Brussels Morning sits down with Pfizer’s Director of Government Affairs to shed corporate insight in the ongoing debate on vaccine diplomacy.
Brussels (Brussels Morning) The enemy is the virus, argue corporates; but the introduction of an effective export ban on COVID-19 vaccines by the European Commission at the end of January spurred political controversy over the question of ‘protectionism’ and ‘Europe first’ vaccination politics. The virus is not the sole enemy in a battle in which public trust is a crucial factor.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) opposes the EC measure, even as pharmaceuticals acknowledge government frustration as regards to supply. Corporates caution that the challenge of producing and distributing vaccines around the world is big enough without additional regulatory constraints. “Supply chain adjustments”, they warn, may add to the rollout delay rather than reduce it”.
Part of the political issue is a perceived standoff between Britain and the EU against the background of Brexit. The UK government boasts one of the most successful vaccination rollouts in the world with supply not appearing to be an issue. By contrast, the EU has been facing increased criticism for the way it has been negotiating the purchase of vaccines in what has become a political blame-game battle, with the European Commission blaming the UK-based AstraZeneca for its sluggish delivery. Demand for vaccines is high across the bloc but delivery remains fragmented and uneven throughout member states. Hungary and the Czech Republic have moved to order the Russian Sputnik vaccine, triggering another semantic battle with Brussels.
Tension rises as a number of EU member states – Italy, France, Spain and Ireland – have frozen the rollout of the British-made vaccine, on allegations of its relation with blood clotting incidents, despite European Medicine Agency (EMA) assurances that the benefits of the vaccine outweigh the risks.
In this context, the significance of disrupting exports of the Pfizer vaccine may be more significant. To get a better grip of the situation, we catch up with Pfizer’s Director of EU government affairs, Andrea Chiarello, to gain corporate insight on this debate. The interview was completed on 16 March, the same day the European Commission announced a deal for an additional 10 million Pfizer vaccine doses to be delivered over the second quarter of 2021.
Marta Pacheco (MA). Pfizer was the first company to reach the COVID-19 vaccine market. Does the need to retain the drug in sub-zero temperature mean that it is not as fit for use in developing economies?
Andrea Chiarello (AC). Thankfully, no, we have ensured this is not the case. In fact, we are already successfully delivering the Pfizer/BioNtech COVID-19 vaccine to many countries around the world. Equitable access for our vaccine has been a guiding principle for Pfizer. We are working closely with local government on this point.
Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs where vaccine can be stored until its expiration. The company’s distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need, minimising requirement for long term storage.
We have developed packaging and storage innovations to be fit for purpose to meet the needs of our global network. We have specially designed, temperature-controlled thermal shippers utilising dry ice to maintain recommended temperature conditions for up to 10 days unopened. The intent is to utilise Pfizer-strategic transportation partners to ship by air to major hubs within a country or region and by ground transport to dosing locations. We also utilise GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes, 24 hours a day, seven days a week. These GPS-enabled devices will allow Pfizer to proactively prevent unwanted deviations and act before they happen.
Once a ‘point of use’ receives a thermal shipper with our vaccine, they have three options for storage, including using the thermal shipper itself as a temporary storage unit. The various storage options at the POU allow for equitable access to the Pfizer vaccine to areas with differing infrastructure.
MA. What are the main factors holding up the scaling up of production worldwide? What are the plans for the production of the Pfizer vaccine in developing economies?
AC. We have made several enhancements to our COVID-19 vaccine manufacturing facilities and processes – which has doubled our output. As a result of these efforts and with the incorporation of the updated six-dose label, we believe we can deliver more than 2 billion doses worldwide by the end of 2021 – an increase from the previous up to 1.3 billion doses initially projected.
Among several other improvements, we have reduced our timelines from approximately 110 days from start to vial-ready, and we are now approaching an average of 60 days – almost a 50% improvement.
The production itself is currently taking place across several of Pfizer’s manufacturing sites including in Puurs, Belgium and Kalamazoo, US.
However, we are already delivering in developing economies — our supply chain is practical and reliable, and we are able to ship directly to vaccination centers within one to three days.
We have allocated doses for supply to low- and lower-middle-income countries at a not-for-profit price. We are also a proud partner to COVAX, providing up to 40 million doses of our COVID-19 vaccine in 2021, subject to the execution of additional agreements under the COVAX structure. We support all efforts aimed at providing developing countries with the same access to vaccines as the rest of the world.
As of 5 March, Pfizer-BioNTech doses allocated through the COVAX facility have reached Rwanda, South Korea and Colombia. Shipments will continue to go to a diverse range of countries in every region of the world.
MA. To what extent was the development of the Pfizer program sponsored by the taxpayer?
AC. Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded.
We have already invested billions of dollars in an effort to find a solution to this pandemic. We prepared to continue bearing the costs of all development and manufacturing scale-up costs.
MA. What do you feel will be the effect of an export ban of the Pfizer vaccine?
AC. Free movement of goods and supply across borders is absolutely critical to Pfizer and the patients we serve. Since the Regulation’s inception in late January, it has caused a significant administrative burden and uncertainty on our tightly calibrated supply chains. Ultimately, we would like all of our people in our sites to be focused on making and distributing the vaccine.
MA. Are all vaccines equally effective? Would you say that “any, will do”?
AC. I’m not a scientist or a doctor so cannot speak to the various data for the COVID-19 vaccines – it is important that people follow their doctor’s advice. But what I do know is that Albert Bourla, our CEO, said from the start that no one company or innovation would be able to bring an end to the COVID-19 crisis.
And that the only real competitor was the virus and time.
What is important to remember, is that all authorised vaccines go through rigorous checks by independent regulators to ensure the safety and efficacy standards are met.
In the case of the Pfizer/BioNtech COVID-19 vaccine, we have more than 46,000 trial participants on our Phase III clinical trial. The participants were followed for a median of two months following the second dose of the vaccine candidate and will continue to be monitored for two years. The data from the Phase III trial are published in The New England Journal of Medicine — these data show a vaccine efficacy rate of 95% and an overall favorable tolerability profile with no safety concerns reported by the Data Monitoring Committee (DMC).