Coronavirus Notebook: EMA To Decide On Comirnaty In 12-15-Year-Olds, Cuba Presses On With Homegrown Vaccine Rollout
At global level, Médecins Sans Frontières has called for all countries to support a revised version of the IP waiver for COVID-19 vaccines, singling out the recalcitrant European Commission for special attention.
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The pharmaceutical industry and Médecins Sans Frontières have both criticized the EU’s proposals for avoiding a waiver of intellectual property rights on COVID-19 vaccines and treatments, albeit for different reasons.
The European Commission is to present the World Health Organization with a set of proposals to tackle the barriers to the global rollout of COVID-19 vaccines. They include allowing the issue of compulsory licenses without consulting the rights holder, encouraging vaccine companies to expand production through licensing deals and contract manufacturing, and eliminating vaccine export restrictions.
Emergency use authorization in 12-15 year-olds follows announcement of a June advisory committee meeting on pediatric data requirements, including the FDA’s criteria for younger children. Authorization for US adolescents has raised ethical questions about prioritizing this lower-risk group over hard-hit populations overseas.