US FDA Sets Immunogenicity Bar High For Changes To COVID-19 Vaccines
Modified vaccines targeted at new SARS-CoV-2 variants must generate immune response rates not more than 10% below those of the original vaccine, agency says in one of a suite of guidances on medical product development to address variants.
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Experts including renowned virologist Peter Piot, FDA’s Peter Marks and CEPI’s Richard Hatchett discussed multiple dimensions pertaining to coronavirus variants and existing vaccines at a recent conference, noting enhanced post-deployment surveillance is underway in the US. While there’s no need to panic for every variant that emerges, equitable access to vaccines is critical to ensure that gains made over last year are not undone, they said.
Coronavirus Notebook: EMA Issues Guidance On Development Of Variant Vaccines, EU Leaders Urge Production Ramp-Up
A batch of AstraZeneca/Oxford University coronavirus vaccines has arrived in Ghana, the first country in the world to receive vaccines via the COVAX Facility.
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.