Different scientists consulted by the prestigious newspaper raised the difficulty of believing that the cure against COVID-19 could be in the near future
A vaccine would be the greatest weapon against the coronavirus and the best way to return to normal life. Officials such as Anthony S. Fauci , the top infectious disease expert in the government’s anti- coronavirus task force of the US President Donald Trump , calculated that a vaccine could be created within twelve to eighteen months.
The sad reality behind this promising forecast is that the vaccine is unlikely to arrive soon. Clinical trials are almost never successful. We have never before launched a human coronavirus vaccine. Our record of developing a completely new vaccine is at least four years – longer than the public or the economy could tolerate orders for social distancing.
However, if any time is ideal to accelerate the development of a vaccine, it is now. So the Opinion section of The New York Times asked vaccine experts how we could shorten the process and create a vaccine in the coming months and not in the coming years.
Next, how could we achieve the impossible.
Let’s assume we already understand the coronavirus
Typically, it takes years for researchers to secure funding, get approval, and get results from piece-by-piece studies. However, these are not normal times .
There are already at least 254 therapies and 95 vaccines related to COVID-19 that are being analyzed.
” If you want to meet that within eighteen months, one way is to put as many horses as you can in the race , ” said Peter Hotez , dean of the National School of Tropical Medicine in the Faculty of Medicine of Baylor University .
Despite unprecedented pressure to get a vaccine , researchers caution thatless than 10 percent of drugs that start clinical trials are approvedby the Food and Drug Administration (FDA).
The rest fail one way or another: they are not effective, do not perform better than existing drugs, or have too many side effects.
Fortunately, we already have an advantage in the first phase of vaccine development: research. The SARS and SROM outbreaks , which are also caused by coronaviruses , generated much research. The SARS and SARS-CoV-2 , the virus that causes COVID-19 , are identical in about 80 percent and both use the so – called spike proteins to adhere to a specific receptor found on cells of human lungs . This helps explain how scientists developed a test for COVID-19 so quickly.
However, there is a cost for moving so quickly. Potential COVID-19 vaccines now in the development pipeline may be more susceptible to failure due to rushing through the research phasesaid Robert van Exan , a cell biologist who has worked in the vaccine industry for decades. He predicts that we won’t see an approved vaccine until at least 2021 or 2022, and even then “this is very optimistic and relatively low odds . “
Still, he said, this kind of fast forward ” is worth the try,maybe we will be lucky“
The next step in the process is preclinical and preparatory work , in which a pilot factory is set up to produce enough vaccines for testing. Based on the preliminary work of outbreaks of SARS and SROM , researchers could theoretically perform the planning steps very quickly.
Sanofi , a French biopharmaceutical company, hopes to start clinical trials within a few months for a COVID-19 vaccinethat it adapted based on the work of the SARS vaccine. If successful, the vaccine could be ready by the end of 2021 .
Do the tests at ‘pandemic speed’
As a rule, researchers don’t start injecting people with experimental vaccines until after rigorous safety checks .
First, they test the vaccine on small groups of people – some during phase 1, then a few hundred in phase 2, and then thousands in phase 3-. Generally, months pass between phases so that researchers can analyze the findings and obtain approval for subsequent phases .
However, “If we do it in the conventional way, there is no way to meet that eighteen-month deadline,” said Akiko Iwasaki., a professor of immunobiology at Yale University School of Medicine and a researcher at the Howard Hughes Medical Institute .
There are ways to cut down on this process by combining multiple phases and testing vaccines on more people without waiting that long.
Last month, the United States National Academy of Sciences displayed an overlapping timeline and described it as moving at ” pandemic speed .”
It is at this point that the discussion about fast-forwarding the timeline runs into real-life problems: what if a promising vaccine actually makes it easier to catch the virus or the disease worsens for those who already have it? infected?
That has been the case for some HIV drugs and dengue vaccines , due to a process called vaccine-induced amplification, in which the body reacts unexpectedly and makes the disease more dangerous.
Researchers can’t simply infect vaccinated participants with the coronavirus to see how the body behaves. Typically, they wait until some volunteers naturally contract the virus. That involves applying doses to people in regions that have suffered the worst impacts of the virus, such as New York , or vaccinating the relatives of an infected person to see if they are infected. If the pandemic persists, this step could be slowed down .
” That’s why developing vaccines takes so long, ” said Iwasaki . “ But we are making everything very short. We hope that we can assess these risks as they occur, as soon as possible . ”
It is at this point that vaccine timelines start to diverge depending on who you are, and where some people may fall behind.
If a vaccine proves successful in early trials, regulators could issue an emergency use provision so that doctors, nurses, and other essential workers could be vaccinated immediately – even before the end of the year. Researchers at Oxford University announced last week thatyour coronavirus vaccine may be ready for emergency use in September if the trials are successful.
So researchers could produce a viable vaccine in as little as twelve to eighteen months, but that doesn’t mean you can get it. Millions of people could be on hold before you. And that’s only if the United States first finds a vaccine. If another country, like China , beats us to creating it, we may have to wait even longer while first applying the doses to its citizens.
However, that could be a good thing, if it turns out that the vaccine whose development progressed rapidly causes unexpected problems. Only after hundreds or thousands of people are vaccinated, researchers will be able to see if a hastily developed vaccine caused problems like vaccine-induced amplification.
” It’s true that any new technology has a learning curve, ” said Paul Offit , director of the Center for Vaccine Education at Children’s Hospital of Philadelphia . ” And sometimes that learning curve comes at a human cost .”
Let’s start preparing the factories now
Once we have an effective vaccine available, companies will need to start producing millions – perhaps billions – of doses, in addition to the millions of doses of vaccines that are manufactured annually for mumps, measles, and other diseases. It is a task of an almost unimaginable magnitude .
Usually companies build new facilities perfectly adapted for a given vaccine, because each one requires different equipment. Some influenza vaccines are produced with chicken eggs, in large facilities where a version of the virus is incubated and harvested. Other vaccines require the use of tanks, where the virus is cultivated in a broth of animal cells, and then deactivated and purified.
Those factories follow strict guidelines governing biological facilities and generally take almost five years to build., with a cost at least three times higher than that of conventional pharmaceutical factories. Manufacturers could accelerate this process by creating or adapting existing facilities during clinical trials, long before the vaccine in question receives FDA approval .
” They just can’t wait, ” said Iwasaki . ” If it turns out to be a terrible vaccine, they won’t distribute it. But at least they will have the ability ”to do it if the vaccine is successful.
The Bill & Melinda Gates Foundation says it will build factories for seven vaccines. ” Even if we end up choosing only two of them, we are going to finance the manufacture of all seven, so we don’t waste time, ” said Bill Gates during an appearance on The Daily Show .
Ultimately, the United States will have the ability to mass- produce just two or three vaccines, said Vijay Samant , former director of vaccine manufacturing at Merck .
” The manufacturing task is unattainable, ” said Samant . “I spend sleepless nights thinking about it .”
Let’s consider just one apparently simple step: placing the vaccine in vials. Manufacturers need to purchase billions of vials and billions of caps to seal them. Sophisticated machines are needed to fill them accurately, and each vial is examined on a high-speed line. Subsequently, the vials are stored, distributed and delivered to the population through a chain of temperature-controlled facilities and trucks. In each of these stages, producers are already having difficulty meeting existing demand, Samant said .
It is a bottleneck similar to the one that caused the shortage of respirators, mouth guards and other personal protective equipmentjust as COVID-19 began to emerge across the United States .
If you talk enough about vaccines, a new type of vaccine called messenger RNA (mRNA) will inevitably come up. There are hopes that it can be manufactured in record speed. Gates even added it to his Time magazine list of six innovations that could change the world . Is this the miracle we are waiting for?
Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines instruct the body to create those antigens itself. Because mRNA vaccines do not need to be grown in large quantities and then purified, their production is much faster. They could change the course of the battle against COVID-19 .
“On the other hand,” said van Exan, “no one has ever made a human RNA vaccine.”
The researchers who are conducting dozens of tests hope to change that. Among them is one made by the modern pharmaceutical company . Backed by investor capital and spurred by federal funds of up to $ 483 million to combat COVID-19 , Moderna has already accelerated the development of an mRNA vaccine . It will enter phase 1 clinical trials this year, and the company says it may have a vaccine ready for front-line workers later this year.
” Could it work? Yes, it could work , “said Fred Ledley , professor of Biology Natural and Applied Sciences of the University of Bentley . ” But in terms of odds of success, what our data says is that there is less chance of approval and trials take longer .”
The technology dates back several decades, but still mRNA is not very stable and can be broken down within the body.
” At this point, I’m expecting anything to work, ” said Iwasaki . “ If it works, wonderful, it will be great. We just don’t know . “
The obsession with mRNA demonstrates the appeal of new and untested treatments during a medical crisis. With the unsatisfactory reality that our standard arsenal takes years to advance, the mRNA vaccine offers a tantalizing narrative, mixed with hope and a pinch of mystery. However, it is riskier than other established approaches.
Streamline regulatory approvals
Let’s imagine that the promised day arrives. Scientists have created a successful vaccine. They have manufactured huge quantities. People are dying. The economy is in pieces. It is time to start injecting the population.
But first, the federal government wants to take a look at it.
That might seem like a bureaucratic nightmare, a stamp on paper that could cost lives. There is a common complaint among researchers: for every scientist employed by the FDA , there are three attorneys. And the only thing that interests them is to establish responsibilities.
However, FDA authorizations are not a mere formality. Approvals typically take a whole year, during which scientists and advisory committees review the studies to make sure the vaccine is as safe and effective as manufacturers say.
While some steps in a vaccine’s timeline may be speeded up or even completely ignored, that of approvals is not one of them. There are horror stories from the past, when vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved within a few hours. It contained a version of the virus that was not completely dead, so the patients to whom it was applied ended up contracting polio. Several children died .
A similar scenario today, with COVID-19, could be devastating, with anti-vaccine movements and online conspiracy theorists eager to hamper the public health response . So while the FDA could do this as quickly as possible, let’s be aware that it will be months before any vaccine receives the go-ahead to be used in the population.
By now, you might be wondering: why then are all these research teams announcing such optimistic forecasts when so many experts are skeptical even about an eighteen-month timeline? Perhaps because it is not only the population that is listening, but also investors.
” These biotech companies are issuing a lot of press releases, ” said Hotez . ” You just have to realize that they are writing this for their shareholders, not for public health purposes .”
What if it takes even longer than the pessimists predict?
The COVID-19 lives in the shadow of the most baffling virus we have faced: HIV . After almost 40 years of work, this is what we have achieved with our efforts to get a vaccine: a few phase 3 clinical trials, of which one actually worsened the disease, and another has a success rate of just 30 percent.
The researchers say they don’t expect to get a successful HIV vaccine until 2030 or later, which would lengthen that timeline to around 50 years .
This is unlikely to be the case for COVID-19 because, unlike HIV, it does not appear to mutate significantly and also exists within a family of known respiratory viruses. Still, any delay will be difficult to bear.
However, the history of HIV offers a ray of hope for how you can continue living even without a vaccine. The researchers developed a litany of antiviral drugs that lowered the case fatality rate and improved health indicators for people living with AIDS . Today’s medications can reduce the viral load in an HIV-positive person to such an extent that the virus cannot be transmitted through sex .
Therapeutic drugs, not vaccines, could similarly change the battle against COVID-19 . In March, the World Health Organization began a global search for drugs to treat patients with COVID-19 . If successful, those medications could reduce the number of hospitalizations and help people recover faster from home while narrowing the time for infection so that fewer people contract the virus.
Let’s combine this with rigorous testing and contact tracking applications – the process where infected patients are identified and their recent contacts are notified and quarantined – and the future is looking a little more hopeful. So far, the United States is conducting less than half the number of tests required, and we need to recruit more than 300,000 contact trackers. However, other countries have started to resume their activities following exactly these steps.
If all of these things are combined, life could return to normal long before there is a vaccine ready to be injected into your arm.
(C) The New York Times