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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