Several companies, including those from India, are racing to develop an effective vaccine shot against the fast-spreading virus. This is largely thanks to the COVID-19 genome sequence which was made available to the public in a matter of days after the virus was first isolated.
Currently, there are no licensed vaccines or therapeutics for COVID-19, a novel coronavirus.
Serum Institute of India (SII), the world’s largest vaccine manufacturer by number of doses, is collaborating with US-based synthetic biology company Codagenix to rapidly co-develop a live-attenuated vaccine against the emergent coronavirus.
Live-attenuated vaccines mount an immune response to multiple antigens.
Codagenix has already designed multiple vaccine candidate genomes using its proprietary deoptimization technology. The vaccine viruses will then be grown and tested in vivo by contracted laboratories suitable for containment, prior to testing in clinical trials.
SII will then scale-up the manufacture of the vaccine to ensure its availability.
“Serum Institute’s role will be to fund and do the clinical trials, scale-up and establish the manufacturing process on the right cell line and then manufacture and sell the product,” said Dr Adar Poonawalla, chief executive officer, SII.
The dose regimen of the vaccine is yet to be determined. Hopefully, it will be a single dose, he said, but added that it is too early to tell. It can be known after a year or so, he added.
SII expects to commence clinical trials on the vaccine after 6 months, by when animal studies are likely to be completed.
Codagenix and SII are pursuing an accelerated development pathway with built-in redundancies to increase speed and the likelihood of success.
According to Dr Poonawallah, the location for the first vaccine trials would be chosen “depending on which country gives us the fastest regulatory pathway”.
The human trials will take at least 1 -1½ years to complete and the company is looking to launch the vaccine by 2022.
Live-attenuated vaccines are ideally suited for outbreak scenarios as they scale rapidly and generally require only modest amounts of the active ingredient for each immunisation, compared to inactivated and subunit vaccines, Codagenix said.
A similar accelerated research programme has also been initiated by Zydus Cadila with multiple teams in India and Europe based on two approaches.
First, the Ahmedabad-based company would develop a DNA vaccine against the major viral membrane protein responsible for the cell entry of COVID-19. The plasmid DNA would be introduced into the host cells, where it would be translated into the viral protein and elicit a strong immune response mediated by the cellular and humoral arms of the human immune system. These systems play a vital role in protection from disease as well as viral clearance.
The second approach deals with the development of a live-attenuated recombinant measles virus vectored vaccine. The recombinant measles virus (rMV) produced by reverse genetics would express codon-optimised proteins of the novel coronavirus and will induce long-term, specific, neutralising antibodies, which will provide protection from the infection.
The measles reverse genetics technology, developed by Etna Biotech, the company’s research arm in Europe, has been used earlier to successfully develop the SARS-vaccine. The vaccines developed through this platform are safe, efficacious and large doses can be manufactured, Zydus said in a statement.
CEPI quickens vax efforts
Globally, several organisations and individual companies are speeding up efforts on similar lines.
The Coalition for Epidemic Preparedness Innovations (CEPI) is now backing three vaccine programmes against COVID-19.
Inovio of Pennsylvania is developing a MERS DNA vaccine candidate in phase II. A ‘molecular clamp’ vaccine is being investigated by the University of Queensland. This will enable targeted and rapid vaccine production against multiple viral pathogens. This method synthesises viral surface proteins, which attach to host cells during infection and ‘clamps’ the proteins into shape, allowing the immune system to recognise them as the correct antigen.
Massachusetts biotech company Moderna plans to manufacture an mRNA vaccine against coronavirus, which will be designed in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID). NIAID will then conduct the Investigational New Drug (IND) programme – enabling studies and a phase I study in the US.
The aim of these programmes is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.
“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,” according to Richard Hatchett, CEO of CEPI.
CEPI has also tied up with GSK on a pandemic-vaccine adjuvant platform technology available to enhance the development of an effective vaccine. The use of an adjuvant is of particular importance in a pandemic situation since it can reduce the amount of antigen required per dose, allowing more vaccine doses to be produced and made available to more people.
Johnson & Johnson said its Janssen will further expedite its investigational coronavirus vaccine programme through an expanded collaboration with the Biomedical Advanced Research and Development Authority (BARDA), at the US Department of Health & Human Services.
The vaccine programme will leverage Janssen’s platform technologies that provide the ability to rapidly upscale production. These technologies were used in the development and manufacturing of Janssen’s investigational Ebola vaccine, as well as Zika, RSV and HIV vaccine candidates.
Sanofi Pasteur, the vaccine division of French pharma major Sanofi, will also be collaborating with BARDA of HHS to develop a potential vaccine for COVID-19
The French vaccine maker plans to further investigate an advanced preclinical SARS vaccine candidate that could protect against COVID-19. The SARS coronavirus emerged in late-2002, and then largely disappeared by 2004.
The company said it will use its recombinant DNA platform to produce a 2019 novel coronavirus vaccine candidate.
US biotech Novavas announced that it is also working on a vaccine for the virus.
Infectious disease start-up Vir Biotechnology has also brought out antibodies in its labs that bind to coronavirus that were collected after the SARS and MERS outbreaks.
German biotech CureVac, a company developing mRNA vaccines, is also working in this area.
A coronavirus vaccine programme is underway at the Baylor College of Medicine in the US as well, reports said.