Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

As the COVID-19 pandemic entered its second year, vaccines from Moderna and Pfizer-BioNTech were being distributed throughout the United States; however, the initial rollout was characterized by confusion, supply shortages, and information gaps overshadowing the impressive performance of drug companies to bring COVID-19 vaccines to people in less than one year.

As of Jan. 24, 2021, the US had administered more than 22 million doses of the vaccine, representing 54% of the doses delivered and about one-third of the global doses administered, according 

 data (1). And while the vaccination rate was scaling up, the nation still had a long way to go and a lot of bugs to work out.

This article was published online on Jan. 26, 2021.

As governors clamored for increased and more predictable supplies of vaccines, Rochelle Walensky, the new director of the US Centers for Disease Control and Prevention (CDC) told F

 on Jan. 24, 2021 that based on the information from the previous administration, the federal government did not know how much vaccine was available and could not tell state officials how many doses they would receive (2).

Some disruption is to be expected with any government transition; the incoming administration criticized the planning efforts of the Trump administration and many local governments are struggling to implement efficient distribution programs. Still, the lack of a reliable inventory of COVID-19 vaccines—and the poor communication with the public—is unacceptable.

In late January, with an uncertain number of vaccine doses available and mutations of the SARS-CoV-2 vaccine threatening more widespread infections, some leaders are suggesting ways to get more doses out of the existing supply. With the United Kingdom considering delays in the dispensing of the second dose of vaccines, a recent CDC statement created confusion in the US.

On Jan. 21, 2021, CDC updated its guidance for administering the vaccines, noting that while the second dose of the COVID-19 vaccines should be administered as close as possible to the recommended schedule—21 days for the Pfizer-BioNTech vaccine and 28 days for the Moderna vaccine—the second dose could be administered up to six weeks after the first. In addition, CDC said in the guidance that in “exceptional situations” where the first-dose vaccine product cannot be determined or is no longer available, any available mRNA COVID-19 vaccine could be administered (3).

For some, this guidance suggests a delay in getting the second dose of the vaccine is acceptable. Walensky strongly clarified that the CDC was not recommending a change in the dosing regimen and urged people to follow the original FDA-authorized dosing guidelines. The January 21 statement, she said, was only for specific situations where FDA recommendations could not be followed (2).

I’ve recently heard vaccinated first responders tell news reporters that they were relieved that the vaccine would protect their families from getting the virus. Reporters failed to clarify that the vaccine has not been proven to prevent transmission. Mask wearing and social distancing are still in order.

For the average person, such government statements and medical details can be confusing. Walensky expects vaccine production to ramp up with fewer supply issues by the end of the first quarter. That leaves little time for the public health information void to be filled with clear, trusted communication.

1. Bloomberg, “More Than 65.7 Million Shots Given: Covid-19 Tracker,” 

, accessed Jan. 25, 2021.
2. Fox News Sunday, “CDC Director Predicts COVID-19 Vaccine Distribution Will Increase Dramatically by Late March,” Interview, Jan. 24, 2021.
3. CDC, Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States, 

When referring to this article, please cite it as R. Peters, “A Hopeful but Dangerous Phase,” 

Articles

A complicated vaccination rollout and mixed messages may derail the pandemic endgame.

A Hopeful but Dangerous Phase

As 2020 dawned, the bio/pharma industry faced major challenges. Drug pricing was expected to be a hot-button issue in the presidential election. Calls to bring drug substance and product manufacturing back to the United States intensified as global competition heated up. And some companies faced ethical questions about their roles in the opioid epidemic.

Digital technology was being adopted across the development and manufacturing continuum, from artificial intelligence for drug discovery and design, to digital simulations and analytics for manufacturing, to smartphone apps to track patients in clinical trials and monitor their adherence to medication regimens. Growth potential for personalized medicine led to a surge in company and facility acquisitions for the development and manufacture of cell and gene therapies.

Early in 2020, however, the SARS-CoV-2 virus erupted worldwide, disrupting the “normal” routine of bio/pharma. For the rest of year, efforts to respond to the pandemic overshadowed many aspects of development, manufacturing, and quality compliance.

Nearly half (48.1%) of the respondents to a December 2020 

 survey said that their organizations had experienced disruptions in the supply of materials or equipment as a result of the pandemic. More than 43% saw work schedules or production modified to accommodate social distancing. One-quarter reported staff shortages due to worker illnesses or quarantines. Respondents also noted delays or suspensions of clinical trials (21.2%); disruptions in regulatory compliance (18.6%); and shutdowns or suspensions of development or manufacturing operations (17.4%) (1).

Intense efforts by bio/pharma company research, development, and manufacturing teams to battle the pandemic began to show results as 2020 drew to a close, with one approved treatment (remdesivir), two Emergency Use Authorizations (EUAs) for monoclonal antibody treatments (from Regeneron and Eli Lily), and vaccines from Pfizer-BioNTech and Moderna heading to patients under EUA.

Meanwhile, drug researchers continued their work and, despite some disruptions to original pipeline development plans, concluded a modestly successful year with 49 approvals for new therapies from FDA’s Center for Drug Evaluation and Research as of Dec. 15, 2020, which surpassed the total for 2019 (2).

Delivering billions of COVID-19 vaccine doses and treatments to combat the effects of the virus will top bio/pharma’s agenda for 2021. At the same time, drug companies will be pressed to produce sufficient supplies of cost-effective generic and innovator drugs for a range of conditions.

The industry will also be challenged by global economic volatility, a new US presidential administration, and supply chain uncertainty. Lessons learned from the pandemic, however, offer new ways for bio/pharma companies develop and bring drugs to market.

Pharmaceutical company executives surveyed in March–April 2020 by the Deloitte Center for Health Solutions predicted an acceleration in research and manufacturing of pandemic drugs and expect drug prices to again be a hot topic. However, the executives also plan increased investment in digital technologies across therapeutic areas and functions to improve the R&D process and safety, with an eye on cybersecurity threats (3).

Respondents to the Pharmaceutical Technology survey were upbeat about business prospects for 2021. Almost two-thirds (64.3%) expected their companies’ businesses to improve, up from 52.2% in the 2020 survey; only 14.7% predicted a decline for 2021. They were even more optimistic about the bio/pharma industry as a whole, with 78.3% projecting that overall business will improve in 2021, compared with 66.1% in 2020; only 7% expect a decline in business in 2021 (1,4).

The dangers of sourcing crucial supplies from a single region surfaced as the pandemic first unfolded. The initial outbreak of infections and subsequent business disruptions in China resulted in shortages of anti-infective drugs, sedatives, analgesic medicines, and other essential generic drugs. Other shortages occurred for drugs previously approved for other conditions, which were investigated as potential treatments for COVID-19.

Currently, approximately 60–65% of global API production is based in Asia, primarily in China and India, explains Unmesh Lal, industry principal for transformational health with Frost & Sullivan. Another 24–27% of production is in Europe, with only 3–5% manufactured in the United States and 5–9% in the rest of the world. This huge discrepancy, he says, has made many countries too dependent on China for essential APIs.

“This is where we saw a significant demand in the short term,” says Lal. Although the pandemic caused a brief disruption and reduction in overall bio/pharma manufacturing capacity at certain sites, most production sites were quickly restored to full capacity by the end of the year, he says.

The pandemic had a broad impact on other aspects of bio/pharma development and manufacturing. To meet the increased demand for pandemic-related treatments and vaccines, manufacturing of COVID-19 vaccines and therapeutics was prioritized, say Lal, impacting clinical pipelines, delaying clinical trials, and putting development projects on hold.

The industry also saw significant disruption in early phase clinical trials that were yet to be initiated, a direct outcome of patient recruitment and capacity challenges during the pandemic. At the peak of the pandemic, there was a 33% disruption of ongoing clinical trials, according to Frost & Sullivan data, significantly impacting small and mid-sized biotech companies, Lal says.

Sites operated by larger contract research organizations (CROs) have resumed studies, Lal says. By employing newer clinical trial models, using virtual trial tools, and working collaboratively with the regulatory protocols devised in light of COVID-19, US and European CROs were able to recover faster than rest-of-the world markets, he notes.

Government investments in the development of COVID-19 vaccines and therapies, such as Operation Warp Speed in the US, have provided funding for some companies. Frost & Sullivan is monitoring R&D activity and government investment to see whether the surge from 2020 will carry over into 2021, especially for therapeutics. Lal expects bio/pharma companies to reduce investments in R&D for non-pandemic therapies by 2–3% in 2021, as they focus on COVID-19 treatments.

COVID-19 has also affected investments in bio/pharma development, beyond the government financing of public-private partnerships to advance vaccine and COVID-19 therapy research and development, according to analysts at Evaluate Pharma. However, biotech investments recovered quickly from initial market drops in the first quarter of 2020, and initial public offerings rebounded in the second quarter, the analysts say (5).

Many emerging bio/pharma companies lack the internal development and manufacturing capacity to move their drug candidates forward and have turned to contract development and manufacturing organizations (CDMOs) for these functions. As a result, CDMOs were busier than ever in 2020 and will get even busier as bio/pharma companies look to build redundancy in their supply chains, according to the market research firm, GlobalData.

“Pharma companies may try to reduce their supply chain risks by deliberately building redundancies—such as through using multiple suppliers and stockpiling. In the future, large pharma companies will want to know more about their contractors, both their CDMOs and their CDMOs’ suppliers,” said Peter Shapiro, PharmSource senior director of drugs and business fundamentals at GlobalData, in a company statement (6).

The manufacturing of vaccines and pandemic-related therapeutics is expected to extend well into 2021, increasing demand—and potential competition—for raw materials and supplies also used to produce other drugs. A tighter raw material supply market will pressure drug companies to reinforce and build redundancy into their supply chains, look to multiple suppliers in multiple geographic areas, and build better relationships with suppliers and contract service providers. The US government could invoke the Defense Production Act to force suppliers to expedite needed raw materials to COVID-19 vaccine and therapeutic manufacturing operations.

Given stronger demand for drugs and uncertainties surrounding the global supply chain, nations and drug companies are looking to become more self-sufficient. Countries are examining options for increasing domestic production of the APIs for essential drugs, says Lal, and traditional pharma companies are increasing their capital expenditures.

Still, demand is exceeding available capacity in some product segments, creating more work for contract manufacturers. Vaccine manufacturers are opting for dual sources, so they need to diversify in their CMO partnerships, says Lal. As a result, CMO capacity utilization has increased from normal levels of 75%, he says, predicting that investments in capacity will continue to increase.

Capacity is an industry-wide challenge, says Olivier Loeillot, senior vice-president, BioProcess, at Cytiva. “While there are bottlenecks and shortages, companies and CDMOs are accelerating expansion plans to meet demand. Long term, companies must think about their commercial manufacturing strategies earlier in the process: do they build or outsource it?” And it’s not enough to build out capacity if you do not have the trained workforce, he says.

Calls to onshore drug development and manufacturing, which became louder during the pandemic, are not new. “This debate over the past 20 years is like a pendulum and keeps swinging either way,” Lal says, first shifting away from Asia due to quality concerns, then shifting back as China increased its regulatory requirements and quality standards. “Now, due to the pandemic, we are seeing a lot of governments take the initiative and bring some manufacturing of the APIs and essential finished dose formulations on-shore,” he says.

With long lead times required to build manufacturing operations domestically, there is no quick fix to reduce dependency for essential drugs on China and India. For now, Lal notes, innovator pharma companies are building the resilience into their supply chains and seeking ways to better manage inventories. For the long term, he says, governments are showing interest in collaborating with bio/pharm to invest in onshoring or reshoring of drug manufacturing for essential medicines and to build regional capacity as a contingency against future pandemics.

However, he also anticipates significant decentralization of manufacturing operations to meet local demand for drug products in China and other Asia-Pacific countries, which is expected to grow exponentially in the future.

Both proven and new technologies were employed—sometimes out of necessity—during the pandemic and may become the norm for broader bio/pharma applications. “We’ve seen a significant surge in the adoption of single-use technologies,” Lal says, particularly for biopharma and cell and gene therapy companies. This is enabling is the growth of small- and mid-size specialized, niche CDMOs, and reducing overall dependence on the larger CDMOs, a trend that Lal expects to continue for the next few years.

“Single-use technologies and remote monitoring have proven invaluable this past year,” says Loeillot. “We will continue to see companies using these tools because they provide the speed and flexibility drug developers need.”

Newer technologies offer benefits for bio/pharmaceutical processing that extend beyond meeting pandemic demands. “While the world needs billions of doses of COVID-19 vaccines, many companies are focusing on small batch therapeutics and orphan drugs. That trend will continue post-pandemic,” says Loeillot. “Single-use technologies are ideal solutions for these drugs because they can produce clinical batches quickly, with reduced risk of cross contamination.”

Advanced technologies will play a greater role in bio/pharma operations, agrees Kevin Seaver, general manager for automation and digital at Cytiva. “Automation is one of the keys to delivering safe, effective, and affordable drugs to patients,” he says. “Flexible, single-use automated solutions allow for rapid adaptation to changing needs, particularly for small clinical batches, while adhering to the high-quality standards needed to control and document the manufacturing process,” Seaver explains.

Perhaps the most visible technology applications were associated with maintaining the extreme cold-chain requirements for shipping the messenger-RNA-based COVID-19 vaccines, from conventional materials such as dry ice, to storage containers, specialized freezers, and remote monitoring sensors using Internet of Things technology (7).

Drug companies, CDMOs, and regulators turned to advanced technology to maintain bio/pharma operations when pandemic travel restrictions made onsite visits and inspections impossible. Remote inspections and monitoring were put into practice at some locations, representing first steps toward more widespread digitalization of bio/pharma operations (8).

The efforts of biopharma experts in 2020 provided medical tools to combat the pandemic, but the battle will continue in 2021. Breakthroughs in science and research, public-private collaborations, investments in facilities, and new technologies applications not only advanced solutions to the pandemic, they also may have set the groundwork for more effective drug development in the future.

2021 Bio/Pharmaceutical Development and Manufacturing Employment Trends Survey

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Biopharma Leaders Prioritise R&D, Technological Transformation, and Global Market Presence

2020 Pharmaceutical Technology/BioPharm International Employment Survey

Pharma, Biotech & Medtech Half-Year Review 2020

 (July 2020).
6. GlobalData, “COVID-19 is Driving More Supplier Redundancy,” Press Release, Nov. 4, 2020.
7. J. Markarian, 

, 34 (1) 38–40 (January 2021).
8. A. Shanley, 


Vol. 45, No. 1
January 2021
Pages: 16–19

When referring to this article, please cite it as R. Peters, “Bringing Bio/Pharma’s ‘New Normal’ Into Focus,” 

Biopharma looks to deliver on COVID-19 vaccines and other promising therapies.

Bringing Bio/Pharma’s “New Normal” Into Focus

In 2020, the bio/pharma industry initiated a monumental effort to rapidly develop vaccines to prevent COVID-19 disease and therapies to treat the symptoms. Researchers, biologists, chemists, process engineers, formulators, quality control experts, and other professionals involved in drug development and manufacturing worked under pressure and sometimes socially distanced from other collaborators or team members.

The long hours and adverse conditions endured by drug development and manufacturing professionals have started to show results with the Emergency Use Authorization of two vaccines and two monoclonal antibody treatments and FDA approval of remdesivir. Nearly 50 drugs for other conditions were approved by FDA as 2020 drew to a close (1).

Drug development and manufacturing professionals participating in the 2021 Bio/Pharmaceutical Development and Manufacturing Employment Trends Survey, sponsored by Pharmaceutical Technology (2), worked longer hours in 2020 than previous years with fewer salary increases. Respondents, however, said compensation was not a top priority and nearly two-thirds expect to stay in their same position in the coming year. (See the infographics for an overview of survey results.)

Bio/pharma companies were very busy during 2020, as evidenced by the increased workloads reported in the survey. Nearly 60% of respondents said they worked more hours in 2020 than in the previous two years compared with 38% in the previous survey.

Nearly 80% of the respondents reported some impact from the pandemic on their daily work. More than half of the respondents (53.2%) changed work schedules to enable social distancing at work. A similar number (53.9%) worked remotely from home. Nearly one-third of the respondents said they assumed additional responsibilities; 20% worked additional hours on pandemic-related projects and 10.3% switched to pandemic-related projects. Development programs were changed or reduced for 13.5% of the respondents. Work hours or responsibility were reduced for 18.6%, and 5.8% said their position was eliminated.

After a difficult 2020, biopharma professionals have an optimistic outlook for the industry for 2021; more than three-quarters of survey respondents expect business to improve; 64.3% expect business at their employer to improve.

Talent-Driven Market for Laboratory Technicians

Satisfaction with compensation increased slightly in 2020, following a few years of downward movement. Almost 43% of the respondents said they were paid fairly or excessively in 2020, compared with 41.5% in 2019. A majority of respondents were not happy with their salary; 37.7% said their pay was at the low end of the salary range for their expertise and responsibility; 19.4% said they were paid below market value.

The percentage of respondents reporting salary increases continued a downward trend. Only 41.7% of the respondents reported a salary increase in 2020 compared with 55.4% in 2019 and nearly 63% in 2017 (2–4). A slightly greater percentage reported a decrease in salary (13.7% in 2020 vs. 11.4% in 2019). More people reported no change in salary (44.6% for 2020 compared with 33.2% in 2019).

Salary ranked second to last on a list of 13 factors contributing to job satisfaction in the 2021 survey, down from fifth place in the 2020 survey. Compensation trailed factors such as challenging projects, intellectual stimulation, company’s potential for success, supportive management, and a good work/life balance as the “main reason I come to work.”

Approximately half of the respondents reported no change in job security comparing calendar year 2020 with 2019. However, only 17.8% said they felt more secure in 2020 vs. 2019, compared with 30% feeling more secure in 2019. Those feeling less secure increased slightly, from 30.6% in 2019 to 34.4% in 2020.

Similar to surveys in previous years, more than half of all respondents said they would like to leave their jobs, given the opportunity; however, 62% said they do not expect to leave in 2021. A significant segment, 21%, said they would like to change careers and leave the bio/pharma industry.

Compared with previous surveys, respondents to the current survey tended to stay in the same position for a longer time. Fewer than 30% of the 2021 survey respondents—compared with 44% of 2020 survey respondents—said they stayed with the same employer, on average, for five or fewer years.

Fewer than 20% of the respondents said they voluntarily changed jobs in the past two years, primarily to pursue a better career opportunity or more challenging work.

Salary was the fifth most-cited single reason for job change, trailing professional advancement, intellectual challenge, scientific opportunities, and work/life balance. Two-thirds of the respondents were confident they could find a job similar to their current position, should they choose—or were forced—to find new employment.

Respondents suggest there is a positive market for job seekers for the bio/pharma market; however, they are somewhat split on the opportunities. More than one-third (35.6%) of respondents said there are few qualified candidates for open scientific/technical positions. A smaller percentage (30.5%) said there were more qualified candidates than open positions. As in previous surveys, respondents expressed somewhat negative opinions about the knowledge and skill sets of new hires; 74% said the new hires were adequately trained but not exceptional; 20.1% said they were poorly trained.

More than 200 bio/pharma professionals from around the world responded to the survey, which was fielded in November and December 2020. Respondents primarily were from innovator and generic-drug bio/pharmaceutical companies (41.4%) and contract research and manufacturing or consulting organizations (17.3%).

The respondents were involved in developing or manufacturing a range of drug types—with some listing multiple types—including small-molecule drugs (55.4%), large-molecule drugs (34.4%), vaccines (17.2%), cell therapies (15.6%), gene therapies (10.2%), and nutraceuticals (19.4%).

Top responsibilities listed were quality control/assurance, validation, production/manufacturing operations, analytical studies, process development, production R&D, formulation, R&D, and technology transfer. More than two-thirds are responsible for managing other employees.

The respondents are experienced in the bio/pharma industry; 16.3% had fewer than 10 years of experience, 25.6% had 10–20 years, 41.8% had 20–35 years of experience, and 16.3% have worked in the industry for more than 35 years. Nearly one-third held a doctorate degree or higher; 44% held a 

Pharmaceutical Technology, 2021 Bio/Pharmaceutical Development and Manufacturing Employment Trends Survey

, 2019 Pharmaceutical Technology/Pharmaceutical Technology Europe Employment Survey


Vol. 45, No. 1
January 2021
Pages: 20–24

When referring to this article, please cite it as R. Peters, “Compensation Does Not Necessarily Align With Job Satisfaction,” 

Essential bio/pharma employees show hard work and dedication can pay off for patients.

Compensation Does Not Necessarily Align With Job Satisfaction

Before the pandemic hit, the life-sciences market was growing at a quick pace, creating a shortage of talent in development and manufacturing, says John Ebeid, senior vice-president, Randstad Life Sciences, a human Resources solutions firm. The onset of the pandemic “has amplified the need for the new roles that have come up because of what we are trying to do in combatting the virus,” he says.

The pandemic has created a demand for people with life sciences, biologic, and chemical training. Jobs that require cellular or molecular biology and knowledge of the techniques and methods used—polymerase chain reaction, gel electrophoresis, cell culture, cell purification, RNA and DNA extraction—have been “in extraordinary demand,” for developing vaccines and for diagnostic testing, Ebeid says.

For entry-level laboratory positions, companies are seeking candidates with at least an associate degree in life sciences or physical sciences and some experience, certifications, or licensure. For positions that require work with advanced techniques, employers typically expect candidates to have a bachelor’s, 

The need for skilled laboratory technicians to process COVID-19 diagnostic tests is high, especially areas with large populations, says Ebeid. And with other markets beyond biopharmaceutical development and diagnostic testing also seeking qualified bench scientists, the demand for people with good laboratory practice, good manufacturing practice, quality assurance, and quality control expertise is high.

“With demand being as high as it is, companies are bringing in people that don’t have exactly the skill set, then are trying to upscale them once they come in,” Ebeid says. “It is definitely a talent-driven market,” says Ebeid, when looking at “the sheer number of openings versus the candidates that are out there.” This competition allows candidates to demand higher salaries when going into new positions.

With some non-executive roles taking more than 100 days to fill, Ebeid says Randstad advises employers to weigh the impact that open positions have on the company and make the most competitive offers they can when hiring for crucial positions, knowing other businesses are competing for the same candidates.

When referring to this article, please cite it as R. Peters, “Talent-Driven Market for Laboratory Technicians,” 

Demand for specific advanced laboratory skills drives creates a positive employment market.

In the waning days of 2020, frontline healthcare workers in the United States lined up to receive the first COVID-19 vaccine injections, a hopeful sign that this could be the beginning to the end of the pandemic. Producing sufficient doses to inoculate enough people around the world to achieve herd immunity, however, will require more than robust manufacturing; a global effort and agreement for the equitable distribution of vaccines is crucial.

Wealthy nations have taken the lead in developing vaccines. Operation Warp Speed (OWS), the US government’s program to accelerate the development and manufacture of COVID-10 vaccines and treatments, issued more than $12.4 billion to six vaccine makers to secure vaccine doses for the nearly 330 million people in the country.

The strategy of having multiple shots on goal—investing in multiple vaccines in case one or more fail during development—has triggered supply-and-demand questions. Will nations have enough doses to vaccinate their populations? Did your government make purchase agreements for the vaccines with the best potential for success? And are wealthy nations “clearing the shelves” of the leading vaccine candidates, reserving more doses than they need?

 analysis found that wealthy nations have reserved more than half of the vaccines to be produced by the end of 2021, more than is needed to vaccinate their populace, in some cases, several times over (1).

An analysis of contracts between vaccine manufacturers and governments showed the US has secured commitments for 455 million doses of vaccines (2). More than half of the committed doses, however, are from manufacturers that—as of mid-December 2020—had not received, or even applied for, Emergency Use Authorization for their vaccines.

The US Department of Health and Human Services (HHS) said in a 

 report that OWS had contracts with six companies with options for up to 3 billion vaccine doses. “We are confident that we will meet our goal to have enough vaccine doses for any American who wants one in the second quarter of 2021,” HHS was quoted in the report.

The rapid global spread of the virus demonstrates the need for vaccine distribution worldwide. Producing sufficient vaccines for the less-developed nations is a concern for global health authorities.

“In developing countries, there are certain companies like the Serum Institute of India, for example, that manufacture significant high volumes of these vaccines that go to low- to middle-income countries and are highly subsidized through organizations like Gavi and the Gates Foundation,” Unmesh Lal, industry principal—transformational health, Frost & Sullivan, told 

To get more vaccines to low- to middle-income countries, Lal recommends identifying manufacturing facilities in small-population and developing countries with strong fill/finish and storage capacities to progressively export to other countries. A second strategy, he says, is to organize the production steps separately and regionally.

Manufacturing logistics aside, Melinda Gates of the Gates Foundation offers perhaps the most appropriate insight: “I’ve met with nationalist leaders who are skeptical. I’ve met with humanitarian leaders who are generous. But COVID-19 has made that distinction irrelevant. In this pandemic, there’s no difference between helping yourself and helping others. The self-interested thing—and the selfless thing—are one and the same” (3).

1. M. Twohey, K. Collins, and K. Thomas, “With First Dibs on Vaccines, Rich Countries Have ‘Cleared the Shelves’,” 

, Dec. 15, 2020.
2. D. Armstrong and T. Randall, “US Ranks Behind EU, Australia, UK in Vaccine Buys but Says It Will Meet Goal,” 

, Dec. 9, 2020.
3. M. Gates, Speech at the Paris Peace Forum, 

When referring to this article, please cite it as R. Peters, “Ensuring Vaccine Supply Meets Global Needs,” 

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Ensuring Vaccine Supply Meets Global Needs

With one month left on the calendar, 2020 has delivered more than its share of major events to fill a decade or a generation. In any other year, a record-breaking hurricane and tropical storm season, devastating wildfires, a presidential impeachment trial, a presidential election, or widespread demonstrations to address racial inequality could have been the single event marking the year in history.

The year of 2020 will be remembered, however, for the COVID-19 pandemic and the global response—both the good and the bad—and lessons learned.

Starting in January 2020, bio/pharma companies launched unprecedented R&D activity to develop treatments and vaccines. Big Pharma companies Pfizer, Johnson & Johnson, AstraZeneca, Sanofi, GlaxoSmithKline, and Merck fast-tracked vaccine development programs; however, the first clinical trial—for Moderna’s messenger RNA vaccine—was initiated in mid-March, with positive interim Phase I results announced in May.

In the treatment arena, scores of drug companies announced studies on potential new or repurposed therapies. FDA and the public learned lessons about how anecdotal reports and press releases may raise hope but are not replacements for scientific data, notably with the issuance and later revocation of an emergency use authorization (EUA) for hydroxychloroquine.

In April, Gilead reported that clinical studies showed the antiviral drug remdesivir was effective in helping some patients recover faster, leading to an EUA in early May, FDA approval in October, and a conditional recommendation against using the drug from the World Health Organization in November.

FDA also faced criticism from scientists when it issued an EUA for convalescent plasma in August during a White House press conference, despite a report from the National Institutes of Health that the data did not support such an EUA.

Through Operation Warp Speed, the Federal government invested in development, manufacturing, and distribution plans for multiple unproven vaccines at risk, in the hope that effective vaccines could get to patients faster. And throughout the year, scores of research, development, manufacturing, and supply agreements were announced, and nations scrambled to secure sufficient supplies to vaccinate their populations.

By the end of the summer, public confidence in the independence of FDA decision making was eroding, prompting executives from bio/pharma companies and career FDA officials to publicly commit to prioritizing science-based decisions and patient safety over political or business agendas in the review and approval of vaccines.

November may have been the turning point when promising antibody treatments from Eli Lilly and Regeneron received EUAs. And messenger RNA vaccine candidates from Pfizer/BioNTech and Moderna demonstrated 95% effectiveness, based on two months of clinical trial results. The news suggested that a scientific solution to the pandemic was in sight; EUA reviews were expected to follow shortly.

Bio/pharma’s efforts to develop effective vaccines has traveled a long path in a short time. The good news about vaccines and treatments, however, is tempered by an exponential increase in infections and rising number of deaths. Much work is still ahead, including ramping up manufacturing, prioritizing who should get the vaccine, and overcoming the logistical challenges of a cold supply chain.

 extends its appreciation to the bio/pharma professionals and companies who worked tirelessly to drive science-based solutions to the pandemic. Your efforts—often misunderstood or criticized as being too slow by the public and policymakers—were heroic.

We also owe gratitude to the front-line healthcare workers who made personal sacrifices to care for others; and all essential workers who kept everyday life near normal for everyone else.

When referring to this article, please cite it as R. Peters, “Bio/Pharma, People, Perseverance, and Hope,” 

After a difficult year, bio/pharma science delivers promising results.