What Vaccines Mean for COVID-19 Testing Labs
What Vaccines Mean for COVID-19 Testing Labs

COVID-19 vaccines are rolling out in the United States and around the world, but now is not the time for complacency. One, two or even dozens of vaccines won’t immediately turn the tide of this pandemic. Inoculating enough of the population to make a difference will take time. And several issues will extend the pandemic beyond 2021. As a result, COVID-19 testing must be as ubiquitous as air-quality monitoring for years to come.

How Vaccine Distribution is Working in the United States

Operation Warp Speed

As part of Operation Warp Speed, the FDA began issuing EUAs for vaccines that target SARS-CoV-2, the virus that causes COVID-19. The EUAs use data-based evaluations of a potential vaccine’s safety and effectiveness during its developers’ Phase III trials to assess the vaccine’s efficacy and safety for use in the pandemic. Although not a permanent approval, the EUA bypasses the years-long approval process that they traditionally go through.

The Pfizer-BioNTech BNT162b2 vaccine received the authorization in mid-December 2020 and the Moderna mRNA-1273 vaccine received its EUA a week later. Both vaccines use part of the SARS-CoV-2’s messenger RNA (mRNA) to teach the body’s cells how to produce an immune response to the virus before an infection. Even though these are the first mRNA-based vaccines ever produced, development and clinical trials began more than a decade ago in response to the original SARS epidemic in 2003. It is this approach that is enabling previously-unheard-of effectiveness levels of 90% or better.

Large-scale Phase III trials for three other vaccines are either planned or underway in the United States. AstraZeneca’s AZD1222 vaccine, co-developed with Oxford University, uses a more traditional approach to immunizing against COVID-19. A weakened version of the common cold virus produces the spike protein found on SARS-CoV-2, priming the immune system with antibodies. The Janssen COVID-19 vaccine, developed by Johnson & Johnson, is a potential single-dose vaccine that leverages a technology that created vaccine candidates for Ebola and HIV. Novavax’s potential COVID-19 vaccine uses recombinant protein nanoparticle technology to deliver the coronavirus spike protein.

Taking Vaccine - What Vaccines Mean for COVID-19 Testing Labs

Dozens of potential vaccines are in earlier phases of the development process in several countries, but the US government is not waiting. The first EUAs allowed the federal government to buy millions of doses to distribute to state public health departments. Under guidance from the US Centers for Disease Control (CDC), health care personnel and long-term care facility residents are the first priority. The priority for vaccine distribution progresses from there to those 75 years and older and non–health care frontline essential workers. Risk-based criteria determine vaccine recipients at each successive phase until vaccine production can serve the general population.

Missteps and Distrust Delay the Vaccine Program

Unfortunately, America’s vaccine distribution program stumbled out of the gate. Communication miscues and supply chain issues left perishable vaccines for some states sitting in warehouses while other states got their full shipments. Other shipments were spoiled when they could not be refrigerated at the correct temperature.

American public health officials face another challenge: convincing people to take the vaccines. In late November 2020, the Pew Research Center found that 39% of Americans probably or definitely would not take the vaccine. Black and Native American communities have a lingering distrust of experimental drugs based on a history of unethical medical treatments. The fast-track nature of the FDA’s EUA process also creates uncertainty even among some medical professionals. More insidiously, conspiracy theorists and anti-vaxxers continue to sow distrust of the vaccine through social media. To counter this skepticism, political leaders from both parties livestreamed their vaccinations. At the same time, public health officials and community leaders have begun education campaigns.

What Vaccines Mean for COVID-19 Testing Labs

How Vaccine Distribution is Working Worldwide

Taking Vaccine - What Vaccines Mean for COVID-19 Testing Labs

You can see global vaccine distribution working — for better and for worse — much like it is in the United States. Wealthy countries with well-developed pharmaceutical industries and public health systems have already begun inoculating their populations. Within two weeks, Israel administered the Pfizer-BioNTech vaccine to 15% of its population. Yet public information campaigns are still needed to ease concerns among the country’s Arab minority.

The European Medicines Agency granted a conditional marketing authorization for the Pfizer-BioNTech vaccine in late December and for the Moderna vaccine in early January. Following those authorizations, the European Union secured access to nearly half a billion doses of the vaccines.

Russia, China and India are all leveraging their domestic pharmaceutical industries to supply their vaccination programs. India has aggressive plans to vaccinate more than 300 million people — nearly the population of the United States — within the next twelve months.

Rich States Vaccinate, Poor States Wait

Taking Vaccine - What Vaccines Mean for COVID-19 Testing Labs

India’s plans, as impressive as they are, also reveal a deeper issue with COVID-19 vaccines globally. Vaccinating 300 million people in a year leaves more than two-thirds of India’s population susceptible to the virus. More than a hundred nations with even less economic clout find themselves waiting at the end of the line. A recent analysis found that 32 of the world’s richest countries have already pre-ordered half of the production capacity from Pfizer-BioNTech, AstraZeneca and Moderna. While the United States has pre-ordered more than two doses per capita, countries like Egypt, Brazil and Indonesia are closer to a single dose per capita. Financial limitations and weak infrastructure could mean it will take years for these countries to fully immunize their populations.

COVID-19 Risks Will Persist

In a perfect world where public health systems, central governments and pharmaceutical companies executed the pandemic response flawlessly, it would still take a year or more to bring COVID-19 under control. Many of the new mRNA vaccines, especially those with multiple doses, are more than 90% effective. While impressive compared to the seasonal influenza vaccine’s 40-60% effectiveness, millions of people who receive the vaccines will still be susceptible to the coronavirus. Other factors limiting the ideal-world response to COVID-19 include the time it takes to achieve so-called “herd immunity” and the long-term efficacy of the vaccines.

Taking Vaccine - What Vaccines Mean for COVID-19 Testing Labs

But as we’ve discussed, the pandemic response in the United States and around the world has been far from ideal. Economic, cultural and political factors are producing inconsistent vaccination programs. This, in turn, will create large pockets of unvaccinated populations. Some of these populations will be geographically distinct, but others will be dispersed throughout the community. These susceptible populations become environments for the virus to spread — and potentially evolve.

Even before the first vaccines were authorized, we saw the emergence of new SARS-CoV-2 strains. In early December 2020, British health officials saw a sudden surge in cases in southeastern England. A new variant called B.1.1.7 had evolved seventeen distinct mutations. While no more deadly than existing strains, B.1.1.7 is much more infectious and sent a flood of new patients into an already-overburdened National Health System. A different variant called 501Y.V2 drove a renewed surge in COVID-19 cases in South Africa with similar impacts on hospitals.

At this early stage, we don’t know whether the recently-authorized vaccines are more or less effective against the new variants. As the virus continues to circulate in unvaccinated and under-vaccinated regions, we will inevitably see new variants that could undermine the world’s vaccine strategies.

Widespread COVID-19 Testing Must Continue for Years

Assuming the American pandemic response regains its footing and convinces everyone that the vaccines are safe and effective, bringing COVID-19 under control will take most of 2021. Vaccination programs will stretch through the summer before we reach the 70% or higher inoculation rate needed to constrain the virus. People who refuse to take the vaccine and those whose vaccinations prove ineffective will send that timeline slipping to the right.

To stop community spread and make contact tracing effective again, we will still need widespread testing. Labs able to conduct rtPCR tests will continue to see heavy demand for their services. Screening programs in schools, workplaces and international ports of entry will still need laboratories that can perform rapid antigen testing. And even as those tests become more available at point of care, laboratory-based confirmatory PCR tests will continue to be necessary. Additionally, innovative programs like the National Wastewater Surveillance System will provide early warnings by tracing detections of SARS-CoV-2 from treatment plants to communities where fresh outbreaks occur – an emerging fast-growing initiative that looks likely to become an established part of public health programs.

Within the context of America’s pandemic response, central state and federal institutions conduct very little of this testing. It’s up to the thousands of laboratories around the country to take on this task throughout 2021 and beyond. Yet many of the in-the-moment decisions and quick-fixes labs instituted as they rushed to serve their country will not be sustainable — especially as state and federal agencies demand more data, faster.

This is where a laboratory information management system (LIMS) like LabLynx’s COVIDLiMS can streamline laboratories’ operations. Pre-populated with assays and workflows specific to COVID-19, COVIDLiMS lets laboratories automate their data and reporting management without replacing their existing systems. And COVIDLiMS’ extensibility lets the system evolve to handle new SARS-COV-2 variants and future pandemic viruses – as well as any other types of testing labs choose to offer.

To learn more about COVIDLiMS and how it can help your laboratory in as little as a week, contact LabLynx at sales@lablynx.com, 866-LABLYNX (522-5969), or LabLynx.com.

What Vaccines Mean for COVID-19 Testing Labs

References:

US Food & Drug Administration Nature US Centers for Disease Control and Prevention US National Institutes of Health European Medicines Agency

AZD1222 Oxford Phase III trials interim analysis results published in The Lancet, AstraZeneca

Coronavirus: India approves vaccines from Bharat Biotech and Oxford/AstraZeneca, BBC

Johnson & Johnson Announces Initiation of Rolling Submission for its Single-dose Janssen COVID-19 Vaccine Candidate with the European Medicines Agency, Johnson & Johnson

EU Authorizes Moderna COVID-19 Vaccine, Saying It Has 160 Million Doses, National Public Radio

Governors complain Covid-19 vaccine shipments being cut, feds say not true, NBC News

Intent to Get a COVID-19 Vaccine Rises to 60% as Confidence in Research and Development Process Increases, Pew Research Center

Pizza-sized boxes and paying a premium: Israel’s COVID-19 vaccine rollout, Reuters

Mutant coronavirus in the United Kingdom sets off alarms, but its importance remains unclear, Science Magazine

Some Texans are hesitant to get vaccinated for COVID-19. Here’s how health officials are countering skepticism, Texas Tribune

Years of medical abuse make Black Americans less likely to trust the coronavirus vaccine, Washington Post

SARS-CoV-2 Variants, World Health Organization

How Wastewater Labs Can Help Defeat the Pandemic, LIMSforum.com

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