When the COVID-19 vaccine from US-based Pfizer and Germany-based BioNTech starts mass production, China’s Fosun Pharmaceutical Group Co. will wait to distribute it across China through a complicated and expensive system of deep-freeze airport warehouses, refrigerated vehicles and inoculation points.
The shots must be defrosted from -70 degrees Celsius after reaching vaccination centers and injected within five days, or they go bad.
Then the challenging journey must be undertaken all over again from warehouse freezer to rolled-up sleeve, to deliver it again for the booster shot a month later.
The plan outlined by the company that licensed the vaccine for Greater China provides an insight into the vast and overwhelming logistical obstacles faced by those looking to take the experimental vaccine from Pfizer after it showed “extraordinary” early results from final stage trials, raising hopes of a possible end to the nearly year-long pandemic.
Storage and transportation
The euphoria is now diluted by the fact that no vaccine currently used has ever been made from Pfizer’s messenger RNA technology, which instructs the human body to generate proteins that then create protective antibodies.
That means that the deep-freeze production, storage and transport networks required for the vaccine to survive would need to be developed from scratch by countries. The vast investment and coordination required indicates that access is guaranteed only to rich nations and even then, perhaps, only to their urban populations.
“Its production is costly, its component is unstable, it also requires cold-chain transportation and has a short shelf life,” said Ding Sheng, director of the Beijing-based Global Health Drug Discovery Institute, which has received funding from the Bill & Melinda Gates Foundation.
Despite a World Health Organization-backed campaign called COVAX that seeks to raise $18 billion to buy vaccines for poorer countries, the cost of delivering the Pfizer shot would likely increase existing fears that wealthy nations will get the best vaccines first.
Buy or wait?
It also poses a choice now faced in the developing world which is either paying for the costly development of sub-zero cold-chain infrastructure for what appears to be a sure shot, or waiting for a slower, more traditional vaccine that brews lots of protein or inactivated viral particles in living cells and can be distributed across existing health care networks.
“If there is a protein-based vaccine that could achieve the same effect as an mRNA vaccine does and there’s the need to vaccinate billions of people every year, I’d go for the protein-based shots in the long run,” Mr. Ding said.
Even for rich countries that have pre-ordered doses, including Japan, the US and the UK, delivering Pfizer’s vaccine will involve considerable hurdles as long as trucks break down, electricity cuts out, essential workers get sick and ice melts.
Fosun will partner with the state-owned Sinopharm Group Co., a pharmaceutical distributor with well-established networks across the nation, to safely distribute shots in mainland China and Hong Kong.
Packed in cold storage vehicles, these vials will arrive at inoculation sites where they need to be defrosted and stored for a maximum of five days in refrigerators at 2 to 8 degrees Celsius before going bad.
“The requirement for extremely cold temperatures is likely to cause spoilage of a lot of vaccine,” said Michael Kinch, a vaccine specialist at Washington University in US.
According to the company’s chairman, Wu Yifang, the process is likely to cost tens of millions of dollars for Fosun. It is considering importing the vaccine in bulk and filling it into vials at a local plant. That will also require additional production and storage investments.
For several developing nations, like neighboring India, which has struggled to control the second largest coronavirus outbreak in the world and currently has no agreement to buy the Pfizer vaccine, the resulting cost tag could be too high.
Pfizer also has orders some other developing countries like Peru, Ecuador and Costa Rica. But it is unclear as to how broadly those nations intend to deliver the shots, while limited distribution is indicated by their small orders of less than ten million doses.
Some governments have hurried to finalize orders and begin negotiations with Pfizer and BioNTech after the publication of their promising preliminary results. Recently, an order of up to 300 million doses was confirmed by the European Union (EU), while the Philippines, Singapore and Brazil said they were in negotiations.
Even without the subzero problem, it will be a “major challenge” to roll out a vaccine in a short period of time, requiring mass paramedical training to administer two-shot doses, said Pankaj Patel, chairman of Indian drugmaker Cadila Healthcare Ltd., which is developing its own experimental plasmid DNA COVID-19 shot.
This is particularly so in areas where people cannot be easily contacted or have to travel long distances to reach vaccination centers. According to public health experts past vaccination campaigns show that, many simply never show up for the second shot.
The mounting obstacles mean that some developing countries may pass on the Pfizer vaccine, despite early signs of its exceptional efficacy.