Even as U.S. President Donald Trump claims his bout with COVID-19 has granted him immunity, reports of people getting the disease a second time are emerging. While reinfection still appears to be rare, it remains unclear to what extent immunity can truly protect a person.
Immunity is also in the news because a debate is simmering among scientists over herd immunity, the point at which enough people are immune to a pathogen to slow its spread(SN: 3/24/20). While herd immunity might put the end of the pandemic in sight, experts estimate that around 40 to 60 percent of a population would need to be infected to reach it.
One groupof researchers is pushing for governments to reach herd immunity without a vaccine, by allowing COVID-19 to spread among those at low risk while protecting vulnerable populations. This approach, however, puts the entire population at riskof significant illness and death, another group argues in a letter published October 14 in the Lancet.
Because SARS-CoV-2 is a new virus, scientists cant say how long a person will be protected after theyve recovered from an infection. If immunity wanes quickly, that sets the stage for recurrent outbreaks unless theres a vaccine, the authors say.
Heres what we know so far about our long-term defenses against the coronavirus:
Because SARS-CoV-2 is a new virus, scientists cant say how long a person will be protected after theyve recovered from an infection. If immunity wanes quickly, that sets the stage for recurrent outbreaks unless theres a vaccine, the authors say.
Heres what we know so far about our long-term defenses against the coronavirus:
How does the body build immunity
The immune system has two ways to provide lasting protection: T cells that remember the pathogen and trigger a rapid response, and B cells that produce antibodies proteins the body makes to fight off a specific pathogen.
Ideally, long after a person has recovered from an infection, these antibodies stick around in their blood. Then if the person is exposed to the same pathogen again in the future, those antibodies recognize the threat and work to prevent another infection from taking hold.
So-called memory T cells also stick around. Ideally, they live up to their name and recognize a previously encountered pathogen and either help coordinate the immune system or kill infected cells.
With one type of immunity, called sterilizing immunity, the virus never gets a chance to begin replicating and never infects a cell. Sterilizing immunity, however, is hard to achieve. More often, people achieve partial immunity, which provides a rapid response that may make the second bout of the disease less severe, or less easily transmitted to others.
Its unclear what type of immunity people who have recovered from COVID-19 have, and only time will tell. A vaccine could possibly trigger a stronger immune response than a natural infection, although its yet to be seen if that will be the case for the coronavirus vaccinesin trials (SN: 7/10/20).
For some illnesses, like measles, antibodies may last a lifetime. But for SARS-CoV-2, the jury is still out. Its unknown how long antibodies last in the blood, or importantly whether their presence is a sign of immunity. Just because a person has antibodies, it doesnt mean they are effective at fighting the virus.
Neutralizing antibodies are ones that halt the virus in its tracks, stopping it from infecting a host cell and replicating. Such antibodies typically recognize the virus spike protein, which helps it break into host cells. So far, those kinds of antibodies have been a focus of studies seeking to understand whether a person may be immune.
For the majority of people, it does appear that they are generating neutralizing antibodies, says Aubree Gordon, an epidemiologist at the University of Michigan in Ann Arbor. So thats promising.
Yet its still unknown what amount of neutralizing antibody is sufficient for protection. And even if they are protective, its unclear how long these immune proteins stick around. Studies of recovered COVID-19 patients have shown that antibodies for the coronavirus can wane after a SARS-CoV-2 infection, but overall, their levels remain relatively stableover a span of threeto sixmonths.
Because the coronavirus only began its sweep around the world at the beginning of the year, theres just been a limited time for people to study this, Gordon says.
Some data suggest the immune system might not have a great memory for coronavirus infections. One study found that during a COVID-19 infection, the organ that produces memory B cells long-lived cells that will rapidly produce antibodies if a person is re-exposed to a pathogen doesnt properly activatethe cell types capable of becoming memory B cells. Without that immunological memory, antibodies for SARS-CoV-2 may not last very long, researchers report August 19 in Cell.
Maybe that means that those memory responses are going to be on the short side, says Brianne Barker, an immunologist at Drew University in Madison, N.J.
Studies have shown that COVID-19 patients typically developan immune response involving T cells. Even recovered patients without a detectable antibody response have T cellsin their blood, researchers report October 15 in Emerging Infectious Diseases.
But the role of T cells in infection and immune memory remains unclear. Studies have shown that memory T cells can persist in patients who were infected with the coronavirus responsible for the 20032004 SARS outbreak for up to 11 yearsafter recovery. Since that virus no longer circulates, however, its impossible to say whether those T cells might be protective.
Some people may already have T cells that can recognize piecesof the new coronavirus (SN: 5/15/20). Those immune cells may be left over from previous exposures to coronavirusesthat cause the common cold, researchers report August 4 in Science. These cross-reactive T cellsmight help reduce the length or severity of COVID-19 illness. On the flip side, such T cellscould make the disease worse, perhaps by overstimulating the immune system and causing a condition called cytokine storm, which is behind some severe COVID-19 cases.
Researchers have now documented a small number of cases where people have been infected with the coronavirus twice. The first such case was reported in Hong Kong, with additional reports the United States, the Netherlandsand elsewhere (SN: 8/24/20).
But its still unclear how common reinfections are. And with only a handful of cases so far, we cant really say that reinfections are telling us a whole lot at this point, Barker says, either about immunity or whether vaccines will provide long-term protection or will need to become part of our yearly routine, like flu shots.
Some reinfections are expected; some peoples immune memory may not be potent enough to prevent the infection entirely, though it may prevent them from getting sick.
Its hard to prove that someone has been reinfected, because researchers need to conclusively show that two different viruses caused each infection, Barker says. That requires genetic testing. Whats more, experts are not necessarily on the lookout for such cases, especially in people who are not displaying symptoms.
Without knowing how long immunity lasts after an infection, and how much that varies from person to person, its impossible to know whether ending the pandemic through herd immunity is even possible. What is clear, experts say, is that attempting to reach herd immunity without a vaccine will lead to more illness and death.
Promoting the concept of herd immunity as an answer to the COVID-19 pandemic is inappropriate, irresponsible and ill-informed, Thomas File Jr., president of the Infectious Diseases Society of America, and Judith Feinberg, chair of the HIV Medicine Association, said in a statement October 14.
And to date, herd immunity is still far off. Throughout the United States, we are nowherenear herd immunity, Gordon says. Taking the approach of herd immunity through natural infection will lead to hundreds of thousands of unnecessary deaths.
This story was originally published byScience News, a nonprofit independent news organization.
Health leaders in the Coastal Bend say they have a plan to distribute a COVID-19 vaccine based on their experience dealing with the outbreak of H1-N1.
NUECES COUNTY, Texas The City-County Health District tells 3News that doses of the coronavirus vaccine could be shipped to the Coastal Bend as early as January 2021.
This is all subject to change and depends on the approval of a vaccine. It could still be a while before the general public will be able to receive one.
President Donald Trump called it Operation Warp Speed during Thursday night's debate in which he announced the military would be helping to distribute the COVID-19 vaccine.
"We have a vaccine that is coming," Trump said. "It's ready. It's going to be announced within weeks and its going to be delivered."
Nueces County stands at the ready. However, it's still something that might not happen until mid-2021. Also, you would need to get the vaccine twice.
Rodriguez said we have a local plan for the distribution. It's a plan based on their experience dealing with the outbreak of H1-N1 back in 2009.
"The main goal is to distribute vaccines to as much of the community as possible when we have as much vaccine at that point," Rodriguez said.
Rodriguez said the only difference is that instead of the vaccine being sent to the health department first, it will be sent directly to doctors and other health care providers.
That will essentially cut out the middle man, making for an expedited process. Rodriguez said initially, there will be a limited number of doses available.
So, who gets vaccinated first?
It will be broken down into phases. Phase One includes front line workers.
"Those hospital individuals; those people on the front lines, even public health, those people working the drive thru, because they are seeing people who potentially have COVID-19," Rodriguez said.
Emergency Medical Service crews would be included in that phase as well.
Among those in Phase Two are the more vulnerable populations, those 65 years of age or older. This includes those at nursing home facilities.
"The nice thing about nursing homes is that they can also sign up as a provider and they can receive their vaccine directly, vaccinate all of their employees and residents," Rodriguez said.
Then, people with comorbidities would be vaccinated.
"Once we get to the point when we are getting a lot of shipments and doses, we can open it up on a large scale and have as many people in the community who want to get vaccinated against COVID-19 get vaccinated," Rodriguez said.
"The difference with this one, with the last time around, the last one was one vaccine, and you were protected," Rodriguez said. "This one is two vaccines. We know we need to get as many people vaccinated because we need to start round two 21-28 days later."
This is not a vaccine for children. Currently, the vaccine would be for those 18 years and older.
More from 3News on KIIITV.com:
Posted: Oct 24, 2020 / 11:54 AM EDT / Updated: Oct 24, 2020 / 11:54 AM EDT
INDIANAPOLIS The Indiana State Department of Health (ISDH) reported 2,765 new positive coronavirus cases Saturday, bringing the states total to 160,454.
Those new cases were reported to ISDH between May 15 through October 23.
ISDH also announced 24 additional confirmed deaths from coronavirus, bringing Indianas total to 3,882. The new deaths were reported to ISDH from October 20 through October 23.
ISDH dashboard data indicated a 7-day unique individual positivity rate of 13.1%, with a cumulative rate of 9.9% positive.
The latest ISDH dashboard data indicates a 7-day all-test positivity rate of 6.9%, with a cumulative rate of 5.8% positive.
According to the data, 38,746 new tests were administered statewide, with the total number of tests at 2,681,197.
ISDH says 30.9% of ICU beds and 78.1% of ventilators are available across the state.
Marion County reported a total of 25,691 cases and 791 coronavirus deaths to date, the most in the state.
The agency also is reporting 236 total probable deaths in Indiana. Probable deaths are those for which a physician listed COVID-19 as a contributing cause based on X-rays, scans and other clinical symptoms but for which no positive test is on record.
For complete statistics reported by ISDH, including total tests administered and demographic data, visitCoronavirus.In.Gov.
This COVID-19 vaccine trial in Florida and others could be disrupted if the Food and Drug Administration authorizes one vaccine before others.
By Jon CohenOct. 23, 2020 , 3:45 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. governments $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to communities.
As new U.S. cases of the pandemic coronavirus set a daily high of more than 75,000, FDAs Vaccines and Related Biological Products Advisory Committee (VRBPAC) held a 9-hour virtual meeting to discuss a regulatory pathway that could permit the widescale use of a COVID-19 vaccine that has only minimal evidence of safety and efficacy. A so-called emergency use authorization (EUA) could use preliminary data from vaccine efficacy trials now underway to shave many months off the standard approval process, and FDA wanted VRBPAC to weigh in about the wisdom of taking this shortcut. The hearing, live-streamed on YouTube, drew intense interest, and some of the committee membersa mix of academics, consumer representatives, and government scientistshad an unsettling but clear message to FDA: Hold your horses.
Several VRBPAC members worried an EUA could contribute to the publics growing hesitancy toward COVID-19 vaccines by fueling the perception that FDA was compromising its famously high standards. Sheldon Toubman, an attorney on the committee who represents consumers, flat out urged FDA not to issue an EUA for a COVID-19 vaccine, arguing that the agency should stick to the traditional approval process. Theres only one chance to do this right, Toubman said. And if we do it wrong, then were done for, itll be years. Because theres already a serious problem with a lack of trust, and the [lack of] trust will become so severe at that point, we wont be able to dig out of it.
The committee also discussed the possibility that an early authorization of a vaccine could disrupt many of the COVID-19 vaccine efficacy trials now underway, derailing attempts to obtain the most robustand convincingsafety and efficacy data. And several members worried FDAs most recent guidance for vaccine companies that might seek an EUA still does not have stringent enough safety criteria.
Four candidate vaccines selected by Operation Warp Speed now are in efficacy trials, which are comparing the incidence of COVID-19 disease in at least 30,000 participants who blindly receive either a vaccine or a placebo. They are designed to end when they have about 150 cases of symptomatic disease, but independent monitoring boards will tell investigators whether a vaccine looks like its working at 50 cases and again at 100 cases. FDA guidance issued in June says the agency will consider issuing an EUA for a vaccine if it shows at least 50% efficacy at any of these analyses.
FDA has committed to seeking VRBPACs feedback if a COVID-19 vaccine company does request an EUA. Doran Fink, deputy director of FDAs vaccine division, cautioned the committee that permitting the use of a weakly effective COVID-19 vaccine could do more harm than goodand not only because of its impact on trials of other candidates. It could do so by providing a false sense of security that interferes with measures to reduce [COVID-19] transmission, Fink cautioned, citing effective nonmedical interventions such as wearing masks and social distancing.
Researchers from the Reagan-Udall Foundation, a nonprofit set up by Congress to advance the mission of the FDA, told the committee about sobering findings from its COVID-19 Vaccine Confidence Project, which underscored misgivings held by people in underrepresented communities and frontline workers in service, retail, and health care settings. Some people interviewed would want to wait months, or even years, before choosing to receive a vaccine because of widespread distrust of government and the health care system itself, the foundation researchers noted. The countrys racial and ethnic disparities also played a role, especially given the infamous Tuskegee experiment in which Black men were denied syphilis treatment so researchers could better understand the disease. The more they study me, the more they know how to get rid of me, one interviewee told the researchers.
President Donald Trump repeatedly pushed for a COVID-19 vaccine EUA before the 3 November elections, but FDA effectively removed that possibility earlier this month when it issued a second guidance that added a safety stipulation: Two months must have passed after at least half the people in the trial have received all doses of the vaccine, in order to see whether side effects emerge over time. Several committee members and public commenters contended that 2 months was not long enough, however, and urged FDA to extend this to at least 6 months.
Committee member Paul Offit, a vaccine researcher at the Childrens Hospital of Philadelphia, noted that EUAs already issued for COVID-19 treatments have created confusion about how early approval might be granted to a vaccine. Under pressure from the Trump administration, FDA issued EUAs for hydroxychloroquine and convalescent plasma based on the standard that they may be effectivea very low bar that did not require convincing efficacy data from a randomized, controlled trial. Neither treatment actually works, Offit asserted, adding that those EUAs tainted the validity of the process. I think we have a language problem, said Offit, who argued for renaming the process. A vaccine EUA, in contrast, requires evidence of efficacy and at least some safety assurances, which is much closer to the full approval process.
FDA explicitly asked the committee for guidance on what the meetings chair, epidemiologist Arnold Monto of the University of Michigan School of Public Health, referred to as a very thorny issue: whether an EUA for a COVID-19 vaccine could undermine efforts to assess the safety and efficacy of that product and other candidates as well. Before the meeting, Pfizer, which has one of the candidates furthest along in efficacy trials, put the dilemma in sharp focus in a letter it submitted to FDA.
If FDA granted the company an EUA, a senior vice president for the company wrote, Pfizer would want FDAs approval to give those in the placebo arm its vaccinea step that would then compromise the ability of the 2-year study to continue to gather comparative safety and efficacy data of the vaccine and the placebo. A representative from Moderna, which also has a candidate thats far along in efficacy trials, told the committee that participants are beginning to ask when they will know if they receive study vaccine or placebo.
Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back, Fink noted, stressing that future data from the control arm is lost forever.
The FDA representatives suggested a way out of the dilemma: Instead of receiving an EUA, a vaccine could be approved for expanded access, which would limit its use to select populations at high risk of COVID-19. This pathway typically is reserved to allow the use of experimental treatments in patients who have life-threatening conditions, but it has been used before for vaccines, such as one for meningitis B in college students. Because access to the vaccine would be limited, the approach has the advantage of allowing efficacy trials to continue.
Offit suggested after the meeting that to keep collecting vital vaccine efficacy data from trials, FDA may well need to use a mechanism like expanded accessor create a new onethats somewhere in between an EUA and full approval. They just dont have a lot of leeway right now, Offit said.
Harris says she would absolutely take a vaccine if it was recommended by public health professionals, but not if only President Trump says to. USA TODAY
The global effort to develop a COVID-19 vaccine has been apriority since the coronavirus pandemic started. Seven months into the U.S. outbreak,vaccine candidatesare facing skepticismby some in the general public and various elected officials.
Leading health officials, such as Dr. Anthony Fauci, have maintained that a vaccine likely won't be widely available until mid-2021. Meanwhile, President Donald Trump haspromiseda vaccine before Election Day, prompting the Democratic vice presidential candidate Kamala Harris to accuse Trump of politicizingthe vaccineand to question its safety, noting that she would take it only if the health experts said it was safe.
The effectiveness and safety of a COVID-19vaccine is not the only thing people are worried about. Vaccine conspiracy theories that originated in anti-vaxxer communitieshave thrived anew in the COVID-19 era, including claims that the vaccine wouldimplant microchipsor that it will be mandatory for every American.
Apost from from Before It's News, a website that allows anyone to contribute,which was shared 38,00 times as of Oct. 15furthers the conspiracy theory of a mandatory vaccine, witha headline reading, "The Government Has Released Their Initial Plans to Force a Vaccine on Everyone."
The postalso says, "Three potential vaccines are currently in Stage 3 trials in the United States and could be ready in weeks," citing Trump.
USA TODAY reached out to the site's Facebook page for comment.
We'll look at thetwo claims here:Will a vaccine be mandatory? And, what does the development and distributiontimeline really look like?
According to the Centers for Disease Control and Prevention, the general cycle for the development of a new vaccine has six stages:exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing and quality control.
The global prioritization of finding a COVID-19vaccine has shortened the timeline of its development, which for a regular vaccinewould usually take years. However, vaccine developers and institutions like the CDCare following existing protocols to ensure the vaccine's safety and effectiveness.
As of Oct. 15, according to the World Health Organization,42 vaccine candidates are in clinical evaluations and 156are in preclinical evaluations.
16-year-old Katelyn Evans gets the first of two shots as part of a trial testing Pfizer's COVID-19 vaccine in minors.(Photo: Cincinnati Children's Hospital)
The postfrom Before It's News cites a Sept. 15 commentfrom Trump where he saida vaccine could be ready in a "matter of weeks."On Oct. 5, Trump said vaccines would be ready "momentarily."However, scientists disagree.
On Sept. 16, Dr. Robert Redfield, director of the CDC, said that while an effective vaccine could be developed before the end of this year, it won't be available to the general public until the second or third quarter of 2021.
Speculation about mandatory vaccinations for COVID-19 started spreading on social media from the moment scientists began talksabout developing a vaccine.
There is no evidence to support the claim that a COVID-19 vaccine will be mandatory for the entire population.
The post in question cites a COVID-19 vaccineinterim playbook from the CDC, which was created in partnership with theU.S. Department of Health and Human Services and the U.S. Department of Defense.The postmisinterprets and misrepresents the content of the playbook, whichdoes not state that everyone will be required to get a COVID-19 vaccine.
The playbook lays out the plan to effectively distribute the vaccine first to healthand essential workers andvulnerable groups before increasing accessto the general public.
At an August town hall hosted by Healthline, Fauci said the coronavirus vaccine won't be mandatory in the United States, adding that people have a right to refuse it.
I dont think youll ever see a mandating of vaccine, particularly for the general public," Fauci said.
Fauci also said some industries may mandate the vaccine for employees, such ashow the National Institutes of Healthmandates the flu vaccine for its workers. That also is in the playbook.
According to the CDC, "State laws establish vaccination requirements for school children ... . All states provide medical exemptions, and some state laws also offer exemptions for religious and/or philosophical reasons."
Additionally, the U.S. OccupationalSafety and Health Administration took the position that employers canrequire staff to take vaccines, like the flu vaccination.
In general, employers can mandate vaccines for their staff.However, according to the National Law Review,this practice does have limitations and is not always recommended.
Like the exemptions that exist for school vaccine requirements, similar exemptions can also be appliedto workerswho have a reasonablebelief that a medicalconditionmay result inillness or death, according to OSHA.
If someone refuses the vaccine in the general public, then theres nothing you can do about that, Faucisaid. You cannot force someone to take a vaccine.
The claims in the post have been rated FALSE. The claim that a vaccine will be ready within weeks, while stated by the president, has been consistently contradicted by public health officials who say a vaccine likely won't be ready by Election Day, nor would it be available to the general public before the middle of 2021. There is alsono evidence to support the claim that the coronavirus vaccine will be mandatory for the general public.
Thank you for supporting our journalism. You can subscribe to our print edition, ad-free app or electronic newspaper replica here.
Our fact check work is supported in part by a grant from Facebook.
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The important lesson is that people want to know that someone they respect recommends the vaccine. This could be a national political figure, but people are most likely to respond to local leaders, especially family doctors and local nurses, communications experts said. They may also listen to ministers, family members and celebrities. For those who, like Harris, trust science and Dr. Fauci, it could be a scientist. Philip Massey, a health communications expert at Drexel Universitys Dornsife School of Public Health, said public health officials should be talking with groups like Black Lives Matter activists about vaccines.
In the final debate of the US presidential election on Thursday (Oct. 22), president Donald Trump said that two companies are within weeks of having a Covid-19 vaccine ready for the public. Trump also said that he would be putting a military logistics leader in charge distributing hundreds of thousands of doses to the American people as soon as possible.
Earlier in the day, the US Food and Drug Administrations advisory committee held a meeting on Covid-19 vaccines and sought once again to reassure the American people that any approved vaccine would be safe and effective. But no matter how safe the vaccine or sophisticated its rollout, people will still need to choose to take it. A survey from the Harris Poll and STAT News found that as of this month, 59% of people in the US would opt to get a Covid-19 vaccine.
Given that a vaccine is going to be one of the catalysts in ending the pandemic, could the president mandate that people take it? In a word, no. The US president has never been able to impose a federal mandate of vaccines across the country, and that wont change anytime soon.
It goes back to the fact that the federal government is one of limited power, says Dorit Reiss, a professor specializing in healthcare law at the University of California Hastings College of the Law.
First, presidents dont create laws; Congress does. The president signs bills into law (or vetoes them) after the House of Representatives and Senate go through a lengthy back and forth. The president could issue an executive order that covers people who work for or with government agencies, but Congress would still be able to write up another bill to supersede it. Of course, the president could also veto that billbut the whole scenario is highly unlikely.
Largely, matters of public health fall onto states shoulders. The tenth amendment of the constitution says that any law the constitution doesnt cover goes to the statesand the constitution doesnt mention the words public health, Reiss says.
What it does mention are things like collecting taxes, declaring war, and regulating interstate business. If the federal government really wanted to find a way to enforce vaccines, it could look for a way to do so by exercising one of those powers. Congress could pass laws to limit disease spread across state borders, like requiring that all Amtrak passengers be vaccinated, says Reiss. But the US Supreme Court might not let such a law stand, if the justices determined that Congress was overreaching.
States, on the other hand, can mandate vaccines. In the 1905 case Jacobson vs. Massachusetts, the Supreme Court ruled that states have the power to enforce vaccinations when theyre necessary for the public health or the public safety. Back then, the country was worried about smallpox; today, the precedent could let state governors mandate a Covid-19 vaccine.
Not that theyll use that power, necessarily. For one thing, states can only mandate vaccines that have been recommended by the Advisory Committee on Immunization Practices (ACIP), part of the US Centers for Disease Control and Prevention. ACIP would have to recommend the vaccine for all adults and children based on ample evidence that it is safe and effective, beyond the FDAs approval or emergency authorization of a Covid-19 vaccine.
And even with ACIPs blessing, theres still a lot of debate about whats necessary for public health, per the language in the Jacobson ruling. For example, even though Gretchen Whitmer, the current governor of Michigan, mandated masks and limited gatherings in executive orders as the state saw spikes in Covid-19 cases, the states supreme court overthrew that order. Currently, the Michigan Department of Health is trying to uphold these mandates instead.
This is likely why states dont mandate vaccines across the board; instead they require that certain populations get them. Childhood vaccines, for example, are required to attend school (they do allow various exceptions, however, depending on the state). Parents who dont want to vaccinate their children often have to homeschool them instead.
Its not clear whether states would deploy the same strategy for Covid-19 vaccine requirements. Theres just not enough history to go on. Weve never had a universal adult mandate in the US, says Reiss, even at the state level.
So how might the federal government legally get states to require the Covid-19 vaccine? Two words: ample incentives.
I think that the path of least resistance would be for the federal government to establish guidelines for the states, says Margaret Riley, a professor of law at the University of Virginia. Although the federal government wouldnt force states to enforce vaccination, it could dangle a nice carrot, like it did in 1984 by holding federal highway funding over states heads if they didnt raise the drinking age to 21. (It still took four years for every state to get around to it.)
Once a Covid-19 vaccine becomes widely available, however, the commander in chief will probably have to consider all the options on the table to increase confidence in vaccine adherence. When asked on Thursday what he would do to encourage vaccines, former vice president Joe Biden said hed ensure that all the data behind the approved vaccines would be completely transparent to help people make their decisions.
(CNN) When Anny Ku heard that there were coronavirus vaccines on offer in Yiwu, a city in Chinas eastern Zhejiang province, she traveled more than 600 miles (965 kilometers) for a chance to get the shot.
Ku worked in Chile for more than 20 years as an importer and exporter, but she returned to her home in southern China earlier this year after thecoronavirus pandemicworsened and a large number of cases appeared in South America.
There had been no official announcement that a vaccine was available in Yiwu just a series of articles in local media but Ku believed she needed the shot in order to leave China and get back to her job overseas. If one has (the vaccine), its much safer to leave the country, she said.
Yiwu is one of a small number of cities which in recent weeks have begun reportedly offering an experimental coronavirus vaccine to select members of the public, despite the drug still undergoing clinical trials. Jiaxing, another city in Zhejiang province, announced on October 15 it would sell vaccines to citizens with an urgent need.
Citizens with urgent vaccination needs can go to the community clinic for consultation with the premise of voluntary and informed consent, the Jiaxing Center for Disease Control posted to its official WeChat account on October 15. In Jiaxing the vaccine will cost about $60 for the required two doses once it is distributed, according to the statement.
Globally, there is currently no coronavirus vaccine which has been successfully tested and proven safe to use. As of October, four COVID-19 vaccine candidates designed by Chinese companies were in Phase 3 clinical trials, the final and most important step before regulatory approval can be sought for a drug.
When CNN visited the hospital in Yiwu where Ku had gone on October 19, staff confirmed that in the past week they had been giving experimental coronavirus vaccinations to citizens who had an urgent need to travel overseas. No one who CNN spoke to had received the vaccine, however.
The Yiwu government has yet to make a public statement on the release of the experimental vaccines. CNN has contacted them for comment.
Authorities in Jiaxing and Yiwu have not explicitly outlined what constitutes an urgent need for the experimental vaccine, what proof is required to show you need a shot, or why these cities in Zhejiang were allowed to give out emergency doses rather than larger metropolises such as Beijing or Shanghai.
An article in the state-run tabloid Global Times on Tuesday denied that the COVID-19 vaccines were publicly available at all.
However, that hasnt stopped some regular citizens arriving in Yiwu and Jiaxing by train or plane in the hope of getting their hands on the experimental vaccine.
Other cities in Zhejiang are still announcing a rollout of vaccinations using the experimental drugs. On Tuesday, the city of Shaoxing said that emergency vaccinations would be given out in the autumn and winter, with the time and date yet to be announced.
Since the initial outbreak in December 2019, China has slowly brought its local coronavirus epidemic under control, through a combination of citywide lockdowns, mass testing and sophisticated track and trace tools.
Now Beijing is at the forefront of a global effort to finda coronavirus vaccine, with Chinese President Xi Jinping repeatedlyurging the countrys scientiststo accelerate their work. On October 20, Tian Baoguo, an official from the Ministry of Science and Technology said that 60,000 people had been injected as part of the drug trials and no serious adverse reactions had been recorded.
At present, Chinas vaccine research and development work is generally in a leading position, he said.
But ahead of any vaccines approval, the Chinese government has been moving forward with a series of vaccinations for people they consider at risk or in high-profile positions.
The apparent push to make the vaccine publicly available contrasts with other countries, including the United States, where drug makers and regulators have so far exercised caution.
In June, Beijing approved the use of the experimental vaccine byCanSino Biologicsin the countrys military.
Three months later, the Chinese government approved the emergency use of the vaccine by the Chinese National Pharmaceutical Group, also known as Sinopharm, for medical professionals, diplomats in high-risk countries and state-owned company employees working overseas.
A large number of people have already been vaccinated. As of early October, Yang Xiaoming, the chairman of China National Biotec Group, which has two vaccines currently in Phase 3 trials, said their drug had been given to about 350,000 people so far in emergency doses authorized by the Chinese government. These vaccinations are not part of the ongoing drug trials.
Dr. Jin Dong-yan, a virologist at Hong Kong University, told CNN that it was risky to push forward with immunizations before the drug had been fully tested and cleared.
In the history of vaccine development there are many examples that even if the vaccine has passed the phase 3 trials still there might be problems, Jin said. None of the experimental vaccines have passed phase 3 yet.
The Yiwu and Jiaxing vaccine programs are not the first time an unapproved coronavirus vaccine has been offered to select members of the public in China.In early October, an offer was distributed online apparently by Sinopharm for a free vaccine for Chinese students heading overseas to study.
After being advertized for a few days however, the offers were pulled and its not clear whether or not any vaccines were actually provided.
Mino Guo was one of the students who registered for the vaccine while living in her hometown of Guangdong, in the countrys south, because she was keen to return to her studies in the United States in November.
The US situation is a little bit serious. Im not very worried it, but my family and my friends around me worry about my life there. So thats why I think it is necessary to get a vaccine, to make my family feel safe, she said.
Guo said she had been a bit concerned about what effect the vaccine might have on her, but in the end she never received it.
So far, no special treatment is being given in China to people who have received the experimental coronavirus vaccine, such as being allowed to travel without a mask.
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SALT LAKE CITY On Wednesday, Dr. Anthony Fauci, the director of the U.S. National Institute of Allergy and Infectious Disease, said he is "cautiously optimistic that we will, in fact, have a safe and effective vaccine (for COVID-19) by the end of the year, which we can begin to distribute as we go into 2021."
Good news, right? Except trust in the vaccine is hard to come by, according to a recent study.
A Qualtrics study released this week showed that 40% of respondents were either unsure or not planning on getting the vaccine once it becomes available. Of that group, 91% said they didn't think it would be safe enough and 90% said they would have concerns about side effects. So where is the distrust coming from?
In early September, Lt. Gov. Spencer Cox tweeted a plea into the universe: "Let's pray we never have another global pandemic ... but if we do, let's pray it's not during an election year."
The vaccine, like so many other things, has turned into a political argument. That was seen Thursday when President Donald Trump and former Vice President Joe Biden squabbled over the vaccine timeline in the final presidential debate.
The president said: "It's going to be announced within weeks. And it's going to be delivered." Biden responded by going through a list of the times the president's virus timelines were inaccurate. Biden said he would "make sure it's totally transparent," and "have the scientists of the world see it, know it, and go through all the processes."
The vaccine is something that each side is using to try and win points in an election year, so it's no surprise that public trust in a potential vaccine is lacking. With companies and scientists attempting to get a vaccine to market in record time years faster than the average pace for development it only adds to the uncertainty.
COVID-19 cases have skyrocketed in Utah Thursday and Friday were back-to-back record-shattering days and in the country, which means a lack of confidence in a vaccine could be especially troubling.
"Not only are people apprehensive about it but not in our lifetime, maybe in the world, have we had to embark on a worldwide vaccination project. So this is on an entirely new scale for history," Chelsie Bright, the global industry leader of the public sector at Qualtrics, said.
Qualtrics has designed a vaccine management program to help governments deliver the COVID-19 vaccine efficiently to their communities. The program is an automated workflow the company claims will help prioritize which at-risk residents should receive the vaccine first, schedule appointments and follow-ups, and provide a record of vaccination after it has been administered. The hope is it will also allow governments to monitor the capability, impact and reach of the vaccine.
People are going to have to have confidence. And the only way to do that is, first of all, understand what concerns people have, and then be responsive to that feedback.Chelsie Bright, global industry leader of the public sector at Qualtrics
The Provo-based company is currently in talks with state governments for the service. Qualtrics has a current contract with the state of Utah to provide "management software as a service for the state of Utah," but KSL.com has been told that the vaccine management program would not fall under that contract.
"We have just signed up a couple, but we haven't made the announcements," Bright said. "We are in conversations with over a dozen other states right now. It's the really early stages, for most states, right now as they are figuring it out."
Distributing the vaccine will be a big undertaking, but the most important step right now may be gaining trust. Even if a vaccine is ready, what good will it be if no one is willing to take it?
"People are going to have to have confidence," Bright said. "And the only way to do that is, first of all, understand what concerns people have, and then be responsive to that feedback."
The Qualtrics survey found that 81% of responders were more likely to get the vaccine if a doctor recommended it.
That makes the message pretty clear: keep the politics out of it.
Still, its fair to say that most of the general public assumes that the whole point of the current trials, besides testing safety (box 1), is to see whether the vaccine can prevent bad outcomes. How do you reconcile that? The BMJ asked Zaks.
History shows many examples of serious adverse events from vaccines brought to market in periods of enormous pressure and expectation. There were contaminated polio vaccines in 1955, cases of Guillain-Barr syndrome in recipients of flu vaccines in 1976, and narcolepsy linked to one brand of influenza vaccine in 2009.1819
Finding severe rare adverse events will require the study of tens of thousands of patients, but this requirement will not be met by early adoption of a product that has not completed its full trial evaluation, Harvard drug policy researchers Jerry Avorn and Aaron Kesselheim recently wrote in JAMA.20
Covid-19 vaccine trials are currently designed to tabulate final efficacy results once 150 to 160 trial participants develop symptomatic covid-19and most trials have specified at least one interim analysis allowing for the trials to end with even fewer data accrued.
Medscapes Eric Topol has been a vocal critic of the trials many interim analyses. These numbers seem totally out of line with what would be considered stopping rules, he says. I mean, youre talking about giving a vaccine with any of these programmes to tens of millions of people. And youre going to base that on 100 events?8
Great uncertainty remains over how long a randomised trial of a vaccine will be allowed to proceed. If efficacy is declared, one possibility is that the thousands of volunteers who received a saline placebo would be offered the active vaccine, in effect ending the period of randomised follow-up. Such a move would have far reaching implications for our understanding of vaccines benefits and harms, rendering uncertain our knowledge of whether the vaccines can reduce the risk of serious covid-19 disease and precluding any further ability to compare adverse events in the experimental versus the placebo arm.
Itll be a decision well have to take at that time. We have not committed one way or another, Modernas Tal Zaks told The BMJ. It will be a decision where FDA and NIH will also weigh in. And it will be probably a very difficult decision, because you will be weighing the benefit to the public in continuing to understand the longer term safety by keeping people on placebo and the expectation of the people who have received placebo to be crossed over now that it has been proved effective.
Very simply, he replied. Number one, we have a bad outcome as our endpoint. Its covid-19 disease. Moderna, like Pfizer and Janssen, has designed its study to detect a relative risk reduction of at least 30% in participants developing laboratory confirmed covid-19, consistent with FDA and international guidance.2122
Number two, Zaks pointed to influenza vaccines, saying they protect against severe disease better than mild disease. To Moderna, its the same for covid-19: if its vaccine is shown to reduce symptomatic covid-19, it will be confident it also protects against serious outcomes.
But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.
Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths.23 Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality (box 2).26
A vaccine that has been proved to reduce the risk of symptomatic disease by a certain proportion should, you might think, reduce serious outcomes such as hospital admissions and deaths in equal proportion.
Peter Marks, an FDA official with responsibility over vaccine approvals, recently stated as much about influenza vaccination, which only prevents flu in about half the people who get it. And yet thats very important because that means that it leads to half as many deaths related to influenza each year.24
But when vaccines are not equally effective in all populations the theory breaks down.
If frail elderly people, who are understood to die in disproportionate numbers from both influenza25 and covid-19, are not enrolled into vaccine trials in sufficient numbers to determine whether case numbers are reduced in this group, there can be little basis for assuming any benefit in terms of hospital admissions or mortality. Whatever reduction in cases is seen in the overall study population (most of which may be among healthy adults), this benefit may not apply to the frail elderly subpopulation, and few lives may be saved.
This is hard to evaluate in the current trials because there are large gaps in the types of people being enrolled in the phase III trials (table 1). Despite recruiting tens of thousands, only two trials are enrolling children less than 18 years old. All exclude immunocompromised people and pregnant or breastfeeding women, and though the trials are enrolling elderly people, few or perhaps none of the studies would seem to be designed to conclusively answer whether there is a benefit in this population, despite their obvious vulnerability to covid-19.
Adults over 65 will be an important subgroup that we will be looking at, Modernas Zaks told The BMJ. That said . . . any given study is powered for its primary endpointin our case covid-19 disease irrespective of age.
Al Sommer, dean emeritus of the Johns Hopkins School of Public Health, told The BMJ, If they have not powered for evidence of benefit in the elderly, I would find that a significant, unfortunate shortcoming. He emphasised the need for innovative follow-up studies that will enable us to better determine the direct level of protection immunisation has on the young and, separately, the elderly, in addition to those at the highest risk of severe disease and hospitalisation.
One view is that trial data should be there for all target populations. If we dont have adequate data in the greater than 65 year old group, then the greater than 65 year old person shouldnt get this vaccine, which would be a shame because theyre the ones who are most likely to die from this infection, said vaccinologist Paul Offit.8 We have to generate those data, he said. I cant see how anybodythe Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makerswould ever allow a vaccine to be recommended for that group without having adequate data.
I feel the same way about minorities, Offit added. You cant convince minority populations to get this vaccine unless they are represented in these trials. Otherwise, theyre going to feel like theyre guinea pigs, and understandably so.
