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COVID-19 Vaccine Distribution (Blog 1)

COVID-19 Vaccine Distribution (Blog 1)

By Dr. Anne Stolle & Marina Beer

Release date
08/10/2020

October 16th, 2020

The novel coronavirus Sars_CoV2 belongs to the class of RNA (RiboNucleic Acid) viruses and has resulted in the ongoing pandemic that has cost thousands of lives and affected millions. In order to avoid further human suffering as well as economic setbacks, it is of the utmost importance to vaccinate the majority of the global population as quickly as possible. To do so, undertaking research and producing COVID-19 vaccine candidates is only a first step. We discussed aspects that have to be taken into consideration in the global development and distribution of a COVID-19 vaccine with our experts Dr. Anne Stolle, who conducted postdoctoral research in the spread of infectious diseases at leading UK universities, and Marina Beer, expert in the field of pharmaceutical cold chain.

How many COVID-19 vaccine doses are required to immunize the world?
From a healthcare perspective, it is preferable to vaccinate a sufficient percentage of the population so as to achieve herd immunity and protect those who are most vulnerable. Depending on the source, 50 to 85% of the population would require a COVID-19 shot to achieve this. The proportion of the population that needs to be immune to the virus to result in herd immunity depends on the basic reproductive number Ro. That is the number of people one person infects while they go through the various (asymptomatic and symptomatic) stages of the coronavirus disease COVID-19. Based on a conservative Ro of 2.5, that proportion would be 60%. An Ro of ~4 as derived from scientific mathematical modeling papers would require 75%. One might want to even exceed this number as it can be expected that some of those vaccinated will not develop immunity to the virus. With around 7.8 billion humans inhabiting the earth, vaccinating 60% would result in a need of 4.7 billion vaccine doses (assuming one shot is sufficient to induce immunity) or 9.4 billion doses (in the case of a vaccine that requires an additional booster shot).

What are the current global plans to tackle the pandemic?
Making such quantities of vaccine doses available is obviously a major task that will take years to implement. In order to reduce COVID-19-related mortality and to protect health systems, the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), the vaccine alliance GAVI and the United Nations collaborate, with the aim of providing equitable access of all countries to the Covid19 vaccines. 
As a first step they plan to end the acute phase of the epidemic by the end of 2021. To this end, health care staff are planned to be immunized first (to cover a small part of the population ), followed by high risk adults and  eldery people (for a total of 20% of the respective population). To that end, manufacturing capacity for up to 2 billion vaccine doses by 2021has been secured.
In contrast, the governments of many European, North American and other countries seem to be making provisions to vaccinate 60% or more of their respective population by entering into bilateral or multilateral agreements with various vaccine manufacturing companies. Many of these governments, however, also plan to start vaccinating health care staff and vulnerable people preferentially.

Who are the frontrunners in delivering a successful COVID-19 vaccine?
After the genome of SarsCov-2 had been sequenced in January 2020, an overwhelming number of pharmaceutical and biotech companies made it their prime goal to combat the virus. While many looked into developing new therapies against COVID-19 (e.g. Regeneron, Eli Lilly) or repurposing existing medications that proved effective against the virus (e.g. Gilead’s Remdesevir), the majority started tackling the task of finding a vaccine to keep the pandemic from spreading further. The New York Times Coronavirus Vaccine tracker gives a current overview of the number of vaccines in clinical development (more than 50 to date): www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html). The total number of vaccine candidates in any stage of research and development has already well surpassed the mark of 300. As of mid September, nine companies successfully completed the early phases of clinical research and entered their candidates into phase III studies. The data from these studies and their respective patients will be the basis for approval and registration of the vaccines, a necessary step before they can be distributed and administered.

Developing companyType of vaccine & nameNecessary dosesStorage and shipment temperatureCountry
Gamaleya InstituteGam- COVID-Vac-Lyo
Vector-based vaccine (Adenovirus)
2 – 8 °CRussia
J&J JanssenAd26.COV2.S Adenovirus Vector vaccine2 – 8 °CUSA
CanSinoRecombinant Adenovirus Type 5 Vector vaccine2 – 8 °CChina
University of Oxford / AstraZenecaRecombinant viral vector (Adenovirus)
ChAdOx1 nCoV-19 or AZD1222
22 – 8 °CUK
ModernamRNA                
mRNA-1273
2–20 °C US
SinopharmInactivated:  
„SARS-CoV-2 vaccine“
22 – 8 °CChina
SinovacInactivated:    
„adsorbed Covid19 vaccine“
22 – 8 °CChina
BioNTech / PfizermRNA :             
BNT162b2
2–78 °C (dry ice)Germany and USA
Novavax

Protein-based recombiant spike protein nanoparticle plus adjuvant

22 – 8 °CUSA

 

Four of these vaccine candidates are so-called Adenovirus vector vaccines. That means that some crucial genetic information of Sars-Cov-2 (usually coding for the “spike” protein protruding from the envelope of the virus) has been packaged into the envelope of a harmless common cold virus (Adendovirus). The Gamaleya Institute, Astra-Zeneca/University of Oxford, CanSino and Johnson & Johnson utilized this approach. The vaccine candidate developed by Novavax consists of recombinant spike protein nanoparticles with an adjuvant.

What is the global manufacturing capacity for COVID-19 vaccines?
Without the Chinese and Russian vaccine candidates, the above-mentioned companies stated combined yearly manufacturing capacities of more than 5.5 billion doses. The fact that seven out of the nine frontrunner vaccines are predicted to require two doses per person, will prolong the immunization of the global population. In order to be able to deliver on the immediate demand for a COVID-19 vaccine, European and US vaccine developers are entering into contract manufacturing agreements and are acquiring necessary manufacturing capacities, where this is possible. AstraZeneca’s largest partnership is with the Serum Institute of India, who stated a yearly COVID-19 vaccine manufacturing capacity of 1.5 billion doses. AstraZeneca’s total yearly dose capacity is expected to reach 2.5 billion. The largest vaccine manufacturer by dose, the Serum Institute has not only announced a partnership with AstraZeneca but also with Novavax. Moderna has partnered with Lonza to increase its yearly COVID-19 vaccine dose capacity to 1 billion. BioNTech’s cooperation with Pfizer and Fosun Pharma will deliver more than 1.3 billion doses yearly, once approved. 

How do vaccines developed based on different technology platforms differ in storage and shipment requirements?
A novel approach has been initiated by Moderna and BioNTech, who are developing an mRNA (messenger RNA) vaccine. Early development of this new type of vaccine faced several challenges, including the instability of mRNA in vivo and difficulty in efficiently delivering the mRNA into human cells. Recently, these obstacles have been tackled effectively by new technological advances, thereby facilitating the development of several mRNA vaccine platforms. mRNA vaccines may be developed more rapidly and upscaling their production is less costly when compared to conventional vaccine types. However, vaccines developed using mRNA technology usually require deep-frozen storage and transport during the entire lifetime up until a few hours before administration. This requirement is prohibitive for its distribution to many parts of the world, particularly to countries in the developing world. Moderna invested extra time and effort and apparently succeeded in making their mRNA vaccine more stable, thereby apparently allowing for storage and shipment temperatures of -20 °C or even +5 °C (for months only, so ideally at the administering site). Vaccines using inactivated forms of the virus or viral vectors as well as protein-based vaccines can be stored and transported at +2 to +8 °C. Recent news from Johnson & Johnson suggest that their viral vector vaccine will also be stable at -20 °C for up to 2 years. 

Where are most of the COVID-19 vaccines going to be manufactured?
The majority of vaccine manufacturing we know of is taking place in the US, Europe, India and China. Whereas AstraZeneca secured manufacturing capacities with the Serum Institute in India and Shenzhen Kangtai in China in addition to their manufacturing capabilities in Europe and the US, Moderna has expanded their capacity in Europe and the US by cooperating with Lonza. BioNTech is planning to manufacture their COVID-19 vaccine at their German plants (including a newly acquired Novartis site), at Pfizer plants in Belgium and the US, as well as in cooperation with Fosun Pharma in China. Johnson & Johnson has increased their capacity in Europe and the US by working with Emergent BioSolutions and in India by cooperating with Biological E. Whilst the manufacturing of the Chinese COVID-19 vaccine candidates is expected to take place mainly in China, the Russian Gamaleya Institute announced that they entered into a partnership with Dr. Reddy’s in India to support the manufacturing of their vaccine candidate Sputnik-V. 

What do these manufacturing plans mean for the upcoming COVID-19 distribution?
The manufacturing plans indicate that no COVID-19 vaccine will be manufactured in Africa and in only limited amounts in South America. Whereas a certain demand in North America, Europe and partially Asia can be covered with regional distribution according to the announced manufacturing capacities, the distribution in parts of Asia and Africa depends solely on international distribution. For multiple reasons, such as dry ice availability, dry ice limitations in air freight, transport times, handling, etc. COVID-19 distribution requiring dry ice temperatures seems to have limited feasibility in certain low- and middle income countries. Therefore, it is likely that the mass distribution and hence vaccination of the population in these countries will depend on the approval of one of the aforementioned +2 to +8 °C COVID-19 vaccine candidates. The vaccination of health staff might be completed in a first phase, utilizing a vaccine requiring a different (lower) temperature range.

Regional distribution set-ups in North America , Europe and parts of Asia could have a significant impact on the distribution requirements, e.g. air freight vs. road freight, temperature-controlled containers vs. boxes or TCVs , as well as requirements for temperature monitoring.

How can companies best prepare for COVID-19 vaccine distribution?
Cooperation between stakeholders and sharing of information is key. Whilst the COVID-19 vaccine development carries many uncertainties such as vaccine approval by authorities, timelines, supply chain set-ups etc., for the vaccine developers, it is crucial that the various scenarios are discussed with the relevant stakeholders well in advance, so that timelines, volumes, potential risks and required investments can be assessed jointly and acted on. Similarly, bringing all stakeholders of the COVID-19 distribution chain around one table – having a regular platform for information sharing and updates – will add value to the successful distribution of their COVID-19 vaccine.

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