks after the second dose and the ability to neutralize Omicron is maintained, albeit with lower levels than those found against Delta. At the same time, the levels of T lymphocytes able to recognize different parts of the spike protein. Also the third half dose of Moderna (50 micrograms) in use in Italy he has increased significantly i titers of anti-Omicron neutralizing antibodies. Two doses of both preparations would still be sufficient to defend against serious illness. Moderna is also studying a 100 micrograms booster, i.e. at full dose and efficacy results are expected within the week. The American company is finally working on two versions of a multivalent vaccine that could also be useful against Omicron. The unknown, both for the booster and for the updated version of the vaccine, is the duration of protection. In Israel, the very first unpublished Pfizer data would already indicate a decline in antibodies three months after the third dose.
December 20, 2021 (change December 20, 2021 | 09:40)
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