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Almost a year after the Covid-19 pandemic, an image of the other side is emerging. There has been positive news from the major vaccine manufacturers and they are beginning to analyze clinical data from phase III, an important milestone that could tell researchers whether it is safe and effective.
But to distribute those vaccines, the US must undertake the logistically most difficult vaccination campaign in history, with an indecisive and tired public, and at least one vaccine with unprecedented storage requirements.
The cause of optimism is real, but so are the logistical challenges that lie ahead.
Transparency and trust
One of the biggest obstacles any vaccination campaign will face is gaining the trust of the public, even among healthcare workers who will be asked to get vaccinated first.
“One of the really tough challenges before us is getting people to trust the vaccine,” said Dr. Michael Osterholm, an epidemiologist at the University of Minnesota, who was recently appointed to the coronavirus advisory council of the US. Biden-Harris administration.
Pfizer must submit data about its vaccine to the US Food and Drug Administration for approval, but another important step will be publication in an independent peer-reviewed scientific journal and continued transparency about its safety and efficacy.
The general public will also need information on vaccine performance and consistent messages from scientists. This will be a challenge amid a leadership change in the White House, after nearly a year of Covid disinformation perpetuated by Donald Trump, and in the age of fractured social media audiences.
“This is our best way out of this pandemic, so we want to recommend and encourage members of our community to get vaccinated,” said Dr. Umair Shah, executive director of the Harris County Health Department in Texas. .
“The worst thing would be a vaccine that is safe, a vaccine that is effective, a vaccine that is distributed, and vaccine systems now can make vaccines get into people’s arms, and people just don’t take it,” he said. Shah.
Extreme storage requirements
As public health authorities work to regain public trust, they must also address the unprecedented cold storage requirements of the leading vaccine candidate from Pfizer and the German company BioNTech.
This vaccine uses a technology called the messenger RNA platform, which uses the genetic material from Covid-19 to invoke an immune response. The vaccine leads the pack because it is the fastest to manufacture.
But the speed of manufacture is compensated by a complicated delivery. Pfizer’s vaccine should be stored at an unprecedented -94 ° C (-137.2 ° F), a temperature that is only achieved in the coldest freezers.
Pharmacies don’t have freezers this cold, because no approved drug has had to be kept at this temperature. Only large medical centers, universities, and perhaps some public health departments are likely to have these freezers.
To avoid this, Pfizer has developed a reusable, suitcase-sized shipping container that stores 975 doses of the vaccine on dry ice. The vaccine is stable for 10 days from the starting point in this case. If more dry ice can be secured, the vaccine can be kept in the case for another 15 days.
“The clock starts long before you actually receive the product,” said Soumi Saha, attorney, pharmacist, and vice president of defense for healthcare logistics company Premier Inc.
Dry ice is considered a hazardous material, so it cannot be shipped by air or by sea. It must be transported by land, posing potentially serious challenges for rural areas where several days of vaccine viability could be lost in transit.
During this time, the box can only be opened twice a day for one minute per opening. Healthcare workers will need to get an adequate amount of vaccine only twice a day, which means carefully calibrating between getting too little and risking sending patients home, and getting too much and risking wasting very limited doses.
The Nurse Shortage
Health workers are first on the list to get vaccinated, but here too it’s a challenge. Typically, there is a shortage of nurses in the US, but healthcare facilities are facing a more extreme staff shortage due to the huge spread of Covid-19 in the US.
In many cases, the same workers testing the public will have to turn around and vaccinate their co-workers. Those doses will need to be measured, because the virus’s potentially flu-like side effects could miss some. For that reason, a hospital could not vaccinate its entire intensive care unit at once.
“If you have a staff of 25,000 people, you have to vaccinate, it will not be easy to find the staff to do it,” Saha said.
It is estimated that each worker who performs vaccinations can only perform six vaccinations per hour, according to Saha. Those workers will also need to be trained to handle extreme vaccine storage requirements, including how to thaw, dilute and administer.
Then health care providers must have workers return for a second dose of the vaccine, which all but one vaccine candidate requires. Keeping track of who got what vaccine and when will be an important data task.
Additionally, the current vaccine distribution plan provides doses based on the state’s population, not based on the number of healthcare workers who will be vaccinated first. That means some states may have a surplus of vaccines while others have a deficit.
Approve new vaccines
The world needs the approval of multiple vaccines to start meeting demand. But approving multiple vaccines increases the complexity of the delivery effort. Healthcare providers will need to keep track of who got what vaccine and when to make sure people are protected.
The goal is for all Americans to have access to a vaccine “within 18 months of the initial approval of the vaccine,” Saha said.
For example, the first approved vaccine may not be safe and effective for everyone. Vaccines are just beginning to be tested in children, and some vaccines may not be safe and effective in people over 65.
The challenges are huge, but there is hope
As the vaccine infrastructure develops, more advanced versions of vaccines could reduce the logistical challenges of distribution. Pfizer is already working on a powdered version of its vaccine in hopes of reducing cold storage requirements in 2021.
Also, not all vaccine candidates require cold storage at the same extreme temperatures as described here. The other leading candidate from Moderna and the National Institute of Allergy and Infectious Diseases could be kept at -20 ° C, or about the temperature of an existing adult shingles vaccine.
And, for now at least, the best defense against Covid-19 remains social distancing, wearing masks, and hand washing.
“We may be tired of this virus, but this virus is not tired of us,” Shah said. “I hope that the road ahead of us remembering a public health crisis requires a public health response.”
