Moderna has already given a dose of its potential Covid-19 vaccine to a patient
As the deadly coronavirus disease continues to spread across the world, the race is on among pharmaceutical companies to accelerate the development of vaccines.
More than 180,000 people have been infected worldwide by the flu-like pandemic, code-named Covid-19, with over 7,000 killed since it was first reported to the World Health Organisation on 31 December.
Despite many of the victims initially being in China, where the outbreak was first detected, it has since spread globally – particularly across Asia, Europe and North America.
A clutch of firms from the western world are now aiming to fast-track drug discovery plans to find a treatment as quickly as possible.
It can take years to develop a vaccine for widespread use – it wasn’t until December 2019 that the US Food and Drug Administration (FDA) approved the first vaccine for preventing the western Africa Ebola virus, five years after the outbreak – but about 300 separate clinical trials are believed to be underway.
There are also attempts to use existing drugs, such as AbbVie’s HIV vaccine Kaletra, to treat coronavirus.
But with no obvious cure on the horizon just yet, we take a look at some of the organisations at the forefront of coronavirus vaccine development.
Coronavirus vaccines in development
Californian biotech giant Gilead Sciences has been labelled by some experts as the frontrunner for finding a cure to Covid-19 using a drug originally developed to treat Ebola.
It is working with global health authorities to trial the use of its antiviral drug remdesivir which, although it faltered in the fight against Ebola, proved effective against similar coronaviruses SARS and MERS in animal studies.
“This is an experimental medicine that has only been used in a small number of patients with Covid-19 to date, so Gilead does not have an appropriately robust understanding of the effect of this drug to warrant broad use at this time,” Gilead says on its website.
Two clinical trials with infected patients who are hospitalised in China were set up in February – one involving those needing supplemental oxygen and another for patients who don’t need this support – with another three following since then. Results from one study are due to be released in April.
Manufacturing of clinical supplies is also being accelerated even before any regulatory approval for commercial roll-out is granted.
Despite reportedly struggling to find enough patients for the trial at one stage, the WHO’s assistant director-general Dr Bruce Aylward said last month remdesivir was the “only one drug right now that we think may have real efficacy”.
Regeneron Pharmaceuticals and Sanofi
French pharmaceutical company Sanofi and US biotech firm Regeneron Pharmaceuticals are exploring whether an arthritis drug could be used to fight Covid-19.
A clinical trial in New York will test whether Kevzara, which already has approval for treating rheumatoid arthritis, could help reduce patients’ inflammatory response to coronavirus.
Beginning in New York hospitals, the trial could be expanded to 16 sites and will involve 400 critically-ill patients, studying the impact the drug has on their fever and the need for extra oxygen. There are hopes it could prevent deaths or hospitalisation.
Regeneron, based in Tarrytown, New York, is also working alongside the US Department of Health and Human Services (HHS) to develop new antibody treatments to combat coronavirus.
In February 2020, the duo expanded an agreement signed three years earlier to discover and manufacture new drugs to target up to 10 pathogens carrying significant public health risks. This now involves influenza and Covid-19.
Regeneron said it hoped to have drugs available for testing or use in some patients within a few months.
Its VelociSuite drug discovery technology was previously used to develop an experimental drug to treat Ebola in the Democratic Republic of Congo (DRC).
Speaking when the HHS partnership was announced, president and chief scientific officer Dr George D Yancopoulos said: “The life-saving results seen with our investigational Ebola therapy last year underscore the potential impact of Regeneron’s rapid response platform for addressing emerging outbreaks.
“Our unique suite of technologies expedites and improves the drug discovery and development process at every stage, positioning Regeneron to respond quickly and effectively to new pathogens.
“We are eager to expand our productive collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and are already working hard to address the novel coronavirus that is causing worldwide concern.”
Johnson & Johnson
Janssen Pharmaceutical Companies, the Belgian pharma owned by Johnson & Johnson, joined forced with the US government’s BARDA and HHS departments to push a vaccine through trials as quickly as possible.
The collaboration enhances Janssen’s ongoing work to screen a portfolio of existing antiviral molecules with the aim of identifying compounds that could battle against Covid-19.
BARDA will provide resources and funding to support accelerated development of a vaccine into phase one clinical studies, with options for additional funding to progress a promising candidate.
Janssen, meanwhile, will upscale its production and manufacturing capacities, using technologies that were previously used to develop an investigational Ebola vaccine currently used in the DRC and Rwanda.
Speaking in February, Johnson & Johnson chief scientific officer and vice-chairman Paul Stoffels said: “This partnership will ensure that vital research is made possible at rapid speed and underscores the importance of public-private partnerships to tackle the worldwide novel coronavirus epidemic.
“We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world.”
It was announced in March that Janssen would work with Beth Israel Deaconess Medical Center (BIDMC), a Boston-based teaching hospital of Harvard Medical School, to explore further vaccine development.
Pre-clinical trials of multiple vaccine prospects have begun, with the aim of identifying a Covid-19 drug candidate for clinical trials by the end of the month and launching a phase one study by the end of the year.
Tablets, rather than injections, could help supress the symptoms of coronavirus if Vaxart succeeds in creating a drug.
The San Francisco clinical-stage biotech wants to use its oral vaccine platform VAAST, which was previously used to treat seasonal influenza, norovirus and RSV, for creating a Covid-19 treatment.
A recently-published study found Vaxart’s tablet primarily protects against influenza through mucosal immunity, which involves membranes that line cavities covering the intestines, urogenital tract and respiratory system.
The company said this is a potential key factory when targeting mucosal pathogens like Covid-19 because the virus is conditionally an infection of the respiratory tract.
Managing director Wouter Latour added: “The logistical advantages of an oral vaccine that is administered using a convenient room temperature-stable tablet could be of critical benefit when rolling out a major public health vaccination campaign.”
Inovio Pharmaceuticals and Moderna
The Coalition for Epidemic Preparedness Innovations (CEPI), a Norway-based public-private global partnership set up in 2017 to derail epidemics by speeding up vaccine development, is funding three drug programmes – and one of them already looks promising.
US companies Inovio Pharmaceuticals and Moderna, along with Australia’s University of Queensland, have been backed with the aim of progressing coronavirus drug candidates into clinical testing as quickly as possible.
Moderna has already begun its first trial in the US.
The CEPI programme will leverage previous work on the MERS coronavirus, which is very similar to the Covid-19 strain.
Announcing the funding scheme on 23 January when there had been just under 900 cases, CEPI chief executive Dr Richard Hatchett said: “There are no guarantees of success, but we hope this work could provide a significant and important step forward in developing a vaccine for this disease.
“Our aspiration with these technologies is to bring a new pathogen from gene sequence to clinical testing in 16 weeks – which is significantly shorter than where we are now.”
Pennsylvania company Inovio reached human testing for a drug against the Zika outbreak in just seven months but has yet to take a product for an emerging disease into approval.
It received $56m from CEPI in April 2018 to advance DNA vaccines against Middle East respiratory syndrome (MERS) and Lassa fever into a phase two trial. The company hopes to use this research to help deliver a Covid-19 antibody.
Moderna, based in Cambridge, Massachusetts, is manufacturing an mRNA vaccine against the new coronavirus strain using the CEPI funding.
On 16 March, Moderna gave a dose of its potential Covid-19 vaccine to a patient in the phase one trial, having genetically sequenced the virus using new technology just two months earlier.
Its work is being supported by the US National Institute of Allergy and Infectious Diseases.
The University of Queensland, in Brisbane, entered an agreement with CEPI in January 2019 to receive up to $10.6m in funding to develop a “molecular clamp” vaccine platform, a transformative technology that enables targeted and rapid vaccine production against multiple viral pathogens.
German pharma firm CureVac is another company working with the CEPI to find a Covid-19 cure.
The body has provided $8.3m funding to CureVac to build a rapid-response vaccine platform that can accelerate drug development, manufacturing and clinical tests.
The company hit the headlines when it was invited to the White House by US president Donald Trump to brief about its efforts to find a vaccine.
It was reported Trump attempted to buy exclusive access for the US to any drug that was developed.
CureVac has 20 years’ experience in using mRNA-based vaccines for various conditions, including influenza, rabies and malaria, and is now exploring their use for Covid-19.
Shortly after the Trump meeting, the firm said it was already selecting the most suitable vaccine candidates, with a view to beginning clinical trials – involving human participants – in early summer 2020.
Daniel Menichella, who was CEO at the time but replaced on 11 March, said: “We are very confident that we will be able to develop a potent vaccine candidate within a few months.
“We can rely on the data of a phase one rabies study in which we were able to immunise all participants with a very low dose.”
A specialist in developing vaccines like the nanoparticle-based flu cure, Novavax is now working hard on a coronavirus drug.
On 5 February, the Maryland clinical-stage biotech set a goal to make a vaccine ready for human trials in three months after claiming it had identified the coronavirus gene.
While it might sound like an ambitious target, the company said it created an Ebola vaccine in 90 days, and investors sounded confident as shares rose by 146% in a week after the announcement.