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A surge in biotech startup out-licensing deals from the country are paving the way for increased IPO and M&A activities.

Exploring Biopharma's Dealmaking Terrain, Roadmap in China

A growing number of domestic drug developers are setting their sights on overseas markets.

Out-licensing Deals Between Chinese Pharma and Global Companies are Heating Up

Licensing deals, strategy, and COVID among factors to consider for companies entering Chinese pharma M&A.

Chinese Pharmaceutical Cross-Border M&A in 2022

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

Mis- and disinformation on social media is a growing concern for both pharmaceutical companies and patients alike. Distrust in the various different platforms leave patients looking for guidance from any "trusted source," regulated or not, and the consequences could be disastrous. Young adults are increasing looking to their online parasocial relationships for advice on many topics, including health and medical care. This is just one of many challenges that the spread of misinformation presents.

In this Pharmaceutical Executive Q&A, Becky Edwards, Chief Communications Officer of Organon, explores how much power influencers really have, how algorithms contribute to the spread of misinformation, what can be done to combat it, and more. 

PharmExec: How is the spread of misinformation on social media platforms influencing young people's decisions about birth control methods?

Teenagers and young adults spend an average of at least four hours a day on platforms like TikTok and Instagram. So, it’s no surprise they’re exposed to a wide array of topics, including health information. The platforms are designed to prioritize posts with high engagement which can sometimes mean boosting misinformation. A recent survey

 by the Kaiser Family Foundation (KFF) found at least 40% of people have encountered false health claims online, leading to confusion and uncertainty about the credibility of the information. Experts and health professionals are well positioned to counter this misinformation by guiding users towards evidence-based sources.

When it comes to contraception, thousands of social media users share their experiences and opinions on options, including specific potential side effects and usages of different hormonal and non-hormonal methods related to fertility, acne, weight gain, and libido, among others. Although this content is often just anecdotal, healthcare providers are seeing many women and girls influenced by these stories and choosing to use different birth control methods or opting for no method at all. A 2024 TikTok study

 found that nearly 50% of the posts about birth control that were analyzed promoted the same idea, with TikTok creators identifying 57 alleged negative side effects of hormonal contraceptives. This is why credible sources making it a priority to educate around the facts of reproductive health and contraception is important now more than ever.

At Organon, we are doing this through our educational social media series, “The Misses of Health Information,”

 where characters “Miss Information,” “Miss Diagnosis,” and “Miss Understood” share the facts and address incorrect assumptions about women’s health topics, as well as show support for patients. This is just one example of a digestible way to educate patients on social media, while directing them to a healthcare professional as their primary resource for health information.

PharmExec: What are the potential consequences of these misinformed choices?

Misinformation on social media can lead to an increase in false interpretation of scientific knowledge, opinion polarization, and an escalating fear and panic related to healthcare. In reproductive health, misinformation about contraceptive care could boost unplanned pregnancy and STI rates and foster misunderstandings about contraception and broader women’s health topics. There are many different types of contraceptives, daily options like pills or long-acting reversible contraceptives (LARCs) which can last multiple years after one insertion. Choosing a birth control method is a highly personal decision that should be made in partnership with a medical professional, considering factors like life stage and lifestyle, health history, effectiveness, safety, and frequency of administration, among other things. Conversations with medical professionals are crucial for making informed decisions, rather than depending solely on online sources which may not be credible.

PharmExec: What role do healthcare providers play in countering misinformation and providing accurate information about birth control? How can they effectively communicate with their patients in the age of social media?

Healthcare providers play a vital role in countering misinformation and offering accurate information about birth control. They can gain insights into social media conversations to better counsel patients and anticipate concerns. Social media also offers an opportunity to engage in discussions around reproductive health and understand what patients encounter online. By clarifying fact versus fiction, providers support patients in their decision-making process. Encouraging open dialogue about birth control options is crucial, as is providing readily available accurate information.

As a company dedicated to empowering women and girls when it comes to their reproductive health, including making informed decisions around contraceptive options and their correct use, Organon believes in the importance of access to information for women and girls around the globe, including being able to distill the wealth of misinformation on social media. In Brazil, Organon is raising awareness of long-acting contraceptive methods through a creative “larger than life” baby bottle and pacifier display during National Week for the Prevention of Teenage Pregnancy the first week of February. The campaign, called “a decision this size” sparks conversation around the importance of family planning education and contraceptive access.

PharmExec: How do algorithms on social media platforms contribute to the spread of misinformation about birth control? What can be done to improve the accuracy and reliability of information presented on these platforms?

Algorithms curate content based on user behavior and often prioritize engagement. Viewing posts with misinformation can amplify similar content, potentially spreading sensational or misleading information. This is particularly concerning for the one in eight Americans who are already anxious about their health, as social media can reinforce this health anxiety. Birth control is no exception. Contraception misinformation, coupled with a lack of transparency on social media about rare side effects, is causing many women to believe misconceptions about the medication.

To combat this, the healthcare community must come together debunk misinformation and advocate for fact-based evidence across social channels. I’ve been learning a lot from my friend Lisa Kaplan at Alethea that there is also an opportunity to harness AI to promote accurate information by developing systems that flag and reduce the visibility of misleading content. At the same time, we need to make accurate information readily available, including ensuring women have access to comprehensive birth control information and resources that contribute to their overall health and wellbeing.

PharmExec: How significant is the impact of influencers on young people's decisions about birth control? What are the factors that contribute to their influence?

Influencers can significantly impact behavior due to their extensive reach and relatable content. They often assume roles akin to a “cool older sister,” with followers trusting them as credible sources.

 from the World Health Organization found that these types of misleading, shorter messages and anecdotes from influencers may have an even stronger influence on the spread of misinformation. This type of content often resonates with women’s real experiences, potentially discouraging them from having discussions about birth control with their doctors. They also make counterarguments difficult, as they could be perceived as dismissive of women's genuine experiences.

Research has also shown that many of the influencers who discourage the use of birth control promote distrust in the medical establishment and associated regulatory bodies, often leaning into health fears like those related to infertility, cancer risk, and side effects. Consequently, one in seven women ages 18 to 25 say they made a change or thought about making a change to their birth control method because of something they saw or heard on social media.

For younger women, it's crucial that parents are aware of the type of content and misinformation that exists online. Encouraging open and honest communication will ensure young people do not see the internet as their primary or sole source of education and allow for more informed health decisions.

I would have loved to have the exponential sisterhood available through social media when I was younger. I see how my kids benefit from it but they have inherited my husband and my healthy skepticism and “ask more questions” attitude. We were trained as journalists and have passed those skills on to our kids to have while wading through the abundance of content available today.

PharmExec: What additional questions need to be explored to better understand the impact of social media on sexual health decision-making?

To better understand the issue, we need to ask several key questions. First, how can the healthcare community collaborate more effectively to counteract misinformation on social media? What strategies can ensure accurate and accessible information reaches diverse audiences, regardless of location? For instance, through a U.S. initiative

, Organon supported Power to Decide's digital "Beyond the Sheets" campaign. This effort partners with student ambassadors at Historically Black Colleges and Universities (HBCUs) to empower young people and promote reproductive well-being on campus via social media. It's crucial to explore how the healthcare community can expand such partnerships to create community-driven solutions. Lastly, reproductive health isn’t just women’s health, it affects everyone. We must consider how to educate men and encourage shared decision-making responsibility.

https://www.kff.org/health-information-and-trust/poll-finding/kff-health-misinformation-tracking-poll-pilot/

https://journals.sagepub.com/doi/abs/10.1177/15248399231221163

https://www.instagram.com/organonllc/reel/DCo6vTQNqqg/

https://pmc.ncbi.nlm.nih.gov/articles/PMC9421549/pdf/BLT.21.287654.pdf

https://www.organon.com/her-plan-is-her-power/#:~:text=Her%20Plan%20is%20Her%20Power%20drives%20community%2Dled%20responses%20and,halfway%20toward%20meeting%20our%20goal

In this Q&A, Organon's Chief Communications Officer, Becky Edwards discusses how much social media and influencers sway decisions about birth control methods, potential consequences of these misinformed choices, and more.

Social Media's Influence on Young Women's Reproductive Decisions

With any new year, comes change, of course, and for 

, we have an exciting one for our readers. As you may have noticed, our 

It’s been a few years since the publication’s last redesign, but our latest one, we are confident to convey, is much more than simply a refresh. Our goal was to marry the brand’s authoritative content and analysis that you’ve long relied upon with an upgraded presentation to match. After all, the industry we cover is constantly evolving and innovating—so why shouldn’t we?

The result was the creation of a more modern, sophisticated, and sleeker look to the magazine, with a nod to some of those trusted business titles you may still page through at the doctor’s office or on the plane. Ease of navigation was also very important to us. You’ll notice in 

 February issue a smoother and, we hope, a bit more inviting flow of text and visuals. Let’s face it, print today is up against an ultra-fast-paced, attention-packed, digital world. Sprucing up overall eye appeal is one thing, but we know it’s the cohesion of the ingredients inside that will be what differentiates and enhances your content experience the most.

We hope you enjoy the new design. A special thanks to our talented creative team, where Ariana Mexquititla, associate art director, spearheaded the project, in collaboration with editorial. We’re still in tweak mode, so we invite your feedback, good or bad, and suggestions and thoughts on ways we can improve further!

Mike Hennessy Jr. is President and CEO of MJH Life Sciences

Welcome to a bold new look for Pharmaceutical Executive's print and digital magazine.

At First Glance 

Gene Mack became CEO of Gain Therapeutics in January 2025 after previously serving as interim CEO and chief financial officer for the company. Mack brings 25-plus years of experience to the leadership role for the clinical stage biotechnology company, having previously worked in areas such as clinical research, financing, investing, corporate strategy, and business development.

 Mack discussed his transition as the company’s new CEO, its use of physics-based artificial intelligence (AI) for drug discovery, the progress and financing of its lead drug candidate GT-02287 for the treatment of Parkinson’s disease, and strategic decisions regarding clinical development, partnerships, and future growth.

PE: You’re fairly new as the CEO of Gain Therapeutics. Can you speak more about different aspects of the company, such as its physics-based AI, how it could be applied to this new AI paradigm, and speak more about your lead candidate?

I joined the company about a year ago as its chief financial officer. I had a connection to the board. The scientific founder is a CEO I covered as a cell side analyst, and we developed a relationship that continued for the next decade. Last year, he gave me a call since his CFO went off to do something in Europe, and he felt that the current management didn’t have a lot of experience with capital markets. So, they asked me if I would take a look. I have a neuro background, and since it was for Parkinson’s disease, it was natural for me to take the role of CFO.

The CEO and the board parted ways over business development and types of transactions that the company should be pursuing. In June, they agreed to disagree and I became the interim CEO, which was made permanent in January. Small biotech companies live through chronic periods of existential threats, with brief periods of enormous success if they’re good. But for the most part, there are a lot of existential threats out there. In a small company, a CEO has to be available at all times. So, that’s a challenge, but it’s very rewarding and I’m happy to be there.

We have enough capital to complete an interim analysis from our Phase IB trial (of GT-02287), which we think will be a sufficient enough signal finding exercise to design Phase II. At that point, we’re going to share the interim results with our potential partners as well as the market. From there, we either raise additional capital on our own, with partners, or some combination of the two that allows us to maintain significant ownership of the compound.

PE: Are you putting forward additional candidates or are you waiting to see the results of the readout?

We have a backup portfolio of compounds that also target glucocerebrosidase (GCase), which is the target of GT-02287. The interesting aspect is that it’s structurally distinct. In a nutshell, the Magellan platform was initially good at taking known compounds and figuring out the binding kinetics and could do some things intuitively. What we do now is bind kinetics for fragmented molecules that don’t necessarily exist yet but could potentially be formulated based on the structure that the platform builds. Then you see structures flickering in and out of view, you start to see things stick and not come off, because there’s a threshold. As that structure is built, that is a theoretical threshold.

I think the next thing that we need to improve upon is having it spit back more accurately and be something that can stabilize quickly. It takes a tremendous amount of data. Right now, AI is a shiny object, but there’s a million people working in the background to make sure that objects stay shiny. This includes constant data integration. If you don’t do it correctly, it won’t work properly.

PE: What can you tell us about the timeline for clinical data milestones?

In December, we received approval in Australia to start our Phase I study in patients with Parkinson’s disease. In the third quarter of last year, we reported safety and tolerability results from a health volunteer study. The first step in a Parkinson’s disease study is to conduct a health volunteer study for 14 days in order to make sure the drug is well tolerated. We saw the safety and tolerability profile that we wanted as well as target engagement. In health volunteers, we were able to increase Gcase activity, which was an important finding. That’s the target of GT-02287. You shouldn’t see that in healthy volunteers. People in homeostasis work on feedback loops. When something shifts into an imbalance, the body works well at reacting quickly to compensatory mechanisms in order to nail it back down. Based on the snapshot that we took, we were able to see that the enzymes received 53% activation. To me, that’s the reason to believe that we’re on target going forward.

Now we have to demonstrate in another pilot study that it’s safe and tolerable. In our first study, we saw some grade 2 nausea, and we want to make sure that doesn’t turn into something worse, but there’s no reason to believe that it will. Nonetheless, we still need to do the three-month dosing study. We expect to see Gcase activity there as well, but we’re not sure if we’ll see a functional response after three months. Some of these patients have had toxic substrate building up in their brains for four years. Something working into that mechanism is going to take much longer to show functional employment, because you’re basically trying to stop the damage. You’re not repairing or masking anything. But if we can stop it in severe patients, we continue to move that treatment paradigm earlier as long as the therapeutic index remains appropriate.

PE: What are the next steps in the Phase IB study?

We’re going to enroll 15 to 20 patients, and we’re expected to start any day now. The open-label study will dose these patients for three months. We’ll watch enrollment from now through March. By the end of March, I expect to be able to tell the market what will be included in an internal analysis from the Phase I study.

There are a number of decisions that need to be made on the back of the Phase IB interim analysis. We’ll start incorporating and thinking about a Phase II design, but we might keep that protocol open and extend the dosing to 12 months. By the time the Phase IB data reads out, we will be able to incorporate that into the protocol amendment and extend the dosing. As a result, we’ll be able to get an answer much sooner than if we stopped the trial towards the end of this year. The Phase II readout won’t occur until some point in 2027. If I can start dosing patients for 12 months, beginning in the third quarter of this year, I’ll have that data a full year earlier. That’s important for the field, investors, and for patent life.

The next two big milestones coming are an enrollment update at the end of March with guidance on what the interim analysis would say.

PE: Tell us more about the financing of the company up to this point

It’s been very difficult. The private financing went smoothly but the public financing, that became a bit problematic. When the company went public towards the tail end of 2021, the market was starting to cool off. I would guess that Gain Therapeutics was one of the last companies to go public that year before the financing window went away completely. At the time, the company had about two years’ worth of cash. We went back to the market in 2023 and conducted a very difficult financing at around $2.75. We then did another financing round in June at $1.35.

All the while, the fundamentals of GT-02287 have improved. It’s been elaborated through the data. So, the financing tracker has been inversed to the success of the company, and there’s a couple of reasons for that. I think early on, expectations were that this company would get acquired by a strategic partner quickly. With preclinical data, I think that was a bit naïve. The expectation crept out into the market, but there weren’t enough discussions about the clinical development decisions that needed to be made.

People felt that there was no conviction. Meanwhile, the strategic partners are at the gate. We could make a deal tomorrow. Most companies act favorably, but they didn’t consider whether the data will look as good three years from now as it does today. We don’t want to be unfair, but we also don’t want to leave a tremendous amount of money on the table. The early work we’ve done will significantly reduce that risk.

We’ve had some pressure to partner before our Phase IB trial, and we’ve been resistant to that because for little capital, we can deliver a Phase IB result, and then see if we’re still the right company to move forward with, and I think we are.

There’s a lot of debate on the board on what the company’s growth is going to look like in the next year. Is it going to be a partnership, a solo venture, or is it going to have another name on it? That’s something that will be determined by the data. But having activated Gcase in health volunteers, I am content to wait and see how this plays out.

PE: Would you envision that all eyes are on getting GT-02287 to move forward?

Yes, the eyes were initially on Magellan and tweaking it in a way that it can be monetized. When I joined the company, I thought that was all wrong. We have a drug in clinical that will validate the platform rather than keep pumping out molecules that may or may not work. If they fail, it reflects poorly on Magellan. Let’s prove that those end products can make it into the clinic. Since coming in as CEO, I’ve converted us over a little more towards clinical operations and a little bit less towards bench research. It’s not less of an emphasis on bench research but right now, the growth area is in clinical operations.

The people running Magellan, and our early-stage pre-clinical research are awe-inspiring, because we have a pipeline that’s difficult to validate at low levels because of the productivity. We’re trying to consolidate some of that work and build the clinical operations team so that we can make good strategic decisions, which is where the company should have been headed as soon as GT-02287 entered clinical development.

Gene Mack, Gain Therapeutics CEO, provides a look into the future of the company and the use of physics-based artificial intelligence in the drug discovery process. 

Q&A: Gain Therapeutics CEO Discusses AI-Driven Drug Discovery, Strategic Growth Plans

is planning two events to be held next month. First, is our very first virtual conference and expo, Reaching the Healthcare Provider After 

COVID-19, on Aug. 13. Next up is the second of what looks like it could become a popular series, Pharmaceutical CEO Leadership closed virtual roundtables, to be held on Aug. 20. The Pharmaceutical CEO Leadership During the Pandemic roundtable appeared 

. You can also view the video excerpts from the roundtable 

. The next one in the planning stages will be spearheaded by Senior Editor Elaine Quilici and will feature key insights from Rob Jekielek, managing director at Harris Interactive. This should prove interesting as we get insights from the CEOs around “Pharma Image: 2021.”

	There’s a lot that can be said about Image. It’s not just reputation, or public perception, or one topic. It’s the whole of what an organization does internally and externally to offer an overall picture of who they are and what they represent. In this 

 from Quilici in June, as well as my editor’s letter from last month, we referenced reputation as a positive that pharma could achieve during COVID-19 and after. 

	Those sentiments were based on interviews we conducted, presentations we watched, as well as comments from the first roundtable and highlighted by Regeneron CEO Leonard S. Schleifer, MD, PhD, who said, “This is an existential moment for the industry. I think we will rise to the occasion. I am excited about the number of different companies trying incredibly novel approaches for vaccines, the number of companies who are trying different therapeutics. We have to do it scientifically, and we have to do it in an affordable, successful way. If we do, we’ll change industry and, frankly, we’ll change society for a long time.”

	As the pandemic raged on past the May 20 roundtable, the broader public continued learning more about scientific innovation, and the basic workings of clinical trials. But soon, lockdowns ended, people grew tired or forgot about distancing and masking, and now we are in another point of our public relationship with the pandemic. 

	On June 29, CNBC’s Meg Tirrell interviewed Gilead Sciences CEO Daniel O’Day on 

 about the company’s announcement of its pricing of remdesivir (watch video 

). The price was set at $2,340 for a five-day course; however, US insurers, in addition to Medicare and Medicaid, would pay $3,120. Remdesivir received emergency use authorization from the FDA to treat hospitalized COVID-19 patients on supplemental oxygen.

	Tirrell, of course, hit all the right questions, even, maybe, hopefully referencing our own magazine in her opening question: “This is a very important moment both for Gilead and the drug industry as a whole. You know, one industry publication writing this is a moment that could define the conversation around the pharmaceutical industry’s reputation for years to come. You set this price, basically in line I think with what a lot of people expected. You said it’s well below the value the drug brings, but it’s 30% higher to US insurers than to government insures around the world, in developed countries. Tell us about how you set this price.” 

	O’Day went on to inform about the differences in prices and how the therapy would influence reductions in hospital stay and healthcare spend. Tirrell pressed on the role of the middleman in the pricing, as well as the question of supply for America vs. rest-of-world. And O’Day dutifully explained those also.

	But at the end of the day, the headlines were mixed for Gilead. While some thought the announcement would lead to further erosion of pharma’s reputation, others referenced estimates from the Institute for Clinical and Economic Review (ICER) in Boston that remdesivir priced at $2,800 would be “reasonable” given its overall positive effect on those healthcare costs. Still, others voiced concern that the price doesn’t account for US taxpayer money. The same money that helped fund the NIH clinical trial of remdesivir for COVID-19.

	Clearly, this was the first pricing move out of the COVID gate, and it isn’t a vaccine or a “cure.” However, it is a reminder that the next steps are not without image risk. Continuing the dialogue that therapies and medications are important to the whole healthcare spend and quality of life for people, that the middlemen are also not absolved of responsibility, and that there is need for a more transparent patient pricing system would be a major benefit toward a more holistic image makeover. 

Gilead's pricing of COVID drug remdesivir is a reminder of pharma's tenuous path forward as it seeks a more holistic image makeover.

Will the Industry Rise to the Occasion?

	While scientists around the world are striving to discover, produce and distribute safe and effective vaccines to halt the coronovirus outbreak, cadres of anti-vacciners are revving up misinformation campaigns to undermine public confidence in such preventives. Despite the clear danger of COVID-19 to global health, vaccine opponents have gained ground, as fearful populations lose faith in the capabilities of industry and government to protect public health. 

	The latest tactic of anti-vaccine forces is to align with protests against government lock-down policies and restrictions on business and daily life. The “Reopen America” campaign has attracted groups fighting state vaccine requirements for school-age children. Despite strong childhood vaccination rates (over 90%) in the U.S., notable pockets of resistance dot the nation, as anti-vacciners show considerable savvy in communicating their message through social media to fuel more widespread “vaccine hesitancy.” A recent poll by the Associated Press and NORC at the University of Chicago found that while 49% of respondents plan to get vaccinated against COVID-19, 20% say they will not and 31% are not sure. Hesitant responders cite fear of side effects, of getting infected from the vaccine, belief that the new vaccines don’t work well, and 

 – issues that need to be addressed clearly by manufacturers and health authorities. 

	Ironically, the high-profile U.S. campaign to develop and produce vaccines against COVID-19 quickly, as promoted by the Trump administration’s Operation Warp Speed initiative, may fuel such objections. Instead of undergoing five or ten years of pre-clinical and clinical testing involving tens of thousands of individuals, current experimental COVID-19 vaccines are moving quickly through the development and approval process. Although such accelerated discovery is widely applauded, it also opens the door to fears that resulting preventives may be inadequately tested and less safe. 

	Related to this is the rise in novel technologies being explored to expedite vaccine development and production. Among some 150 COVID-19 vaccines in development, early front-runners utilize mRNA, DNA, new gene therapies and additional adenovirus vectors to trigger an immune response. Anti-vacciners describe these approaches as “synthetic” and “unnatural” and likely to generate adverse events more lethal than the virus itself. 

	Suspicions in vaccines also stem from charges that biopharma companies and international organizations are foisting risky treatments on the world just to make huge profits. Anti-vaccine crusaders have levelled conspiracy charges for years, particularly at the Bill and Melinda Gates Foundation and the World Health Organization for seeking to control the global health system in ways to track individuals’ activities. Such accusations have undermined international efforts to expand vaccine access to developing nations and to vulnerable populations. 

	Pharma critics also oppose industry patents on pandemic treatments, particularly those discovered and tested with significant financial support from government and public agencies. Although manufacturers of early experimental therapies have provided some treatments at no cost, and analysts have calculated fairly high values for vaccines that save lives and help restore the world economy, the debate over cost and access will continue. 

	Policy makers face further disagreement over the extent that anti-COVID-19 vaccination will be required for individuals to engage in activities involving greater personal interaction. With clear evidence that COVID-19 is highly contagious and dangerous, local and state governments may move beyond requiring certain vaccinations for children to attend school to mandating or recommending vaccination for those in certain jobs, to attend public events, and to utilize public facilities. Employers and service firms may impose similar requirements on staff, while the federal government could require vaccination for travel in and out of the country. Medical authorities estimate that 60-70 percent of the population would need to be vaccinated or found immune to achieve “herd immunity,” a high number that will require millions of vaccine doses fairly quickly. 

	The Centers for Disease Control and Prevention (CDC) has launched a “vaccinate with confidence” campaign to address concerns of those hesitant about vaccination, as opposed to the relatively few vocal vaccine opponents, explained Nancy Messionnier, director of CDC’s National Center for Immunization & Respiratory Diseases, in a recent virtual meeting on tackling vaccine access and hesitancy issues organized by the Forum on Microbial Threats at the National Academies of Sciences, Engineering and Medicine (NASEM). The group will further examine the impact of declining vaccine confidence at a 

	CDC also is concerned that scheduled vaccinations for young children have declined in recent months, largely because parents have delayed routine doctors’ appointments for fear of infection at medical facilities. While vaccination rates are expected to return to normal, the current drop raises fears of measles and meningitis and other outbreaks in coming months. Health authorities already are pressing for widespread seasonal influenza vaccination in the fall to reduce health risks from a second COVID-19 outbreak when cold weather returns. 

	Transparency and full disclosure of vaccine benefits and risks are important for overcoming public fears of new preventives. Manufacturers and regulators need to clearly communicate potential adverse events, while moving away from the long lists of possible side effects that confuse and scare the public. Clear assurance of product quality and safety also will be critical, especially for any vaccine produced overseas. 

While scientists are striving to discover and produce safe and effective vaccines to halt the coronovirus outbreak, anti-vacciners are revving up misinformation campaigns.

Adam Zhang Yu

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