In this blog, we reflect on some of the key learnings from the recent pull and push strategies to develop COVID-19 vaccines in the UK, the US, and the European Union. We use our recent work on portfolio management, pricing, and procurement of COVID-19 vaccines (forthcoming as an OHE report) to organise the review.
After the shock caused by the first wave of COVID-19, discovering vaccines against the virus and administering them quickly to the population became the utmost priority worldwide, especially once subsequent waves of COVID-19 were inevitable. Non-medical interventions such as lockdowns and social distancing to prevent the spread of the disease and the collapse of healthcare systems translated into unprecedented falls in gross domestic product. Vaccines became a critical tool not only to save lives but also to ensure that those alive could conserve their livelihoods. Yet, while many of us spent most of 2020 following the number of deaths associated with COVID-19, we started 2021 confronted with the stunning disparity of the COVID-19 vaccination rollout within OECD countries. As of April 14, 2021, the UK has administered 47.79 doses per 100 population, the US 37.05, while the EU lagged at 16.94. The difference in the vaccination rollout between the UK and the US on the one hand, and the EU on the other, have been the subject of many articles and commentaries [a,b,g].
To understand how this problem could be overcome, we were commissioned by a European Parliamentary Group (Renew Europe) to investigate ‘Key factors on how to procure, pay for, distribute, and use vaccines for COVID-19: A European perspective’. In that piece, we discussed tactics for optimal procurement, pricing, and distribution of COVID-19 vaccines, as of November 2020, focusing on portfolio management and rollout strategies. This blog summarises the report’s recommendations and reflects on possible factors behind the slower pace of rollout of the EU vaccination programme.
In the report, we advocate for a vaccines portfolio management strategy that incentivises vaccine candidates’ simultaneous development to achieve vaccine-induced herd immunity as fast as possible. We also suggested that candidates in the portfolio be classified in two priority levels, with homogenous tiers in terms of vaccine development stage, probability of success, and vaccine type (i.e. viral vector, mRNA, proteinic subunit, or inactivated SARS-COV-2).
We also advise that advanced purchase agreements (APA) are a tool to stimulate rapid scaling up of production capacity. For this purpose, we suggest that the expected (and later, observed) quality of vaccines should steer the negotiation of volumes, prices, and delivery timeframes.
In terms of processes, we recommend creating an EU Steering Committee (SC) to design and oversee the process of contracting vaccines based on a banded system. The banded system would consider a pre-defined Target Product Profile(1) (TPP), including vaccine efficacy and safety and immunogenicity, ease of delivery and storage, dose regimen, and durability of protection. The SC should ensure that the European Commission, the European Medicines Agency, and the Member States’ (MSs) healthcare agencies coordinate via the European Network for Health Technology Assessment (EuNetHTA), so that vaccine prices relate to their value, including their extended value-added elements (d). Value-based pricing would be especially beneficial after the initial urgent round of vaccine procurement, whose rapid development and roll out might otherwise be at risk.
We advise that the SC should establish a robust monitoring and pharmacovigilance system to update data on vaccines in the pipeline and those already rolled out. Over time, production capacity should be shifted from lower to higher-value vaccines according to new information and MSs’ unmet needs, as appropriate. The MSs should also develop strategies to avoid overreacting to very rare or ultra-rare safety issues, which are to be expected if only from the sheer volume of the population vaccinated in a short amount of time.
In the report, we also provide some general recommendations for allocating vaccines to MSs and distributing vaccines within MSs, advocating for the guiding principles of effectiveness and solidarity. For that purpose, considering factors beyond population size would be advisable, i.e., the pressure of COVID-19 on the country’s healthcare system and the economy, the MS’s infrastructure, etc. The distribution of vaccines within each MS should prioritise vulnerable groups and key workers, and be flexible to accommodate individual levels of mobility and the availability of each vaccine type.
Finally, we discuss the need to develop a targeted public communication strategy about benefits, risks, and the importance of achieving high vaccination rates to stop COVID-19 deaths, reach vaccine-induced herd immunity, restore the healthcare systems’ capacity to serve all who need care, and rebuild the economy. Information campaigns should understand and responsibly use social media and mass media communication tools to connect with populations unsure about vaccination and monitor the campaigns’ effectiveness to fine-tune them.
Since the report’s launch on November 20, 2020, the European Commission’s executive team has implemented some of the recommended strategies. There have been negotiations with different vaccine producers simultaneously. APAs have been used to guarantee rapid scaling up of production capacity. Most countries have developed a plan for vaccine delivery.
However, we have identified areas in which the proposed tactics have not been applied due to inaction or unforeseen events. These may partly explain the slower rollout of vaccination in the EU. We discuss a list of them below:
- We recommended APA contracts as the appropriate pull mechanism, which have been pursued. Yet, looking at the issues that emerged with the vaccine supply to the EU, the procurement contracts may have been poorly designed. Insufficient liability specification could be a factor in the failures and/or delays in the supply of vaccines [a, b].
- We advised to set up APAs with vaccine producers of three different types: mRNA, viral vector, and protein subunit. Further, we suggested establishing two tiers: Tier 1 containing the first line of prioritised candidates and Tier 2 those that, at that moment, seemed to be second-best options.
- Having two tiers or a contingency plan would minimise both the risk of failure in developing some candidates and the risk of real-world safety concerns about one particular vaccine to disrupt the supply critically.
- Diversification of types within each tier might prevent delays stemming from vaccines of the same type having a similar probability of development failure, safety issues, and vaccination interruptions compromising rollout.
In retrospect, our suggestion of tactical negotiations of contracts with another Tier 2 protein subunit would have been beneficial. Novavax, a protein subunit vaccine we classed in Tier 2, is currently under review by EMA, and negotiations are only ongoing now [e,f]. A two-tiered plan and negotiations starting before the end of 2020 would have been preferable to rushing it in 2021.
- Through a joint procurement strategy, the EC has exerted its bargaining power, resulting in cheaper doses for the EU than the US and the UK [g, k]. However, this strategy might be partly behind the observed failures and delays in the supply to the EU [b, c, h]. Using some aspects of value-based pricing or cost-effectiveness, coordinated by EUnetHTA, might have avoided firms’ lack of incentives to prioritise supplying the EU.
- We proposed continuous renegotiations and re-contracting for volumes, prices, and delivery timeframes based on vaccines’ demonstrated quality. In the light of their real-world performance, the EU should have sought earlier to increase the number of doses of the mRNA vaccines [i, j].
- As we forewarned in the report, ultra- and even very-rare adverse events were likely to arise due to the population’s massive vaccination. The robust EMA pharmacovigilance system has accounted for them efficiently [h]. Nevertheless, we also highlighted that anticipatory campaigns informing vaccines’ risks and benefits were vital to mitigate vaccine hesitancy. Yet, the opportunity to inform and educate the public preventatively has been missed. Very rare adverse events have triggered interruptions in MSs’ vaccination programmes, intensifying citizens’ distrust of COVID-19 vaccines’ safety, and slowing down the vaccination pace [a, b, c, h].
- A more speculative point is the lack of a more effective joint vaccine push strategy in the EU. The US and UK both contributed substantial funding for some vaccines (push incentives) [m, n, o]. Their negotiating focus compounded this strategy: they concentrated less on low prices and liability and more on volumes. This may, to some extent, explain why manufacturers have prioritised these two markets over the EU [a, b, c, h].
The vaccination rollout puzzle has been subject to intense debate producing multiple views and explanations. In sum, despite its incommensurable devastating effects, COVID-19 has taught the world valuable lessons such as the need for pandemic and catastrophes preparedness and the necessity for innovating regulatory strategies to achieve medical innovations at an extraordinary pace. The ultimate message has probably been how much humans value health and the lengths they will go to re-establish it when threatened.
(1) See the WHO TPP for Covid-19 vaccines for an example: https://www.who.int/publications/m/item/who-target-product-profiles-for-covid-19-vaccines
[b] Why the EU’s covid-19 vaccination programme went wrong? The Commission should have done much better. The Economist. Briefing, April 3, 2021, Edition.
[c] Why has the EU been so slow to roll out a Covid vaccination programme? | Bruegel by Guntram Wolff, Director of the Brussels-based Bruegel think tank.
[e] EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373), February 3, 2021.
[f] EU close to vaccine supply deal with Novavax February 11, 2021.
[g] What Covid vaccines cost - and the countries paying over the odds. The Week. March 30, 2021.
[h] Vaccines: A Very European Disaster - P. Krugman. The New York Times. March 18, 2021.
[m] Funding and manufacturing boost for UK vaccine programme - GOV.UK (www.gov.uk)
Posted in Innovation, Pricing and Reimbursement, Risk-sharing Arrangements | Tagged Briefing