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COVID-19 Vaccine Updates
1. COVID-19 vaccines that have been modified to work against virus variants should have clinical immunogenicity studies that support that they are effective, and make sure that the vaccines work not only against the variant strain, but also the initial strain, noted the FDA in updated guidance.
2. Manufacturers are required to conduct booster studies, where the modified vaccine is administered to those who have already been inoculated with the initial vaccine, in order to ascertain the immune response in these people as well.
3. FDA wishes to determine whether the immune response is comparable against the new variant and also wants to ensure that it is safe to boost those who have already received vaccination.
4. The studies would include hundreds of people and would take a few months to complete.
5. The guidance recommends that immunogenicity studies must compare neutralizing antibody seroresponse rates and geometric mean titers (GMTs) for the modified vaccine against the variant, and the modified vaccine against the initial virus that was used for the primary vaccine.
6. Updated guidance about monoclonal antibodies has also been issued.
7. The new guidance urges test manufacturers to consider the variants also and to monitor mutations that can affect the performance of molecular diagnostic tests.
8. Tests with several targets and appropriate result interpretation criteria have been used to determine the signals that a sample may include a variant and must be followed up with additional testing or sequencing of the viral genome.
9. The FDA has cautioned that variants may lead to false negative results with some diagnostic tests.
[Source: Medpage Today]
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA