The Pfizer COVID-19 Vaccine Challenges
By Devin Partida, Editor-in-Chief, ReHack.com
Twitter: @rehackmagazine
When the news broke that early data showed the BioNTech-Pfizer vaccine against COVID-19 far surpassed expectations, the world rejoiced. The companies said they achieved 95% efficacy against COVID-19 and that there were no serious safety concerns reported in the more than 43,000 people participating in the Phase 3 trial.
Those outcomes are undoubtedly positive. However, the vaccine faces numerous challenges that could negatively impact manufacturing, distribution and interest.
Ultra-Cold Storage Required
The first hurdle to overcome is that Pfizer’s vaccine requires storage at nearly -100 degrees Fahrenheit. The company plans to accommodate that need with its specially developed “suitcases” that close tightly to maintain the goods in deep-freeze conditions — even when nonrefrigerated trucks carry them.
That’s a start, but the cases only stay cold for 10 days after shipment. Moreover, recipients can only open them twice daily for less than three minutes each time. The vaccine can go in a typical refrigerator, but only for five days.
Many pharmaceutical products require rigidly controlled environments. A fluctuation of as little as 2 degrees could spoil an entire batch. However, even facilities that regularly store sensitive medications don’t have the infrastructure required from Pfizer’s vaccine.
Dr. Gregory Poland, a virologist and vaccine researcher at the Mayo Clinic, remarked, “We’re a major medical center, and we don’t have storage capacity like this. That will be true for everybody. This is a logistical obstacle.”
Developing Nations Will Struggle to Get It
People are also concerned about the fair distribution of the vaccine around the world. Production targets are to make up to 50 million doses by the end of 2020 and as many as 1.3 billion in 2021. However, it bears mentioning that each person needs two doses of the vaccine, spaced three weeks apart, to have full protection.
Moreover, many of the world’s most developed nations have preordered huge quantities. The European Union bought 300 million, while Japan ordered 120 million and the United States reserved 100 million.
As Rachel Silverman of the nonprofit Center for Global Development pointed out, that severely limits developing countries’ supplies. The difficulties don’t end there, either. “In the U.S., they’re projecting it’s going to be very difficult for this vaccine to be administered in just a normal doctor’s office. So, the vaccine is probably not going to be a great option for most low- and middle-income countries,” she noted.
Distribution Questions Abound
The task of getting people vaccinated will undoubtedly pose further challenges. How will countries and states decide which groups get doses first?
In the United States, the Centers for Disease Control and Prevention (CDC) released a national “interim playbook” in mid-September. It contains the things states must do to prove their readiness to receive the vaccine once available.
State governments and health departments bear the responsibility of getting people vaccinated. There is a tough road ahead, however. Those entities do not know how many doses they will receive. Each state will also likely need to create a distribution plan without that information.
Other Unknowns Remain
The primary goal in Pfizer’s vaccine trial was to stop people from developing COVID-19 symptoms. However, the investigation did not assess whether it stopped infection and transmission.
The question remains, then, whether a vaccinated person could become infected and transmit the virus to others despite feeling fine. That possibility means people will still need to keep wearing masks and practicing social distancing even after getting vaccinated. That’s true until researchers collect data that gives more details about the transmission aspect — which could take years.
It’s also too early for scientists to know how long immunity lasts. It may become apparent that people can get the vaccines every year — similar to the flu shot — or would stay protected for even longer. However, trial participants have not had the vaccine long enough to know that yet.
Public trust is another aspect that could impact vaccination rates. A global study showed that 71.5% of people were very or somewhat likely to take the vaccine. However, the vaccine’s acceptance rates around the world varied from less than 55% to more than 90%. Even people who fully support vaccines and the science behind them often have hesitations and want to see how things play out first, especially given that this will be the first shot.
A Remarkable Achievement, but Not a Total Solution
Medical professionals must keep these things in mind when explaining the benefits and downsides of the BioNTech-Pfizer vaccine to their patients or colleagues. It will undoubtedly be valuable since it stops people from having symptoms. However, it will not allow for a speedy return to normal.
