An article explaining when we could expect a Covid-19 vaccine to be available and proposed treatment options
The race is on to produce a coronavirus vaccine
If vaccine development is accelerated and rushed through, could safety and effectiveness be compromised?
What are our treatment options for COVID-19?
Vaccine manufacturers and academics are frantically working on developing
a vaccine against COVID-19 but will it be too late for this current pandemic?
Even if a vaccine becomes available, how can we be sure it will work?
When will a corona vaccine be ready?
Typically, a vaccine takes 10-15 years to develop, however, pandemic flu
vaccine development is accelerated and can take approximately 5-6 months. The sped-up
process starts with identifying the new strain of influenza virus with pandemic
potential, refining bulk manufacture procedures, conducting clinical trials and
finally, approval by regulatory authorities. The accelerated emergency
procedure allows for fast-track approval of a new vaccine once an influenza
pandemic is declared.
One US based firm started testing their candidate COVID-19 vaccine in human volunteers in a Phase 1 study7
in March and this week, researchers from the Oxford Vaccine Group have begun
recruiting for Phase II/III human trials8. Other companies in
pursuit of a COVID-19 vaccine include
Pfizer9, Johnson & Johnson10, Sanofi Pasteur11
and GSK12.
How will we know the vaccine will work?
Did you know that in Europe, when your regular annual flu vaccine undergoes
human clinical testing, it is tested for safety but not actually tested for its
‘effectiveness’ to prevent us getting the flu?
Instead, what scientists look for when testing a new flu vaccine in human
clinical trials is establishing whether people get an immune response, meaning do
they produce antibodies, against the flu strains in the test vaccine. This
gives us an indication on whether the vaccine may be protective. In addition,
there is no guarantee that the flu strains chosen to be in the vaccine will be
the same circulating strains causing flu in your country during the forthcoming
winter season – it’s a predictive guessing game that scientists have to manage16.
Why can’t all flu clinical trials look at true vaccine effectiveness?
Investigating whether the test flu vaccine works is challenging and often requires conducting large and
expensive clinical trials. We usually observe how well a vaccine has worked after
each flu season once it has been given to the population. Vaccine effectiveness
varies from one season to the next and in the UK, overall effectiveness has
been estimated at between 30-60% for adults aged 18 to 65 years (flu infection
in primary care)19.
Can we be sure the corona vaccine will be safe?
Withresearchers working at breakneck speeds with
pressure to develop a pandemic vaccine as fast as possible, how can we be sure
the vaccine has undergone the accustomed thorough safety test requirements?
Back in 2009, during the H1N1 (swine flu) influenza pandemic, an influenza
vaccine was used in several European countries which was later found to have an
increased risk of narcolepsy21 (a condition that causes a person to
suddenly fall asleep at inappropriate times).
For a final pandemic vaccine, large-scale safety data will be generated by
using the vaccine during a pandemic and the WHO advises24 all
countries administering pandemic vaccines to conduct intensive monitoring for
safety and to report adverse events. In
Europe, in preparation for a pandemic vaccine, some manufacturers would have
conducted advance studies using a so-called “mock-up” vaccine which can greatly
speed up regulatory approval.
Will there be enough vaccine to go around? Who should get the vaccine
first?
Even if an experimental vaccine appears to work in clinical trials, mass
producing them quickly is certainly a massive challenge. Around 90% of flu
vaccines are made in chicken eggs26. Production takes six months —
an eternity during a pandemic situation. Faster, alternative manufacturing techniques
are emerging, such as using cell-based methods.
If there aren’t enough vaccines to go around, who gets priority? Wealthier
countries? Richer individuals who can afford to pay out of their own pockets? The
elderly vulnerable patients or those with underlying medical conditions? Or do
we protect front line healthcare workers first?
What are my treatment options if I get the corona virus? It has been
reported that intravenous vitamin C, tocilizumab/Zinc
supplements/garlic/anything else has cured patients with coronavirus.
The reality is, there is no empirical evidence
that any medication, chemical or substance is effective as treatment against
COVID-19. Some compounds could help with symptomatic relief but are not
effective medical treatments for the disease yet.
There is a difference between proposed treatments for symptoms (e.g.
vitamin C) and a proposed curative treatment for the disease27.
The WHO are focusing on some promising drugs which are currently licensed
for treating other conditions. These include an experimental antiviral compound
called remdesivir; the malaria medications chloroquine and hydroxychloroquine; and
a combination of two HIV drugs, lopinavir and ritonavir.
[-link to previous article discussing digital advancements proposing
treatment]
What does it take to develop an effective treatment for a disease and
have it approved for market?
The medication’s efficacy would need to be tested, it’s safety profile would
have to be proven and longer-term studies on its use in wider population groups
need to be studied which all take time, from 7 years and sometimes up to 12
years28.
When would a treatment for COVID-19 be ready?
One of the benefits of researching existing approved drugs is that we
already know they are safe, so in theory it would take less time to get the
drug approved to treat corona. Time will
tell if any treatment will be available fast enough to impact the current
pandemic.
What do we know
about the current potential treatment, remdesivir, reported to be in use in
several active clinical trials around the world?
medDigital first wrote about the Chinese and
American investigations into remdesivir as a potential treatment for COVID-19
back in February 2020. Since then, it has risen in prominence as more investigative
trials have opened in different countries around the world (including the WHO’s
adaptive, randomised, open-label multi-centre safety and efficacy trial in
hospitalised adults)30.
The Food and Drug
Administration (FDA) in the USA has rapidly authorised remdesivir for the
treatment of coronavirus patients but this is not a formal approval – so far,
the investigative medication has not been officially approved for any purpose
anywhere in the world.
Interim clinical
data in the international trial has indicated remdesivir shortened recovery
time from 15 to 11 days in hospitalised patients31, which resulted
in a stop to the study when there was clear evidence the drug was effective.
The Principal
Investigator of the study, Dr Andre Khalil of the University of Nebraska, noted
that sicker patients (across the racial, gender and age spectrums) fared as
well on remdesivir and their average time to recover is slightly faster,
regardless of whether they began treatment before or after 10 days of symptoms32.
These results are
a sign of hope for an effective treatment’s availability in the battle against
COVID-19, though there is a consensus that wider scale studies and more data
are needed, and as of May 2020, it looks like this will be incoming by the end
of the year.
What do we know
about hydroxychloroquine as a potential treatment for COVID-19?
Of all potential
treatments under recent investigation, the anti-malarial drug hydroxychloroquine
has been mentioned in various new media the most – likely due to the President
of the United States, Donald Trump’s admission33 that he has been
taking it in an attempt to prevent hydroxychloroquine.
The latest (as of 22nd
May 2020) study in the Lancet reports34 that hydroxychloroquine might
increase the number of deaths among those in hospital with COVID-19 (with death
rates of 9% in a control group compared to 18% in patients treated with hydroxychloroquine,
and even higher in those treated with a comination of hydroxychloroquine and antibiotics) and there
were no benefits to treating coronavirus patients with the drug.
Shortly after this
research was published, the WHO announced it had halted its testing of the drug
over safety fears35. Hydoxychloroquine has been shown to be safe for
malaria and conditions such as lupus or arthritis but there is no evidence from
any clinical trial that it should be recommended for use in treating COVID-1936.
What is “flattening the curve”, how can it be achieved and what are the benefits?
4.35 million. This is the number of total confirmed cases of COVID-19 globally as of today, 14th May 2020.1 Our world is facing an unprecedented challenge, potentially affecting everyone, but particularly certain vulnerable groups of the population.2 The WHO has underlined the importance of “flattening the curve” in order to control the coronavirus outbreak3 and you may be wondering “what does that mean?”
In epidemiology, an epidemic or “epi” curve is an illustrative way to demonstrate how an illness or outbreak progresses over time, using a simple diagram.4 The horizontal axis (x-axis) is the time when infection cases are confirmed, while the vertical axis (y-axis) is the number of cases confirmed.4 Each data point of the line represents the number of cases detected at a certain time. Due to the “bell” shape of the line, we call it “curve”.5 During ongoing outbreak investigations, the epi curve is updated as new data become available.4 When the infection rate is high, the curve appears sharp and its peak is higher, as many new cases are detected day after day within a short period of time.
The coronavirus infection rate is particularly high, with only 7 days needed for the cases to double.1 The problem healthcare services across the world are facing is that when the coronavirus infection curve goes up, it skyrockets.6 Too many people are infected at the same time. This means that all medical resources and supplies for testing, treating and managing those patients are used up instantly. 6 During an outbreak like the COVID-19 one, without a functional public health intervention, the demand exceeds what the healthcare system can offer and the outbreak is out of control.
Following the WHO guidance, public health systems worldwide are putting measures in place to “flatten the curve”. Governments aim to decrease the infection rate, so that the number of cases does not peak rapidly, and fewer people are infected at the same time.7 In a “flattened curve” the cases increase more gradually, reaching a lower peak. This doesn’t necessarily mean fewer people will eventually become infected, but that these infections will be distributed over a longer period of time. A slower infection rate means a less stressed healthcare system, fewer hospital visits on any given day and fewer sick people being turned away. 7 Overall, “flattening the curve” allows capacity and time to treat the ones in need.
The question is “How to achieve a flattened curve?”. As there is no current safe and effective treatment or vaccine specific to COVID-19, the main way to achieve this is through certain interventions. “Social distancing” and quarantine of confirmed or suspected cases are the main ones and the sooner they take place, the better. The UK, among many other countries, has announced strict measures to tackle the spread of the virus and has advised people to stay at home as much as possible and avoid unnecessary social interactions.8 Moreover, the NHS advises you follow some simple steps to prevent viral expansion, such as:9
Wash your hands well and regularly or use sanitizer
Cover your mouth and nose with a tissue or your sleeve and not your hands when you cough or sneeze
Put used tissues in the bin immediately and wash your hands afterwards
Do not touch your eyes, nose or mouth if your hands are not clean
If you feel any suspicious symptoms call 111
Another measure that helps prevent transmission is testing, testing (and) testing!10 Early detection is key, especially in asymptomatic cases. Apart from enabling early initiation of the right treatment before severe pneumonia occurs, it also allows isolation of those cases. For example, South Korea followed massive testing approaches which led to a drop of viral spread and the number of new cases per day has quickly reached a plateau.1
Are there any real benefits in “flattening the curve”? To answer this question let’s take a look at China. The first cases in China were recorded at the end of December 2019 and by January 23rd 2020 the city of Wuhan was placed under quarantine. Hubei province followed within days.11 Moreover, China put in place extensive public monitoring of citizens, as well as various methods of punishment and rewards to encourage adherence to such measures.12 According to the WHO, China’s most effective measures were “extremely proactive surveillance” to detect cases with extensive testing and immediate isolation of patients, rigorous tracking of close contacts and an “exceptionally high degree of population understanding and acceptance” of such measures.12 Thanks to these interventions, China today counts 0 new cases daily.1
In conclusion, measures to “flatten the curve” are essential in order to sustain a pandemic like COVID-19. But strict measures are not enough. It is important that you take them seriously, stay disciplined and follow them. Health officials predict many more people will become infected, but let’s not let this all happen at once! Consider this a personal responsibility, a little sacrifice you can do now that will save lives in the long-term.
With a significant shift in government
advice to the UK public around
COVID-19, medDigital and medCrowd team have continued working withing our
clients, old and new, to ensure we offer solutions that protect them, their key
stakeholders, our employees and partners.
All the medDigital team
are working from home, checking in with our clients and each other daily and
staying as productive, positive and healthy as possible:
Our medCrowd platform is available 24/7 as a compliant communications option for
healthcare teams and life sciences clients, a vital remote connectivity method as
the importance of social distancing increases (read more about medCrowd here).
Over 80 Digital Advisory Boards
later, we are ready, now more than ever, to help more companies with the
essential digital transformation that the current COVID-19 epidemic has forced
many to adopt.
We have increased our capacity to
work with clients on more Digital and Virtual Advisory Boards, webinars and
digital communications solutions. We wish to continue supporting
and guiding our clients by:
Fully run and
manage or consult on Digital Advisory Boards, talking publications
and live webinars
Providing strategic
insights or direct content development to achieve your objectives
Conducting full-service
scientific advisory review, from scientists with in-depth knowledge of the ABPI
code and experience working across several therapy areas
Lending our
specialist knowledge and skills, so you can effectively communicate
medical information across a variety of platforms
Dynamically
harnessing medical, commercial and digital capabilities through compliant digital
strategy, process optimisation and project management.
Whilst the priority remains staying safe and healthy,
your business needs don’t have to take a backseat during this challenging time.
We are ready to proactively help your team fully adapt to new practices using digital
scientific communications and can provide total support throughout your transformative
digital projects.
Let us discuss what we can do for you – get in touch with Lisa to make an inquiry about your projects or arrange a call.
We’ve also been working on some great content mythbusting, fact-checking and sharing credible information about COVID-19, which we will be sharing very soon on our social media channels!
We hope you continue to stay safe, look out for each other and
stay connected.
As a global healthcare challenge, how has health literacy affected what most people know about the coronavirus outbreak?
A modern, global PHEIC
The spread of Wuhan nCoV-2019, officially named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, by the International Committee on Taxonomy of Viruses[i]) has dominated news headlines around the world since the beginning of 2020. It was declared a Public Health Emergency of International Concern (PHEIC) by the WHO at the end of January, only 2 months after it was first reported by physicians in Wuhan, China.
Room for speculation
The information about the 2019-nCoV symptoms (usually including a dry cough and fever), related fatal viral diseases (SARS and MERS to name two of the other six human coronaviruses) and treatments in development are released at an extremely fast rate thanks in part to social media and digital communications.
Most readers of this blog will be allied to the life sciences industry or healthcare professions and therefore able to understand the science and health-related information behind these reports and better sift through the conjecture.
Rumours and the unknowns
So much speculation has been shared so widely and so quickly, it is often difficult to attribute any particular piece of news or rumour to one source. Initial reports about the 2019-nCoV disease origin, for example, ranged from zoonic (bats or snakes) to man-made.
There is a lot that
remains unknown about 2019-nCoV, probably more than there is speculation. We
still don’t have any known treatment for any coronavirus; treatment is
symptomatic and supportive.
Potential treatments?
In early February 2020,
a single case from the United States was documented about an nCoV-2019 patient
whose severe pneumonia improved after receiving treatment with an experimental
drug developed for Ebola.
Soon thereafter, Chinese media reported they were taking the same experimental treatment, remdesivir, into a large phase III randomised control trial with a planned enrolment of 761 subjects, currently ongoing. However, they did not highlight enough the treatment is not yet approved for use in humans.
As news of this experimental treatment’s use is being circulated, two large digital innovation companies have recently released their proposals for treatments based purely on digital development algorithms.
Possible digital solutions
Babylon AI’s report to the Lancet[iii] proposed a treatment based on its own algorithms. Insilico Medicine has also come up with six potential (theoretical) treatments based on its findings[iv].
Both companies have invited researchers and medicinal chemists to provide a practical assessment of their treatments’ feasibilities to treat nCoV-2019.
Although these signal promising digital and in-lab treatment options to explore, mainstream news stories are predominately focussed on the virus’s spread and the number of deaths or new infections.
medDigital will be keeping an eye on developing stories about promising treatments, especially those involving digital innovations
[iii] The Lancet, Correspondence, Volume 395, ISSUE 10223, Pe30-e31, February 15, 2020, Baricitinib as potential treatment for 2019-nCoV acute respiratory disease, Peter Richardson, Ivan Griffin Catherine Tucker, Dan Smith, Olly Oechsle, Anne Phelan, et al.
The ABPI announces new guidance out in Spring 2020!
A DAY WITH THE ABPI
As Affiliate Members of the ABPI, medDigital took part in the ABPI’s Social Media and Digital Day, which was held on 31st January 2020.
The day was a huge success – it offered ABPI members an opportunity to network, share best practice about using social media and explore its influence and effect on the work of pharmaceutical companies, through talks by representatives from the PMCPA, ABPI Code working group, pharmaceutical companies and specialist digital and social media agencies.
UPCOMING ABPI GUIDANCE ON DIGITAL COMMUNICATIONS
The ABPI announced that new Guidance on Digital Communications will be available in electronic form on the PMCPA website in Spring 2020.
The digital guidance is in the late stages of development, with significant input from our founder Dr Felix Jackson, who is working with the ABPI Code working group and members of the PMCPA to finalise for release.
Dr Felix Jackson was publicly thanked by the PMCPA Director Heather Simmonds on the day for his contributions thus far – reception to the news that this digital communications guidance was to be released was unanimously positive, especially from company representatives.
The ABPI receives numerous queries from pharmaceutical companies and PMCPA cases involving social media and digital communications and the challenges involved in navigating their use around the prohibition from promoting prescription-only medicines to the public.
COMPLIANCE IS KEY
A lot of great work is done within the life sciences industry for patients and the advancement of healthcare. Due to restrictions on advertising prescription-only medicines to the public, it can be difficult to tell the public about it using digital communications and social media. This is also the case when navigating the ABPI Code of Practice’s non-digital-specific guidance on how to use these channels to share good quality information.
On the day, the speakers shared some brilliant examples of the use of social media to share information with the public in a compliant and effective way. One such example was the Twitter campaign for #valuingmedicines run by the ABPI, which provided a very successful framework later shared by Pfizer and MSD for recruitment purposes.
“Pharmaceutical companies want, and indeed should be able to use digital media, and need to identify ways of utilising digital communications whilst complying with compliance restrictions.”
PMCPA Digital Communications Guidance, coming Spring 2020
OPPORTUNITIES FOR THE INDUSTRY
Social media platforms provide companies with the opportunity to share what they are doing for patients on a broader stage, rebut misinformation and respond to crises and criticism. Creating content for social media platforms has helped keep news stories down, also known as “rebuttal in action”, by allowing companies to frame their own strategic narratives to a captive audience.
Social media platforms are not just a commercial marketing tool for pharmaceutical companies – they can also be used very successfully for non-promotional activities (more on that later).
A number of key takeaway points for running successful social media campaigns came up numerous times as common themes for the most effective campaigns that engage audiences on life sciences industry social media platforms.
STEPS FOR SUCCESSFUL ENGAGEMENT
Tell stories people care about
People care about people. It can be presumed that at least some of the audiences on social media platforms owned by pharmaceutical companies are sceptical about the intentions of any content shared. One way to mitigate this is to use the voices of patients to tell their stories directly to the audience. Social listening has gathered that these are the stories people care most about.
Target the right audience
Different social media platforms will reach different audiences. LinkedIn content is likely to reach professionals and businesses with an interest in specific fields, whilst Instagram content is likely to reach young teens and under 30s. With that in mind, the social space is constantly changing, and there are up-to-date statistics available for each platform that can help with the decision about how to tailor content for each one.
It can also be advantageous to keep content regional where possible, relating it to people in that geographical region specifically.
Think:
mobile first
Most people access social media platforms through mobile phones. Considering how the content will look, feel and work on a mobile device is key, often more important than how it would look on any other electronic device such as a tablet or laptop. This is true regardless of the platform used, with significant improvement in engagement by keeping content square-shaped (square videos, square photos) and adding subtitles for videos.
Redefine who your influencers are
It is difficult to discuss social media without mentioning influencers, but this term can take on a completely different meaning from the usual (think: Kardashians) in the life sciences industry.
SOCIAL MEDIA INFLUENCERS
Engaging influencers for pharmaceutical companies are often the patients whose lives have been changed by the innovative research they do. Aside from being influencers, this also benefits patients by giving them a voice on social media platforms.
Another effective influencer for a pharmaceutical company can be an internal advocate such as an employee; this approach is most successful when the advocate is used long term. Although Novartis’s CEO Vas Narasimhan (one of LinkedIn’s Top Voices: Global Influencers 2019) is a great example of this, it is not necessary to use a senior figure within the company to engage an audience.
Pfizer’s non-promotional social media campaign for meningococcal meningitis was a hugely successful example of maintaining the balance of authenticity and being compliant by using social media influencers. Regardless of the exhuasting amount of medical review required (60+ pieces at last count!), the engagement and rewards were worth it for the company and reaped dividends strategically in a successful collaboration between medical and marketing.
CRISIS MITIGATION RULES
It would be remiss to omit the obvious need for crisis mitigation for when the use of digital communications goes wrong in the highly regulated pharmaceutical industry. Brand Anarchy and #Brand Vandals author Steve Earl gave the following simple advice on crisis fundamentals:
Establish if it is a crisis or not
Act and respond quickly, with agile approval
Pause scheduled posts
Take it offline where you can
Keep everyone (internally) informed
With most large pharmaceutical companies employing an average of 1.8 full-time employees in a dedicated social media team, most crises can be mitigated.
INCREASING INVESTMENTS
The ABPI conducted a member survey on companies’ social media activities ahead of the Social Media and Digital Day. This revealed that as of 2020, 61% of respondents include social media as part of their crisis communications planning. It also revealed that 1 in 10 companies are spending over £500,000 per on social media activities, compared to none in 2018 – across the board, companies are spending more now than they were in 2018.
The opportunities afforded by digital communications are evidently very investible for the industry and are being taken advantage of. With the PMCPA guidance out soon, sharing information using digital communications will be done even more compliantly and effectively than before – we’ll keep you updated on the release.
If you asked healthcare professionals, industry experts and patients what they thought the definition of “digital healthcare” was, you would likely get a myriad of varied answers. Anything ranging from patient-generated data in wearable technology to companion diagnostics in genomic medicine is likely to get a mention or be covered by any one definition. Thus, the potential for confusion around the term and its true definition – if there is one.
Pharma meets big tech
In the pharmaceutical industry, the trend for partnership with big tech firms, whilst not new, has taken place at a faster rate in recent years[1] (Novartis with Microsoft, Roche with Spark Therapeutics, Pfizer with IBM to name a few). So, where does the integration of pharma and healthcare organisations with big tech end? And where does digital healthcare on its own merit begin? Is there even a difference?
According to the Digital Therapeutics Alliance , [i]for digital healthcare to distinguish itself from other healthcare categories:
“its primary function should be delivering software-generated therapeutic interventions directly to patients to prevent, manage or treat a medical disorder or disease”.[2]
This could more or less read: “all the above” as
a correct definition from the industry’s biggest consortium of commercial
leaders. At the JP
Morgan Healthcare Conference that took place on the 13th-16th January 2020,
the themes of this breadth of inclusion in the term’s definition, the potential
confusion it causes and how it might be hurting the sector were big topics.[3]
Because of the diverse approaches to the definition,
there are big differences in quality and strategy from many new companies
dabbling in digital healthcare. We are yet to see how many of these can be
successful.
Old technologies
It has also been questioned whether an
industry that still uses fax machines in daily communications is ready for the
digital innovation available. One counter argument is that fax machines and
other ubiquitous “dinosaur/retro” technologies still used in healthcare today are
reliable, easy to operate and fix – if it works for healthcare professionals
and patients, does it need to be replaced by something new at all? (medDigital
have written an article
about the “dark side” of using fax machines on the medCrowd blog).
At the JP Morgan conference, American Medical
Association CEO James Madara said that better curation is needed in order to
help healthcare professionals make informed decisions about recommending new
technologies under the label of “digital healthcare” to patients.
There has been no consensus as to whether this
broad scope has a potential to harm the sector. The question remains: how would
defining “digital health” in a more nuanced way add value to the healthcare
sector? Could it be defined and differentiated from other healthcare as succinctly
as say, champagne is distinguished from all other drinks on the market?
What the future holds
The truth is probably that time will tell. Digital
healthcare has arguably been integrating itself into everyday clinical practice
and healthcare research for many decades now. So, its increased umbrella use by
emerging partnerships and innovations may help distinguish its application eventually.
As time goes on, this could transform it from an aspiration today into a well-defined
entity in the future.
What do you think the definition of digital
healthcare is?
