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On Monday, a press release from transnational pharmaceutical company Pfizer threw a rare spark of hope in the ongoing misery of the COVID-19 pandemic. Yes, the new infections have reached an all-time high in the United States and, yes, cities and states around the world are returning to reopening. But Pfizer claims it has the results of a massive clinical trial showing its vaccine against the disease works and works well. The release advertised “a vaccine efficacy rate greater than 90 percent” and announced the company’s intention to apply for an authorization from the US Food and Drug Administration to begin giving injections to people. The company is set to produce 50 million doses this year and 1.3 billion doses in 2021.
It’s a brand of hope, but it’s sitting under a bucket of cold water, ready to pour. The Pfizer vaccine is fussy: difficult to manufacture, transport and supply. Out of desperate need, it is in short supply even before it becomes available: 1.3 billion doses are several billion fewer than what the world needs. The press release was not peer-reviewed science and lacked critical details about how the vaccine works and who. Even the mere fact of this vaccine’s existence, some analysts have argued, could jeopardize the testing and success of potentially better vaccines across the board – a case where the imperfect is the enemy of the good.
Before the embers go out completely, here’s a theory: no. The imperfections of the Pfizer vaccine make it a perfect prime mover, because if it works like the company says, it will help people now and will require research on more, better, and different vaccines for later. All the things nobody knows about the Pfizer vaccine means the door is wide open. “If its effects are lasting, if it is effective on the elderly, if it has safety concerns, problems with the cold chain, the possibility of having access,” says Wayne Koff, president and CEO of the non-profit project Human Vaccines, “all of this which points to the need for a series of vaccines “.
Working with a smaller company called BioNTech, Pfizer left the starting block quickly and without the money from the US program Operation Warp Speed which funded the trials of other pharmaceutical companies. This vaccine (like another candidate produced by the Modern Society) is actually a bespoke fragment of genetic material called messenger RNA; give it to people and the mRNA acts like biological software, teaching cells to make the “spike” protein on the outer coat of the virus that causes COVID-19. Those people’s immune systems then learn to recognize and attack the spike, which gives them the ability to fight off the virus. It’s an interesting idea and, as my colleague Megan Molteni wrote, it could change the future of vaccinology and infectious diseases.
Cold case
But this is the first mRNA vaccine and turns out to be a precious snowflake. Pfizer’s vaccine must be stored and shipped in ultra-cold temperatures, minus 80 degrees below zero – it will keep for a few days in higher but still very cold conditions. And it needs vials made of a special glass that is able to tolerate freezing temperatures. (This is neat, actually, the key is that the glass is low in boron, just the opposite of the famous temperature change resistant Pyrex glass, which is a mix of boron and silicon dioxide. The glass maker Corning has a $ 204 million contract with the government to do so and strike a deal in May to provide it to Pfizer. Whether Corning can make enough is the hard part.)
All of this transport and freezing requires a level of technical refinement that, at least for now, exists primarily in hospitals and laboratories, posing significant logistical challenges in rural areas and developing countries. These are the problems of the “cold chain” mentioned by Koff, the problem of refrigerated shipping. (A critical Ebola vaccine needs the same deep freezing, and engineers have taken steps to create specialized refrigerators to transport it across West Africa, but that was a pandemic that affected tens of thousands of people, not billions, and the people who made the chillers have since stepped out of the cold chain innovation game.)
“Minus 70 is almost a nonstarter”
Those logistical challenges and an overall vaccine shortage will further limit who gets the vaccine first. A Pfizer spokesperson says the company has built its own network of specialized distribution centers, freezers and shipping containers. And, meanwhile, Phase I of any vaccination plan will likely involve administering it to healthcare workers and first responders, the kind of people who will have easier access to places that actually have the drug and perhaps are more likely to return for. the second shot the Pfizer vaccine requires.
“We know Pfizer has a network of locations that it has worked with to conduct its clinical trials in the United States,” says Anna Legried Dopp, senior director for clinical guidelines and quality improvement at the American Society of Health. System Pharmacists. Dopp says he understands there are over 100 of these locations. “They will leverage the ultra-cold freezers that have been provided to them for the purpose of the clinical trial,” he says.
This is good; freezers will be able to change temperatures to accommodate other future vaccine candidates who need cold, but don’t such as cold, conditions (like, apparently, from Moderna).
OK. So at least a number of weaknesses could also be a strength. So could others. “We will probably find out how to solve the cold chain in the short term just because the economic cost estimates I have seen in the United States are in the trillions of dollars. In the long run, in the United States and around the world, something that must be minus 70 is almost a failure, “says Sam Scarpino, a mathematical epidemiologist at Northeastern University who studies the spread of disease.” We will continue to discover more and more about vaccine as it goes from Phase III to injection into 100 million people, and then into a billion people, if it turns out that there are other things we need from a vaccine and if other things remain in the pipeline. “
Science from the press release
What Scarpino means is that the Pfizer vaccine may be good enough to start healing the world but not good enough to finish the job. Pfizer has promised detailed, peer-reviewed accounting of the results, but for now it’s just a press release and leaves a lot out. (Getting the science via the press release is never ideal.) Pfizer and the FDA resisted tremendous political pressure to forgo faster data releases that didn’t include potential side effects, but the release said nothing about the whether the vaccine exhibits different levels of protection in different demographic groups (especially children, adults and the elderly) or has long-term safety concerns.
How could it? The vaccine is too new and studying the efficacy of the vaccine in subgroups is notoriously difficult. But policymakers will need that data, as they will have to decide how to distribute limited supplies. If they know a vaccine is better for older people, that helps tell them where to send it and the vaccines will surely have different skills.
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