Covid vaccine development sees unparalleled progress
Projects around the world pick up pace with some firms likely to be ready with a vaccine by year-end or Apr ’21
NEW DELHI : US President Donald Trump’s re-election campaign took off with him telling potential voters that a coronavirus vaccine will be ready by the end of 2020, even as European leaders pledged to raise US $8.3 billion to “kickstart an unprecedented global co-operation” between scientists, industry, governments and philanthropies for vaccine development.
Global efforts to develop a vaccine against the coronavirus disease (Covid-19) have progressed at an unprecedented pace aiming to stop the spread of the pandemic, which has infected 3.5 million people, killed 250,000 and wrecked global economies within four months.
At least 120 vaccine projects are in various stages of development since China shared the genetic sequence of Sars-CoV-2, which causes Covid-19, with the World Health Organization (WHO) on January, 12, 2020. Of these, seven have entered human trials to test the safety and efficacy of the vaccine on healthy volunteers, according to WHO. Another 82 are in pre-clinical animal trial phases, and at least two have been found to protect monkeys from infection.
Johnson & Johnson, which was singled out by Trump as an example of vaccine success, said last month that it will be ready to produce 600 million to 900 million doses of its potential vaccine by April 2021 if human trials set to begin in September go as planned. Pfizer and the German company, BioNTech, said if their human trials are successful, they can produce millions of doses by the end of 2020.
Vaccine development, on average, takes 10.71 years from the preclinical phase, and has a market entry probability of 6%, according to a study in peer reviewed journal, PLOS One. The development includes at least three human trials to test their safety, dosage and the strength and duration of the protection they offer, followed by production, licensure, deployment of vaccines and plans for post-marketing surveillance.
“With Covid-19, the goal is to develop, test and manufacture a vaccine on a scale of hundreds of millions of doses within 12 to 18 months. Since the vaccine will be needed very quickly, an unprecedented approach has been taken by the companies. Since approvals are expected for an emergency use of the vaccine, they will start mass manufacturing as soon as they finish phase 2 trials and move to phase 3, and, in doing so, risk the failure of phase 3. In such cases, consortiums and countries fund for risk reduction and provide market commitments,” said Dr N K Ganguly, former director general, Indian Council of Medical Research (ICMR).
Pune-based Serum Institute of India started work 10 days ago on manufacturing in parallel to the human safety trials, the Oxford experimental vaccine, ChAdOx1 nCoV-19, at its own risk. “SII plans to begin manufacturing the ChAdOx1 vaccine in anticipation of the clinical trials in the UK succeeding by September/October. SII will initiate the manufacture at its own risk to jump-start manufacturing and have enough doses available, if the clinical trials work,” said SII CEO, Adar Poonawalla in a statement.
WHO last week organised a meeting of vaccine manufacturers and national regulatory authorities in its South-East Asia Region, of which India, Indonesia and Thailand are a part. The three countries are among the world’s largest vaccine manufacturers.
“The manufacturing capacity that exists in the region is of the quality and scale required to produce and roll out a Covid-19 vaccine globally. This region is a vaccine manufacturing powerhouse, and it must now also play a lead role in overcoming the ongoing pandemic,” said Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia. At the virtual meeting, leading manufacturers from India, Indonesia and Thailand discussed timelines and production capacity, while regulatory bodies discussed how to fast-track processes to make large scale production and deployment of Covid-19 vaccines possible by the end of the year.
“The way this pandemic is progressing, we are left with no choice but to have an emergency use vaccine within eight months, we can’t afford to wait for years. In the case of Covid-19, we already have some experience from SARS CoV-1 and MERS platforms, which have been used previously for delivering other vaccines. The same is the case with proven adjuvants [a substance which increases the body’s immune response to an antigen], which could be used. So considering the fact that we are not starting from scratch, it is in the realm of possibility,” said Dr Ganguly.
Last month, WHO launched the Access to COVID-19 Tools Accelerator, which brings together key global health actors, private sector partners and other stakeholders to accelerate the development and production of Covid-19 essential health technologies, including vaccines, and to help guarantee equitable access.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said it’s “within the realm of possibility” to have a vaccine widely available by January, but only if drug companies are willing to assume the risk of beginning to ramp up production of the vaccine before it is fully tested and approved.
Vaccines have led to the global eradication of small pox, and wiped out polio from most countries of the world, except Pakistan, Afghanistan and Nigeria, where it remains endemic. Vaccines for diseases such as HIV, however, remain elusive after two decades of effort. “All countries are now preparing to safely transition towards a new normal in which social and economic life can function amid low or no Covid-19 transmission. No country is safe until we all are safe, for which an effective vaccine that is accessible to all is needed,” said Dr Khetrapal Singh.