COVID Mutants: Vaccine Changes Likely To Need Immunogenicity Studies, Not Big Efficacy Trials
US FDA considering approach that is similar to, but more stringent than, influenza strain changes, CBER Director Marks says. Meanwhile, vaccine developers face challenge of when to change antigens to get the best results, NIH’s Graham notes. As FDA and sponsors gain more experience with tweaking the vaccines to account for new coronavirus variants and strains, the process may be expedited further.
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Pfizer and Moderna execs note they have sufficient resources with their partners to meet their vaccine production commitments. J&J, which has a manufacturing arrangement with Sanofi, is ready to ship four million doses of its vaccine upon receiving authorization from FDA.
Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.