When the novel coronavirus (SARS-CoV-2) emerged in late 2019 and began its spread around the world, the global innovation community mobilized quickly to initiate the development of a vaccine for COVID-19, the disease it causes. Hundreds of individuals and institutions—in academia, biotechnology, government, and pharmaceuticals—embarked on one of the most consequential scientific endeavors in living memory. Funding poured in from governments, multilateral agencies, not-for-profit institutions, and the private sector. Regulators showed uncanny speed in working with innovators. Now, months later, more than 250 vaccine candidates are being pursued globally, with 30 already in clinical studies and another 25 or so poised to enter human trials in 2020.

As the novel coronavirus continues to spread (with roughly 1.5 million new cases of COVID-19 globally each week) and the pursuit of a vaccine intensifies, debate has grown among corporate leaders, economists, public-policy makers, and scientific experts—and even in our own living rooms. Will we have a COVID-19 vaccine? If so, when? And how much value can it provide to society?

To bring more clarity to the conversation, we conducted an in-depth review of the COVID-19-vaccine pipeline and the range of potential immunization and demand scenarios. We looked at publicly available information on the potential time to develop COVID-19 vaccine candidates compared to other vaccines, as well as potential barriers. We spoke with experts in epidemiology and public health, as well as important participants in the vaccine ecosystem (among them, developers, funders, and government organizations). We synthesize that body of research and analysis in this article. Our goal wasn’t to judge whether vaccine development should be accelerated or not; ensuring that safety protocols are being followed and outcomes are being rigorously monitored is of the utmost importance.

Here is what we found:

• Vaccine developers and government officials are publicly reporting timelines for potential emergency use of vaccine candidates between the fourth quarter of 2020 and the first quarter of 2021.
• The early data on vaccine safety and immunogenicity in Phase I and II trials are promising—although in a limited number of subjects to date.
• The discrete characteristics of the virus, the sheer number of development efforts, and innovators’ unprecedented access to funding all provide reasons to believe that a COVID-19 vaccine can be developed faster than any other vaccine in history. (It took four years to develop the mumps vaccine, which was previously the fastest developed novel vaccine.¹ ) More than 50 candidates are expected to enter human trials in 2020, and 250 total vaccine candidates are being pursued. Historical attrition rates would suggest that such a pipeline could yield more than seven approved products over the next few years.
• A number of hurdles remain, including validating unproven platform technologies, demonstrating vaccine candidates’ safety and protection against COVID-19, and delivering the highest-impact vaccine profiles.
• Regulatory bodies are still finalizing guidelines for COVID-19 vaccines. Recent guidance from the US Food and Drug Administration (FDA), for example, suggests the need for more data prior to granting Emergency Use Authorizations (EUAs). Details are still being worked out.
• Vaccine manufacturers have announced cumulative capacity that could produce as many as one billion doses by the end of 2020 and nine billion doses by the end of 2021.

Taken together, all the evidence suggests that COVID-19 vaccines are likely to become available for focused populations somewhere between the fourth quarter of 2020 and the first quarter of 2021. The ultimate role they will play in the world’s response to the pandemic will depend on a range of factors—for instance, the disease’s epidemiology and transmission, the duration of immunity from natural infection, the profile of vaccines, and the availability of complementary therapeutics and diagnostics. It’s assumed, however, that vaccines will play an important role in most response scenarios and may “save the world” in worse scenarios. In all scenarios, vaccines will serve as an insurance policy against continued health and economic shocks from the pandemic.²

What isn’t up for debate is that business leaders, governments, and policy makers will need to continually monitor and respond to those exogenous factors.

Depending on their roles, participants in the vaccine ecosystem must be prepared to focus on some combination of the following six critical actions: adapt to a range of demand scenarios; ensure that manufacturing is flexible and fungible; understand that multiple vaccines may play different roles over time; collaborate with others to drive vaccine delivery, adoption, and monitoring; prepare now to support uptake of a vaccine; and consider endemic and postpandemic time horizons when making decisions.

Focusing on those tasks today can help stakeholders build the capacity and response system required to address not just the COVID-19 pandemic but also any future pandemics.

A question of timing: Will we have a vaccine, and if so, when?

A question of timing: Will we have a vaccine, and if so, when?

Developers are under an unprecedented level of scrutiny as they move their vaccine candidates into clinical trials—not so surprising when you consider how many experts have tied the availability of a COVID-19 vaccine to the world’s return to “a semblance of previous normality.”³ Experts have proposed a range of potential timelines, with some speculating that a vaccine will be available by the end of 2020 and others arguing it may take 12 months longer, at least, to bring a COVID-19 vaccine to market. What follows is an overview of publicly available evidence of vaccine timelines, promising early evidence from Phase I and II clinical trials, and several other virus-specific and innovation-related development factors.

Developers’ and government officials’ publicly available timelines

Given the sheer number of potential COVID-19 vaccines in development and the public statements from several developers, it seems likely that one will be available in the United States between the fourth quarter of 2020 and the first quarter of 2021, with more following throughout the year—potentially granted under the FDA’s EUA guidelines.⁴ Under that authority, the FDA “may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN [chemical, biological, radiological, and nuclear] threat agents when there are no adequate, approved, and available alternatives.” Similar approvals are being sought by companies in China and Europe: at least five large vaccine developers have announced that they intend to submit applications for EUA, or the local equivalent, for their candidates before the end of 2020 (Exhibit 1).

Government officials have also publicly stated that a vaccine could be approved by the end of 2020 or early in 2021. As Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, recently said, “… by the end of this calendar year and the beginning of 2021, I feel optimistic. Nobody guarantees, but I feel optimistic that we will have a vaccine, one or more, that we can start distributing to people.”⁵

Early evidence from Phase I and II clinical trials

Several companies have released data from Phase I and Phase II clinical trials that are promising:

• In June, Sinovac Biotech released preliminary results from a Phase I/II trial of its candidate, citing the induction of neutralizing antibodies in more than 90 percent of people who were tested 14 days after receiving two injections two weeks apart, with no severe adverse events reported.⁶ China National Pharmaceutical (known as Sinopharm) presented interim readouts from a Phase I/II trial of its candidate in the same month, claiming that 100 percent of participants who received two doses over 28 days developed neutralizing antibodies.⁷
• In early July, Pfizer and BioNTech published preliminary results from a Phase I clinical trial of their candidate, indicating that “geometric mean neutralizing titers reached 1.8- to 2.8-fold that of a panel of COVID-19 convalescent human sera.”⁸ In that same time frame, Moderna published interim data from a Phase I trial of its vaccine candidate, demonstrating that 41 of 41 vaccinated participants developed neutralizing antibody titers using both a live virus and a pseudovirus assay. Across dose levels, titers were either comparable to or above those seen in a panel of convalescent sera. The geometric mean titers post-boost at the 100 microgram dose were between 2.1- and 4.1-fold higher than those seen in convalescent sera.⁹
• In mid-July, AstraZeneca published interim data from a Phase I/II trial of its vaccine candidate, indicating that a single dose resulted in a fourfold increase in antibodies in 95 percent of participants one month after injection.¹⁰ Also in that time frame, CanSino Biologics published interim Phase II data for its vaccine candidate, demonstrating that a single dose induced antibodies in more than 85 percent of participants and a T-cell response within 14 days of receiving the vaccine.¹¹

Further data on those and other vaccine candidates are needed, but initial results point to the idea that candidates are developing neutralizing antibodies to some degree—a potential indicator of efficacy.

Reasons to believe in accelerated development of a COVID-19 vaccine

A closer look at three key development factors—the novel coronavirus’s underlying characteristics, the unprecedented size of the vaccine pipeline and number of technology platforms being used, and greater access to funding—points to the potential for the accelerated development and approval of a COVID-19 vaccine, faster than any other vaccine in history.

Virus characteristics

Unlike some families of viruses, such as HIV and the one related to seasonal influenza, coronaviruses overall have been shown to mutate at relatively low to moderate rates. The MERS-causing coronavirus, for instance, hasn’t mutated substantially since it was detected in the population in 2012.¹² In fact, early data suggest that the novel coronavirus is mutating at a rate four times slower than that of the virus causing seasonal influenza.¹³ Some evidence is emerging that mutations are affecting the transmission of COVID-19, but so far these appear to have had a minimal effect on antigenicity.¹⁴ Such mutation patterns are advantageous for vaccine developers, as they alleviate the complexities associated with designing a vaccine for a moving target. Speed is of the essence, of course: all viruses always have the potential to mutate and evolve, particularly the longer they are in circulation in the population.

The sustained attack rate of the disease may allow developers to assess vaccine efficacy rapidly in Phase III. Some developers are seeking to conduct clinical trials of their COVID-19-vaccine candidates in those regions that have seen recent upticks in infection rates, such as Brazil, India, and parts of the United States, including Arizona, Florida, and Texas.¹⁵

Pipeline and technology platforms

There has been unprecedented activity around the development of a COVID-19 vaccine. The first vaccine candidate was created 42 days after the genetic sequencing of the novel coronavirus. At the time of publication, there are more than 250 announced candidates globally, with more than 50 planned entries into human clinical trials in 2020 (Exhibit 2). What’s more, the candidates have incorporated a broad range of technologies, from proven vaccine platforms (such as protein-subunit and viral vectors) to novel ones (such as messenger RNA and DNA). Of the candidates that companies intend to enter into trials this year, more than 30 are already in human studies, according to data from clinical trial registries.

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