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Three Vaccine Assumptions for 2021

Summary:
As COVID-19 vaccination programs scale up globally, they must be able to withstand reality. Policymakers need to incorporate three realistic assumptions into their immunization plans: delays are inevitable, inequality will increase, and vaccine procurement could be a proxy for geopolitics. KUALA LUMPUR – Vaccinating the world against COVID-19 is one of mankind’s most critical non-wartime efforts ever. Many countries have developed ambitious, politically sensitive, and carefully sequenced vaccination plans, but executing them successfully will be a challenge. To succeed, policymakers should build three realistic assumptions into their vaccination planning for 2021 and beyond. No Time to Waste

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As COVID-19 vaccination programs scale up globally, they must be able to withstand reality. Policymakers need to incorporate three realistic assumptions into their immunization plans: delays are inevitable, inequality will increase, and vaccine procurement could be a proxy for geopolitics.

KUALA LUMPUR – Vaccinating the world against COVID-19 is one of mankind’s most critical non-wartime efforts ever. Many countries have developed ambitious, politically sensitive, and carefully sequenced vaccination plans, but executing them successfully will be a challenge. To succeed, policymakers should build three realistic assumptions into their vaccination planning for 2021 and beyond.

First, delays are inevitable. More than two months after the world’s first COVID-19 vaccine injection on December 8, 2020, hopes of a rapid rollout are fading in many countries. Production holdups have triggered European Union threats of legal action and export restrictions. And there are several reasons to expect further delays.

For starters, the manufacturing constraints are daunting. Firms must scale up or repurpose factories to produce billions of doses annually, and vaccine supply chains are still being built even as they are being stretched. For example, the Pfizer/BioNTech and CureVac vaccines use lipid nanoparticles manufactured by the same supplier.

Moreover, capacity expansion through technology transfer – say, from AstraZeneca to Thailand’s Siam Biosciences – involves legal and technical hurdles. If new coronavirus variants reduce current vaccines’ effectiveness, vertically integrating the research-to-manufacturing process may enable a faster and more agile response.

Other legal and regulatory obstacles also could cause delays. Many countries have signed bilateral advance purchase agreements (APAs) with vaccine manufacturers, most of which are subject to the vaccine gaining regulatory approval and involve phased delivery and a refundable deposit. But APAs may be difficult to enforce, and international law must evolve rapidly for dispute resolution to be effective.

The United Kingdom’s regulator was the first to approve the Pfizer/BioNTech vaccine because it benefited from rolling data submissions from clinical trials – an opportunity that should be accorded to other regulators, regardless of market size or wealth. A new approval process may be needed for vaccine variations in response to new coronavirus variants, perhaps modeled after the abbreviated approval pathway for seasonal variations in influenza vaccines.

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