EU, UK & Brazil Take Steps To Boost Access To Monkeypox Vaccines
Regulators in the EU and the UK are exploring the intradermal use of monkeypox vaccine as a dose-sparing measure to stretch out scarce supplies, while Brazil is to waive the registration requirements for imported vaccines and therapeutics for monkeypox.
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Immunogenicity Data Drove Monkeypox Dose-Sparring Decision…It Also Drove Initial Approval
Comfort with the initial approval based on inferred effectiveness may have made the current EUA process more palatable to US FDA officials but means there is a bigger gap in what’s known about the vaccine’s effectiveness overall.
EMA To Track Monkeypox Medicines Stock & Boost Emergency Task Force Output
The European Medicines Agency is taking more actions to tackle monkeypox now that the disease has been declared a public health emergency.
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.