Manufacturing Pace Is Key For COVID-19 Vaccine Candidates Hoping To Jump To ‘Warp Speed’
Ease of manufacturing scale up may determine which candidates advance furthest in the US government's partnership with industry to speed COVID-19 vaccines to patients. Senior government officials also discussed approval standards, how a vaccine would be distributed, and how much the government and Americans could pay in a 16 June press call.
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Drug pricing experts are concerned the US government may not follow through on its commitment to pay less for COVID-19 vaccines it has helped fund given reports Moderna may be pushing a $50-$60/course price. The US also has little ability to control pricing in the private market – even for some government payers.
Ability to quickly scale manufacturing is a key criteria for Operation Warp Speed therapeutics, but for monoclonal antibodies the most effective approach may mean fewer doses. FDA’s Janet Woodcock said the government is supporting a range of antibody approaches for COVID-19 so that if virus escape mutants emerge from single antibody treatment there will be other options, while Regeneron argues the cocktail approach is safer, even though it will likely mean fewer doses of drug will be available.
CBER Director Marks explains that too high a bar might result natural herd immunity before vaccine trials could be completed, while too low a threshold could result in approval of products with limited efficacy.