A doctor holding a vaccine. (Photo courtesy of RF._.studio on Pexels)
In a CNN poll taken early this month, only about half of Americans said they would get a Covid-19 vaccine once one is available.
A recent survey from STAT and The Harris Poll cites similar data. Alarmingly, 65% to 70% of Americans expressed a desire to get the vaccine just a few months ago.
The growth of the anti-vaccine movement and vaccine hesitancy was increasing long before Covid-19. In 2019, the World Health Organization (WHO) named vaccine hesitancy as one of the top ten threats to global health.
These trends indicate a high level of distrust in vaccines and by extension, doctors, scientists, and other health care officials who create or endorse them. The lack of confidence in a safe vaccine is often attributed to misinformation and isolated historical events, but lately, many Americans’ concerns derive from the governments’ stance on a vaccine.
President Trump’s repeated promises to provide a vaccine before or near election day raises concerns that his administration will compromise the safety of a vaccine for political gain. His ambitious timeline is often met with criticism from top health officials who urge caution.
As development of a vaccine reaches critical stages, health officials must not make the mistake of bowing to the pressure to create faster, not smarter. It is critical that government officials not do anything to spread doubt about a vaccine that could play a crucial role in returning the nation to normal. The best way to ensure acceptance is to insist on a thoroughly tested vaccine proven by scientists and health officials to be safe for the general population.
The alternative, a vaccine that is neither safe nor effective, could be catastrophic.
Vaccines save lives every year, every week, even every day. Health officials administer vaccines to people to help prevent illness if they get exposed to a virus. They typically contain a part of a virus that triggers an immune response when given to people. The CDC estimates vaccines in low income-countries averted a total of 23.3 million deaths in the last nine years.
Despite the tremendous benefits to vaccines, there is a bleak historical precedent of allowing speed to trump caution in vaccine development. The danger lies in rushing the process. In the past, some efforts to rapidly develop and distribute a vaccine had serious consequences.
The Cutter Incident
In the late 1940’s and early 1950’s, the U.S. (and Canada) saw a spike in Polio cases, with outbreaks increasing during the summer. In its most severe form, the highly infectious virus causes nerve injury leading to paralysis. The virus frequently infected children.
In circumstances comparable to Covid-19, health officials imposed quarantines on homes and towns where polio cases cropped up. Scientists were desperately trying to develop and distribute a polio vaccine. In 1955, mass immunization campaigns were launched after a polio vaccine was licensed.
The vaccine, produced in Cutter Laboratories, was supposed to contain parts of inactivated polio but instead was administered to children with the activated virus. Of the 120,000 children given the Cutter vaccine, five died, fifty-one were paralyzed, and 40,000 contracted a slightly milder form of polio which included symptoms such as fever, sore throat, vomiting, headache, and muscle pain.
The deadly production error led to more safety regulations and testing but came too late for the few fatally affected. Unsurprisingly, the government became directly involved in ensuring maximum precautions in the testing process. The CDC says, “the Cutter Incident was a defining moment in the history of vaccine manufacturing and government oversight of vaccines, and led to the creation of a better system of regulating vaccines.”
The vaccine was recalled, improved upon, and retested. A new wave was sent out in the Fall of 1955, resulting in a severe drop in cases that eventually led to the eradication of the virus in the late 1970’s.
In 1976, there was an outbreak of a type of swine flu at Fort Dix, an army post in the U.S. At the time, the strain was similar to the 1918 influenza that caused the so-called “Spanish Flu,” leading to concern of a revival of the deadliest pandemic in recent history. Scientists and other health and government officials, who expected a resurgence of swine flu that fall, urged President Gerald Ford to implement mass vaccination of the public.
Even though no other swine flu cases were reported outside of Fort Dix, the president, fearing the risk of doing nothing, approved a national swine flu vaccination program. “No one knows exactly how serious this threat could be. Nevertheless, we cannot afford to take a chance with the health of our nation,” said Ford in a 1976 announcement.
If it had worked, the program would have been the largest immunization operation in U.S. history. However, scientists encountered problems right from the start. According to history.com, “one drug company produced 2 million vaccine doses with the wrong viral strain” and “tests could not achieve suitable antibody levels in children.”
Over forty million people were vaccinated against swine flu. The CDC says the risk was that out of every 100,000 people who received the vaccine, approximately one person developed a serious neurological disorder called Guillain Barré Syndrome (GBS). Due to this small connection, the government stopped the program to investigate.
In circumstances comparable to that of today, Ford’s critics accused him of playing politics (doing things for political gain instead of for other people’s sake) with the vaccine since a presidential election was approaching. Once again, pressure to distribute a vaccine as soon as possible led to complications and damaged public trust in vaccines.
Even though health officials are condensing the process into as small a time frame as possible, developing and approving a vaccine proceeds slowly.
According to WHO, the steps in vaccine development are as follows:
- Pre-clinical studies – testing vaccines in animal studies for safety and efficacy
- Phase I clinical trial – small groups of healthy adult volunteers receive the vaccine
- Phase II clinical trial – people (typically several hundred) who share characteristics with intended recipients (such as age and health) receive the vaccine
- Phase III clinical trial – thousands of people are given the vaccine
- Phase IV post marketing surveillance – ongoing studies after vaccine is approved to monitor any long term effects and complications in the population
- Human challenge studies – studies in which a vaccine is given before the virus to study effectiveness (rare because it can be unethical)
Normally, scientists do each step one after the other, but to expedite the process, they now do several steps at a time. Scientists complete the first few steps quickly, often at once. They pay much more time and attention to the fourth phase than ever before. It is extremely vital to monitor long term effects, especially in the current climate, where any more loss of trust in vaccines could extend the pandemic far longer than need be.
Even if a vaccine is approved and distributed, it won’t do any good without a large part of the population ready and willing to receive it.
In an interview with Elizabeth Cohen on CNN, Dr. Anthony Fauci said that he would “settle” for a vaccine that is 70% to 75% effective. However, if only 70% to 75% of the population takes a vaccine that has the same effectiveness, Fauci believes it “unlikely” the U.S. would reach herd immunity. Herd immunity is when a significant portion of the population is immune to the pathogen, either through vaccine or prior infection.
“There is a general anti-science, anti-authority, anti-vaccine feeling amongst some people in this country – an alarmingly large percentage,” said Fauci. Considering this, health and government officials need to support a vaccine that scientists thoroughly tested, not sow more doubts among the public by insisting a vaccine is pushed out before it is ready.
Vaccine hesitancy is an urgent issue. “Those who are vaccine hesitant have had their hesitancy enhanced by a variety of things that are happening right now, particularly the unfortunate mix of science and politics,” said Dr. Francis Collins, National Institutes of Health Director, at an event hosted by the National Academies of Sciences, Engineering and Medicine.
President Trump frequently promises a vaccine “in a matter of weeks” or “by the end of the year.” His administration and other top health officials say otherwise. The Trump administration’s Operation Warp Speed’s goal is to provide a vaccine by the beginning of 2021, a sentiment most health officials believe more realistic than one this year.
While creating a vaccine quickly is a smart strategy to deal with the pandemic, the name of the Trump Administration’s initiative raises doubts. Although vaccine development in the operation is so far quick and safe, “Warp Speed” does not imply confidence in a slow, methodical process.
Fauci, in an interview with PBS NewsHour, said the name “Operation Warp Speed” is an “unfortunate terminology” in that it is indicative of “reckless speed.” Despite this, he believes the U.S. is developing vaccines safely and with enough precautions.
Why can just a name inspire so much doubt? The answer: Trump playing politics.
Earlier this month, the Trump administration attempted to block new federal guidelines for the emergency release of a Covid-19 vaccine. The Food and Drug Administration (FDA) released the stricter guidelines anyway, decreasing the chances a vaccine will be released anytime soon.
President Trump’s efforts, on the eve of a presidential election, seem to many health officials as a play at political power. Vaccine hesitancy increases the further the pandemic progresses and the more Trump and his administration try to forgo science for convenience. It is crucial that this not continue. The more pressure the government places on rushing a vaccine, the more mistakes could be made and the more doubts people have. If the country will ever have a chance of achieving any form of normalcy with a vaccine, vaccine development and politics need to stay far apart.
“I don’t want to have us, a year from now, having a conversation about how we have in our hands the solution to the worst pandemic of more than 100 years, but we haven’t been able to actually convince people to take charge of it,” said Collins.