Challenges to overcome with the SARS-CoV-2 vaccine rollout

Dec. 22, 2020

As the new year dawns, people around the world hope for a return to their pre-pandemic lives. The first step on that road, of course, is widespread availability of vaccines against SARS-CoV-2.

But manufacturing, distributing and inoculating billions of people worldwide is a monumental undertaking.

The U.S. government has inked purchasing deals totaling more than $8 billion with numerous pharmaceutical companies to secure access to hundreds of millions of doses of these vaccines.

Supply chain readiness is one hurdle in the mass inoculation process. Just think about the supplies involved: glass vials, syringes, needles, alcohol wipes, and band aids, among others.

Freezers and dry ice are important for some of the vaccines, too. For example, the vaccine from Pfizer and BioNTech needs to be stored at temperature conditions at around -70 degrees Celsius. That is why the companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes.

The Pfizer-BioNTech vaccine can also be stored in ultra-low-temperature freezers for up to six months.

Moderna said its vaccine can be stored at -20 degrees Celsius (-4 degrees Fahrenheit), which is equal to most home or medical freezer temperatures, for up to 6 months. Meanwhile, the vaccine from Astra Zeneca can be stored, transported and handled at normal refrigerated conditions (2-8 degrees Celsius/ 36-46 degrees Fahrenheit) for at least six months.

In addition to supply chain logistics, another hurdle rests on the shoulders of providers and pharmacists. They need to keep track of who has gotten which vaccine and when they should come in for a second dose, if needed.

Vaccines from Pfizer-BioNTech and Moderna require two doses. Astra Zeneca is evaluating two dosing regimens for its vaccine candidate: a first dose given as a half dose, followed by a second full dose; the other option involves two full doses. Meanwhile, Janssen Pharmaceutical Companies, part of Johnson & Johnson, is studying a single-dose regimen for its vaccine.

If ever there was a time when user-friendly, accurate and interoperable electronic health records were critical to help the healthcare system track its work, this is it.

Clinical labs probably will have a role in the vaccine rollout as well. Pharmaceutical companies are using quantitative SARS-CoV-2 antibody tests to assess the effectiveness of their vaccine candidates during the clinical trial process. But those same tests could be used to assess the effectiveness of the vaccines at the individual and community levels once mass inoculation efforts begin.

Diagnostics companies, which have developed these tests, have been advocating for the use of antibody tests to measure people’s antibody levels after vaccination and at regular intervals afterward to assess immunity over time. This type of testing would help answer questions about the durability of immunity to SARS-CoV-2 from various vaccines.

Ultimately, the return to pre-pandemic life depends on herd immunity, which occurs when enough people develop antibodies to SARS-CoV-2 – either through vaccination or prior infection. The percentage of people who need to develop antibodies to an infectious disease to achieve herd immunity varies, according to the World Health Organization, which says the herd-immunity threshold is 95 percent for the measles and 80 percent for polio. Time will tell us what the threshold is for SARS-CoV-2.

But if we overcome these challenges – at least reasonably well – 2021 could end up being a much better year than 2020.

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