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Russia releases clinical data on COVID-19 vaccine

Mounir Jamil

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Russia releases clinical data on COVID-19 vaccine

Earlier last month, Russian President Vladamir Putin shocked the scientific community when he claimed that Russian authorities had approved the world’s first COVID-19 vaccine, dubbed Gam-COVID-Vac. This was despite the fact that no specific data had been published regarding the COVID-19 vaccine safety or efficacy, and furthermore, no large scale trials were completed.

Now, the highly anticipated safety and immunity data of two initial early phase clinical trials have been published in the Lancet medical journal and experts have been quick to offer their opinions on the data. 

The trials of the COVID-19 vaccine (Gam-COVID-19 NCT04436471 and NCT04437875) that were conducted earlier this year in June, employed a sample cohort of 76 healthy individuals, ages varying from 18-60 years old. Both samples were non-randomized 42-day long trials

The results of the trial were published in The Lancet, and they indicate that the COVID-19 vaccine has been well tolerated, and produced cellular and humoral immune responses in the chosen sample. 100 percent of the sample developed an antibody response to Coronavirus, and were even presented with mean antibody titres that measured exceptionally higher than the samples that were obtained from patients that recovered from Coronavirus.

The scientific community holds a general response that these results are promising and encouraging, although some concerns have been raised regarding the size of the trials.

Senior lecturer at the SPRU (Science Policy Research Unit), University of Sussex, Dr. Ohid Yaqub commented about another possible flaw in the design of the trials, which is the lack of randomization. He said “Normally, such a study would be the basis for debating whether to proceed into larger trials and the costs that entails.”

However, Russian authorities had made previous statements regarding the next steps for the COVID-19 vaccine, and they were quite ambiguous. Yaqub mentioned that when it comes to regulatory approval, size and design of a Phase I/II study are nowhere near sufficient to be recognized as standards for wide scale approval. As the study was not randomized and was not large enough to detect rare safety issues.

Senior research fellow in global health at the University of Southampton, Michael Head seems to agree with what Dr. Yaqub has to say. Head is aiming for transparency when it comes to the COVID-19 vaccine development and deployment on a global scale, he mentions this is specifically important given the possible impact of vaccine hesitancy.

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MedTech

The pandemic’s hidden digital divide

Mounir Jamil

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Digital Divide

The current pandemic has really opened our eyes to the importance of interconnectivity. Lockdowns, curfews, and quarantines helped us realize how our progress and prosperity is a function dependent upon one other, and we can clearly see this on an individual-micro level and on a group-macro level (companies, groups, governments).

The larger the company, the more complex the ecosystem of partners and their interdependence. Studies show that this is particularly true in developing countries where brewing beer sustains millions of livelihoods dependent on a fragmented and traditional trade such as corner shops, grocery stores and small retail.

Naturally, as a company grows larger, a more complex ecosystem of partners is required, but what about smaller micro retailers? The current pandemic has shed light on a critical weakness for small retailers. In most developed countries, the general consensus is that citizens enjoy high speed internet access therefore transitioning a business from brick-and-mortar to online seems relatively straightforward (with some training and practice). However, when we look at other countries where Wi-Fi is not as readily available, or when citizens have to walk lengthy distances to access Wi-Fi, that’s when you understand the daily impact of the digital divide.

As the pandemic continues, access to technology becomes another source of vulnerability and inequality as smaller retailers struggle to make the shift to digital, which only makes it harder for them to deliver across their value chain. Businesses that played vital roles in their communities are now unable to meet the growing demands online.

The pandemic has forced us to face the issue of the digital divide; while some might think we are all moving toward a digitally enabled future, the reality is that there are many communities across the world still falling behind. The issue of what needs to be done rests in the hands of governments and leaders worldwide to ensure that digital inclusion is extended to all citizens and disadvantaged groups.

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MedTech

UK to rollout first-round of Pfizer/BioNTech vaccine

Mounir Jamil

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Pfizer BioNtech

The British Medicines and Healthcare products Regulatory Agency (MHRA) recently gave the green light to rollout the Pfizer/BioNTech vaccine for commercial use in the UK.

The first batch of vaccines are already making their way to the UK, with 800,000 units expected in the coming days. Matt Hancock, Secretary of State for Health and Social Care said that the NHS will do its part in contacting people for the vaccine shot.

Based on vaccine storage requirements (-70°C), hospitals will be the first to receive supplies since they already have the correct storage facilities; the first round will likely take place in hospitals for care home staff, NHS staff and patients.

While the typical vaccine usually takes 10 years to be fully accepted, the Pfizer/BioNTech vaccine was developed and introduced in just 10 months.

The UK has ordered enough units to vaccinate 20 million people – around 40 million doses in total. These doses will be given out as soon as they are made available by Pfizer in Belgium. The first round is expected next week, and “several millions” will be made available throughout December said Hancock. He also added that the majority of the rollout will take place next year.

The vaccine will be free, and it will not be mandatory. In addition, there are 3 ways of vaccinating citizens in the UK

  • Vaccination Centers
  • Hospitals
  • In the community, with general practitioners and pharmacists

As we speak, 50 hospitals are on stand-by and vaccination centers in venues like conference centers or sport stadiums are now being set up. The Pfizer/BioNTech vaccine will hopefully mark the beginning of the end of the pandemic.

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MedTech

New technology has made COVID-19 group tests possible

Adnan Kayyali

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COVID-19 group tests

An independent technology and product development company, The Technology Partnership (TTP) has developed CoTest, a pooled screening device for conducting COVID-19 group tests. 

The vaccine is coming but when and who will get it first still remains unclear, but what is for sure is that testing cannot stop now, or in the next year at the very least. TTP states that their solution allows tests to be done on up to 40 people at a time, revealing the result within 30 minutes.

The equipment used for testing is reportedly easy to handle – samples are taken the conventional way, through a nasal or oral swab.

“We believe this technology represents an important step forward in distributed screening capacity, reducing the risk of transmission and allowing organizations to take greater control over their health security, stay open and relieve pressure on central services”.

Given the easy use and transportation of the CoTest, businesses and institutions of all kinds may want to get their hands on it. Essentially the COVID-19 group tests are just one test, but for up to 40 people at a time. This is an empowering level of efficiency that can take the load off central testing centers and labs while providing a more immediate response.

“With support, it’s entirely possible that ‘CoTest’ could be in schools and businesses and being used as a key tool in how we manage the virus.” said Peter Crossley, product development lead at TTP. The cost efficiency of this technology becomes increasingly powerful as infection rates decrease and health security monitoring becomes key.”

TTP is seeking more partners to push their new COVID-19 group test solution, which could prove to be a crucial tool in the coming months and years. While the world waits for a vaccine, we will have to continue finding ways of mitigating the spread of COVID-19.

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