Welcome to Molecular Ideas, and thanks for sharing your time with us today! Today, we briefly look back on the first year of having vaccines to counter the COVID-19 pandemic, including previous (in)correct predictions and new ones for the year ahead!
Our Discussion At A Glance
The sum of individual judgements of risk tolerance and short-term rewards will continue to define how much COVID-19 remains a part of our lives and economics over the next two years.
Key predictions from last year were mostly realized, including the failure to eliminate COVID-19 (even in highly vaccinated areas), the evolution of our annual vaccine schedule, and new mechanisms of administration are under development.
We offer five predictions for the year ahead. These include updates in the definition of 'fully-vaccinated' and an evolution at-home COVID-19 testing to include device-and-cartridge based models for increased ease-of-access.
Happy anniversary and thank you for sticking with Molecular Ideas for a whole year!
We're Still Through the Looking Glass
It has been around a year since Pfizer & BioNTech were granted Emergency Use Authorization for their COVID-19 vaccine, COMIRNATY®, by the U.S. FDA.
New technology being developed and validated so quickly represents the work of millions across the world - from the executive level to practitioners on the front lines to patients who stepped up to put their faith in the scientific process in real-time.
Yet, this glimmer of hope has failed to be the bright north star that we all hoped would be used to end the pandemic. The rise of subsequent strains, including Delta, Delta+, and Omicron have caused the case and death toll to continue mounting.
Image Source: Unsplash via Wix
Where We Are
As of this writing, COVID-19 has killed over 800,000 people in the U.S. and a staggering 5.5 million people worldwide. Cases continue to skyrocket as Omicron and more infectious variants continue to emerge. It is clear, if not an understatement, to assume that COVID-19 will continue to be a part of our lives for the foreseeable future. While vaccination has been able to stagnate infections and deadly cases in certain areas, the data clearly show that greater adoption of vaccines and more rigorous public health measures are needed to contain the spread of this disease. These data below show that we have a long way to go to get to the ideal 90% mark for herd immunity - only 63% of the US is fully vaccinated.
Vaccination Status of US by Age | Image Source: Mayo Clinic | Data Source: CDC
The question at hand is whether we can best defeat this disease through direct approaches (like vaccination and masking efforts en masse) or management through staunching the diseases other effects (like mental health deterioration) and treating infection as it comes.
It will be nearly impossible to defeat this disease in the next few years without some version of a stricter quarantine, transit protocols, and greater vaccine adoption while balancing mental health and working needs. Achieving this is the responsibility of individuals and organizations alike.
Millions of Americans who rely on in-person, face-to-face interactions for their jobs. The spike in COVID-19 cases has had an economic ripple effect in the most celebrated time of year. Retail stores, including electronics (like Apple) that relied on the pre-holiday shopping rush have suffered from unprecedented labor shortages due to outbreaks and employees at risk.
Meanwhile, vaccines are among the most equitable low-cost, high-impact public health measures when implemented on the national level, and preventative measures like masking limit the risk of person-to-person transmission. Without these measures, we limit the ability to export vaccines to areas at high risk for transmission and new variant emergence. A year ago, the 'British' variant (B.1.1.7) emerged. Six months after that, Delta (B.1.617.2) (shortly followed by Delta+) took the world by storm. Now, six months later, we have Omicron as the world was trying to get 'back to normal' once again. Imagine what would happen if the next Omicron-level variant arose six months from now.
Current COVID-19 Variants, as designated by the WHO. Variant acronyms and meanings can be found here. | Data Sources: CDC & WHO | Image Source: Molecular Ideas
Where We've Been
About a year ago, the second post on Molecular Ideas offered five key predictions on what 2021 would bring. Here's how they panned out over the past year.
Prediction #1: "COVID-19 isn’t likely to be eradicated in the next year; even if the US and other high-prevalence countries achieve 70-90% immunization around the same time, there are still likely to be pockets of un- or insufficiently vaccinated populations that will allow this disease to persist."
Result #1: TRUE. Unfortunately, the US has not achieved our goal of 70%-90% vaccination to counter COVID-19. There have been shortages of the vaccines shortly following approval due to supply chain and operational difficulties, which have persisted in low-income countries. However, the most significant barrier to reaching this target has been low vaccine adoption, fueled by misinformation and disinformation on every media plane. This 'infodemic' (information pandemic) has been led by several individuals across social media sites and traditional media, but has persisted on the personal level. Overcoming this misalignment is tantamount to defeating COVID-19 itself.
Image Source: Fitchburg State University
Prediction #2: "Changing the route of administration may smooth the way to increasing adoption of the vaccine,..."
Result #2: TRUE. Unfortunately, one of the justifications people use for not getting vaccinated against COVID-19 is a fear of needles. Fear has played the most significant role in people's lives throughout this pandemic. Whether people are afraid of catching COVID-19, the effect of new regulations or policies on their liberties, or simply not feeling their best, fear has seemingly supercharged every component of our common discourse.
Fortunately, scientists at DIOSynVax and Cambridge University are developing a 'needle-free' injection device and COVID-19 vaccine specific to the latest variants. Using a "high-powered jet stream", the vaccine is inserted into the body without pricking the skin. The device is reminiscent of the Hypospray found in every Star Trek sickbay. Hopefully, the device and vaccine pass muster under regulatory scrutiny so we can see it in clinics soon.
Image Source: Bloomberg
Prediction #3: "...especially if COVID-19 becomes a necessary part of our year-to-year vaccination plans."
Result #3: TBD. It's unclear as to whether COVID-19 will become part of our regular vaccination plans. On the one hand, recent approvals and authorizations for vaccines to be administered to broader age groups (like children) may indicate that that regulatory agencies and clinicians are ready to make this part of the standard vaccination course. The need for boosters as new variants arise reinforces this, following suit with endemic diseases like the flu.
However, whether or not this prediction comes to pass is dependent on the answers to the following five questions:
How frequently will new variants (be expected to) emerge?
How effective will (existing) vaccines be against these new variants (especially in those who have been vaccinated before)?
How long will the immunity granted by these vaccines last?
How serious will the disease be in fully-vaccinated, partially-vaccinated, and non-vaccinated patients?
How quickly can the disease spread in fully-vaccinated, partially-vaccinated, and non-vaccinated populations (per age category)?
This will be an evolving discussion in research centers, policy shops, and epidemiologist offices around the world. As previously mentioned, we're still on the wrong side of the looking glass for us to be sure.
Image Source: Unsplash (via Wix)
Prediction #4: "We can expect that the market will settle to accommodate future vaccine approvals as a) preferable by means of specific population needs, b) preferable by means of formulation, and/or c) preferable by means of strain coverage."
Result #4: FALSE. The COVID-19 vaccine market is still wide open. Even with the first-mover advantage of Pfizer-BioNTech, many other major vaccine developers in the U.S. have entered to meet this critical public health need. Moderna continues to be the gold standard of COVID-19 vaccines in the US (despite supply issues). While J&J's one-shot solution has been met with tepid responses around the world, the vaccine developed through the AstraZeneca-University of Oxford partnership accounts for nearly 2.2 billion doses given given throughout the world. While most of these have been outside the U.S. (due to reports of rare side effects depressing domestic interest), the comparatively low price-per-dose and wide distribution network has clearly appealed to patients across the world.
What's more, Sanofi and GlaxoSmithKline (GSK) have taken up the fight again after reformulating their COVID-19 vaccine. Merck has repositioned as a vaccine manufacturing partner, but is locked in head-to-head competition with Pfizer for the new COVID-19 antivirals market. Even Novartis is throwing its hat in the ring.
Image Source: Shutterstock
Prediction #5: "While it is unclear as to whether our approved vaccines will provide protection against these emerging strains, we have seen established vaccines like Gardasil® (HPV) evolve to encompass numerous valents – leading to the latest iteration, Gardasil®9."
Result #5: TBD. Our efforts to rapidly develop and distribute COVID-19 vaccines has been awe-inspiring to watch. With that said, we're always a beat behind. RIght now, the industry is still working on meeting the global demand for vaccines based on what is already approved. Following full FDA approvals and similar actions by their international counterparts, we can expect to see some consolidation and increased valent coverage (meaning that more strains will be covered in a single vaccine).
Where We're Going
With this record in mind, here are five new predictions for the year ahead with regards to COVID-19, vaccines, and notable public policy shifts. As a disclaimer, these are known as SWAGs - Scientific Wild Arse Guesses. While based in reporting from global health authorities and industry discussions, there are no facts about the future. Further, each of these predictions are increasingly optimistic, as they reflect notable upside for patients, practitioners, and other stakeholders in play.
New Prediction #1: Mo' Variants, Mo' Problems
As mentioned above, we can expect to see at least one new variant of concern emerge in the next year. While highly transmissible variants like Omicron may continue to dominate, these will continue to pose a progressively lower threat to fully vaccinated patients as long as vaccine uptake doesn't stagnate.
New Prediction #2: Redefining 'Fully Vaccinated' in the Coming Year
If there's one thing that Omicron and the emergence of new variants has taught us, it's that the definition of 'Fully Vaccinated' is up for debate. As it stands, the definition does not necessarily include the booster shot (though this varies per local businesses and states). This evolving definition does not necessarily help anyone who isn't already partially vaccinated to come out to the clinic. However, it may help get us closer to that 90% mark when accounting for people who have their base shots but not the booster. Boosters will also help combat waning immunity.
New Prediction #3: Insurance will Take a Curtain Call
A new initiative from the Biden administration will force private insurance companies to cover up to eight at-home COVID-19 tests per month. This groundbreaking initiative will be critical to prevention efforts by enabling people to remain quarantined when at-risk. Effectively, this rewards responsible testing behaviors by helping people recoup the costs, while also reducing the burden on COVID-19 testing sites in cities.
This will serve as a rallying cry for insurance companies to upgrade their image. We saw an analogous shift in the tone around the pharmaceutical industry when they stepped up to repurpose and develop therapies and vaccines to address COVID-19.
While insurance companies help people avoid crippling debt and ensure relatively efficient hospital payments, they are painted as obfuscators. This perception is so prevalent that Pixar actively pokes fun at the industry in their box-office hit, 'The Incredibles'. Covering more than the minimum eight tests, streamlining the claims process, and actively marketing will create numerous - and memorable - positive brand touchpoints.
New Prediction #4: Policy will Shift Towards 'Living' with COVID-19
It's no surprise that we're all a little tired of COVID-19. Some might say that is no reason to not remain vigilant. However, the CDC's announcement to shorten the quarantine period coinciding with the holiday shopping and travel rush seems at odds with the policy of the last two years. While Omicron has a shorter incubation period than previous variants, there is little risk in maintaining the policy to limit confusion.
Unless there is a broader set of priorities. Shorter quarantine periods means that we are 'free to move about the cabin' as it were. It's no secret that a major spike in mental health challenges has accompanied COVID-19. With more and more people being vaccinated, but the overall vaccination rate slowing, there will likely be a fundamental shift in U.S. policy. This shift will focus on addressing pandemic-induced mental health challenges, possibly at the cost of COVID-19 infection prevention measures.
New Prediction #5: At-Home Testing will Evolve to Encompass Chip-Based Diagnostic Tests
At present, COVID-19 testing mostly takes place in labs from patient-collected samples or via at-home, disposable testing kits. As supply for tests fluctuate with the emergence of Omicron and other new variants, adding a more efficient way to produce and stockpile tests is needed.
Our final formal prediction is that COVID-19 testing will evolve to include at-home testing devices with refillable cartridge tests. Such a product would likely use microfluidics chip diagnostics. Following a razor blade model, you have a consistent reader device (the 'handle') and a chip (the 'blade') in which the sample is inserted and a reaction happens to show whether a given compound (like virus antigen) is present. In addition to being accurate, they also eliminate the complexities of needing to mix reagents together manually. Imagine being able to order a box of COVID-19 test chips that you can drool into (or apply a nasal swab sample to) and insert into a reader device on your bathroom counter. Further, microfluidics chips are notoriously cheap to produce for diagnostics and may come with higher long-term stability.
Honorable Mention: Making Masking 'Cool' with Public-Private Partnerships
As mentioned previously, these predictions get progressively more optimistic. Our honorable mention prediction is that some combination of advertising, policy, and incentives backed by public-private partnerships will crack the code on making masking and vaxxing 'cool'. This may seem like wishful thinking more than anything. However, the last year has taught us that divided we fall, and together we rise.
Happy Anniversary and Thank You
Image Source: Unsplash via Wix
It has been an honor to write Molecular Ideas for you over the past year. I hope that these stories have been as entertaining and informative to read as they have been to write. Thank you for your time, support, and thoughtful comments along the way. Discussing the cutting-edge of the life sciences and medtech industries with you has been one of my greatest professional pleasures.
Stay safe, stay sane, and keep your Molecular Ideas coming!
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