WASHINGTON—Massive resources are being poured into the development of a fast-tracked vaccine for COVID-19 as the United States enters the tail end of an unprecedented shutdown.
President Donald Trump said that roughly $10 billion in taxpayer money is being pumped into vaccine development, as well as therapeutics. Currently, 45 clinical trials are being publicly funded.
Trump, who dubbed the project Operation Warp Speed, has instructed the military to prepare for the possible delivery of 150 million to 200 million vaccine doses. The administration hopes a vaccine will be ready by the end of the year, but possibly as soon as October “for everyone that wants to get it,” Trump says.
“Not everybody’s going to want to get it.”
While some experts are saying life can’t return to normal without a vaccine, others say it’s impossible to create a vaccine within months, let alone a safe and effective product. Scientists have failed for 20 years to develop a safe coronavirus vaccine.
Dr. David Heymann, who led the World Health Organization’s response during the SARS epidemic, told The Guardian, “We don’t even know if a vaccine can produce an immune response which would protect against future infection.”
The Centers for Disease Control and Prevention (CDC) states that “vaccinations are one of the best ways to put an end to the serious effects of certain diseases.”
CDC Director Dr. Robert Redfield said in June that at least 70 percent of Americans would need to be vaccinated or have natural immunity to accomplish the goal of “herd immunity,” which would then provide the rest of the population with a measure of protection against the disease.
Redfield sent a letter to governors on Aug. 27 urging them to fast-track the establishment of vaccine distribution sites to make them fully operational by Nov. 1.
The Department of Health and Human Services (HHS) has pledged $1.2 billion to UK-based drug company AstraZeneca to pre-purchase 300 million doses of its vaccine to be delivered to the United States as early as October.
The company paused its third phase of clinical trials on Sept. 8 after a participant in the United Kingdom developed a “potentially unexplained” illness. AstraZeneca began recruiting 30,000 participants in the United States in August. Thousands of people in Britain, Brazil, and South Africa are also part of the trial.
Moderna and Pfizer are also conducting large-scale final-stage trials in the United States for vaccines that work differently from AstraZeneca’s. Moderna and Pfizer have recruited roughly two-thirds of the needed participants.
HHS is the umbrella agency above the Food and Drug Administration (FDA), the CDC, and the National Institutes for Health (NIH).
President Donald Trump, flanked by officials and business leaders, announces a national emergency with regard to the coronavirus in the White House Rose Garden in Washington on March 13, 2020. (Charlotte Cuthbertson/The Epoch Times)
During the initial stages of the pandemic, leading health officials said the shutdown measures were to “flatten the curve” and buy time for hospitals to prepare. More recently, Dr. Anthony Fauci, director of the NIH’s infectious disease department, said the development of a vaccine is “an absolute necessity” to return to a semblance of previous normality.
The number of Americans who have died with COVID-19 is almost 195,000, as of Sept. 15, according to Johns Hopkins University. The CDC reported that in 94 percent of the fatal cases, the individuals suffered from an average of 2.6 additional health conditions, while 80 percent of deaths have occurred among adults 65 years and older.
Most people with the virus experience mild flu-like symptoms and naturally develop antibodies to immunize against further infection, although it is unknown for how long. It’s rare for children to get the disease.
Making it Mandatory
Conversations are also brewing about the possibility of making a vaccine mandatory, or at least implementing punitive measures that make it difficult to avoid getting one. Some states are already taking steps in that direction.
On Aug. 19, Massachusetts mandated the flu vaccine for children aged 6 months and over who attend child care, preschool, kindergarten, K–12, and colleges and universities. State public health officials said students must get the vaccination before Dec. 31 to be allowed to continue with the 2020–2021 school year.
“The new vaccine requirement is an important step to reduce flu-related illness and the overall impact of respiratory illness during the COVID-19 pandemic,” the public health department stated.
Homeschooled students are exempt from the new rule, as are higher education students who are completely off-campus and engaged in remote learning only. Elementary and secondary students in online-only classes aren’t exempt. Some exemptions for medical or religious reasons are provided.
Hundreds of people protest a mandate from the Massachusetts governor requiring all children to receive an flu vaccine to attend school for the 2020–2021 year, outside the Massachusetts State House in Boston on Aug. 30, 2020. (Joseph Prezioso/AFP via Getty Images)
In Virginia, State Health Commissioner Dr. Norman Oliver said on Aug. 21 that he would use his authority to mandate COVID-19 vaccinations.
“It is killing people now, we don’t have a treatment for it, and if we develop a vaccine that can prevent it from spreading in the community, we will save hundreds and hundreds of lives,” Oliver told 8News.
Subsequently, Virginia Gov. Ralph Northam’s office told 8News that the governor isn’t planning on mandating a statewide COVID-19 inoculation.
All states already have some sort of mandatory vaccination schedule for children to attend school. And states would likely have the legal authority to mandate a vaccine on their populations during a public health emergency or outbreak of a communicable disease. Generally, the power is held by the governor or state health officer.
In all states, exemptions can be provided for medical reasons. All states but California, New York, Missouri, West Virginia, and Maine also provide for religious exemptions, and some also provide for philosophical exemptions.
The New York State Bar Association’s health law section issued a report in May that recommends mandatory COVID-19 vaccinations for all New Yorkers, except those with a medical exemption.
In Ohio, three professors from Case Western Reserve University School of Medicine argued for compulsory vaccines for all Americans in an Aug. 10 opinion article in USA Today.
“To win the war against the novel coronavirus … the only answer is compulsory vaccination—for all of us,” wrote Dr. Michael Lederman, a medical professor; Maxwell J. Mehlman, a law professor; and Dr. Stuart Youngner, professor of bioethics.
The trio wrote that COVID-19 vaccines should be free, no religious exemptions should be given, and penalties should be placed on people who refuse to comply.
“Broad induction of immunity in the population by immunization will be necessary to end this pandemic,” the authors wrote. They list ways to punish those who refuse, including losing tax credits, being denied nonessential government benefits, being subject to higher health premiums, being denied entry on public and commercial transport, and expecting public and private auditoriums to require evidence of immunization for entry.
Tech billionaire Bill Gates, who is a major advocate for and investor in vaccines, is using his foundation to work with “all the groups who make diagnostics, therapeutics, and vaccines to make sure the right efforts are prioritized,” he wrote in a Reddit Q&A session in March.
“For the world at large, normalcy only returns when we’ve largely vaccinated the entire global population,” Gates said in an April interview with the Financial Times.
“Eventually, we will have some digital certificates to show who has recovered or been tested recently—or when we have a vaccine, who has received it,” he wrote in the Reddit session.
“It’s quite clear that the [vaccine] push is going to be extremely hard,” said Mary Holland, the general counsel for Children’s Health Defense. She has fought against the elimination of exemptions for mandatory vaccinations for children, especially those who are medically fragile.
“I think if people get full information, and it’s voluntary, and it honors the bedrock requirement of ethical medicine of prior free and informed consent, I have no objection if people really know what they’re getting into and then they accept the risks associated with that. I have zero objection to that—that is an individual’s right to make that choice.”
Public enthusiasm for getting a COVID-19 vaccine has waned over the last several months. A poll undertaken in May found that around 50 percent of Americans said they would get a COVID-19 vaccine injection, while 20 percent said they wouldn’t, and 30 percent were undecided. The poll, carried out by The Associated Press-NORC Center for Public Affairs Research, reflects similar views regarding the 2019 flu vaccine.
A more recent CBS News poll, published on Sept. 6, found that 21 percent would get a free vaccine as soon as possible, while 21 percent said they wouldn’t, and 58 percent said they would consider a vaccine but would wait to see how it had worked for others.
Supreme Court’s 1905 Decision
The Supreme Court decision used as precedent in most mandatory vaccination cases today is the 1905 Jacobson v. Massachusetts case. In that case, the Supreme Court upheld a smallpox vaccination mandate in Massachusetts and allowed a $5 fine to be levied against the defendant, who refused to take the vaccine.
At the same time, the court cautioned that such mandates could devolve into the abuse of police powers, but upheld the decision because vaccination decisions were made through state legislatures, which allowed citizens a democratic process.
However, since 1905, layers of federal agencies have removed citizens from the process, and many states simply adopt the recommendations of the CDC or NIH without holding hearings, Holland said.
She cited a 2019 measles case in New York.
“In June 2019, the religious exemption to vaccination was repealed on the basis of measles outbreaks that were in the thousands of cases. It was certainly not throughout the whole state—no child died, a handful were hospitalized,” Holland said.
“But there was not a single debate in the legislature. It was simply repealed without a single hearing.”
Holland said she will continue to fight mandatory vaccination orders in court, including a potential COVID-19 one.
“It has never been lawful to engage in forced vaccination, or to engage in de facto social exclusion and internal exile of people who aren’t vaccinated, depriving them of the ability to go to school, or to go to workplaces, or to get on a bus, or to get on an airplane,” she said. “To me, that is a gross violation of the U.S. Constitution.”
Holland said making a vaccine compulsory, while giving pharmaceutical companies indemnification on the backend, is “very unjust.”
Under the Public Readiness and Emergency Preparedness (PREP) Act, any company that develops, manufactures, tests, distributes, or uses a treatment during a national public health emergency can’t easily be held liable for any harm it may cause. Victims of side effects and injury would need to prove the company showed “willful misconduct” and cases would be conducted in private.
Vaccine Development Stages
The CDC states that vaccines usually undergo extensive lab testing over several years before they’re tested on people. “Once testing in people begins, it can take several more years before clinical studies are complete and the vaccine is licensed,” the CDC states on its website.
However, the current vaccines being developed for SARS-CoV-2, the virus that causes COVID-19, have a fast-track authorization, which allows them to move to clinical trials on humans within months, often by skipping the animal testing stage.
Vaccines aren’t subject to double-blind, placebo-controlled studies, which are considered the most scientifically rigorous.
The CDC outlines six stages to vaccine development: exploratory, pre-clinical, clinical development, regulatory review and approval, manufacturing, and quality control.
After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials, according to the NIH. During clinical trial development, the vaccine is progressively tested on more people in three phases.
Then, if the FDA determines a vaccine to be safe and effective, and that the benefits outweigh the risks, it will license the vaccine for use. FDA Commissioner Dr. Stephen Hahn said in July that his agency would greenlight a vaccine as long as it’s safe and at least 50 percent effective.
Globally, 62 vaccines or treatments for COVID-19 are currently being tested on humans, according to the NIH’s clinical trials website.
On July 1, German biotech firm BioNTech and U.S. pharmaceutical giant Pfizer said their vaccine has shown potential and was found to be well-tolerated in early-stage human trials.
Biotech company Moderna announced the results of its phase one human trials on May 18, citing “positive interim clinical data.”
Moderna didn’t release its data for independent review, but said 17 percent of its test subjects had developed antibodies that may protect them from COVID-19. The trial was conducted on 45 people, of which four suffered Grade 3 adverse reactions, which the HHS describes as “severe or medically significant but not immediately life-threatening.”
The company noted that the FDA has never approved a product using the messenger RNA technology it’s using in its vaccine. The mRNA’s purpose is to direct the body to make certain proteins. The immune system is then supposed to respond to those proteins by issuing a protective response if it encounters the COVID-19 virus.
A laboratory technician supervises the large-scale production and supply of a COVID-19 vaccine candidate at biologics manufacturing facility Catalent in Anagni, southeast of Rome, on Sept. 11, 2020. (Vincenzo PINTO/AFP via Getty Images)
Coronavirus and Flu Vaccines
Following the 2002 SARS pandemic, scientists attempted to develop different vaccines. None were able to get past the animal-testing phase, with one causing hepatitis in ferrets and others causing serious lung complications in mice. A concern with vaccines for such viruses is that the antibodies produced by the vaccine can cause the subject to get even sicker if infected in the future (known as “antibody-induced enhancement”).
Although a vaccine has never been successfully developed for a coronavirus, the closest comparison available is the flu vaccine, which the CDC recommends annually for everyone over 6 months old.
Dr. Sherri Tenpenny, a board-certified physician based in Ohio, has spent 20 years investigating issues with vaccines. She analyzed 19 years of flu data from the CDC and found that the agency now tests more than 600,000 swabs from people who have influenza-like symptoms each year.
Of the 600,000 swabs, an average of 15 percent are found to be positive for influenza virus, which is what flu shots are developed for.
“The rest, 85 percent of the time, what you’re getting sick from is some other virus, not influenza,” Tenpenny said. Coronaviruses are attributable to around 40 percent of that 85 percent, she said.
“There are 36 known coronaviruses, four that routinely cause 40 percent of illness year after year, and three strains that they label as pandemic strains—the one that caused SARS, the one that caused MERS, and now this one that caused SARS CoV-2,” Tenpenny told The Epoch Times. “We believe that there are some proteins on the surface of this virus that makes it a little bit more virulent, but it’s still in the same family of coronaviruses.”
The CDC says the flu vaccine can reduce the risk of getting the flu by 40 percent to 60 percent during seasons when the vaccine is well-matched to most of the circulating flu viruses.
“During years when the flu vaccine is not well-matched to circulating influenza viruses, it is possible that little or no benefit from flu vaccination may be observed,” the agency states on its website.
One recent study that is yet to be peer-reviewed found that a COVID-19 vaccine would need to have an efficacy of at least 70 percent for it to “prevent or largely extinguish” an epidemic without any other measures such as social distancing.
Before accepting a vaccine, Tenpenny encourages people to educate themselves on the side effects versus the risks of getting or passing on COVID-19.
“Because if I take the vaccine, I take on all the risks of that injection,” she said.
The CDC said it receives about 30,000 vaccine injury reports each year. The reporting system is voluntary and estimates suggest it captures about 1 percent of all adverse effects, according to a report by Harvard Pilgrim Health Care, Inc.
Most of the reports are for mild side effects, but the CDC says 10 percent to 15 percent of the adverse reactions include permanent disability, hospitalization, life-threatening illness, or death.
The CDC didn’t respond to a request by The Epoch Times for comment about whether it would recommend that states make a COVID-19 vaccine mandatory.