‘Sister’ Initiatives Commit US $129 Million to R&D for COVID-19 Vaccines & Cures; Funding To Manufacture Still A Barrier
Electron microscope image of SARS-CoV-2— the virus that causes COVID-19—isolated from a patient in the U.S. Virus particles shown in red with their signature “crown-like” spikes in green.

The Bill and Melinda Gates Foundation, Wellcome Trust, and Mastercard on Tuesday announced a US $125 million commitment of seed funding to a new COVID-19 Treatment Accelerator – whose aim as its name implies, will be to speed up the development of urgently needed drugs to treat people infected with COVID-19.

Just hours later, the Coalition for Epidemic Preparedness Innovations (CEPI), which is engaged in a similar race for new vaccines, announced a $4.4 million investment to advance preclinical and Phase 1 trials of two of the most promising vaccine candidates that it has identified.

As cases shot up in Italy to over 10,000, spurring a nation-wide lockdown; and US Centres for Disease Control officials warned the US public to prepare to move into the “mitigation phase,” of reducing the worst consequences of the disease – rather than containing it, these ‘sister’ initiatives reflect how the global R&D community is racing against time to find game-changing drugs and vaccines. 

The downside, however is this. Neither initiative has enough funding right now to fully finance a drug or vaccine to from end-to-end.

CEPI issued a statement warning that it lacks financial resources needed to continue the next steps in the development process and “deliver the vaccines the world needs.”

Trevor Mundel, president of the Gates Foundation, told STAT News that there is not enough funding for the COVID-19 Treatment Accelerator to take a one all the way from discovery to disbursement into providers’ hands.

Even if new treatments and vaccines are successfully developed, some infectious disease experts worry that the biggest barrier may be scaling up manufacturing capacity of an approved product.

Normally, drugs get stuck in a regulatory bottleneck waiting for approval from agencies like the US Food and Drug Administration (US FDA), Stephen Morse, professor of Infectious Disease Epidemiology at Columbia’s Mailman School of Public Health, told Health Policy Watch.

But this time, he said, “the problem isn’t going to be FDA approval… they’re going to put this on a fast track, they want to have this quickly.

“In this case… the rate-limiting step is producing enough of [a vaccine] in time,” he said. Only “a handful” of large pharma companies have the capacity to produce the quantities of vaccines that would be needed to protect entire populations against the disease – which has infected more than 118,000 worldwide as of Tuesday night.

Out of some 50 different COVID-19 vaccine development programs, only two vaccine candidates are housed by large, multinational pharma companies according to a round-up by Biocentury. The others are being developed by small biopharma companies or academic institutions – the types of organizations which Morse says do not have the manufacturing capacity to scale production by themselves.

New Funding for COVID-19 Treatment Accelerator 

The US $125 million infusion into COVID-19 treatment research will still be able to help push forward treatment candidates stuck at certain stages of development.

“Viruses like COVID-19 spread rapidly, but the development of vaccines and treatments to stop them moves slowly,” said Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation in a press release.

“If we want to make the world safe from outbreaks like COVID-19, particularly for those most vulnerable, then we need to find a way to make research and development move faster.”

Modeled after CEPI’s vaccine development platform, the new COVID-19 Treatment Accelerator offers funding at all stages of development – including identification of drug candidates, clinical trials, and working with regulators and manufacturers to bring a treatment to patients.

More than 300 trials on COVID-19 are currently registered with WHO’s International Clinical Trial Registry with at least 15 trials testing antiviral treatments, and no treatments have so far been approved. With the abundance of treatment candidates, WHO officials have said they are nailing down a system for prioritizing clinical trials for the most promising treatments.

Many collaborations across borders have been forged. Sixthtone reported that some 60% of academic papers on potential treatments were rapidly disseminated through open-access pre-print servers such as MedRxiv, which allowed researchers to share key findings and exchange knowledge before going through long peer review processes.

“Science is moving at a phenomenal pace against COVID-19, but to get ahead of this epidemic we need greater investment and to ensure research coordination,” said Jeremy Farrar, director of Wellcome.

“The Therapeutics Accelerator will allow us to do this for potential treatments with support for research, development, assessment, and manufacturing. COVID-19 is an extremely challenging virus, but we’ve proved that through collaborating across borders we can tackle emerging infectious diseases.”

The Gates Foundation and Wellcome are each contributing up to $50 million, and the Mastercard Impact Fund has committed up to $25 million to catalyze the initial work of the accelerator.

CEPI Announces US $4.4 Million Investment In Two New Vaccine Candidates, Asks For Additional Funding

CEPI’s additional US $4.4 million investment announced today would fund Phase 1 trials for a COVID-19 vaccine candidate currently in the pipeline of the pharma company, Novavax, along with the preclinical and Phase 1 safety trials of a potential vaccine developed by the University of Oxford. The two new commitments bring the total number of candidates in CEPI’s portfolio to six.

Novavax, a company that has previously conducted vaccines research into MERS and SARS coronaviruses, is using a proprietary technology to create a vaccine that targets the signature (S) spike protein on the surface of SARS-CoV-2 – the coronavirus that causes COVID-19.

The University of Oxford is working on a COVID-19 vaccine using a simian adenoviral vaccine vector, which has been used as a delivery vehicle in vaccines for other viruses like MERS, Nipah, and Influenza.

However, the organization says that donors need to step up funding to help finance the COVID-19 vaccine projects to completion.

Without “immediate additional financial contributions,” the vaccine programs CEPI has begun will “not be able to progress and ultimately will not deliver the vaccines that the world needs,” the organization warned in the press release announcing the new investments.

“Vaccine development is complex and difficult and will require concerted global effort,”  said CEO of CEPI Richard Hatchett. He clarified CEPI was investing in a variety of different options in order to maintain a “balanced portfolio” and “ensure multiple shots on goal.”

“There are no guarantees of success, but we are working as fast and as hard as we can,”  he added, but the organization hopes to deliver a safe and efficacious vaccine for broader use within the next 12-18 months.

The commitments resulted from submissions made to a global call for proposals that CEPI issued in early February, which invited funding applications for proven vaccine technology that could be used to rapidly develop a vaccine against the new coronavirus. Most importantly, the new vaccine must be able to be manufactured at scale and with the necessary equitable access provisions.

The two new investments join the CEPI-funded COVID-19 vaccine development initiatives by Inovio Pharmaceuticals, Moderna and the US National Institutes of Health, Curevac Inc., and the University of Queensland.

Image Credits: NIAID-RML.