The coronavirus vaccine frontrunners are advancing quickly.

Scientists, drugmakers and governments are moving with unprecedented haste to develop a vaccine against the new coronavirus. The fastest of them have already delivered promising data from initial human studies, and further results from larger tests should come quickly over the next three to six months.

The goal, at least in the U.S., is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world.

Researchers' success or failure could determine whether the virus becomes endemic, recurring in countries around the world year after year, or is ultimately checked.

With the health of their citizens at stake, governments are investing enormous sums of money into vaccine research and development, and to prepare to manufacture and distribute what will likely need to be billions of doses necessary to keep infection at bay.

Vaccines have become political as well. Russia, seeking a Sputnik-like achievement to tout to the world, approved a vaccine before completing testing, while China has cleared experimental shots for limited use in the military and, reportedly, high-risk groups.

In the U.S., the Trump administration has unveiled "Operation Warp Speed," so far pledging more than $11 billion in funding and support for seven candidates. Concerns have grown, however, that President Donald Trump, looking to boost his reelection prospects, will pressure the Food and Drug Administration to grant an early emergency authorization.

Lucrative supply deals between drugmakers and governments should secure early vaccine access for the U.S, Europe and other developed nations like Japan and Canada. The rest of the world might not be so fortunate, even with well-intentioned efforts by the World Health Organization and groups like GAVI, The Vaccine Alliance.

"It's not like we can expect 7 billion doses the day after licensure so we can vaccinate the whole world," said Emory University vaccines expert Walter Orenstein. Yet, to truly curb circulation of the SARS-CoV-2 virus in humans, getting vaccines to nations wealthy and poor will be a vital mission.

Expect a flurry of data, new answers and likely fresh questions to come through the remainder of 2020. Here's where things stand for 13 of the most advanced, most promising or best funded vaccine candidates in the pipeline.

One of the great allures of messenger RNA technology — an unproven approach that instructs cells to produce specific proteins — is that it can be used to make a vaccine much faster than traditional methods. Moderna's experimental coronavirus vaccine is proof.

The vaccine went from a computer design in January to human study in just three months, making Moderna the first U.S. company to reach that point.

Since then, Moderna has kept up its record pace. Snippets of Phase 1 results came in late May, as did the start of a mid-stage trial. A Phase 3 study began on July 27, and was almost fully enrolled by mid-October, making the company's effort one the best hopes for a vaccine by early next year.

Results to date showed Moderna's shot can spur immune responses in both young and elderly adults that were similar or higher to what's been observed in recovered COVID-19 patients. The vaccine also appears safe, although only the large trial now underway can fully answer that question.

Much still needs to go right. No mRNA vaccine has been proven to prevent an infectious disease, and none have been manufactured and distributed at scale, let alone during a pandemic. Moderna's findings to date are encouraging, but don't guarantee success.

The company has also come under scrutiny, both for the price it plans to charge the U.S.

government as well as for the intellectual property it claims for its vaccine. Government scientists have supported Moderna's work and could hold rights to some of the underpinning technology. Seemingly in response, Moderna has said it will not enforce patent rights related to its vaccine technology for the duration of the pandemic.

Author:Jonathan Gardner, Ned Pagliarulo, Ben Fidler

Published: https://www.biopharmadive.com/news/coronavirus-vaccine-pipeline-types/579122/