It’s been two years since COVID-19 was officially named a pandemic by the World Health Organization (WHO), and it seems we are finally on the edge of moving from a pandemic to an endemic.
But what does this mean—and what lessons can we take with us as we think about COVID-19 staying with us, or perhaps the next pandemic that may come sooner than we’d like?
“Year 2 showed us that there's some durability to these vaccines,” said Phyllis Arthur, BIO’s Vice President of Infectious Diseases & Emerging Science. “Year 2 showed us that we can vaccinate at younger ages, and we found that heterologous boosting could actually lead to very interesting duration protection, which is a powerful thing scientifically.”
“Another thing we learned in Year 2 was the power of activating messengers to talk to their specific community about vaccination is incredibly important and that that is what we need to be doing across all kinds of health care,” continued Arthur. “The lack of understanding also opened the window for those who are anti-vaccine to actually take advantage of those misgivings. And people spread misinformation in communities that they weren't even a part of.”
“What does the end of the pandemic look like?” asked Arthur. “For me, it's the stabilization of the incidence of disease and prevalence of the strains. That change is coming […] If you can literally, generally manage the number of people who are ill and hospitalized with existing medicine and have relatively controlled, or no, breakthroughs amongst people who are vaccinated, then we are kind of where the flu is.”
But it is important to plan for the next pandemic now. “Everybody wants to get on with the rest of their lives, and this is fine for the American people,” she continued. “But the legislators and the administration needs to actually take the moment to step back and look at this and ask, what are the systems and safeguards I need to keep?”
Why IP protection is critical to pandemic preparedness
The proposed waiver of IP for COVID vaccine technology could counteract future pandemic preparedness. While some have argued a waiver of the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement would facilitate COVID-19 vaccine development and distribution, the exact opposite is true, experts told us.
We’ll say it again: Waiving IP rights would compromise global vaccination efforts. “They argue that eliminating IP protections would allow any willing company to produce lifesaving COVID-19 vaccines, making them cheaper and more widely accessible in low-income nations,” BIO’s Dr. Michelle McMurry-Heath responded succinctly. “If true, that would be a compelling argument. But it isn’t.”
The problem with access is not so cut and dry, BIO’s Senior Manager of International Affairs, Hillary Stiss, explains: “It is not an issue of IP that is preventing people from getting vaccines particularly in Africa. Really it is issues around African healthcare systems not being able to absorb vaccines and deliver it into arms.”
As Hans Sauer, BIO’s Deputy General Counsel and Vice President for Intellectual Property, further explained, there have been over 30 COVID vaccines developed—not just the Pfizer, Modern, and Johnson & Johnson vaccines—apparently without interference by anyone's patent rights. So, the idea that patents are getting in the way is incorrect.
Yet the very arguments used by governments to waive COVID IP rights seem to be a red herring to deflect from problematic global north government policy, while simultaneously disrespecting the work done by the private sector to step up and address this pandemic in record time – all with the added risk of disrupting investment, as well as R&D within biotech companies that would do absolutely nothing to help safeguard against the next big pandemic.
“There are certain folks who are willing to trade the next decades’ innovation for access today as opposed to thinking of ways to manage access in a way that doesn't trade future innovation,” noted Arthur.
“You don't sell the rug out from under companies in order to do that,” she continued. “Companies' memories are actually quite long and if we have another pandemic and ask companies to help after forcing them to share their trade secrets they are going to resist.
Biotech's Response to COVID-19, 2020-2022 Timeline
Year 1
- Early 2020:The U.S. biotech industry was already leading the way on COVID-19 solutions, and by February, some vaccines and therapeutics are ready for early trials.
- March 2020:BIO launches the Coronavirus Business Resource Center, the Coronavirus Hub, and holds a virtual summit to help companies stay on top of news, obtain and share information and supplies, and maximize collaboration on vaccines, therapeutics, and diagnostics.
- May 2020: BIO unveils the COVID-19 Therapeutic Development Tracker.
- June 2020: BIO holds the first-ever BIO Digital, which brought together more than 7,000 attendees from 64 countries for virtual partnering and conversations with experts like NIH’s Dr. Anthony Fauci and then-FDA Commissioner Dr. Stephen Hahn.
- August 2020: BIO launches the first pillar of the BIOEquality Agenda in response to the disproportionate impact of COVID-19 on communities of color, highlighting the importance of diversity in clinical trials.
- September 2020: BIO hosts the first COVID Treatment Access Summit, which brought together 60+ industry leaders to discuss’ access to COVID therapies. December 2020: FDA authorizes the first COVID-19 vaccine, developed by BIO member Pfizer-BioNTech, for emergency use, followed shortly by the vaccine developed by BIO member Moderna. BIO launchesCOVIDVaccineFacts.org with scientific and evidence-based information in both English and Spanish.
- January 2021: BIO releases 100 Days of Innovation, a blueprint with policy priorities to end the pandemic and build resiliency.
- February 2021: FDA issues an emergency use authorization (EUA) for the COVID-19 vaccine developed by BIO member Janssen Pharmaceutical Companies of Johnson & Johnson. In March, Merck announces it will manufacture it.
Year 2
- March 2021: The biotech industry begins Year 2 focused on vaccine hesitancy and vaccine equity, with BIO’s Dr. Michelle McMurry-Heath and Phyllis Arthur driving thought leadership.
- May 2021: BIO proposes the COVID Global Strategy for Harnessing Access Reaching Everyone (SHARE) Program.
- June 2021: BIO Digital convenes where biotech leaders reflect on how biotech jumped to action and what still needs to be done.
- July 2021:155,884,601 Americans are fully vaccinated, which equals about 54.9% of the eligible population (12+) and 47% of the total population. In addition, 63.9% of the eligible population (54.6% of total population) had received at least one dose.
- August 2021: The FDA approves the Pfizer-BioNTech vaccine for people 16 and older, making it the first fully approved COVID-19 vaccine, while CDC releases data showing the COVID vaccines are safe for pregnant people.
- October 2021: 3.3 billion of the world’s 5.8 billion adults are vaccinated, with the biopharmaceutical industry producing 9.3 billion doses of COVID-19 vaccines by the end of the month.
- November 2021: U.K. approves world’s first COVID-19 pill. CDC authorizes vaccines for kids ages 5-11. BIO and international counterparts meet with WTO Director-General Ngozi Okonjo-Iweala in Geneva.
- January 2022:FDA fully approves the Moderna vaccine, and Novavax applied for emergency use authorization. WHO says boosters are 80% effective against hospitalization even during the surge of the Omicron variant.
- February 2022: BIO holds the hybrid BIO CEO & Investor Conference, bringing a safe return to in-person meetings–thanks to the work of BIO members to address the pandemic.
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