Preliminary results find COVID-19 vaccine candidate based on inactivated SARS-CoV-2 virus is safe

A Chinese COVID-19 vaccine candidate based on the inactivated whole SARS-CoV-2 virus (BBIBP-CorV) is safe and elicits an antibody response, findings from a small early-phase randomised clinical trial published today in The Lancet Infectious Diseases journal have found.

A previous clinical trial reported similar results for a different vaccine that is also based on inactivated whole SARS-CoV-2 virus, but in that study the vaccine was only tested in people aged under 60 years.

The latest study included participants aged between 18 and 80 years, and found that antibody responses were induced in all recipients. Participants aged 60 and over were slower to respond, taking 42 days before antibodies were detected in all recipients compared with 28 days for participants aged 18-59. Antibody levels were also lower in those aged 60-80 years compared with those aged 18-59 (Mean neutralising antibody titre 42 days after receiving a 8μg vaccine dose was 228.7 for people aged 18-59, and 170.9 for those aged 60-80).

The trial was not designed to assess efficacy of the vaccine, so it is not possible to say whether the antibody responses induced by the vaccine, called BBIBP-CorV, are sufficient to protect from SARS-CoV-2 infection.

Professor Xiaoming Yang, one of the authors of the study, from the Beijing Institute of Biological Products Company Limited, Beijing, China, said: “Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease. However, vaccines are sometimes less effective in this group because the immune system weakens with age. It is therefore encouraging to see that BBIBP-CorV induces antibody responses in people aged 60 and older, and we believe this justifies further investigation.”

There are currently 42 vaccines for COVID-19 in clinical trials. These vary in type and include DNA plasmid vaccines, inactivated virus vaccines, adenovirus-vectored vaccines, RNA vaccines, protein subunit vaccines and virus-like particle vaccines. Some of these have already been shown to be safe and to elicit immune responses in early phase clinical trials.

The BBIBP-CorV vaccine used in the study reported here is based on a sample of the virus that was isolated from a patient in China. Stocks of the virus were grown in the lab using cell lines and then inactivated using a chemical called beta-proprionolactone. BBIBP-CorV includes the killed virus mixed with another component, aluminium hydroxide, which is called an adjuvant because it is known to boost immune responses.

The first phase of the study was designed to find the optimal safe dose for BBIBP-CorV. It involved 96 healthy volunteers aged between 18 and 59 years and a second group of 96 participants aged between 60 years and 80 years. Within each group, the vaccine was tested at three different dose levels (2μg, 4μg and 8μg, 24 participants per group), with two vaccinations administered on day 0 and 28. A fourth group within each age group (24 participants in each age group) were given two doses of a placebo vaccine. In total, in phase 1 of the study, 144 participants received the vaccine and 48 received the placebo.

The second phase of the study was designed to identify the optimal timing schedule for vaccination. 448 participants aged between 18 and 59 years were randomly assigned to receive either one 8?g shot of vaccine or placebo, or two shots of 4μg vaccine or placebo (at 0 and 14 days, 0 and 21 days or 0 and 28 days). In this second phase, there were 112 participants per group, with 336 receiving the vaccine, and 112 receiving the placebo.

Participants were asked to report any adverse events for the first seven days after each vaccination and these were verified by the research team. Thereafter, participants recorded any adverse events using paper cards for the following 4 weeks. During phase 1, laboratory tests were carried out after the first and second vaccinations to assess kidney function, liver function and other organ functions. Blood samples were taken to test antibody levels for SARS-CoV-2 before and after vaccination.

No serious adverse events were reported within 28 days of the final vaccination. The most common side effect was pain at the injection site (phase 1 results: 24% [34/144] of vaccine recipients, vs 6% [3/48] of placebo recipients). A small number of participants reported experiencing a fever (phase 1 results: 4% [5/144] of vaccine recipients, vs 6% [3/48] of placebo recipients). There were no instances of clinically significant changes in organ functions detected in laboratory tests in any of the groups.

The greatest antibody responses were elicited by two 4μg doses of the vaccine at either days 0 and 21 or 0 and 28 (Mean neutralising antibody titres 28 days after second vaccination were 282.7 for two 4μg injections at day 0 and 21, and 218.0 for two 4μg injections at day 0 and 28).

Professor Xiaoming Yang said: “Our findings indicate that a booster shot is necessary to achieve the greatest antibody responses against SARS-CoV-2 and could be important for protection. This provides useful information for a phase 3 trial.”

The authors noted some limitations with the study, including the short duration of follow up at just 42 days. They also highlighted that the study did not include children and adolescents aged under 18. Trials with these groups will be carried out when the full analysis of data from adult groups is completed, the researchers say.

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Scientists develop new precise therapeutic leukemia vaccine

Exploration of new leukemia antigens and construction of appropriate delivery systems using FDA-approved material are important strategies for developing leukemia vaccines for clinic use.

Researchers from the Institute of Process Engineering (IPE) of Chinese Academy of Sciences and Zhujiang Hospital of Southern Medical University have developed a new type of precise therapeutic vaccine against leukemia. It utilizes self-healing polylactic acid microcapsules for co-encapsulating a new epitope peptide and PD-1 antibody.

The study was published in Nature Biomedical Engineering on October 12.

Although the possibility of treating leukemia through vaccination has been established, therapeutic performance still falls short of expectations in clinic.

“Our clinical findings revealed the high expression of EPS8 and PD-1/PD-L1 in leukemia patients, which could be respectively used as a new type of leukemia antigen and a checkpoint target for a leukemia vaccine,” said Prof. Li Yuhua from Zhujiang Hospital.

In the novel vaccine, epitope peptides and PD-1 antibodies can be simply, mildly and efficiently loaded into polylactic acid microcapsules, facilitated by the unique self-healing feature of the microcapsule.

After a single vaccination, the deposition and degradation of microcapsules at the local injection site lead to recruitment of activated antigen-presenting cells and sustained release of both cargos.

“With the synergism of these two aspects, we observed a significant improvement in specific Cytotoxic T Lymphocyte (CTL) activation,” said Prof. Wei Wei from IPE.

The researchers also verified the availability of the novel vaccine using various epitope peptides in different models, such as murine leukemia, humanized cell line-derived leukemia xenograft (CDX) and patient-derived leukemia xenograft (PDX) models.

The microcapsule-based formulation demonstrated its superior performance over that of the ISA adjuvant (commercialized adjuvant) in all leukemia therapeutic models, showing the promise of the microcapsule-based vaccine for use against various leukemia antigens in clinic.

“With the advantages of FDA-approved polylactic acid material, convenience in preparing the vaccine formulation, diversity of vaccine components, and excellent therapeutic effect, the microcapsule-based vaccine exhibits great potential for clinical translation,” said Prof. Ma Guanghui from IPE.

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White House nixes tougher FDA guidelines on vaccine approval

The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented their approval before the Nov. 3 election.

At issue was the FDA’s planned requirement that participants in the ongoing mass clinical trials for nearly a half-dozen vaccine candidates be followed for two months to ensure there are no side effects and that the vaccines provide lasting protection from the virus in order to receive emergency approval. A senior administration confirmed the move Monday evening, saying the White House believed there was “no clinical or medical reason” to add additional screening protocols.

The White House action was first reported by The New York Times.

FDA Commissioner Stephen Hahn has pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe. Vaccine development usually takes years, but scientists have been racing to shorten that time.

“Science will guide our decisions. FDA will not permit any pressure from anyone to change that,” Hahn said recently. “I will put the interest of the American people above anything else.”

The FDA has faced criticism for allowing emergency use of some COVID-19 treatments backed by little evidence, but Hahn has said if vaccine makers want that faster path to market, they would face additional standards. Vaccines, unlike therapies, are given to healthy people and thus usually require more proof.

But President Donald Trump made clear last month that he was skeptical of any regulatory changes that might delay a vaccine’s authorization, even if those changes are aimed at increasing public trust. Asked about the FDA considering stricter guidelines for emergency approval, Trump suggested the effort was politically motivated.

“I think that was a political move more than anything else,” he said then, arguing that that the companies testing the vaccines, such as Pfizer, Johnson & Johnson and Moderna, are capable of determining whether they work. “I have tremendous trust in these massive companies,” he said.

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The three types of vaccine hesitancy authorities need to combat

There are high hopes that one or, with any luck, several of the COVID-19 vaccines in development will bring an end to the pandemic. The most promising are often invoked in government briefings and by the media, with their progress closely followed. Optimism is tempered by uncertainties regarding how effective any vaccine will be.

However, recent polls show that even if an effective vaccine is produced, uptake will not be universal. Reports suggest that between one-sixth and half of the UK population would refuse a COVID vaccine, and there is considerable vaccine skepticism elsewhere too, particularly in high-income countries. This poses a serious challenge to achieving herd immunity.

Politicians rarely engage with vaccine skepticism—and when they do, often don’t understand the complexity of people’s feelings. In the case of COVID, they and public health experts need to pay attention to the different sources of skepticism that will affect uptake, and engage with people who hesitate or refuse to be vaccinated.

Skeptics aren’t all the same

There are three types of vaccine hesitancy that governments and health authorities need to be aware of.

The first reluctant group are those with concerns about safety testing. Many people will hesitate to have a newly developed vaccine even after it has passed the safety and efficacy tests of the main regulatory agencies. This is because it will still be too soon to know what long-term effects it may have.

These concerns are likely to become more prominent if a vaccine is rolled out to the public before it has been licensed – that is, before the regulatory authorities give it their seal of approval, having conducted a final review of all the testing data—and therefore without the usual legal framework governing liability and accountability should anything go wrong.

The UK government is considering temporarily authorizing an unlicensed vaccine if it feels its quality and safety is sufficiently clear and the need for it is high.

The second set of skeptics are notoriously unmoved by science: these are the anti-vaxxer groups. Too often, any vaccine resistors are tarred with this brush and are portrayed as people for whom opinion is more important than fact, swayed by outlandish conspiracy theories about hidden interests rather than by evidence.

Nevertheless, plenty of people hold these beliefs. Opposing sides are sharply demarcated, often accompanied by claims that reason is on the side of science and unreason prevails everywhere else. In this way, the discussion becomes increasingly polarized.

The third reluctant group has received little attention so far. It comprises people motivated by animal welfare and environmental concerns. The number of vegans and vegetarians is increasing rapidly, with many in recent years spurred by environmental concerns. Vegans don’t automatically refuse vaccination on animal welfare grounds; however, there’s a cocktail of environmental and animal welfare concerns around COVID vaccines that may drive some to reject vaccination.

A case in point is a petition currently circulating on social media, which shows a specific concern that some people have. It claims that a number of COVID vaccines in development use squalene as an adjuvant—that is, as a helper ingredient—and that the squalene is sourced from sharks.

It’s not yet clear whether any of the vaccines in development do actually contain shark squalene, but it is used in other vaccines. If used in ones for COVID, conservationists warn this will vastly increase the number of sharks that will be killed.

With a growing number of consumers shunning products that are not sustainable, and influential voices claiming that the pandemic itself resulted from human-induced damage to natural environments, these sorts of environmental arguments against vaccines are likely to become more common.

Each of these sources of skepticism may then be compounded by worries that vaccination will be mandatory, depending on the policy each country chooses to adopt. This adds fuel to the fire of those who argue that vaccines should be refused on the grounds that they’re an infringement of civil liberties.

How to respond

These three very different kinds of concerns need to be taken seriously. Rather than a blanket response to vaccine resistors, politicians and public health leaders need to acknowledge the different concerns, values and beliefs people have.

One-way science communication, expecting the public to passively accept what they are told by politicians and scientists, will be a serious mistake. To combat each form of skepticism, transparency about any forthcoming vaccine is a minimal requirement. Beyond this, there needs to be a meaningful engagement with people’s concerns.

For those with safety concerns, this means being open about the safety testing of the vaccine and each of its ingredients. Authorities should participate in discussions with these people about benefits and risks, who will be most affected by both, and how to balance them.

For those with environmental concerns, there needs to transparency about the way that all ingredients are sourced and their potential environmental impacts. There should be an openness to seek and use alternatives where possible. In the case of squalene, for instance, there are potential natural sources other than sharks.

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Giving HPV vaccine to girls 'cuts risk of cervical cancer by 88%'

Giving the HPV vaccine to schoolgirls slashes their risk of getting cervical cancer by 88%, major study claims

  • The Swedish study is the biggest one to evaluate the success of the vaccine 
  • They tracked 1.7million women over 11 years — around a third had had the jab
  • Rates of cervical cancer were lower in women vaccinated before the age of 17 

Giving the HPV vaccine to schoolgirls slashes cervical cancer rates by 88 per cent, a study has revealed.

In the biggest study yet to evaluate the success of the vaccine, experts followed 1.7million women over 11 years, including half a million who received the jab.

They found that rates of cervical cancer were 88 per cent lower in women who were vaccinated before the age of 17, and 50 per cent lower in older women who had been immunised.

The HPV vaccine prevents infection from human papillomavirus, a common group of viruses that are behind 90 per cent of cases of cervical cancer.

In the biggest study yet to evaluate the success of the vaccine, experts followed 1.7million women over 11 years, including half a million who received the jab

It has been given to teenage girls in UK since 2008, and was last year made available to schoolboys at the age of 12 and 13 for the first time.

Currently 3,200 cases of cervical cancer are diagnosed every year in Britain, leading to more than two deaths a day.

But this research suggests cervical cancer cases will drop sharply over the next few years as more and more people are vaccinated, with experts hopeful the disease could eventually be eliminated.

Co-author Professor Pär Sparén, from the Department of Medical Epidemiology at the Karolinska Institutet in Sweden, said: ‘Girls vaccinated at a young age seem to be more protected, probably because they are less likely to have been exposed to HPV infection and given that HPV vaccination has no therapeutic effect against a pre-existing infection.

‘Our study shows that HPV vaccination may significantly reduce the risk of cervical cancer, especially if completed at an early age.

‘Our data strongly supports continuing HPV vaccinations of children and adolescents through national vaccination programs.’ 

Of the 1.7million women included in the study, just 19 vaccinated women were diagnosed with cervical cancer compared to 538 unvaccinated women.

Robert Music, chief executive of Jo’s Cervical Cancer Trust, said: ‘The HPV vaccine is an important tool in the fight against cervical cancer. 

‘Sadly Covid-19 has disrupted many vaccination programmes and led to increased vaccine hesitancy. 

‘We must ensure those eligible do not miss out on the opportunity to reduce their cervical cancer risk and communicating the benefits of the vaccine is essential. 

‘For countries without a HPV vaccination programme, this data should help to demonstrate the impact it could bring.’ 

The research was published New England Journal of Medicine. 

WHAT IS HPV? THE INFECTION LINKED TO 99% OF CERVICAL CANCER CASES

Up to eight out of 10 people will be infected with HPV in their lives

Human papilloma virus (HPV) is the name for a group of viruses that affect your skin and the moist membranes lining your body. 

Spread through vaginal, anal and oral sex and skin-to-skin contact between genitals, it is extremely common. 

Up to eight out of 10 people will be infected with the virus at some point in their lives.

There are more than 100 types of HPV. Around 30 of which can affect the genital area. Genital HPV infections are common and highly contagious.

Many people never show symptoms, as they can arise years after infection, and the majority of cases go away without treatment.

It can lead to genital warts, and is also known to cause cervical cancer by creating an abnormal tissue growth.

Annually, an average of 38,000 cases of HPV-related cancers are diagnosed in the US, 3,100 cases of cervical cancer in the UK and around 2,000 other cancers in men.

What others cancers does it cause? 

  • Throat
  • Neck
  • Tongue
  • Tonsils
  • Vulva
  • Vagina
  • Penis
  • Anus

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Coronavirus therapeutics 'more complicated' than vaccine, expert says

WHO warns of surge in coronavirus cases in Europe

EEurope is seeing more weekly coronavirus cases than it did in March’s peak; Amy Kellogg reports.

Editors of a highly respected medical journal discussed on Wednesday "Operation Warp Speed" and the government's response to COVID-19, focusing mostly on therapeutics.

"Operation Warp Speed" is the U.S. government's plan to quickly ramp up the development and production of vaccines, therapeutics and diagnostics.

“Therapeutics are, in a way, more complicated than vaccines," said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine (NEJM). “There are a limited number of approaches to vaccination and a similarly limited number of endpoints, but for therapeutics, there is an enormously wide range of targets and goals.”

Rubin explained that therapeutics can take a number of approaches, like trying to target the virus, target the host or target the interface between the host and the virus, all possibly leading to different consequences. Researchers can opt for small synthetic molecules or large biological macromolecules, also leading to different development paths, he said.

PFIZER TO GET $2B FOR CORONAVIRUS VACCINE UNDER 'OPERATION WARP SPEED'

“Therapeutics are, in a way, more complicated than vaccines," said Dr. Eric Rubin, editor-in-chief of the New England Journal of Medicine (NEJM)." 
(iStock)

ADULT OBESITY ON RISE IN US, CDC SAYS

“The development time from discovery all the way to a useful drug is even longer than in vaccines, it’s often extending for decades," he said.

Rubin said "Operation Warp Speed" set three criteria for supported therapeutics: the candidate has to be ready for clinical testing this fall, there must be strong preclinical data supporting its use, and any candidate chosen must be deliverable at scale by the end of 2020.

Rubin said the criteria “strictly limit” the potential candidates. However, antibody-based therapies were said to have several advantages due to their well-understood development and production processes, in addition to their relatively known safety margins.

It was noted that small molecules like the experimental antiviral remdesivir and dexamethasone were previously shown to have some success. While the former can benefit patients earlier on in infection, the latter showed to lower the fatality rate of patients with more severe disease.

While remdesivir may benefit patients earlier on in infection, dexamethasone showed to lower the fatality rate of patients with more severe disease. 
(iStock)

“Dexamethasone sets a very high bar because it’s cheap and widely available and most of the other things that we’re talking about are antibodies or expensive small molecules so they’ll have to do better than dexamethasone in order to be widely adopted," Rubin said.

CORONAVIRUS DEATHS SIGNIFICANTLY REDUCED BY STEROIDS, ANALYSIS SHOWS

These small molecules were said to have unique properties, and it’s difficult to generalize between them, even within the same chemical class. Each drug has its own pharmacology, subject to investigation and safety testing.

Rubin explained that “often times, it’s very difficult to guess what the issues are going to be for a small molecule as opposed to some of the, for example, antibodies, so there are often not very good guesses about potential toxicities before you get into people.”

Dr. Lindsey Baden, deputy editor of NEJM and co-principal investigator for Moderna’s Phase 3 trial, is involved with "Operation Warp Speed." Baden questioned how to bring out the best in the U.S. government, industry and academia to create a fast, appropriate response to the global health crisis.

“It’s a real balance because we don’t want to get lost in for-profit considerations but we also need responses that are temporally appropriate, so speed, and how to do things quickly in response to this pandemic that is spreading so fast,” Baden said. “It’s something that the different communities haven’t always thought about together that this crisis forced us to [do]

CORONAVIRUS CAUSING 'PERSISTENT FATIGUE' IN MORE THAN HALF OF RECOVERED PATIENTS, STUDY FINDS

"I think the speed with which this response is occurring on the biomedical side is encouraging in many ways despite some failings in our response," Baden added.

Finally, Baden addressed the question on the minds of many: How can drug developers speed along these clinical trials without risking safety in the end product?

“There are ways to take risks in manufacturing that are financial that don’t engender safety risks in the studies and those financial risks have to be thought about in the manufacturing side and the delivery side, that I would argue are appropriate risks in this setting," Baden said, elaborating on the nations' daily new case and death count, which is around 36,000 and 750, respectively, per the AP.

He said shaving off a week, month or just a day "has significant potential implications," given the widespread disease.

Click here to listen to the NEJM interview.

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Could religious exemptions trump a COVID-19 vaccine mandate? Well, that depends

The longer COVID-19 rages on, the more the United States appears to be hanging its hopes on the development and rapid, mass distribution of a vaccine.

Getting a safe and effective vaccine out to the public could be a game changer, health experts believe. But stopping the virus’s spread will only happen if enough people choose—or are required—to get vaccinated.

But while some people may see it as their “patriotic duty” to get vaccinated, others won’t.

Opponents may challenge vaccination requirements based on claims of religious liberty or under specific laws that would allow for a religious exemption from any COVID-19 vaccine mandates. In some states including Indiana and Massachusetts, there are laws allowing parents to cite religious reasons to opt out of childhood immunization requirements.

As a public health lawyer and ethicist who has researched issues related to vaccination policy, I’m often asked about the role a vaccine mandate could play in our COVID-19 response. My answer is a common lawyer’s response: “It depends,” as this question raises numerous questions of its own.

‘Safe and effective’?

Whether or not a vaccine mandate is appropriate will depend upon how safe the vaccine is determined to be, what it protects against and how well it offers protection. The Food and Drug Administration Commissioner Stephen Hahn has been adamant that the agency “will not cut corners” in their vaccine review process, and that the decision “will be based on science and data.” Any suggestion otherwise would damage public trust.

But public hesitancy to vaccines was already one of the biggest global public health concerns even before the COVID-19 pandemic.

Added to this are the vaccine misinformation and conspiracies that have flourished during the epidemic.

These may explain why 35% of Americans say they will not get the vaccine. While troubling, it’s unclear how many in this camp will keep that opinion if COVID-related illnesses, injuries and disruptions to our lives continue, and a vaccine becomes readily available.

And we do not know enough about COVID-19 immunity yet to know what share of the population would need to be vaccinated for a community to achieve herd immunity and stop the virus’s spread. A mandate may not be necessary, although those refusing vaccination tend to cluster, leaving potential pockets of continued vulnerability.

‘If/then’ mandates

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said he would be “pretty surprised” if vaccination became mandatory for any part of the population.

But other experts have raised the possibility of a vaccine being mandatory as part of a “if/then” proposition – in other words, someone can only do something if they are first vaccinated. For example, proof of vaccination could be required to engage in certain jobs, such as prison staff or line workers in meat processing plants. Some businesses, such as nursing homes and hospitals might require vaccination for those who work with certain high-risk populations.

It also could be required to gain access to certain spaces, such as schools or sporting events, or to qualify for certain benefits, like freedom to travel to other states without having to quarantine. These types of rules already exist, for example, in many universities, which require students living in dorms be vaccinated against meningitis.

Another approach would be to mandate the vaccine for certain populations based upon risk characteristics, such as those who live in nursing homes.

Under these scenarios, would religious or personal exemptions override any mandate? That depends on who issues the mandate.

Recent guidance from the U.S. Equal Employment Opportunity Commission suggests that a request to be exempted from an employer’s flu vaccination mandate based on “sincerely held religious belief, practice, or observances” would be protected under Title VII of the 1964 Civil Rights Act. The guidance doesn’t explicitly state that the same rule would apply for COVID-19—because there is no COVID-19 vaccine at this time—but it seems clear that the commission would prefer that “employers consider simply encouraging employees” to get vaccinated.

That said, there is a provision under the law that would allow businesses not to honor this exemption if it created “undue hardship.” In care facilities, where employees interact regularly with vulnerable populations, employers likely will be able to make “undue hardship” arguments and prevent exemptions. But people working in a typical office environment, or in a service industry position, would probably be able to make a religion-based claim to opt out.

It gets a little more complicated when it comes to any state-issued vaccine mandate. A number of states have created laws protecting religious rights beyond the First Amendment. Florida and Texas, for example, allow parents to opt their children out of school vaccinations citing deeply held religious beliefs or philosophical opposition.

Twenty-one states have religious freedom laws prohibiting even minimal interference with residents’ right to practice their faith. In states with these laws, legislatures may need to amend the statute to avoid challenges and allow for universal vaccination mandates for adults.

These exemptions for religious beliefs are political choices. There are no Constitutional or ethical obligations to require an opt out to a vaccine that may be key to stopping a pandemic, should a state wish to prioritize protecting their residents from COVID-19 through mandating vaccination.

Even during this pandemic, most courts, including the Supreme Court, have been hesitant to interfere with the decisions made by state officials taking steps to keep the community safe from a dangerous outbreak. As Chief Justice Roberts recently described, these are emergency circumstances “fraught with medical and scientific uncertainties,” and moment-to-moment management of such situations are best left to the elected officials who are directly accountable to the public.

‘No liberty to expose community’

A requirement that someone be vaccinated imposes a greater burden on personal liberty than, say, having to attend church virtually as opposed to in person. However, as the Supreme Court stated in 1941, “The right to practice religion freely does not include liberty to expose the community … to communicable disease.” Justice Antonin Scalia, speaking for the court nearly 50 years later, came to a similar conclusion that laws advancing civic obligations such as compulsory vaccination may override claims of religious freedom.

In any case, as Dr. Fauci alludes to: Talk of a mandate may be moot. Almost two-thirds of the American public have said they would get the vaccine if it were available today. Should a safe, effective vaccine be developed, there will likely be tremendous demand to get the shot.

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Coronavirus: back Impfbereitschaft in the population, Naturopathy, naturopathic specialist portal

Corona: Fewer people to Vaccinate ready

Experts assume that the Corona of a pandemic will be to the end, when vaccines against the Coronavirus SARS-CoV-2 available and enough people have been vaccinated with it. However, in European countries the willingness to be against Corona vaccination drops.

All over the world have already infected more than 13 million people with the novel Coronavirus SARS-CoV-2. In European countries the increase in case numbers in recent weeks, not as strongly as before. The led probably also to the fact that less people are Worried because of an infection. This could be a reason why the Impfbereitschaft drops.

Would benefit the population a vaccine?

In the fight against COVID-19, a vaccine is considered to be crucial. Would benefit the population but also? While in April 2020, 70 percent of the people in Germany were willing to be vaccinated, the number dropped in June to 61 percent, according to the University of Hamburg, in a recent communication. Many citizens are particularly concerned with possible side effects.

Lowest approval in Germany

In a representative study under the direction of the Hamburg Center for Health Economics (HCHE), University of Hamburg were surveyed in April and June 2020, more than 7,000 people in Germany, Denmark, France, Italy, the Netherlands, Portugal and the United Kingdom.

The information suggests that the Impfbereitschaft against the Coronavirus fell in the countries surveyed a total of 74 per cent in April to 68 percent just two months later. Except Portugal, all countries reported lower Figures, the largest deviations are in Italy (down 13 percent) and Germany (minus nine percent).

In addition, Germany has – in addition to France – the slightest consent to the vaccination among the surveyed European countries. At the same time, the number of people who do not want to be vaccinated has doubled in this country. In Germany, this says, in the meantime, every fifth person.

“Of concern is that more and more people refuse vaccination against Coronavirus, and these are far more people than those who reject, in principle, vaccinations,” explains Prof. Dr. Jonas Schreyögg, scientific Director of HCHE.

Severity of the Virus is questioned

By far the majority of people in all surveyed countries are concerned from the potential side effects and inadequate efficacy of a possible vaccine. According to the report, 45 percent of the people who reject vaccination, and 61 percent of those who are unsure to call, this as the most important reasons. Every Seventh is against a vaccination, does not believe that the Virus is dangerous for your health.

However, the study also shows that Respondents who say of themselves that they trust information from government, the European Union and the world health organization (WHO), are more open to vaccination.

“Politics and science should therefore communicate about possible side effects and the effectiveness of a vaccine in a very transparent manner and for the confidence of the citizens advertise,” advises Jonas Schreyögg.

Women are insecure

“The highest approval in all countries we find men who are older than 55 years, and for those living in a household with older people or with a Person with a chronic pre-existing conditions”, says Schreyögg.

As the survey shows, women across all age groups was uncertain whether or not you want to vaccinate or not. Especially in Germany, shows that families and households with physically or mentally disabled people have the slightest Impfbereitschaft among all household constellations.

In addition, the Impfbereitschaft within Germany is distributed differently and takes from the North (67 percent), South (56 percent). In Bavaria, for example, only every Second (52%) is ready to be vaccinated. Between the old (60 per cent) and new Federal States (65 percent), there are only small differences. (ad)

Authors and source of information

China's COVID-19 vaccine 'safe' in world's first completed human trial

China’s coronavirus vaccine is deemed ‘safe’ and triggers an immune response in world’s first completed human trial of 108 volunteers – but it may not ‘neutralize’ infection, expert says

  • Chinese CDCs and universities tested a candidate vaccine in 108 people
  • With results published Friday, it’s the first human trial to be completed in the world
  • It was found safe after no serious side effects were seen in any of the volunteers, though some had mild reactions, such as fever, pain and muscle aches 
  • Immune responses were seen in most patients, though more research is needed to determine if its enough to prevent infection 
  • A US vaccine expert told DailyMail.com he’s concerned, however, that the Chinese shot didn’t trigger enough ‘neutralizing’ antibodies to block the virus
  • Here’s how to help people impacted by Covid-19

A coronavirus vaccine trialled in 108 healthy volunteers in China safely triggered an immune response in the participants, a new study reveals. 

Antibody production seen in the patients is a good sign that the vaccine may protect them from infection, but it’s too soon to say for sure. 

The Chinese vaccine was the very first shot to enter clinical trials earlier this year – months ahead of human testing for the UK’s lead candidate jab – made by Oxford University – or the American lead-contender, made by biotech Moderna. 

Most of the people dosed with the vaccine had immune responses, although their levels of antibodies thought to neutralize the virus were relatively low. Researchers saw a stronger ramp-up of other immune compounds, called T-cells, that might also help fight the infection off. 

There were side effects – primarily pain, muscle aches and fever – but they subsided within 28 days, and no serious or dangerous side effects were reported. 

Promising results from the completed first human trial China’s Ad5 coronavirus vaccine place it at the front of the global race for a shot, though only by a slim margin, an expert told DailyMail.com. 

Chinese researchers have become the first to complete a human trial for a coronavirus vaccine, which was safe and triggered an immune response in participants, but a US expert worries the shot didn’t produce enough ‘neutralizing’ antibodies to block infection (file) 

The study, conducted by the collaborating universities and local CDC’s in China, recruited 108 patients ranging in age from 18 to 60, and split them into three groups the received, respectively, low, middle and high doses of the vaccine 

At the study’s start, none of the patients – who had never been infected with coronavirus – had neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19. 

Within two weeks, researchers started to see signs that their levels of antibodies were ramping up ‘moderately,’ and peaked 28 days after the volunteers got their shots, according to the study published Friday in The Lancet.

Levels of neutralizing antibodies – a type of immune cell that binds to a virus and may be able to completely block infection – were more than twice as high among the participants who got the high dose shot, compared to those given the low dose.  

While any increase in neutralizing antibodies was a significant gain over the subjects’ starting levels (zero), Dr Peter Hotez, a vaccine expert at Baylor College of Medicine in Texas, was unimpressed with the levels produced in the trial participants. 

‘The one thing not we’re not seeing is a really high neutralizing antibody titer,’ he told DailyMail.com. 

‘The question is whether we’re going to need that and whether these vaccines will be adequate to stimulate an immune response.’ 

Patients in the trial did have more robust increases in their levels of T cells, immune cells that perform a search and destroy function, rather than the blocking work done by neutralizing antibodies. 

More studies will be needed to determine whether the vaccine can protect against infection in practice. 

Encouragingly, none of the 108 patients had serious side effects. 

More than 80 percent did have some side effects, but these were mostly mild or moderate, like muscle aches, fever and pain. Most subsided within a couple of weeks, and almost all resolved by the end of the study. 

Moderna is working closely with the NIH to develop its vaccine, and is leading the US race 

The US government has placed an order for 300 million doses of AstraZeneca’s shot, developed with Oxford University 

‘That’s pretty good,’ Dr Hotez says. 

Side effect profiles may be particularly important to getting people to get vaccinated against coronavirus once one is available. 

A Reuters poll published Thursday found that a quarter of Americans were not very or not at all interested in getting a vaccine for the virus that has infected more than 1.6 million people in the US. 

Many of them said they were concerned the vaccine would be riskier than the disease itself because development is moving so fast. 

So far, the US government is supporting the development of 14 candidate vaccinations through its Operation Speed initiative. 

It’s unclear if the US is coordinating with the Chinese vaccine developers. 

In the US and UK, vaccines from Moderna and Oxford University (collaborating with AstaZeneca) are in human trials, and have shown promising early results. 

China’s completed trial puts it ahead – but not by much, says Dr Hotez. He says that all of the vaccines will need to go through large, Phase III trials before they become available, bringing their timelines close together.  

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A big problem later: A majority of antivaxxers plan to refuse a COVID-19 vaccine, study suggests

The availability of a vaccine for the novel coronavirus will likely play a key role in determining when Americans can return to life as usual. Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on April 30 announced that a vaccine could even be available by January 2021.

Whether a vaccine can end this pandemic successfully, however, depends on more than its effectiveness at providing immunity against the virus, or how quickly it can be produced in mass quantities. Americans also must choose to receive the vaccine.

According to some estimates, 50% to 70% of Americans would need to develop immunity to COVID-19—either naturally, or via a vaccine—in order to thwart the spread of the virus. If these estimates are correct, that could mean that nearly twice as many Americans would need to elect to receive a COVID-19 vaccine than those who currently opt to be vaccinated against seasonal influenza. Just 37% of American adults did so in 2017-2018, even in the midst of a historically severe flu season.

Making matters more complicated is the possibility that people who hold skeptical views about vaccine safety—sometimes referred to as “anti-vaxxers”—will not opt to receive the coronavirus vaccine. According to some estimates, about one fifth to two fifths of Americans express reservations about vaccine safety. If most of these individuals forego receiving a COVID-19 vaccine, they could potentially jeopardize the recovery process.

One of us is a doctoral candidate, and the other is a professor, who both study vaccine resistance. We conducted a study, which is currently undergoing peer review, where we estimate the number of Americans who report being willing to receive a COVID-19 vaccine, once it becomes available. We also investigate the reasons some Americans might refuse the vaccine.

We found that about one fifth of Americans, and more than half of people who hold skeptical views toward vaccine safety, may be unwilling to pursue vaccination. Although most Americans do plan to get vaccinated, non-compliance rates may be high enough to pose a threat to collective immunity.

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Is coronavirus changing minds about vaccine safety?

On the one hand, a pandemic may be encouraging anti-vaxxers to change their minds. One reason so many Americans doubt vaccine safety is due to complacency – the idea that, because high rates of vaccine compliance have kept us safe from diseases that once reached epidemic proportions in the U.S., segments of the population can hold anti-vaccine views without endangering public health.

Consistent with this view, research finds that when people are concerned that once nearly eradicated diseases might re-emerge to reach epidemic levels, people are more likely to trust recommendations from public health experts. Additionally,cross-national survey research suggests that people who live in parts of the world where the threat of epidemics are more likely tend to hold more positive views toward vaccines than the rest of the world.

Studies based on in-depth interviews with parents further suggest that parents who chose not to vaccinate their children are often willing to accept treatments for children with life-threatening illnesses.

On the other hand, however, it could be the case that anti-vaxxers remain suspicious of a COVID-19 vaccine, when it becomes available. Prominent anti-vaccine websites have already begun circulating misinformation about the COVID-19 vaccine—such as the idea that a vaccine has existed for years and has been kept from public consumption. Additionally, recent research suggests that anti-vaccine views are tied to deeply held psychological and moral aversions to inoculation, implying that attitudes may be difficult to change.

What do anti-vaxxers say now?

We set out to investigate this important question. In a demographically representative survey of 493 U.S. adults conducted on April 15, 2020, we investigated whether people who hold skeptical views toward vaccine safety plan to receive a vaccine against COVID-19.

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Specifically, we asked respondents whether they would be willing to get vaccinated against COVID-19 once a vaccine becomes available. Nearly a quarter (23%) of respondents said that they would not.

Additionally, and consistent with the view that even a global pandemic may not persuade anti-vaxxers to get vaccinated, we find that 62% of people who are skeptical of vaccines said that they will forego COVID-19 vaccination.

To assess this, we measured vaccine skepticism by asking respondents three questions about whether they find vaccines to be safe, effective, and/or important—which is how vaccine skepticism is typically measured. Respondents indicated whether they thought each characteristic described vaccines “quite a bit,” “a moderate amount,” “a little bit,” or “not at all.” We then averaged the score across the three to create a scale of vaccine skepticism.

Nearly one-fifth (19%) of respondents were more vaccine skeptical than not. Among vaccine skeptics, 62% stated that they would not get vaccinated against COVID-19. By contrast, just 15% of those more supportive of vaccines than skeptical said that they would not get the COVID-19 vaccine.

We also asked respondents if they self-identified as anti-vaxxers, and nearly 16% said they did. For those that identified as anti-vaxxers, 44% said they would not vaccinate against COVID-19, compared to 19% of people who did not identify as anti-vaxxers.

A threat to collective immunity?

We believe that these findings, although preliminary, suggest that many people who hold anti-vaccine beliefs may jeopardize the effectiveness of a COVID-19 vaccine once it’s available, due to issues of non-compliance. Furthermore, it appears that anti-vaccine sentiment is at least as widespread as it was before the pandemic began.

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