The unprecedented speed with which medical science is developing a COVID-19 vaccine is one of the most inspiring stories in this historical chapter. Vaccine candidates emerged just weeks after scientists identified SARS-CoV-2 and sequenced its genetic code. University and Big Pharma have formed teams to develop vaccine candidates in a short time. But just as quickly, the search for a vaccine has become a political issue, and the sad result is that while the chances of an effective vaccine increase, so too does public distrust.
It’s a shame, because the medical and scientific task of developing a COVID-19 vaccine isn’t the only key ingredient for a successful vaccination campaign. Public consent is essential, because a vaccine is only effective when people agree to be injected. The political spectacle surrounding the vaccine efforts is undermining public confidence. Mixed messages that look set to continue for the next two months of the presidential campaign will complicate communication efforts by doctors and public health officials, just as the threat of an autumn wave of infections approaches.
The race for a vaccine took shape early on. By July, Moderna, the Massachusetts pharmaceutical company, transferred the vaccine candidate it was developing with nearly $ 1 billion from the U.S. National Institutes of Health (NIH) into Phase 3 clinical trials. Phase 3 is the gold standard in medicine, the final stage of testing a new vaccine must be completed before the Food and Drug Administration decides whether its benefits are large enough and its risks small enough to warrant releasing millions, perhaps billions, of other healthy people . To persuade the FDA and the rest of the medical community, Moderna will enroll 30,000 people, give some of them the vaccine and the rest a placebo, and wait until 150 of them come with COVID-19.
Russia’s Gamaleya Research Institute wasn’t far behind Moderna in the race to be the first to come out with a vaccine. But in August, as Moderna was beginning the vast logistical operation of enrolling participants for its trial, Russia decided to authorize the use of its vaccine even though it had not yet published the results of its phase 1 and 2 trials. which are used to collect toxicity and efficacy data from a small number of closely monitored participants. Russia was releasing a vaccine that had only been tested on 76 people.
Scientists denounced the move as “reckless”, “foolish”, “immoral” and potentially “disastrous”. If the vaccine proves dangerous or ineffective, it could undermine public confidence in vaccines around the world, at a time when persuading people to accept vaccination is important to containing COVID-19.
Undaunted by Russia’s example – or perhaps encouraged by it – President Trump earlier this month began hinting that the United States could authorize its own vaccine before the November 3 election. “We remain on track to deliver a vaccine before the end of the year and possibly even before November 1,” he said at a news conference. “We think we can probably have it during the month of October.” He repeated the statement.
The answer came from many directions. Democratic candidates Joe Biden and Kamala Harris were quick to attack Trump for mixing politics and science. “I wouldn’t trust Donald Trump and he should be a credible source of information talking about the effectiveness and reliability of whatever he’s talking about,” Harris told CNN. Scientists also objected. Dr Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said a vaccine before the end of the year “is not impossible” but “unlikely”. Francis Collins, the director of the NIH, told senators in a hearing that any decision to release a vaccine would be made on a scientific basis. “I just hope Americans choose to get the information they need from scientists and not from politicians,” he said.
Even drug companies have taken action to avoid any politically programmed vaccine authorizations. The executives of nine pharmaceutical companies, including Moderna, Pfizer and AstroZeneca, have committed to apply for government approvals only “after they have demonstrated safety and efficacy through a phase 3 clinical trial.” Two prominent NYU bioethicists, commenting on the view of Big Pharma apparently defending the American public against a “politically compromised” FDA, wrote on STAT, a health science news site, that “hell is frozen.” Dr. Fauci said Newsweek that a (hypothetical) presidential edict to force the FDA to launch a vaccine would be “thrown out of the water publicly by people who understand what it takes to declare a vaccine safe and effective. It would be a public embarrassment.”
Insurance apparently hasn’t stabilized a nervous audience. According to a recent CBS poll, Americans are deeply concerned about the safety of vaccines. The number of US voters who say they would receive a vaccine as soon as possible if one were available for free dropped to 21%, from 32% at the end of July. And two-thirds of voters would consider a vaccine announced this year to have been rushed for political rather than scientific purposes, and only 13% of them would get one. A new poll from the Kaiser Family Foundation found similar apprehension, with 62% expressing concern that political pressure would force the FDA to approve a vaccine without making sure it is safe and effective, and the majority saying it wouldn’t get the shot. even if free, if the vaccine was approved before election day.
As if to underline the risks, earlier this month AstraZeneca suspended Phase 3 trials of the vaccine developed with the University of Oxford after a patient developed symptoms of a neurological disease (the trial was then resumed).
Can you trust that a coronavirus vaccine will be safe and effective when it is finally approved? Should you inject once a vaccine is approved in the United States? To help resolve any uncertainties, we have put together the latest information on COVID-19 vaccines and frequently asked questions. Here’s what we know so far: about science, not politics.
How confident are we that a COVID-19 vaccine will be on the way?
Less than one in five vaccine candidates typically survive the test challenge, but there are currently more than 100 being tested for COVID-19. The chances of at least one of them working are high. To date, nine vaccines are in Phase 3 trials: Moderna’s, which uses fragments of the coronavirus to stimulate an immune response; a similar vaccine from Pfizer, Biontech and Fosun Pharma; and the AstroZeneca-Oxford vaccine, which uses an adenovirus to carry coronavirus genes to cells, causing an immune response. Trials are also underway for a vaccine called BCG, which is used in poor countries for tuberculosis and which can protect against COVID-19.
However, a lot can still go wrong.
Clinical trials, for example, are notoriously difficult to predict. Vaccines can look good in stages 1 and 2 only to fail in stage 3, where the huge number of participants can reveal side effects that smaller tests have missed, while refining efficacy rates. As was the case with the hydroxychloroquine drug, a vaccine could prove to confer benefits that don’t outweigh the harmful side effects, meaning treatment is worse than no treatment. Or it may simply fail to provide much protection against COVID-19. Failures, of course, are what tests are designed to eliminate.
It is important to keep in mind the speed at which medical science is acting. Typically, it takes four to five years to develop a vaccine. It took Jonas Salk three years just to test the polio vaccine. That a COVID-19 vaccine could arrive just a year after the virus was discovered is surprising.
However, it is not known when the ongoing trials will end. Scientists must first collect enough data to be sure they know what the risks and benefits are. Unlike, for example, cancer drugs, where patients can often face premature death unless something is done to stop the progress of the disease, vaccines are given to millions of healthy people, which puts a safety premium. . Moderna, for example, has so far enlisted about 22,000 people in its trial; the FDA requires data on 150 participants who become ill with COVID-19. How quickly this will happen depends on the prevalence of the virus in areas where clinical trials are taking place – a trial could go faster in Arizona, where many people are infected, than in Maine, where infection rates are lower.
It also depends on the effectiveness of the vaccine. A vaccine that protects 80 percent of inoculated people would generate statistically significant results more slowly, because fewer people would fall ill, than a trial that only protects half. For COVID-19, the FDA is aiming for a 50% reduction in disease, which effectively means it would accept anything above 30%. By comparison, annual flu shots are generally about 60% effective, which doesn’t provide iron-coated protection. However, Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, an architect of the federal government’s COVID-19 program, hopes the effectiveness will be “well above 40%.”
What happens if a weak vaccine is released?
Even a vaccine that leaves 40 or 50 percent of inoculated people vulnerable to COVID-19 is better than no vaccine. And it would help accelerate herd immunity, which happens when enough people are immune to a virus to stop its spread.
Conventional wisdom is that herd immunity occurs when 70% of a population has immunity, although some statistical models suggest that 50% may be enough for COVID-19. That doesn’t mean a vaccine that protects 50 percent of those who are injected will be enough, because not everyone will take it: fewer than half of Americans plan to get a COVID-19 vaccine, according to an NBC survey, and one in three say who will openly refuse to take one, according to Gallup. Public health officials worry that people may be put off to hear that a vaccine only works half the time and decide, why bother?
Most COVID-19 vaccines require two doses, which greatly complicates the logistics of launching because twice as many shots need to be produced and distributed. Another unknown is how long these vaccines will last: how long will they last? The odds are on the order of months or years, but we don’t know and we may not know until after the vaccines are released.
All of this means that the discipline of wearing masks and social distancing and keeping restaurants partially full will continue for the time being, probably for a long time. “We should consider vaccines as part of the paraphernalia we have against this virus,” says Dr Alan Bernstein, a member of the Canadian coronavirus task force. “The other part is washing our hands, keeping our distance and wearing a mask. Of course, if I were immunized, I would still do these things.”
What’s the problem with early vaccine release?
Releasing a vaccine before there is enough data to know that the risk of harming people is much less than the risk of helping them would violate public trust. “We can’t have a vaccine released with great fanfare and then find that we have to withdraw the vaccine because it has an unacceptable risk of side effects, because then the public’s trust in the medical establishment – the FDA and vaccines in general, will be serious. damaged, possibly permanently, “says Richard Malley, professor of pediatrics at Harvard Medical School. The reputation of U.S. medical institutions has already taken a hit after the missteps on hydroxychloroquine, wearing mask, convalescent plasma, and COVID-19 testing. Another vaccine mistake would only encourage anti-vaxxes, which in recent years have made it more difficult than it otherwise would be to protect people from measles, whooping cough and other diseases.
The early release of vaccines also complicates the task of studying other potential vaccines. Clinical trials require comparing a group of people receiving the vaccine being tested with another group receiving a placebo or standard vaccine. If an effective vaccine is already available, it is difficult for scientists to recruit people who are willing to risk taking just a placebo for the sake of a new candidate who may or may not prove better.
“There is an urgency to develop a vaccine,” says Malley, “but that doesn’t mean you should rush and bypass the usual criteria that have been set for decades to come up with a vaccine that may not be very effective.”
When a vaccine comes out, how can we know it’s safe?
Occasionally scientists will be ethically compelled to finish a phase 3 study early because the data suggests that the drug, treatment, or vaccine is extremely effective, meaning they cannot in good conscience continue to withhold it from some test participants who might instead receive the placebo. If a vaccine had been released this way before Election Day, it would have gone through phase 1 and 2 testing, which focus on safety, and at least partly through phase 3 testing, but it should have gone so well in the phase 3 in order to provide scientists with enough data to know unequivocally that the vaccine is safe and effective.
What if the White House insisted on shorting that process and releasing a vaccine with no extremely positive data from the phase 3 studies? I asked Dr. Corey, who worked with Dr. Fauci to design Operation Warp Speed, the government’s COVID-19 vaccination program. He pointed out that such a scenario would require the complicity of a large number of scientists who collaborated on the nation’s vaccine initiative. “We built these studies with incredible scientific experience and review. There are hundreds of people who have seen the protocol. There are many levels of review committees. Clinical trial sites involve infectious disease professors in essentially all of our universities across the country and people who have been at the forefront of caring for people with COVID. “
Has there been talk of an early release of the vaccine so far? “I can say very emphatically that it isn’t,” says Corey.
If the worst case scenario occurs and the entire executive branch of the US government – the FDA, the Centers for Disease Control, the Department of Health and Human Services – is compromised by the political influence of the White House, we will have to rely on it. these scientists to speak. So far they have.
Is a vaccine our only hope?
Although vaccines are important for long-term control of the coronavirus, there is also the possibility that drug companies will come up with treatments that make the disease less deadly. Imagine a drug you might take early in symptoms or after being exposed to someone who had COVID-19, which would eliminate the risk of being hospitalized or having long-lasting symptoms. For many people, this could turn COVID-19 from a terrifying disease to simply an unpleasant one.
Pharmaceutical companies are working on oral or nasal treatments similar to remdesivir, the therapy that showed some success earlier this year, which could be particularly effective if given early. So far, the drugs have shown promise in animal studies, Malley says. Drugs are much easier to test than vaccines, which require people to inoculate and wait for them to get sick. With a drug you take people who are already sick, cure them and see if they improve. For this reason, Malley thinks early-stage drug therapies could be available in six months. “Obviously, taking pills whenever you’re sick isn’t a long-term solution,” he says. “But in a way, this could be more like bringing us relief from having to quarantine and avoid activities than a vaccine.”
When will life return to normal?
“It is always dangerous to make these kinds of predictions, but I would say at the very least, we will do it well in 2021,” said Dr. Maw Newsweek. “Going into the summer and fall, I would predict that we will get close to some degree of normalcy, not completely, because we will still have coronavirus in circulation, but it will not be something that is immobilizing society as it currently is.”
It’s hard to wait that long.
When the coronavirus pandemic hit the Seattle area in February, Hilary Godwin, dean of the University of Washington School of Public Health, stopped visiting her elderly parents in Oregon. The train ride, which he loved because he could read, sleep and look out the window, was now a potential virus spread event and how he could justify the health risk to his parents by staying in their guest room and eating in their kitchen ? So, like millions of other people, he decided to suspend his family life, squat and wait for a vaccine.
But as autumn approaches, the prospect of having to give up congregating in courtyards and sidewalk restaurants is enough to make a person think about stepping out of the bunker. So Godwin drove with her husband and son for five and a half hours to sit in his parents’ yard and talk from six feet away.
“It was the realization that it’s not just another three months, or another 10 months. It really is that we will have to learn to live with this new reality for another year or two, and that there is no point in waiting. If I can invent a way that could not be perfect, but at least it’s relatively safe, where I can spend time with them, I should do it now. “