Preliminary analysis of the coronavirus vaccine developed by the US pharmaceutical company Pfizer and Germany’s BioNTech has been found to be over 90 per cent effective in preventing Covid-19.
This raises the possibility of a vaccine by Christmas, on the proviso that it is signed off by health authorities. Pfizer boss Dr Albert Bourla called it “a great day for science and humanity”.
That the US Food and Drug Administration requires a 50 per cent efficacy rate in order to be approved speaks to the astonishing initial performance of this vaccine. But as remarkable a scientific breakthrough this appears to be, the logistical challenges remain vast.
The vaccine made by Pfizer and BioNTech, which is expected to be one of the first to get authorization from the Food and Drug Administration, must be stored at minus 70 degrees Celsius — much colder than what most medicines and vaccines require. That’s when Ryan Stice, who oversees pharmacy services at Sutter Health, jumped into action.
It was “the starting gun,” Stice said, signaling the beginning of a complicated and months-long planning effort to distribute vaccines. One critical component could be how to store and transport the Pfizer vaccine, which must be kept very cold because it contains fragile genetic material.
“We could see right away the cold chain logistics were going to be a challenge,” Stice said. “Like many systems, we didn’t have the infrastructure in place to handle this type of temperature.”
Health care providers and local health departments have long had systems in place to vaccinate large numbers of people against the flu and other illnesses. But most of those vaccines — such as the vaccine for the H1N1 influenza outbreak in 2009 — could be stored in refrigerators.
The prospect of building a cold chain infrastructure poses new challenges. While research labs and hospitals affiliated with research institutions often have these ultra-cold freezers, many community hospitals and clinics do not.
The August meeting was held virtually by the CDC’s Advisory Committee on Immunization Practices, which develops vaccine recommendations. It was closely monitored by doctors, health officials and health industry leaders across the country, including Stice and his colleagues.
Sutter, which runs 24 hospitals and dozens of outpatient centers in Northern California, does not typically use ultra-low-temperature freezers except to store specimens in its research institutes, because it does not have medications that need to be stored at such cold temperatures.
Now, like many other health care providers and local health departments, Sutter is moving quickly to buy ultra-freezers and place them strategically to facilitate the distribution of the Pfizer vaccine, should it gain FDA authorization soon.
Stice and Sutter’s vaccine planning group has acquired about a dozen large freezers, at $10,000 apiece, that can each store about 30,000 doses of vaccines at temperatures as cold as minus 80 degrees Celsius. It also bought three smaller portable freezers, which cost roughly $8,000 each, that will be used to transport doses from one location to another.
The portable freezers can potentially store up to 12,000 doses each. The freezers can accommodate a range of temperatures. So if it turns out they won’t need to store vaccines at that low of a temperature, they could also store, for example, the Moderna vaccine, which must be kept at minus 20 degrees Celsius.
The rollout of vaccines will start as a trickle, with a small number of highest priority people first, most likely health care workers who work with COVID-19 patients. During that first phase, just 20 million people in the entire U.S. are estimated to be eligible for vaccination. For that reason, it’s possible the cold chain infrastructure will only make up a small, or initial, part of the eventual overall vaccine distribution.
The other leading vaccines under development do not require ultra-cold storage. By the time the broader public is able to get vaccinated, which will likely be mid-or late-2021, there may several other vaccines available that don’t require ultra-cold storage._Agencies