When Pfizer Inc. and BioNTech SE’s Covid-19 vaccine rolls off production lines, Shanghai Fosun Pharmaceutical Group Co. will be waiting to distribute it through a complex and expensive system of airport warehouses, refrigerated vehicles, and inoculation points in China.
Once they arrive at the vaccination centers, the injections must be thawed at -70 degrees Celsius and injected within five days, if they do not spoil.
Then the herculean journey from the warehouse freezer to the rolled-up sleeve must be undertaken again, to administer the second booster injection a month later.
The roadmap outlined by the company, which has licensed the vaccine for Greater China, offers a glimpse into the daunting and daunting logistical challenges faced by those seeking to deliver Pfizer’s experimental vaccine after it showed “extraordinary” early results from the end-stage trials, raising hopes of a possible end to the nearly one-year pandemic.
That euphoria is now fading with the realization that a currently used vaccine has never been made from the messenger RNA technology deployed in Pfizer’s injection, which instructs the human body to make proteins that then develop protective antibodies.
That means countries will have to build from scratch the deep-freeze production, storage and transportation networks necessary for the vaccine to survive. The massive investment and coordination required almost ensures that only wealthy nations are guaranteed access, and even then perhaps only their urban populations.
“It is expensive to produce, its component is unstable, it also requires cold chain transport and has a short shelf life,” said Ding Sheng, director of the Beijing-based Global Health Drug Discovery Institute, which has received funding from Bill & Melinda Gates Foundation.
The expense of implementing the Pfizer injection will likely heighten existing fears that wealthier nations will get the best vaccines first, despite a World Health Organization-backed effort called Covax that aims to raise $ 18 billion to buy. vaccines for the poorest countries.
It also presents an option now faced throughout the developing world: pay for the expensive construction of a subzero cold chain infrastructure for what seems like a safe bet, or wait for a slower, more conventional vaccine that produces batches of protein or inactivated viral particles. in living cells, and can be delivered through existing healthcare networks.
“If there is a protein-based vaccine that could achieve the same effect as an mRNA vaccine and there is a need to vaccinate billions of people each year, I would go for long-term protein-based injections,” Ding said. . .
Even for rich countries that have booked doses, including Japan, the US, and the UK, delivering the Pfizer vaccine will pose considerable hurdles whenever trucks break down, power goes out, essential workers get sick, and the ice melts.
Safe delivery
To deliver injections safely in mainland China and Hong Kong, Fosun will partner with the state-owned Sinopharm Group Co., a pharmaceutical distributor with well-established networks across the country. One of Sinopharm’s subsidiaries has also been developing Covid-19 vaccines.
Packed in cold storage trucks, those vials will make it to inoculation sites where they can be thawed and stacked in refrigerators at 2-8 degrees Celsius for up to five days before spoiling.
“The extremely cold temperature requirement is likely to cause many vaccines to deteriorate,” said Michael Kinch, a vaccine specialist at Washington University in St. Louis.
It is also likely to cost Fosun tens of millions of yuan, according to company president Wu Yifang. Fosun is considering importing the vaccine in bulk and filling them in vials at a local plant. That will also require more investment in production and storage.
The resulting price may be too high for many developing nations, including India, which has struggled to contain the world’s second-largest coronavirus outbreak and currently has no agreement to purchase the Pfizer vaccine.
‘Forget this’
Many working in the country’s public health and pharmaceutical industry have already expressed concern that India lacks the capacity and capacity to deliver a vaccine in its vast rural hinterland and a population of more than 1.3 billion people living there. breakneck speed now expected.
“Most of these vaccines need minus 70 degrees, which we just can’t do in India, just forget about it,” said T Sundararaman, a global coordinator for the New Delhi-based People’s Health Movement, an organization that brings together local activists. academics and civil society groups working in public health.
“Our current cold chains cannot cope with the need for measles vaccines in some districts, and that is only for children under 3 years old,” he said. “It’s a really trivial number of people compared to the number that will need a Covid-19 vaccine.”
When asked in a briefing on Tuesday whether the government would seek to buy any of Pfizer’s vaccines, Rajesh Bhushan, the secretary of the Ministry of Health, said New Delhi is in talks with all vaccine manufacturers. He added that India was in a position to “increase and strengthen” its existing cold chain capacity, but declined to release details of the purchase immediately.
Pfizer already has orders from some developing countries such as Peru, Ecuador and Costa Rica. It’s unclear how widely those nations plan to distribute the injections, but their small orders of less than 10 million doses suggest limited deployment.
After the release of their preliminary positive data, some governments were quick to finalize orders and begin negotiations with Pfizer and BioNTech. The European Union confirmed an order for up to 300 million doses on Tuesday, while the Philippines, Singapore and Brazil said they were in talks.
‘Last Mille’
Even without the problem of freezing temperatures, implementing a vaccine in a short space of time will be a “great challenge” that will require massive training for paramedics to administer doses of two injections, said Pankaj Patel, president of Indian pharmaceutical company Cadila Healthcare Ltd., which is developing its own Covid-19 experimental plasmid DNA injection.
This is especially true in areas where people are not easily contactable or have to travel long distances to reach vaccination centers. Past vaccination campaigns show that many simply never show up for the second injection, public health experts said.
Growing hurdles mean that some developing countries may pass the Pfizer vaccine, despite early signs of its exceptional efficacy.
“If we were to wait another year and have something that is feasible for us to deliver to as many people as possible in this country, would that be a bad trade-off?” asked Gagandeep Kang, professor of microbiology at Vellore, Christian Medical College and a member of the WHO Global Advisory Committee on Vaccine Safety.
“Based on the cost of the Pfizer vaccine, the logistics of ultra-cold storage, I don’t think we’re ready and I think this is something that we have to weigh the benefits and the costs very, very carefully.” she said.
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