Multi-billion dollars are being invested in finding the vaccine against the novel coronavirus, as possible candidates are being prepared for production to fight the global pandemic.
Many experts consider the US target dates for a vaccine unrealistic, as it is one of the most dramatic examples of short cuts, since it is not even known whether any of the samples will work, reports USA Today.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the US, has repeatedly said that a vaccine against the Sars-CoV-2, the new strain of coronavirus that causes the deadly Covid-19 infection, may be ready in 12 to 18 months.
All precedents for developing a new vaccine, which typically takes many years, would shatter that timeline.
It took four years to get the vaccine for mumps.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said: “I think the goal of 18 months is one that will be very, very difficult to achieve, but it just may be our moon shot.”
The urgent need to have solutions ready as quickly as possible to stop a pandemic that has killed almost 200,000 people worldwide so far, and decimated the global economy, has been underscored, the report also said.
It is uncertain that any of the experimental vaccines will work.
If one does prove effective, getting it into the arms of people around the world will require another bold move, for which the Food and Drug Association (FDA) would have to speed up its normal approval process.
As testing data becomes available, vaccines with unacceptable side effects will be stopped, and stockpiles will be destroyed.
“This is indeed a brave new world,” said LJ Tan, chief strategy officer at the Immunization Action Coalition.
'Absolutely unprecedented'
The report also mentioned that pharmaceutical giant Johnson & Johnson, one of several major vaccine developers, is taking the leap.
It has begun work to produce a whopping one billion doses of vaccine, even with human trials months away, said Macaya Douoguih, the company’s head of Clinical Development of Vaccines.
The move is risky financially, but could shave a year or more off of the process.
Another US-based pharmaceutical giant, Pfizer, is expected to enter clinical trials soo - possibly in a week.
The company told USA Today that it has started ramping its production capacity to produce millions of vaccine doses by the end of the year – long before it knows which, if any, will work at all.
Phyllis Arthur, vice president of Infectious Diseases & Diagnostics Policy at the Biotechnology Industry Group BIO, said: “It is absolutely unprecedented, and it shows the strong commitment by our industry to eradicate Covid-19 and get any future vaccine to patients as quickly as possible, despite the incredible risks involved.”
The biggest bet has been made by an international public-private partnership comprising 14 governments, as well as the Bill and Melinda Gates Foundation and the UK's Wellcome Trust, which is backed by the Coalition of Epidemic Preparedness Innovation (CEPI), based in Oslo, Norway.
With $2 billion in financial support, it is helping 10 leading candidates manufacture vaccines “at risk,” James Robinson, a consultant managing the manufacturing strategy for CEPI, said.
“At risk” means CEPI is taking on all the financial costs, all the legal liability and the clinical trial costs, with no guarantee of a market.
“Production has started for many programs at limited scale; full-scale production should be underway by summer,” Robinson said.
The goal is, as testing progresses, scientists will be able to identify the most promising candidates and have substantial quantities of doses need to be deployed.
The chance of failing is high but CEPI has confidence some of the 10 vaccine candidates will be successful. "It's the bet we need to take to be sure we have one to three that will work," said Robinson.
The financial risk to the companies is also unprecedented, the report further added.
Gregory Poland, a professor of medicine at the Mayo Clinic in Rochester, Minnesota, and editor-in-chief of the journal Vaccine, said: “You have potentially just spent a million dollars to learn something interesting but have nothing to show for it.”
Even in normal time, vaccine manufacturing and production is tricky.
The rates of return are low and outbreaks can pull public attention and money away. That makes the decision to produce multiple vaccines before they are tested all the more remarkable.
Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland School of Medicine, said: “Companies do not want to risk making all those doses until they know a vaccine is going to be licensed and can be sold.”
Neuzil also said: “It is absolutely a gamble. There is no doubt about it.”
A Covid-19 vaccine may be impossible
There is a possibility that there will be no vaccines, as vaccines for respiratory ailments have a history of setbacks.
In 1966, two toddlers died from a vaccine for Respiratory Syncytial Virus, or RSV. It was until late last year that any vaccine for that respiratory virus was approved.
Vaccine developers also have to contend with antibody-dependent enhancement, where a possible vaccine ends up making it easier not harder for the virus to infect a cell.
There is also a history of problems in making a vaccine against coronaviruses, and Covid-19 is one of them.
No one has ever developed a vaccine for the common cold, which is often caused by different strains of the coronavirus.
Attempts at a vaccine for Severe Acute Respiratory Syndrome led to animals getting sick. The Sars virus is closely related to the Covid-19 virus.
Esther Krofah, executive director of FasterCures, a Washington, DC-based think tank, focused on accelerating medical research, said the urgency to stop the pandemic has brought together unprecedented resources and expertise to find a solution, yet it remains extremely difficult to develop a vaccine. It is one reason there is still nothing for HIV or the common cold,
“There is no absolute guarantee, even though we have all these efforts underway,” she said.
Osterholm, who wrote the bestseller "Deadliest Enemy" about public health crises, believes we must presume one will not be found which will put the burden on treatments and social distancing until the disease will course. He recently estimated 800,000 Americans will die of Covid-19.
Osterholm, who has been involved as a public health expert in numerous epidemics over 35 years, also said: “I think our planning for responding to the pandemic has to be as if there is no vaccine.”
“With a disease of this infectiousness, you probably are talking 60% to 70% of the population would have to be infected and develop immunity for us to see substantial reduction in transmission,” he further added.
There are more than 70 vaccine candidates for Sars-CoV-2, according to the World Health Organization.
A single vaccine maker cannot make enough doses for the entire population of 7.8 billion people in the world, and will require multiple vaccines produced at dozens of facilities.
Jon Andrus, a professor of Global Vaccinology and Vaccine Policy at the Milken Institute of Public Health at George Washington University, said there might be a Covid-19 vaccine in late 2021 or early 2022 but it is hard to say.
“We are building this plane as we fly it,” he said. “With science, you expect the unexpected.”
