This week it was revealed by the New York Times that the Centres for Disease Control and Prevention (CDC) told public officials across the country to prepare to distribute a potential coronavirus vaccine as soon as late October, mere days before the November election.
The search for a coronavirus vaccine has become a key focus in the pandemic, as the introduction of an effective formula could aid countries in protecting citizens while working to eradicate Covid-19.
But the research and development into the coronavirus vaccine has hit bumps in the United States following the implementation of Operation Warp Speed – a programme created by the Trump administration to facilitate in accelerating the development, manufacturing, and distribution of the Covid-19 vaccine and other treatments.
A CNN poll published this month found that 40 per cent of Americans would not take the coronavirus vaccine.
Part of the hesitancy from the public comes from it being an election year, causing concern that politics could be playing a part into how fast a vaccine would be rolled out to the public.
The revelation came after the Food and Drug Administration (FDA) announced it would consider issuing emergency authorisation to a coronavirus vaccine prior to the end Phase 3 human trials if the benefits were to outweigh the risks.
“We have a convergence of the Covid-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles,” FDA Commissioner Dr Stephen Hahn told the Financial Times after being asked if the Trump administration influenced the rush in vaccine development.
“This is going to be a science, medicine, data decision,” he added about the emergency authorisation. “This is not going to be a political decision.”
Experts have warned, though, that the appearance of rushing a vaccine, whether effective or not, could further push the public away – specifically if people believe politics influenced the timeline.
What does it mean to be in Phase 3 of a vaccine trial?
AstraZeneca began Phase 3 of its US human trials for a Covid-19 vaccine on Tuesday with a goal to enrol 30,000 people in the next eight weeks for the shot.
The vaccine became the third final-stage trial of a Covid-19 vaccine in the US, with Moderna and Pfizer already in the middle of their Phase 3 trials.
Dr William Hartman, a University of Wisconsin lead investigator on the AstraZeneca trial, told The Independent that Phase 1 and Phase 2 offered promising results, which encouraged the group to move on to Phase 3.
“The phases were able to show that after one dose about 90 per cent of people were able to generate antibodies to the spike protein, which is what’s in their vaccine, and they also showed that they were able to induce a T-cell response,” Dr Hartman said.
The vaccines attacked the virus in two ways: neutralizing it with antibodies and attacking it with “killer” T-cells, a type of white blood cell that plays a central part in a body’s immune response.
“So now, as we move into Phase 3, we still want to make sure that we get the antibodies and get the T-cell response,” he added, “but we also want to see in the larger population if we can decrease the incidence of a Covid-19 infection in people who get the vaccine.”
AstraZeneca’s Phase 3 double blind, randomized trial will last two years with an eight-week enrolment period. Participants will receive a shot, either a placebo or the coronavirus vaccine, on day one and then that same shot on day 29.
“The two years is really important in terms of how long these antibodies stay in someone’s system,” Dr Hartman said. This information would determine if people need to get a vaccine every year, similar to that of the flu shot, or if the antibodies would last longer to not need it as frequently.
But researches will also monitor in the two-year period if anyone develops severe side effects. Thus far with the AstraZeneca vaccine phases, participants have only developed headaches and muscle aches that went away in about one day, Dr Hartman said.
How has the timeline for vaccine trials accelerated?
Rarely has a vaccine in the past been developed in less than five years.
The mumps vaccine, licensed by Mercks & Co, won regulatory approval in 1967, four years after one scientist first started working on the shot, making it one of the fastest developed in US history.
Compared to the mumps vaccine, the coronavirus vaccine timeline has been significantly accelerated, but there are multiple reasons why researchers have moved quickly from one phase to the next.
“Never before has there been this type of focus on developing a single vaccine,” Dr Hartman said.
Oxford University, which created AstraZeneca’s Covid-19 vaccine, previously worked on a vaccine to treat Middle East Respiratory Syndrome (MERS) – another form of a coronavirus. Dr Hartman said the work that went into developing the MERS vaccine helped fast-track the development of the current Covid-19 vaccine.
“You have the people power, the money power, and you’re building on top of a vaccine that has already worked before,” Dr Hartman said. “With all those things, it was kind of a perfect storm of being able to develop a vaccine and carry it through the animal trials and Phase 1 and Phase 2 to get it to this point.
“Yes, it has gone very fast, which is relatively unprecedented. But also what is unprecedented is all of the effort and all of the money that has gone into developing it,” he added.
Dr Kathryn Stephenson, director of the Clinical Trials Unit for the Centre for Virology and Vaccine Research at Harvard University’s Beth Israel Deaconess Medical Centre, told The Independent that the vaccine clinical trials she’s seen are all being conducted with the same safety measures as past trials.
“I wouldn’t be conducting a clinical trial that I didn’t believe was happening safely,” she said, “and that’s true of everyone I know in this field.
“Where we see a lot of acceleration occurring in a safe manner is the manufacturing of these products, in the investment of manufacturing earlier in the process, and the scaling up of the clinical trials much faster than we normally would,” Dr Stephenson added. “All of which requires money and investments but is not sacrificing safety.”
Dr Stephenson, though, has been one of several health experts calling for an independent commission to review the vaccine research and data prior to one being manufactured and distributed to the public.
“What is concerning for me … is that we may actually get really cool, fast results because it’s been an extraordinary investment and every scientist in the vaccine world that I know has been working tirelessly for months,” she said.
But Dr Stephenson wanted to make sure that the public understood how researchers reached their conclusions within the trials so they, too, would feel confident receiving the vaccine.
“The main message is not that I am worried about the vaccines, it is more that I believe in vaccines and I want the public to believe in them as much as I do,” she said.
Arthur Caplan, director of medical ethics at NYU Langone Health, told CNN he also would like an independent commission to review the data prior to rolling out a vaccine.
“We’re used to this world where if the FDA or the CDC … says something is safe and effective, that’s enough, but I don’t think this time that’s sufficient to overturn public scepticism,” he said. “I think we desperately need an independent national commission.”
The FDA has called for a public meeting of the Vaccines and Related Biological Products Advisory Committee on 22 October to discuss the development, authorisation, and licenses of Covid-19 vaccines.
“I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible,” Dr Hahn said in a statement released last week.
“A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent Covid-19 and the data needed to facilitate their authorization or licensure,” he added. “It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”
How would a coronavirus vaccine be distributed to the public?
If a coronavirus vaccine were to gain emergency authorisation from the FDA, it would then need to be manufactured and distributed across America – an effort that would take time.
“Just because a vaccine is found to be effective in a clinical trial does not mean you have five million vaccines boxed and ready to ship in January 2021,” Dr Stephenson said.
The National Institute of Health (NIH) and CDC commissioned The National Academies of Science, Engineering, and Medicine to create a framework for how a coronavirus vaccine should be distributed that would be equitable and most beneficial to the public.
In a report released this week, the 18-person panel detailed four criteria to be considered when distributing the vaccine at the beginning: risk of acquiring infection, risk of morbidity and mortality, risk of negative societal impact, and risk of transmitting.
“Our overarching goal is to maximise societal benefits by reducing illness and death – morbidity and mortality – caused by the transmission of Covid-19,” Dr Helene Gayle, co-chair of the committee, told The Independent.
“First and highest priority was on reducing the consequences, so people getting sick and dying,” she added.
But it was also recognised that those on the frontlines, such as healthcare workers, should also take priority when distributing the vaccine.
The committee then recommended a four-phased approach to distributing the vaccine, with healthcare workers and vulnerable populations – such as people over the age of 65 and those with underlying health conditions – taking priority. The first phase would include about 15 per cent of the US population, the report added.
“This would be a vaccine that we would hope would be available and effective for the whole population,” Dr Gayle said. “And that is going to be an important part about how we get our society back to normal and people being able to congregate, etc.
“But because we know that in the beginning it will probably not be enough to go around for the entire population, that is why we have the phases that we have,” she added.
Phase two would include essential workers, teachers and people in homeless shelters as well as those in jails, prisons, and detention centres. Then phase three would be made up of young adults, children, and workers “essential to the functioning of society”, which would mean about 85 to 95 per cent of the population would be vaccinated.
The final phase would involve everyone else.
“Our phases are based on what we think risk is and being able to provide the vaccine first to people who have the highest amount of risk in the four categories we mention,” Dr Gayle said.
“Equity is an also important part of what we try to do because of the disproportionate impact particularly on the communities of colour and people who have limited opportunities to keep themselves safe from getting the infection,” she added.
The public can provide a comment to the framework and four-phase approach until Friday at 11:59pm EST. Then the committee will review the feedback and provide a final report to the NIH and CDC for their consideration when rolling out a coronavirus vaccine.
