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Coronavirus vaccine trials underway but outcome remains unclear

Mounir Jamil

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Coronavirus vaccine trials underway but outcome remains unclear

As coronavirus vaccine trials take place all over the world, scientists gather data to help maximize research potential and to ensure a more efficient, effective and ethical study design. Despite rigorous vaccine efforts however, the picture remains unclear.

In mid-May, Moderna a US biotech firm exposed the first data from a trial. Its coronavirus vaccine triggered an immune response in individuals, and has protected mice from the lung infections caused by the coronavirus SARS-CoV-2. The results, which were announced in a press release, were translated as widely positive and caused stock prices to go up.

Other fast-tracked test for coronavirus vaccines indicate that they have prevented infections in the lungs of monkeys that were exposed to SARS-CoV-2, but not in other parts of the body. A vaccine that is being developed at the University of Oxford, has protected six monkeys from pneumonia, however, the animals’ noses fostered as much virus as those of unvaccinated monkeys.

Moderna’s coronavirus vaccine, co-developed with the US National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, began safety testing on humans at the beginning of March. The vaccine is constituted of mRNA instructions that build on the coronavirus’s spike protein, it causes human cells to churn out the foreign protein, and alters the immune system. Even though such RNA-based vaccines can be easily developed, none have been licensed anywhere in the world yet.

In a press release, Moderna also reported that 45 participants in the study that have received one or two doses of their vaccine have developed a strong immune response to the virus. Researchers have measured virus recognizing antibodies in 25 of the participants and have successfully detected levels close to or even higher than those that were found in the blood of individuals that fully recovered from the virus.

However, it is still not clear if their responses are enough to protect people from the virus, due to the fact Moderna hasn’t shared its data, claims Peter Hotez, a vaccine scientist at Baylor College of Medicine and says that he is not sure if this is actually a positive result. He refers to an earlier May 15 bioRxiv preprint3 showing that most who actually recovered from the virus without need for hospitalization did not produce high levels of the neutralizing antibody that prevents the virus from infecting cells. Moderna has measured the potent antibodies in eight different trial participants and revealed that their levels were similar to the patients who recovered.

Hotez also expressed his doubts regarding initial results of the Oxford study, that found that monkeys produced modest levels of neutralizing antibodies after being administered only one dose of the coronavirus vaccines. He says it seems that those numbers need to be significantly higher to afford protection. The vaccine is composed from a chimpanzee virus that has been genetically modified to produce a protein for the coronavirus. Hotez added that the coronavirus vaccines being developed by Sinovac Biotech in Beijing seem to have shown a more promising antibody response in macaque monkeys after they were administered three doses.

Sarah Gilbert, an Oxford vaccinologist has co-led the study alongside Vincent Munster, a virologist at NIAD’s labs in Hamilton Montana. Gilbert mentioned that the Oxford monkeys were administered a really high dose of the virus after receiving the vaccine. This could be reason why the vaccinated animals had just as much SARS-CoV-2 genetic materials located in their noses as the control animals, although the vaccinated monkeys didn’t develop any sign of pneumonia. By administering high doses, the test ensures that the animals will be infected with the virus, however it might not replicate natural infections.

Even though assessing the efficacy of a coronavirus vaccine is challenging, the most recent data focuses on safety, according to researchers. The monkeys vaccinated at Oxford and Sinovac did not develop an exacerbated disease post-infection, which was a key fear because an inactivated vaccine that causes SARS (severe acute respiratory syndrome) manifested signs in macaques.

Moderna is set to begin phase II of the trial soon, which will involve 600 participants. It aims at beginning a phase III efficacy trial in July, to determine if Coronavirus vaccines are able to prevent disease in high-risk groups such as healthcare workers with underlying problems.

The team at Oxford have already enrolled over 1,000 participants for their UK trial. Some of the volunteers have received a placebo, allowing researchers to determine if the vaccine works in humans over the coming months. Gilbert says that the lack of problems present in the monkey study was very reassuring.

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MedTech

90-minute COVID-19 testing device

Mounir Jamil

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CovidNudge-Testing-Device-scaled

Since the emergence of the novel Coronavirus, scientists, healthcare workers and physicians have stressed on the need for more rapid diagnostic testing. A recent study from Imperial College London shows that a new testing device can yield results in just 90 minutes.

The new paper, published in the Lancet Microbe, claims that the new testing device, dubbed CovidNudge, has successfully matched time-consuming laboratory test results. This means that waiting days for a COVID-19 test result will soon be a thing of the past.

The testing on the CovidNudge started back in April, when a research team led by Professor Graham Cooke began trawling three different hospitals across London and Oxford looking for noses and throats to swab. They managed to obtain 386 samples from three different groups: emergency department patients with suspected Coronavirus, self-referred healthcare workers with suspected Coronavirus, and hospital-admitted patients with or without COVID-19.

Paired samples indicated that Cooke’s group can directly compare the accuracy of their 90-minute testing device with centralized lab tests. Cooke explained in a press release that the results were remarkable. He claimed that the CovidNudge does not have a trade-off between speed and accuracy, the testing device can achieve both.

The CovidNudge is basically a portable PCR platform that is spread across two devices:

a blue container, weighing in at 40g, called the DnaCartridge, which looks similar to the container you might put your retainer in at night. A nose and throat swab are taken from the patient and are then inserted directly into the DnaCartridge. The cartridge is then placed in the NudgeBox processing unit, a box roughly the size of a shoebox and coming in at 5kg. This packs in all the testing equipment needed to run a real-time PCR test.

The CovidNudge had spectacular performance, as it achieved an overall sensitivity of 94% and a specificity of 100% when compared with lab-based tests. Out of the 386 samples collected, the CovidNudge confirmed 67 positive results, compared to 71 positive results from lab tests.

The testing device is produced by DnaNudge, an Imperial start-up that includes clinicians and doctors from Imperial College Healthcare NHS Trust, Chelsea & Westminster Hospital NHS Foundation Trust, DnaNudge, and Oxford University Hospitals NHS Trust. So far, it has been deployed and installed in eight London hospitals.

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Nurturing your mental health during a pandemic

Mounir Jamil

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Nurturing your Mental Health during a Pandemic

Certain COVID-19-related words such as social distancing, pandemic, and quarantine are enough to make anyone feel anxious. While maintaining a distance from others helps mitigate the spread of the coronavirus, it does take a certain toll on our mental health. Luckily technology presents possible solutions for those of us who are battling with depression and anxiety.

The Center for Disease Control and Prevention (CDC) has surveyed upwards of 5,000 American adults and has found that symptoms for anxiety and depression skyrocketed between April and June this year. The number quadrupled, as approximately four times the amount of people have reported that they are depressed in 2020 compared to 2019.

From the population surveyed, almost 10% claimed that they seriously considered suicide over the past 30 days, and ¼ of young people aged 18-24 admitted the same. With this survey indicating that 40% of US adults are struggling with mental health conditions or substance abuse, researchers wondered if certain factors such as unemployment, lack of school structure, isolation, and other financial concerns were key stressors amid the pandemic.

CDC offers telehealth as a practical and effective means of treatment for COVID-19 mental health conditions. Earlier in March, the Centers for Medicare and Medicaid Services announced that it will be expanding what Medicare would pay for regarding virtual visits. Patients will have more access to e-visits after payment for doctors, clinical psychologists and licensed clinical workers have been approved.

Not everyone is comfortable with visiting a doctor for their mental health. Mobile apps offer practical and convenient methods that are applied in face to face therapy.

Take Sanvello as an example. Sanvello now has more than three million people using their app for peer support, self-care, therapy, and coaching. The app offers daily mood tracking, coping tools to manage stress, anxiety and depression, along with guided journeys. You can speak directly to a coach that is trained in cognitive behavioral therapy (CBT) or even join a live video group class.  A study from the Oregon Health and Science University has found that adults aged over 60 that used video chat applications had almost half the risk of depression. In the survey, researchers found that using texting and social media showed little effects in boosting spirits. However Skype and FaceTime seemed to be better tools for alleviating depressive symptoms and uplifting one’s mental health.

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Impacts of the pandemic on SMEs: First in, first out

Adnan Kayyali

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Impacts of the pandemic on SMEs First in, first out

The pandemic sent shockwaves across the world with many SMEs bearing the brunt of the crisis due to the reduction in global demand for goods and services.  

The worst effect of the pandemic on SMEs were the mass layoffs seen throughout all industries, although disproportionately. Disposable income that could have circulated in the economy became scarce, leaving many SMEs susceptible to permanent closure as people spend their money with greater caution. This was only a few weeks into the crisis, and prior to any government aid.

Business owners had very different predictions about the duration of the pandemic, leading them to make varied decisions on whether or not to keep their employees, cut their losses, or whether to save up or spend their stimulus checks. Many business owners were paying from their own pocket to stay afloat, and could not last more than a few weeks or few months, with layoffs.

A survey of more than 5,800 small businesses between March 28 and April 4, 2020 was conducted to determine how adaptable businesses were to the sudden change of the market and social landscape, and the impacts of the pandemic on SMEs.

According to the survey, 92% of SMEs changed at least one thing in their business model to adapt to COVID-19, most using some form of digital technology to bypass, adapt, or improve many traditional – potentially risky – ways of doing business.

Noting that some companies selected more than one option, the changes were listed as follows:

  • 58% of businesses said that they had adopted a new online delivery channel
  • 40% created new virtual services
  • 36% listed the use of a new offline delivery channel, such as Uber Eats.
  • 31% had released a new product.
  • 19% new customers

Consequently, the survey also listed the 5 most commonly mentioned challenges that these businesses have experienced:

  • 22% lack of employee skills
  • 16% lack of adequate funds
  • 14% setting up new online delivery channels
  • 9% developing new products.
  • 8% faced challenges adapting to the new health and safety standards
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