Enlarge /. In this picture, taken on April 29, 2020, engineers in the quality control laboratory of the Sinovac Biotech facility in Beijing are working on an experimental vaccine against the COVID-19 coronavirus
View more stories
When Donald Trump launched Operation Warp Speed last week, he borrowed a Star Trek language to describe the drive for a Covid-19 vaccine. "That means big and fast," said the US President, promising an effort "to continue at record, record, record speed."
His hope that a coronavirus vaccine could be ready "before the end of the year" was even faster than the optimistic – but often repeated – schedule for the completion of a vaccine in 12 to 18 months.
The race for a vaccine seemed to be picking up steam this week when Moderna, a Boston-based biotech company, early released positive results for its potential vaccine in a small study – and AstraZeneca said it could be the first doses of another vaccine from will be delivered October if the attempts are successful.
The announcements delighted politicians who were trying to give hope to citizens who were desperate to leave lockdowns, and investors who were looking for economic activity to return.
However, many scientists feel obliged to dampen enthusiasm. They say a vaccine could take much longer because little is known about the disease and how the body responds to attempts at immunization. Some even warn that we will never develop a vaccine against Covid-19.
President Donald Trump said US efforts to find a vaccine "are proceeding at record, record, and record speeds."
Drew Angerer | Getty Images
Soumya Swaminathan, chief scientist of the World Health Organization, believes that an optimistic scenario is a vaccine that will be in the double-digit millions next year and will be distributed mainly to healthcare workers and in much larger quantities in 2022. The defeat of Covid-19 could be four to five Take years, she says.
We don't have a "crystal ball" to tell the future, she told the Financial Times. "It depends on how the virus behaves: whether it mutates, whether it becomes more or less virulent, more or less transmissible."
Peter Hotez, a professor at Baylor College of Medicine in Houston who is developing a vaccine, says the US president sees vaccines as a "manufacturing problem," such as building adequate ventilators or testing.
“Manufacturing is not the hurdle. It takes time to collect enough efficacy and safety data, ”he says. "The" Operation Warp Speed "language coming from the White House and biotech and pharmaceutical companies [who say] that they'll get a vaccine by autumn – or in weeks or days – are doing so much harm . "
Soumya Swaminathan, chief scientist at WHO, predicts that fighting the virus could take four to five years.
Vaccines are usually developed over many years and even decades. According to a 2013 study by Dutch scientists, the average vaccine lasted 10.71 years and had only a 6 percent success rate from start to finish. Each phase is an experiment: from the small phase 1 studies to the large phase 3 studies required for regulatory approval.
There are good reasons to believe that this time will be faster. The Covid-19 vaccines benefit from the basics for the Sars and Mers corona viruses, even if they have never been approved, says Walter Orenstein, professor at the Emory Vaccine Center in Atlanta.
New technologies raise hope for a faster process. Morgan Stanley analysts estimate that Moderna's vaccine has a 65 percent chance of success. They believe we saw vaccines from Pfizer and its German partner BioNTech, AstraZeneca and Oxford University before the end of the year.
However, advances such as the MessengerRNA programming from Moderna, BioNTech and another German company, CureVac, have never been used to create products that have been approved by a regulatory authority. The technique translates a protein from the virus into human cells and shows it to the B cells that secrete antibodies.
The pandemic has urged governments and businesses to put money into Covid-19 vaccines, even if global cooperation is lacking. Peter Bach, director of the Center for Health Policy and Results at Memorial Sloan Kettering, says it helps that there are so many horses in this race.
Peter Hotez, professor at Baylor College of Medicine, says developing a vaccine should not be seen as a manufacturing problem.
Bloomberg | Getty Images
It takes time to prove that a vaccine is safe and effective. Participants must be exposed to the virus to prove that a vaccine works. That probably means recruiting thousands of people around the world to ensure that enough people live in an outbreak area, unless the vaccine manufacturers opt for the ethically complex trials of human challenges that the participants are deliberately infected with.
"I don't want to be Debbie Downer, but let's be clear: getting a vaccine by 2021 would be like drawing several straight lines in a row to use a poker analogy," says Dr. Brook.
Waging a warIt helps to know your enemy. Originally only considered a respiratory disease, Covid-19 has triggered surprise attacks from our eyes to our toes. Different tactics appear to be used in children, with reports of some suffering from a serious inflammatory disease.
Ian Bott | Financial Times
Moderna announced the first results of its phase 1 study on Monday, which shows that its vaccine triggered immune responses that are at least as robust as those in recovered patients.
However, some scientists asked how the study defined an average patient response. Dr. Hotez says the release took days after a study showing that recovered patients had low levels of antibodies. Umer Raffat, biotech analyst at Evercore, says it is important to know when the convalescent antibody level was tested – as it tends to fade over time. If tested later, it may not be as promising a comparison.
There are big questions about how long an immune response will protect patients. Most scientists believe that the disease gives some immunity – but we don't know how long it will last. Sars' immunity lasted only a few years.
So far, the virus behind Covid-19 has not been significantly mutated, so its shape changes less quickly than the flu. However, we have only been tracking the virus for months, so there is a risk that it will continue to mutate. Most vaccine manufacturers focus on the "spike" protein that it uses to penetrate cells. They try to teach the body to recognize this protein and to produce antibodies. If the peak changes, many of the potential vaccinations would miss their target.
Former US President Gerald Ford received a swine flu shot in 1976.
Early studies are conducted in healthy, younger populations: Moderna's first results were achieved by people aged 18 to 55. However, it is people over 65 who have suffered the most from Covid-19 and whose immune system tends to be less responsive. The US National Institute of Allergy and Infectious Diseases adds an older age group to the study.
Howard Koh, a former U.S. Secretary of State for Health, says: "A common problem is whether older people are able to generate a response that makes it an effective vaccine."
Mr. Trump is not the first president to see a vaccine as a means of neutralizing the political risk of a virus. In 1976, Gerald Ford pulled out a vaccine because he feared it would be a massive swine flu outbreak. His photo was taken in the White House. However, the vaccine had a serious side effect: hundreds of people developed Guillain-Barré syndrome, in which the body is paralyzed by the nervous system that attacks the nerves.
Covid-19 has proven to be the pandemic that swine flu never became in 1976. However, easing regulatory requirements could bring vaccines to market before we discover any side effects. In the United States, the easing of regulations during the pandemic has already led to struggles for security and accuracy. Government agencies and doctors have disputed whether it is safe to treat patients with hydroxychloroquine, a trumpet malaria drug used by Mr. Trump with cardiac and psychiatric side effects, and the Food and Drug Administration has warned of the inaccuracy of many antibody tests.
Cambridge, Massachusetts-based moderna biotech company Moderna presented early positive results for its potential vaccine in a small study involving patients ages 18 to 55.
Boston Globe | Getty Images
Scientists still haven't ruled out the bleak prospect that a vaccine could make the disease worse. In some conditions, including dengue and frequent RSV infection of the respiratory tract in children, vaccines have actually exacerbated the disease. In the first attempts to produce a Sars vaccine, a certain immune boost was found in animal experiments. So far, there is no evidence that this is a problem for Covid-19 – but the first studies refer to tens rather than hundreds or thousands of people.
Dr. Swaminathan says that this "antibody-dependent enhancement" is why the vaccines need to be tested very carefully. "Sometimes antibodies can actually make the situation worse."
If a vaccine turns out to be safe, there are still questions about its effectiveness. Paul Stoffels, scientific director at Johnson & Johnson, says one of the biggest questions is whether to stop the infection or just the disease or, as with the flu shot, prevent only the most severe symptoms of the disease.
"It would be good if it protects against both," he says. "If you can prevent infection, it will prevent it from spreading in the community."
Before a vaccine is made, developments in treatments such as antivirals and antibodies can help improve outcomes for Covid-19 patients. A vaccine that is only 60 or 70 percent effective could still be approved by the regulator and have a significant impact on the spread of the disease, says Stéphane Bancel, CEO of Moderna.
He is "cautiously optimistic", he will see the effectiveness in the large and final phase three study – but does not know whether it will be 70 or 95 percent. "Even if it were 70 percent effective, it would greatly reduce the problem of the virus being so contagious," he says.
Political leaders will declare victory if a vaccine manufacturer manages to move safely at speeds that are better for science fiction. However, the mass vaccination that could accelerate the return to normal life is still further away. The first vaccines are likely to be given to healthcare workers who will be examined as if they were still part of a study.
Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota, says we must remember that there is still a chance that we will not get a vaccine at all. It's not a "slam dunk," he says.
He is concerned that due to the “optimism and enthusiasm” for a vaccine, people will not take any other public health measures to stop the spread.
"People will just assume it's like a Hollywood movie, and at the last minute someone with a new vaccine made a day ago will fly in their helicopter. And the whole world is saved," said Osterholm "It's human behavior. When faced with such a serious challenge, you want to receive good news. "
© 2020 The Financial Times Ltd. All rights reserved. No disclosure, duplication or modification.