COVID-19: Infections are rising as developers race to find a vaccine

Lisa LaMotta Editor-in-Chief, Risk & Regulatory, PwC US April 10, 2020

As of April 1, there were 49 vaccine candidates in development against SARS-CoV-2—the virus that causes COVID-19—with three already being tested in Phase I human trials, according to an analysis by HRI. Despite the focus of the pharmaceutical and life science world, the reality of an approved, working vaccine isn’t likely until mid-2021. 

The Biomedical Advanced Research and Development Authority (BARDA), part of HHS, has aligned itself with Johnson & Johnson’s Janssen Research & Development, and separately with Moderna, to accelerate both of their vaccine candidates.

J&J announced that it plans to begin first-in-human trials by September. Candidates that have already started Phase I are being developed by the CanSino Biologics and Beijing Institute of Biotechnology, and by the University of Oxford. 

Meanwhile, Moderna began a Phase I trial in March, run by the National Institute of Allergy and Infectious Diseases (NIAID). Its candidate, mRNA-1273, was given to the first healthy participant on March 16. The trial is expected to enroll 45 healthy adults ages 18-55 to be treated with the vaccine over a six-week period. The trial is meant to test the safety and immunogenicity of the messenger RNA vaccine. 

Moderna has said it is ramping up supply and manufacturing capabilities to prepare for a Phase II trial, and expects the vaccine could be available on an emergency use basis for healthcare workers before the end of the year if the trials prove mRNA-1273 to be effective. The vaccine candidate is being developed on the same platform as Moderna’s other vaccine candidates in development—none of which have reached the approval phase yet. 

Messenger RNA carries genetic information from DNA to a cell’s ribosome to produce proteins. Moderna’s vaccine aims to hijack this process in order to introduce the genetic code of the virus and prompt the body to make antibodies. Nine other vaccine candidates from other companies and institutions currently in the preclinical stage are also based on an RNA platform. 

Pharmaceutical and biotech companies, as well as academic institutions, are rushing to develop a vaccine that can mitigate the spread of the virus.
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About 30%, or 15, of the other candidates being investigated are based on protein subunits. These types of vaccines introduce an antigen into the immune system without using any viral particles. Many of the platforms being used to develop vaccines for SARS-CoV-2 were previously used to create vaccines for other coronavirus diseases like MERS and SARS. 

Another method that is popular with developers is nonreplicating viral vectors—seven compounds using this method are currently being investigated. These vaccines use viral vectors to deliver antigens to a cell or tissue target. 

HRI impact analysis

Vaccines typically take five to seven years to progress through development to approval. But US federal healthcare agencies have been rapidly deregulating over the past month to expedite the availability of medical supplies to areas with high infection rates, including a focus on moving forward vaccines and therapeutics that could potentially treat COVID-19 (for HRI’s overview of the FDA’s deregulation spree, click here). 

In mid-March, the FDA and the European Medicines Agency began collaborating to streamline global vaccine development, with a focus on the data needed to move vaccines from preclinical to first-in-human trials. “Their discussions included the need for data evaluating the theoretical risk for vaccine-induced disease enhancement, which is when vaccinated individuals who are subsequently infected with a virus develop disease that is worse than if they had not received a vaccine at all,” wrote Peter Marks, the director of the Center for Biologics Evaluation and Research (CBER), on the FDA website. 

At the same time, the agency has been working diligently to prevent the spread of misinformation about the availability of vaccines and therapeutics for COVID-19. The FDA has released multiple statements emphasizing that no treatments are available for infection with SARS-CoV-2 or the resulting disease. 

“The FDA is closely monitoring the market to combat these products with fraudulent claims. It is unacceptable that anyone would take advantage of Americans during this public health crisis, and the FDA wants to make sure everyone knows what legitimate products are being developed,” said the agency in a statement.

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