The WHO declared the spread of the SARS coronavirus-2 (SARS-CoV2) a public health emergency of global concern on January 30th, 2020. Since that time, the world has registered nearly than 57 million infections, with deaths surpassing 1.3 million[1]. Since this respiratory virus spreads from person to person through close contact, and without a vaccine or treatment medications, the tools that are available to us are to practice social distancing, wash our hands, and wear a mask or face covering when in public. These measures are crucial to keeping schools open and our economy running until such time as a safe and effective vaccine is ready to be distributed, likely not until mid-2021 for the general public.
What does it really mean when a vaccine becomes readily available? (Think supply and demand, prioritization concerns, and logistics.)
Once Phase 3 trial results are ready, reported to, and acknowledged by the FDA, manufacturers will seek emergency use authorization (EUA) to begin distributing their vaccines. In order to speed up the process, the production of vaccines is well under way in advance of receiving approval. Shipments can begin as soon as approval is received. Currently there are 12 vaccines in Phase 3 trials and two candidates for whom preliminary results have been widely reported.
There are many logistical issues for these two candidates, the most significant of which is keeping the vaccines sufficiently cold, i.e. maintaining the ‘cold chain’. The Pfizer/BioNTech version requires the vaccine be kept at -70 oC which involves specialized containers for transportation. In addition, distribution of the vaccine will need to be through hospitals that have the required storage capability. The Moderna vaccine on the other hand needs to be stored only at -20 oC for transport and bulk storage, which is similar to other vaccines. It also can be stored in regular refrigerators for seven days allowing for easier community distribution. Several other vaccine candidates being trialed have less challenging storage requirements.
Likely prioritization categories are:
- first responders (doctors, nurses, health care workers, police, firefighters),
- the vulnerable (long-term care residents, elderly and other individuals at high risk),
- the general public
Both of these vaccines (Pfizer, Moderna) will require two doses (three and four weeks apart respectively).
The need for unambiguous leadership.
While at least two manufacturers will be seeking EUAs for their vaccines imminently, it will be months before sufficient quantities of the vaccines are generally available. In the interim, government, public health officials, and others in positions of leadership must continue to stress the need for adherence with the control measures already in place to keep our health care system and our economy from collapsing.
Communication supporting vaccine acceptance is also crucial. You can’t have it both ways; you can’t play down or diminish the seriousness of the virus (don’t wear masks, don’t social distance) and then expect the public to immediately line up to willingly receive the vaccine.
Because the manufacturing process for genetic vaccines is novel, it is imperative that any concerns regarding safety be addressed as openly as possible. Communication will need to be clear and extensive to garner support from open–minded people who are merely concerned about their safety. High–profile individuals (eg. ex-presidents) accepting the vaccine will go a long way to providing confidence to the public regarding the safety of the vaccines.
Why getting vaccinated makes sense – particularly in light of the current hesitation to get vaccinated.
Herd immunity is achieved when approximately 65% of the population is immune. Current statistics show 11+ million cases in the US + 40% asymptomatic= ~16 million potentially immune. With the U.S. population at approximately 330 million, there will be 314 million still vulnerable. Without the vaccine the number of illnesses and deaths to reach herd immunity is staggering. Currently the number of deaths directly attributed to COVID-19 is more than 250K with excess (indirect) deaths estimated at an additional 309K (Nov 12, 2020 – New York Times).
Why getting vaccinated does not mean we still don’t have reasonable and responsible protocols in place (i.e. temperature monitoring, testing, contact tracing, etc.).
Allowing infections to proceed without any intervention until either a vaccine is available, or herd immunity is achieved would result in unacceptable levels of suffering and stress to our hospital systems, our communities, and our society. While the new vaccines have shown to be very efficacious (~95%) regarding preventing serious infections, we do not yet know if they prevent virus transmission.
With so many unknowns, it is imperative that an approach be developed not only to distribute vaccinations throughout the U.S., but to track them as well. Collecting, storing, and sharing this sensitive medical information properly will drive the science to build upon vaccine successes and address any shortcomings in a calm, systematic way.
written by Dr. George Astrakianakis
[1] COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (accessed November 19, 2020, https://coronavirus.jhu.edu/map.html))