If President Trump is to be believed, the COVID-19 Vaccine is merely weeks away. While the wait may be a little longer than the President suggests, the vaccine is nonetheless eagerly anticipated. The question must be asked: will the vaccine be the silver bullet we’ve all been waiting for? To better address this question, a lot can be learned from the history and impact of the smallpox and polio vaccines. However, history alone cannot answer this question. With “herd immunity” the end goal, many factors will likely contribute to the vaccine’s success, including the vaccine itself, public confidence, refusal rates, and growing dissent to some of the restrictive measures.
The Lessons of Days Gone By
- The word ‘vaccine’ derives from the Latin word for cow, a nod by British Doctor Edward Jenner to the cow’s role in arguably the first vaccine. Back in 1796, Dr. Jenner figured out that infection with the relatively minor cowpox created an immunity to the considerably more serious smallpox. It was not, however, until the late 19th century that a vaccine was produced. Even then, smallpox prevailed. From 1958, the World Health Organization undertook a global vaccination campaign to eradicate smallpox. In 1977, 179 years after the vaccine was discovered, smallpox was declared eradicated. It is the only human disease to this day to be eradicated.
- Of course, today’s world is a very different place from the world in 1796, and a COVID-19 vaccine will not have the burden of being the first.
- Some have described paralytic poliomyelitis (polio) as a horror movie arriving each summer and striking children without warning for over half a century. It peaked in the 1950s. At the beginning of the decade, the number of cases in the US rose to around 20,000 annually. In 1953, this figure soared to nearly 58,000. The following year there were 35,000 cases. The number of polio deaths for those two years rose to almost 3,200 and 1,400, respectively. Of the survivors, many suffered significant and permanent disability. Many spent months in iron lungs, their respiratory systems paralyzed. The victims, predominantly children. The early 1950s would later become known as the “summers without children,” as parents kept their children isolated to stop them from catching the disease.
- At the height of this epidemic, millions were invested in finding and distributing a vaccine for polio. It was the most feared disease of the 20th century. In 1952, Johan Salk and his team at the University of Pittsburgh developed a vaccine. Salk first tested the vaccine on his own three sons. Two clinical trials followed. One involved nearly 1.8 million children in 44 states.
- The vaccine was not licensed for commercial use until 1955. Salk became the most celebrated scientist of his generation, having refused a patent for his work, saying the vaccine belonged to the people. A mass vaccination campaign was undertaken between 1955 and 1962. It reduced the incidence of polio by 90%.
- The legacy of the polio epidemic should not be underestimated. Polio created an infrastructure for delivering a vaccine, one that has been employed to fight diseases like ebola, malaria, and soon coronavirus. Perhaps more importantly, a spirit of defiance and solidarity developed in communities the world over, that spirit is partly attributed to the polio vaccine’s ultimate success. If any COVID-19 vaccine is to be successful, this spirit will need to be reignited. But, the world in 2020 presents as one vastly different from its 1950s counterpart, new obstacles and challenges have emerged.
- Both of these examples illustrate that, without a doubt, a vaccine presents as a solution to COVID’-19. They both also demonstrate the development of a vaccine takes time, as does the time it takes for the population to reach the level where herd immunity is conferred, and the population protected, even if each individual member has not had the vaccination.
- Herd immunity is often mentioned in the context of the pandemic. As the LA Times put it, “For a term that’s at least 100 years old, “herd immunity” has gained new life in 2020.” Herd immunity occurs when the majority of the population is immune to a particular infectious disease, providing indirect immunity to the remainder of the population. The percentage of the population that needs to be immune for herd immunity to take effect varies from 50-90% and is largely dependent on how contagious the infection is.
- The following graphic provides a visualization of herd immunity, illustrating how a virus is less likely to spread because fewer people will come in contact with it once herd immunity is achieved.
- Several figures have been discussed concerning the proportion of the population that needs to be immune against COVID-19 for herd immunity to take effect. Currently, the consensus seems to be around 70%,
- To put this in perspective, the US sits atop the world table in both cases and deaths. Recent studies of a number of cities n the US have shown immunity levels well below the herd immunity threshold. New York City has the highest levels of immunity (measured by the presence of antibodies) at 24%, but others like Missouri (2.8%), Philadelphia (3.6%), and Connecticut (5.2%) have much lower rates. The national average is estimated to be between 10-16%.
- What few commentators have mentioned is there are different rules relating to herd immunity during a pandemic, and achieving the herd immunity threshold during a pandemic does not mean it will stop the pandemic. Instead, the number of new cases each day will start to decline. “A substantial infectious population will continue to spread the virus.” In most instances, this means “the final number of people infected will far exceed the herd immunity threshold.”
The Vaccine — What we Know
- According to the World Health Organization (WHO), there are currently 169 possible COVID-19 vaccines in development, 26 of these are now in the clinical trial phase, a further 67 are set to begin clinical trials before the end of 2021.
- Ted Ross, the director of the Center for Vaccines and Immunology at the University of Georgia, is working on one of the vaccines set to begin clinical trials next year. Despite his vaccine seemingly appearing to be an “also-ran” in the race for a vaccine, Ross disagrees, arguing, “the first vaccines may not be the most effective.” He is not alone in this thinking; a number of researchers agree, worried that too much hope is being placed on a strategy that has not been proven before; a protein that covers the surface of the virus, prompting an immune response. The majority of the vaccine front runners have taken this approach.
- It is expected a vaccine will be available commercially before the end of 2020, less than 12 months after research first began on creating one. Put in the context of smallpox and polio, the time frame is almost unbelievable. Some experts have raised doubts relating to the time frame. Any vaccine will have to prove its safety and efficacy. It will also represent many unknowns. These unknowns could ultimately prove determinative factors in its uptake.
Math and the Vaccine
- Even if the clinical trials are successful, researchers have questioned whether a vaccine can be produced fast enough to meet global needs. For example, the vaccines being developed by two of the front runners, Moderna and Pfizer, are RNA-based, using designs that have never been put into production before.
- Moderna has committed $1.3 billion to upgrade its facilities and believes it can produce 500 million doses per year. Bearing in mind the Moderna mRNA-1273 vaccine will likely require two doses, this equates to doses for 250 million people. The US population is over 331 million.
- Of course, there are other candidates; Pfizer has agreed to produce 600 million doses of its BNT162 vaccine, 100 million before the end of the year, in a $1.95 billion deal with the US government. Like Moderna, Pfizer is developing a two-dose vaccine. This means by the end of 2021, Pfizer will not have produced a sufficient number of doses for the US population, to say nothing of the other nearly 7.5 billion people in the world.
- There seems little doubt affordability will become an issue. Tapping into well-established vaccine methods, a group from Baylor College is developing a vaccine that will cost around $2 per dose. On the other hand, Pfizer has a deal with the US government for a vaccine that will cost $19 per dose. This will inevitably raise issues of cost for some of the poorer and undeveloped countries.
- WHO has given assurances that when a safe and effective vaccine becomes available, a group tasked for the purpose will ensure its equitable distribution globally, with those most at risk receiving it first. However, in light of the recent deals between pharmaceutical companies and governments, the reality may prove quite different.
Safety and Efficacy
- There is considerable debate on how effective a vaccine should have to be to be approved. The US Food & Drug Agency has suggested a level of 50%. The majority of experts agree that this is too low to establish the protective immunity required. Putting herd immunity to one side, there are real questions regarding how willing the world’s population will be taking a vaccine with only 50% or even 75% efficacy.
- The speed at which the vaccine has been developed will undoubtedly raise serious issues around safety for some. There have been over 200 million malaria cases and around 420,000 deaths every year for the last ten years alone. The only vaccine has such low efficacy, WHO doesn’t recommend its use in one of the most affected population groups. It has taken more than ten years of research and multiple trials to get this far. The vaccine is being introduced in a pilot study that started in 2019. Further distribution will be decided after that pilot. Compared to COVID-19 that only appeared at the end of 2019, it is not hard to see that the speed at which any potential vaccine has been developed may weigh heavily on people’s minds.
- There is a generation, many still alive today, that knows firsthand the devastating impact a drug can have if introduced before all safety issues or uses have been adequately addressed. Thalidomide was a drug manufactured as a sedative that quickly gained traction as an effective treatment for morning sickness in pregnant women in the late 1950s. During its development, it was noted it was almost impossible to give animals a lethal dose. The same was thought to apply to humans, and the drug became widely available, without prescription over the counter. What scientists did not know was Thalidomide could pass through the placental barrier. When it did, it could impair fetal development, resulting in damage to limbs, internal organs, including the brain, eyesight, and hearing. Over 10,000 babies were affected globally, many dying within months of birth. It took five years to link the birth defects and Thalidomide and for the drug to be withdrawn.
- Granted, the context and situation are different, but the lessons learned from Thalidomide still play on a generation’s mindset. The questions relating to the shortened time frame for development and reduced clinical trials must be addressed if the population is to accept the vaccination as safe.
- Safety issues aside, COVID-19 is a new virus, unseen before late 2019. There is no body of evidence that provides an accurate time frame beyond three months regarding the length of immunity. Suppose vaccinations were required on an annual basis, such as with the seasonal flu. In that case, there will be serious issues relating to manufacturing capacity, which will see the effect of any vaccination weakened considerably.
The Small Issue of Children
- None of the current vaccinations in development are undergoing clinical trials involving children, and the latest evidence suggests that it may be fall 2021 in the Northern Hemisphere before a vaccine suitable for children is available.
- Young people have been attributed with much blame for continuing to party and attend bars over the course of the pandemic, which many argue has lead to the spread of the virus. The reality is much simpler, young people are more likely to spread the virus because they come in contact with the most people. Given a vaccine for children will not be available for some time this raises a real concern. Children are social butterflies, and will act as conduits for COVID-19 until a vaccine is available for them.
The Anti Vax Movement
- The anti-vax movement may be the most significant obstacle for any COVID-19 vaccination. The foundation of the anti-vax argument is the serious adverse effects caused by vaccinations. The measles, mumps, and rubella (MMR) vaccine is often cited as the primary culprit, and the paper written by Andrew Wakefield and colleagues in 1998, the evidence. No attention is paid to the multiple studies subsequently that prove there is no causative link between the MMR and autism. The free exchange of information provided by the internet has undoubtedly contributed to the growing number of people subscribing to the “harm theory.”
- In mid-2019, a UK-based research charity surveyed more than 140,000 people in 140 countries on their views on science and major health challenges. Of those surveyed, 79% felt vaccines were safe; however, those living in higher-income countries were found to have less confidence in vaccinations than those in lower-income countries. At that time, the Ukraine had the least confidence in vaccines, while developing countries like Bangladesh and Ethiopia had the highest confidence.
- In 2018, 33% of the population of France disagreed with the proposition vaccinations were safe. Other European countries reflected similar high numbers, including Switzerland (22%). Austria (21%), Belgium (21%), and Iceland (21%).
- Since then COVID-19 has reared its head, “conspiracy theories,” ranging from the plausible to the outrageous have emerged. These theories have no doubt contributed to an upsurge in anti-vaxer numbers. A survey of Twitter accounts conducted earlier this year found that anti-vaxers were most likely to share unreliable information, with 35.4% of their posts containing unreliable information. Tweets from those pro vaccination contained unreliable information in 11.3% of tweets.
- Experts are clear this misinformation will affect vaccine uptake rates, and presents as a serious hurdle. Valid concerns have been raised that those that do not identify as anti-vaxers, but express a hesitancy toward vaccination are more susceptible to misinformation, and will as a result not take the vaccine.
- A CNN poll conducted back in June 2020 found that one-third of Americans would not agree to a COVID-19 vaccine even if it were widely available at a low cost. Even Canada, where only 1% of the population identify as anti vaxers, only 75% of the population have indicated they would be prepared to receive a COVID-19 vaccination.
- Dr. Tim Lahey, a professor at the Dartmouth Institute for Health Policy and Clinical Practice, has said, “Immunity is a “game of numbers,” in which the way to win is to get as many people as possible immunized so that it just disappears from the population.” There is considerable truth in his words.
- Dr. Anthony Faucini, director of the National Institute of Allergy and Infectious Diseases, explains just how significant the anti-vax numbers are. He has said that he would settle for a vaccine that was 70-75% effective. However, he concedes that this incomplete protection, when coupled with the number of people that will refuse the vaccine, may not get the US home in the herd immunity stakes.
- The unfortunate reality is that despite the considerable toll COVID-19 has already taken, 90% of the world’s population remains susceptible. Waiting for natural immunity to kick-in will be a long wait and result in countless new infections and deaths. Even if a given community could establish immunity at the level required, it would constantly be eroded by births and new arrivals into the community.
- Looming on the horizon is the possibility of mandatory vaccinations. Some European countries have used this route before, among them France, who from 1 January 2018 made 11 childhood vaccinations mandatory. The change was made because the number of children completing the vaccination schedule had fallen below the WHO guidelines. The consequence of refusing to vaccinate a child in France is that they will not be accepted into school.
- Several other European countries, including Germany and Italy, have adopted similar tactics making vaccination mandatory if the child is to attend school or kindergarten.
- In relation to childhood immunizations, the US has adopted a similar stance. All states refuse to enroll children in schools without evidence of their vaccination status (subject to medical, religious, and philosophical exemptions). This has resulted in increased uptake rates.
- Australia is another country with strict rules around vaccinations, adopting a “no jab, no pay” policy, which offers both financial incentives and disincentives to parents. This approach has increased vaccination rates in Australia.
- There is a difference between uptake rates for vaccinations for childhood diseases and COVID-19. COVID-19 affects the adult population; it is the adult population that has been most affected by COVID-19. The UK survey finding that 79% of those surveys disagreed with the proposition vaccines were safe also showed that 90% of those surveyed would or had vaccinated their children, illustrating that uptake rates for childhood illnesses do not accurately reflect the likelihood of adults agreeing to a vaccination. This corroborated the findings of a 2015 study into attitudes towards vaccination in Europe.
- While the previous examples provide some context, the prospect of mandatory vaccinations for adults is a somewhat more complex beast. The autonomy of the person to have control over their bodies is a well-established ethical principle of medicine. In many countries, it forms part of the oath taken when one becomes a doctor. Mandatory vaccinations would undoubtedly create a moral dilemma for the medical profession, and there is a real possibility many would simply refuse to administer the vaccination based on their ethics.
- Although the study is somewhat dated, a 2004 study found that just 21% of adults that are not considered high risk are vaccinated against the seasonal flu. Granted, COVID-19 is in a different category, this number reflects the general level of apathy among the adult population.
- In recent years in the US, the uptake of the seasonal flu vaccination among those considered high-risk has fallen. Between 2015 and 2016, there was a 3.1% decrease, with only 70.4% of high-risk adults aged 65 or older receiving the vaccination. The rate of uptake for pneumococcal vaccine fell 3.3% in the same age group.
- Just 26.6% of adults in the US are vaccinated against tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine. The HPV vaccination rate for those aged 19-26 who had not been previously vaccinated sat at just 8.6% for females and 2.7% for males. Again the data is useful, but COVID-19 presents a more imminent danger. The reality is that no one knows what the level of uptake is likely to be for a COVID-19 vaccination. The evidence suggests it will be a challenge to persuade a proportion of the adult population to become vaccinated. The more complex the schedule and the greater the number of doses required will be determinative factors.
The Consequences of Refusal
- n August 2020, Australian Prime Minister Scott Morrison said, “the coronavirus vaccine would be as mandatory as you could possibly make it.” Perhaps recognizing the social and legal difficulties such a policy would create, just over a day later, he backtracked, saying, “There will be no compulsory vaccine, but there will be a lot of encouragement and measures to get as high a rate of acceptance as usual.” Legal obstacles and public pressure present as two significant hurdles for governments to overcome.
- As the examples above illustrate, mandatory vaccination usually carries a disincentive for failing to comply. Exclusion from the schooling system is a logical consequence concerning childhood vaccinations, but less so for adults. In fact, barring fines or imprisonment, neither of which result in vaccination, there are few pathways open that provide a disincentive significant enough to dissuade the adult population.
- Mandatory vaccination is also unlikely due to feasibility issues. There will not be enough of any vaccine available to force vaccination. The other reality is that if the COVID-19 vaccination were made mandatory, legal action would ensue.
- The US Supreme Court has found in the past that mandatory vaccinations could be enforced. The case of Jacobson vs. Massachusetts in 1905 rejected the autonomy argument saying, “a person’s bodily integrity is not an absolute right and is not at all times and in all circumstances wholly free from restraint… As long as a state law has a real and substantial relation to the protection of public health and safety, it will likely pass constitutional muster. However, a state must still act reasonably and out of public necessity.” This would set the stage for an exciting period in US legal history, had the decision not been dismissed in every case brought before the Supreme Court since. The court has repeatedly reaffirmed the right of a person to have control over their own body.
- The US is but one example of many countries that are unlikely to be able to enforce mandatory vaccinations. This could give rise to situations where although the vaccination is not mandatory, the consequences effectively dictate a person must receive the vaccination. Employment and travel present as two possible pressure points.
- Many medical professionals in several countries are already required to be vaccinated against a range of different infectious diseases. The possibility of employers requiring vaccinations as a condition of employment presents as a real possibility. The consequences of unemployment would serve as a powerful persuader. This would no doubt necessitate legal action to determine the legality of such a condition. An employer’s right is very rarely, if ever unfettered, and the likely test in most countries will be whether the condition is overly restrictive on an individual’s right to make their own informed decision concerning their body. The likely standard of proof will be whether the public good outweighs that of the individual. There is already considerable binding precedent in most countries that will stand behind any employee argument. Unless there are extremely unique circumstances, the employer will be typically be prevented from taking this action.
- Travel presents as one of the few means of getting adults opposed to the vaccine to take it. Countries ultimately have control over their borders. Already countries are exploring the logistics of a health passport. The likely outcome of people refusing vaccination would be they would be denied entry into a country without clear evidence of their immunity status. Already countries are adopting these measures; Belize and Guatemala are two examples of many. There are concerns about such an approach’s legalities and ethics. Still, international law is not overly supportive of the individual’s rights and even more unlikely to impinge on a country’s sovereignty. Were this approach adopted, the emergence of a new class system dividing the immune and the non-immune presents as a possibility.
Is the Vaccine the Silver Bullet?
- Thinking back to the Smallpox vaccination and the ultimate eradication of the disease, what is not widely known is that it took the lessons learned as a 16-year-old firefighter to deliver smallpox its deathblow. While the mass vaccination campaign had effectively stopped smallpox in its tracks in North America and Europe, the disease still had a hold on Africa, Asia, and South America, where there were still thousands of cases annually. Smallpox was becoming a threat again in disease-free areas given immunity only lasted five years.
- On 16 December 1966, a small village in the southeastern Nigerian region of Ogoja reported four cases in the village. Protocol dictated that all in the village should receive the vaccine, but there were insufficient doses to go around. Remembering the lessons he had learned as a 16-year-old volunteer fireman, the now adult, William Foege working in distributing the vaccine, directed that vaccinations be provided to those who had been in contact with the infected first. The practice bore a striking resemblance to a firefighter clearing trees and shrubs in the path of a wildfire. It later became known as ring vaccination, and over the next eight years, it was vital in overcoming the remaining smallpox strongholds. This practice took into account the realities of the real world that the herd immunity theory does not; not all members of a population are in equal contact with each other.
- What this example illustrates is that no matter how effective the vaccine, a range of other factors beyond the number of people receiving the vaccine will dictate its success or otherwise. In the case of COVID-19, the numbers do not look promising. High numbers of people have indicated a reluctance to undergo the vaccine. The growing dissent in populations worldwide means that refusal rates could climb higher than the current numbers reflect.
- The reality is the effectiveness of any available vaccination, the number of doses that are capable of being manufactured, the number of people willing to undergo vaccination, the level of dissent, and a host of other factors, mean it is unlikely the vaccine will be the definitive solutions many hoped it would be. Unfortunately, the signs seem to point to a difficult up coming winter in the Northern Hemisphere, when seasonal flu will be added to the mix.
- A vaccine for COVID-19 will be a welcome addition to the arsenal in countries attempting to subdue the virus. Unfortunately, the numbers suggest it will not be the silver bullet. COVID-19 looks set to remain a feature of the global landscape for at least the foreseeable future.