Due to the number of emails and/or messages about the COVID-19 vaccines and MS I have been receiving I have put together a rough-and-ready decision aid to deal with the most common questions that have arisen so far.
Please note this is a beta version using Google Slide’s technology. As questions come in I will update the decision aid. If you think it is worthwhile we may be able to convert the decision aid into one of our ClinicSpeak web apps.
Your feedback on the design and format of the decision aid would be much appreciated. Thanks.
The horse’s mouth = the MHRA (Medicines and Healthcare products Regulatory Agency)
I have received several vexatious emails accusing me of subjecting my patients, and people with MS (pwMS) in general, to an experiment by recommending and promoting the COVID-19 vaccines. I want to remind the readers that we need to listen to experts. I was challenged that may be the experts are wrong. So if the experts are wrong which regulators should I challenge first; the FDA, EMA, MHRA, Russian, Swiss, Japanese, Canadian, etc.? Have they all got it wrong?
Yes, occasionally a single regulatory authority may get things wrong, but they have checks and balances in place to correct their errors. As so many regulatory authorities have approved these vaccines is very telling. In addition, for most of the regulatory authorities above their approvals have been unanimous, i.e. all the experts and representatives on their panels have agreed that the safety and efficacy of the COVID-19 vaccine warrant their emergency marketing authorisations.
Some of these vexatious commentators state that these vaccines were developed too quickly. Yes, they were developed quickly, but not too quickly. The platforms used for these vaccines were already in place and all that had to be done was to slot in the SARS-CoV-2 spike protein immunogen, tweak the production methods and the vaccines were ready for mass production. For the Oxford-AstraZeneca vaccine, all they had to do was swap out the sequence for the coronavirus that causes MERS for SARS-CoV-2. The latter process happened within a week or two.
Instead of doing trials in series a lot of the clinical development was done in parallel, i.e. phase 1b/2 immunological studies were done as part of phase 2 trials and phase 3 studies were added-on in an adaptive way to phase 2 trials. The reason for this turbocharging or the development pathway was that governments had derisked the development of the vaccines and given money to the companies to develop and test vaccines. In parallel governments also provided capital to build production facilities etc.
So in summary the vaccine development programme was sped up by capital and contracts by governments for a defined number of orders. In normal times this does not happen, hence the many years it ‘normally takes’ to develop a vaccine. In my opinion, no short-cuts were made in terms of testing these vaccines for safety and efficacy. In fact, one could argue that the COVID-19 spike protein vaccines, as a body, represent the largest safety trial programme in vaccine history.
Now that the vaccines have been used on millions of people if there were any rare sinister adverse events we would have expected the regulatory agencies to have reported them. And yes they have. The only one that sticks out from the Israeli and UK experiences is Bell’s palsy, as a rare adverse event, with the Pfizer-Biontech and probably the AstraZeneca-Oxford vaccine as well.
I would like to remind these vexatious commentators that there is no conspiracy theory behind the COVID-19 vaccines and vaccination programmes. What public health officials are doing is simply trying to save lives, protect healthcare services and to stop the pandemic.
Dare I suggest that the ‘post-truth era’ is coming to an end and that politicians, patients and the public will start to value experts again? As a society, we spend an extraordinary amount of time and money to educate and train experts to manage and run institutions such as the FDA, EMA, MHRA, CDC, WHO, etc. These experts need to be trusted and respected; all they are doing is what they have been asked by us to do.
We all have a responsibility to act responsibly and to not dismiss COVID-19 vaccines as being ineffective, unsafe and designed to anything else other than what is in their labels. In general, these vaccines are very effective, safe and reduce your chances of getting severe COVID-19 and dying from COVID-19 by well over 95%. Why wouldn’t you want the vaccine?
Ingrid Torjesen. Covid-19: First UK vaccine safety data are “reassuring,” says regulator. BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n363 (Published 08 February 2021)
Excerpts:
… The UK’s medicines regulator has described the first safety data related to covid-19 vaccines as “reassuring,” with most side effects reported being mild and in line with those seen with other types of vaccine. “The benefits continue to far outweigh the risks,” said June Raine, chief executive of the Medicines and Healthcare Products Regulatory Agency (MHRA).
… The agency published yellow card data for covid-19 vaccines given between 9 December 2020 and 24 January 2021, which comprise 22 820 reports from 7 164 387 first doses and 474 156 second doses. Most of the reports (16 756) are from people who received the Pfizer-BioNTech vaccine, and these list 49 472 suspected reactions. Administration of the AstraZeneca-Oxford vaccine began later, on 4 January, and 6014 yellow cards were reported up to 24 January, detailing 21 032 suspected reactions. A further 50 yellow card reports did not specify the brand of vaccine.
… By 24 January an estimated 5.4 million first doses of the Pfizer-BioNTech vaccine and 1.5 million doses of the AstraZeneca-Oxford vaccine had been administered, and around 0.5 million second doses, mostly of the Pfizer-BioNTech vaccine. Overall, the data show around three yellow card reports per 1000 doses of the vaccine given—a smaller proportion than the 10% of patients reporting them in clinical trials.
…. Severe allergic reactions were reported after administration of the first doses of the Pfizer-BioNTech vaccine on 9 December. Subsequently, the MHRA advised against its use for people with a history of severe allergic reactions to any ingredients in the vaccine and said that recipients should be monitored for at least 15 minutes.
…. A total of 101 anaphylaxis or anaphylactoid reactions after the Pfizer-BioNTech vaccination (1-2 cases per 100 000 doses) have been reported to the MHRA up to 24 January, and 13 anaphylaxis reactions after the AstraZeneca-Oxford vaccine.
….. Bell’s palsy is listed as a possible side effect of the Pfizer-BioNTech vaccine, and facial paralysis or paresis after this vaccine was mentioned in 69 yellow card reports; facial paralysis was mentioned in six reports after the AstraZeneca-Oxford vaccine. Philip Bryan, vaccine safety lead at the MHRA, said, “Bell’s palsy is something that can also happen naturally, so its association with the vaccine hasn’t been established.”
… The MHRA received 107 reports of death after the Pfizer-BioNTech vaccine, 34 after the AstraZeneca-Oxford vaccine, and 2 in which the brand of the vaccine was unspecified. Most reports were for older people or people with underlying illness, the MHRA said, and a review of individual reports and patterns of reporting did not indicate that the vaccine played a role in the death. “We know, for instance, based on data from [the Office for National Statistics], that for every 100 000 doses given to people aged 80 or over, around 200 people die of natural causes within a week,” Bryan said.
Did you know that as of September 2020, only 54.1% of the public in the UK and 42.5% in the USA would ‘definitely’ accept a COVID-19 vaccine to protect themselves?
I sincerely hope these figures are wrong and have changed substantially since September 2020. Why? These vaccine acceptance rates are lower than the proportion of vaccinated people required to achieve the anticipated herd immunity levels for SARS-CoV-2. Interestingly, in the study that produced these disturbing figures (see below), a higher proportion of individuals in both the UK and the USA would ‘definitely’ vaccinate to protect family, friends and at-risk groups, suggesting that effective altruistic messaging may be required to boost vaccine uptake. This is why I have always taken the line that vaccination is not necessarily about you, but society and in the case of COVID-19 vulnerable people.
It is clear that misinformation/disinformation campaigns on social media have a remarkable effect on individual behaviour and lead to vaccine hesitancy. It is clear from recent political events across the globe that we need to move beyond the ‘post-truth era’ and reclaim the moral high ground and to start trusting our experts again. We have put in place institutions, such as our drug regulatory agencies, to protect the public. The fact that they have the necessary ‘deep expertise’ and have vetted and licensed several COVID-19 vaccines makes them safe to use at a population level. So my message is simple if you are offered a chance to be vaccinated with one of the COVID-19 vaccines take up the offer ASAP. The vaccine will not only protect you but your fellow citizens as well. In fact, you will be saving lives.
The more unvaccinated people there are. particularly unvaccinated immunosuppressed individuals, the more opportunity the virus has to mutate and develop immune escape variants, i.e. new virus strains that are resistant to immunity from the current vaccines. These new strains will extend the pandemic, killed more people and make the economic impact of the pandemic worse. Based on this alone several commentators make the point that we all have a duty to be vaccinated.
What this study also shows that there is more to simply fighting the virus to end this pandemic; we have a propaganda war on our hands fighting both misinformation and disinformation about the safety and efficacy of COVID-19 vaccinations. I think we all have a responsibility to join this battle. Everyone needs to say something like ‘I am a vaccinee and proud of it’ or ‘I have done my duty and have had the vaccine’. I am not a marketeer or advertising creative, but if you could come up with some catchy slogans we could then all push them out on social media and start a campaign. What do you think?
The widespread acceptance of a vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) will be the next major step in fighting the coronavirus disease 2019 (COVID-19) pandemic, but achieving high uptake will be a challenge and maybe impeded by online misinformation. To inform successful vaccination campaigns, we conducted a randomized controlled trial in the UK and the USA to quantify how exposure to online misinformation around COVID-19 vaccines affects the intent to vaccinate to protect oneself or others. Here we show that in both countries—as of September 2020—fewer people would ‘definitely’ take a vaccine than is likely required for herd immunity, and that, relative to factual information, recent misinformation induced a decline in the intent of 6.2 percentage points (95th percentile interval 3.9 to 8.5) in the UK and 6.4 percentage points (95th percentile interval 4.0 to 8.8) in the USA among those who stated that they would definitely accept a vaccine. We also find that some sociodemographic groups are differentially impacted by exposure to misinformation. Finally, we show that scientific-sounding misinformation is more strongly associated with declines in vaccination intent.
One of the reasons I started blogging was to counteract misinformation and eventually disinformation about CCSVI. CCSVI which started off as a hypothesis, supported by flawed and biased initial studies (misinformation) that was rapidly spread via social media channels, which then morphed into a disinformation campaign.
The CCSVI disinformation campaign included several conspiracy theories to explain the reluctance of neurologists to accept CSSVI as the cause of MS and to refer patients for so-called ‘liberation therapy’ procedures. The latter was soon followed by unscrupulous medical practitioners who opened up treatment centres to address the so-called unmet medical need for liberation therapy. The MS scientific and medical community were taken off guard but eventually responded and performed well-designed controlled trials to show that CCSVI was not a pathological entity and was not the cause of MS. Many of these studies demonstrated that liberation therapy was ineffective and probably caused more harm than good. Over time CCSVI has faded and is now rarely spoken about or searched for online (see Google trend metrics below).
The lessons learnt from CCSVI must not be forgotten, because the parallels between CCSVI and COVID-19 vaccine-hesitancy are remarkably similar, which is why we need to act. One way is for the medical and scientific community to get out there (1) to educate the community about vaccines and how they work, (2) to debunk the conspiracy theories about the COVID-19 vaccines, (3) make themselves available to the MS community to answer questions about the vaccines, (4) to be transparent with efficacy and safety data, (5) to admit that there are data gaps in relation to people with MS and (6) to set-up studies to answer questions and create an evidence base.
It is also important not to create a ‘them and us’ conflict. People who are hesitant about having a COVID-19 vaccine have valid personal reasons for not wanting to be vaccinated. We want to understand your reasons, discuss them and see if the science and data available is able to reassure you so that you may reconsider your position on vaccination.
We at Barts-MS are planning to host an online webinar or series of webinars to answer the many questions from you in response to the post on vaccine hesitancy. Rather than using email can you please complete the following short survey and leave your questions in the open field at the end. Thank you.
If you are interested there is a great piece in this week’s BMJ on vaccine misinformation & disinformation. I suggest you read the article.
….. As the world looks to the new covid-19 vaccines with hope, there are major worries about how social media will affect uptake.
….. The major social media companies are facing wide criticism for failing to deal with vaccine misinformation on their platforms.
…. Disinformation and misinformation are not the same things. When someone deliberately creates or shares false or misleading content, and they intend to cause harm, that’s disinformation. When they do so unwittingly and don’t intend harm, it’s misinformation.
…. Before the covid-19 pandemic, social media companies had taken a hands-off approach, at least until 2016 when the Brexit referendum, along with elections in the Philippines and US, woke them up to political disinformation. And until recently they had done next to nothing to combat health misinformation. To experts, this oversight was especially worrying.
….. This laidback approach changed in 2018 when a series of measles outbreaks in the US seemed to be fuelled by vaccine misinformation. This was certainly not the first time that misinformation potentially affected a public health crisis, but because this took place in America, home of Facebook, Google, Twitter and others, it got the companies’ attention.
….. It’s only now, as pressure on the companies from governments, scientists, doctors, and the public hits breaking point, that they have changed their health misinformation policies all together. Facebook, Twitter, and YouTube all took a more assertive and expansive view of “harm.”
…. Despite this stronger stance, Facebook, Google, and Twitter are still uncomfortable accepting responsibility. They are not, they claim, “arbiters of truth,” merely middle men providing a platform to their users, the public. The companies fall back on directives from health organisations to determine what counts as false, misleading, or confusing, whether it’s international bodies like WHO or national bodies like the US Centers for Disease Control and Prevention and the NHS.
… . The decision to rely on expert organisations makes sense in principle, but in practice matters aren’t so simple. For one, scientific consensus struggles to keep pace with misinformation. Through the summer of 2020, health agencies flip flopped on guidance concerning masks and airborne transmission, while misinformation on these topics was allowed to fester.
… Unfortunately, you can’t just factcheck, label, or remove a narrative. They shape and sometimes dangerously warp how we make sense of the world. No matter how companies tackle these issues, their policies will come up short. On the one hand, even the most clearly written policies have flaws. Bad actors spreading disinformation will find loopholes, like those who posted websites that had been removed, by using new, seemingly harmless, links from the Internet.
…. As we enter 2021 and covid-19 vaccines are at last rolled out, misinformation is undoubtedly going to pose a serious barrier to uptake. The social media companies are at least showing a willingness to intervene. But people wishing to undermine trust in the vaccine won’t be using outright lies. Instead, they will be leading campaigns designed to undermine the institutions, companies, and people managing the rollout. They will be posting vaccine injury stories and providing first person videos detailing side effects that are difficult to factcheck. And, when well meaning local radio stations ask on Facebook, “Will you be getting the covid vaccine?” the comments will be flooded with conspiracy ideas and suggestions.
….. The question for the companies is whether they’re prepared to tackle this, even if such posts don’t break their current guidelines. This will sit uneasily with people who recognise that changing policies during a public health emergency could lead to a slippery slope that ends up curtailing freedom of speech. What’s required is more innovative, agile responses that go beyond the simple questions of whether to simply remove, demote, or label. We need responses that acknowledge the complexity of defining misinformation, of relying on scientific consensus, and of acknowledging the power of narratives. Unfortunately, we don’t have time to design them. So while we implore the social media companies to take a more active role, it is us, those who use social media, who need to start taking responsibility for our posting and sharing.
…. Let’s hope that, by the next pandemic, these challenges will have been tackled in ways that don’t leave us feeling as vulnerable to disinformation and misinformation as we do today.
She is in her early thirties and is a first-generation ethnic minority immigrant to the UK. She was diagnosed as having MS 6 months ago after presenting with optic neuritis and a subsequent spinal cord syndrome. She is due to start on ocrelizumab in the next few weeks, but we want to delay her start until she has her first dose of one of the COVID-19 vaccines. However, she doesn’t want the COVID-19 vaccine. She is worried that it will ‘affect her DNA and any children she may have in the future’. I spent a lot of time explaining to her that what she has been told about the vaccine affecting her DNA is incorrect and simply not possible biologically and therefore the vaccine will not affect any children she has in the future. Fortunately, a 30-minute phone call to this particular patient seems to have worked. She has now agreed to take-up one of our early Barts-MS vaccination slots next week.
The above scenario represents just one of the conspiracy theories doing the rounds on social media concerning different COVID-19 vaccines. It is clearly incorrect. Similarly, there are many other conspiracy theories about the vaccines that also need to be dispelled.
The survey below done quite early in the pandemic shows that in the USA only two-thirds of pwMS were willing to have a COVID-19 vaccine. This figure is over 90% in the UK but is highly variable globally. Just across the channel in France, a recent Ipsos survey showed that just over 40% of people said they would have a COVID-19 vaccine. A recent Lancet study (see below) highlights the variation in attitudes to vaccinations across the world.
In the US survey below vaccine willingness, is associated with education level, perceived risk for COVID-19 infection, and trust in COVID-19 information sources.
Among less-educated communities trust, like knowledge, is built socially. People are more inclined to believe what their friends tell them, either in person or on social media. Clearly, the downside of this is that conspiracy and anti-science theories spread. However, this also provides us with an opportunity to build trust where it is lacking. What we need are local vaccine influencers from ethnic minorities and other communities to come forward to have the vaccine and spread the word that they are safe and that by having them you are not only protecting yourself but the wider community from getting severe COVID-19 and potentially dying from it.
COVID-19 vaccination is about public health, saving lives, protecting the NHS and getting society and the economy back to normal or let’s hope a more compassionate new normal.
Scientists, pharma companies, regulators, governments and the NHS have delivered us effective, safe and accessible vaccines, which is the only realistic way out of this pandemic. It is now up to the population to take up the offer of having the vaccine. We in the UK are in a very privileged position when it comes to COVID-19 vaccinations; you only have to watch the shenanigans going on politically in terms of ‘vaccine nationalism’ to appreciate the significance of this.
So if you want to become a local COVID-19 vaccination champion please contact us (bartsmsblog@gmail.com) we can provide you with the necessary information to educate your friends and family. I and my colleagues are also prepared to set-up and run online meetings to answer any questions you may have about COVID-19 and the available vaccines.
Please feel free to share any conspiracy theories about COVID-19 vaccines that you have heard about. The point is not to just dismiss them but to discuss them and hopefully convince people that they are not a good reason not to have the vaccine.
We are in this mess together and we need to get of this mess together and that means not leaving people behind and vulnerable to COVID-19.
Global trends in perceptions towards the safety of vaccines in November, 2015, and November, 2018 (Figure from the Lancet)
Background: As vaccines for the coronavirus become available, it will be important to know the rate of COVID-19 vaccine acceptability in adults with multiple sclerosis (MS), given that vaccination will be a key strategy for preventing SARS-CoV-2 infections. Using a national sample of adults with MS in the United States obtained early in the COVID-19 pandemic, the current study aimed to: (1) assess willingness to get a COVID-19 vaccine when available; (2) determine demographic, MS, and psychosocial correlates of vaccine willingness; and (3) measure where people with MS get their COVID-19 information and their perceived trustworthiness of such sources, which may influence COVID-19 vaccine willingness.
Methods: Adults with MS (N = 486) living in the United States completed a cross-sectional online survey (between 10 April 2020 and 06 May 2020) about their willingness to receive a COVID-19 vaccination once available. Participants also completed measures to describe the sample and to assess factors potentially related to vaccine willingness, including demographics, MS-specific variables, psychological measures, COVID-19 information sources, and perceived trustworthiness of their information sources.
Results: Approximately two-thirds of the participants (66.0%) reported a willingness to obtain a future COVID-19 vaccine, whereas 15.4%of the sample was unwilling. Greater willingness to receive the vaccine was associated with having a higher level of education and holding a higher perception of one’s risk of catching COVID-19. Participants reported accessing COVID-19 information from many different sources. Approximately a third (31.6%) of the sample reported getting their information from healthcare providers. Healthcare providers and the National MS Society had the highest perceived trustworthiness for COVID-19 information. The perceived trustworthiness of information sources was highly associated with vaccine willingness.
Conclusion: Early in the pandemic, willingness to get a COVID-19 vaccine was not universal in this large sample or people living with MS. Vaccine willingness was associated with a few variables including education level, perceived risk for COVID-19 infection, and trust in COVID-19 information sources. These results have important implications for guiding healthcare providers and the MS community as COVID-19 vaccines become widely available.
Background: There is growing evidence of vaccine delays or refusals due to a lack of trust in the importance, safety, or effectiveness of vaccines, alongside persisting access issues. Although immunisation coverage is reported administratively across the world, no similarly robust monitoring system exists for vaccine confidence. In this study, vaccine confidence was mapped across 149 countries between 2015 and 2019.
Methods: In this large-scale retrospective data-driven analysis, we examined global trends in vaccine confidence using data from 290 surveys done between September, 2015, and December, 2019, across 149 countries, and including 284 381 individuals. We used a Bayesian multinomial logit Gaussian process model to produce estimates of public perceptions towards the safety, importance, and effectiveness of vaccines. Associations between vaccine uptake and a large range of putative drivers of uptake, including vaccine confidence, socioeconomic status, and sources of trust, were determined using univariate Bayesian logistic regressions. Gibbs sampling was used for Bayesian model inference, with 95% Bayesian highest posterior density intervals used to capture uncertainty.
Findings: Between November, 2015, and December, 2019, we estimate that confidence in the importance, safety, and effectiveness of vaccines fell in Afghanistan, Indonesia, Pakistan, the Philippines, and South Korea. We found significant increases in respondents strongly disagreeing that vaccines are safe between 2015 and 2019 in six countries: Afghanistan, Azerbaijan, Indonesia, Nigeria, Pakistan, and Serbia. We find signs that confidence has improved between 2018 and 2019 in some EU member states, including Finland, France, Ireland, and Italy, with recent losses detected in Poland. Confidence in the importance of vaccines (rather than in their safety or effectiveness) had the strongest univariate association with vaccine uptake compared with other determinants considered. When a link was found between individuals’ religious beliefs and uptake, findings indicated that minority religious groups tended to have lower probabilities of uptake.
Interpretation: To our knowledge, this is the largest study of global vaccine confidence to date, allowing for cross-country comparisons and changes over time. Our findings highlight the importance of regular monitoring to detect emerging trends to prompt interventions to build and sustain vaccine confidence.
Good news! Another UK-backed COVID-19 vaccine, developed by Novavax, proves to be a winner with a point estimate of vaccine efficacy of 89.3% and no cases of severe COVID-19 in those who received the actual vaccine. The vaccine also works against the UK and South African variants of the virus.
This vaccine is important because it is based on using a recombinant form of the spike protein produced in insect cells and not bacterial or mammalian cells, and uses a brand new adjuvant to boost the immune response.
Insect cells are interesting because they are really easy to grow and don’t necessarily require the same expensive infrastructure as other recombinant protein manufacturing platforms. This vaccine also needs very small amounts of the recombinant protein, making scale-up production easier. This new vaccine technology, similar to the RNA vaccines, will lower the entry-level for other vaccines in the future; for example, new SARS-CoV-2 variants and strains and just possibly EBV?
The UK Government has pre-purchased 60 million doses of the Novavax vaccine, which means the UK now have more than enough pre-ordered vaccine purchased for the UK’s population.
Importantly, the Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of the vaccine for the phase 2b South African clinical trial (see below), which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation. This vaccine may therefore prove just as important as the Oxford-AstraZeneca vaccine for low and middle-income countries.
When historians write the history of the COVID-19 pandemic I have little doubt that Bill and Melinda Gates, as indiviudals, will be seen to have done more than any other individuals to tackle the pandemic globally. They are trying to ensure the vaccines are distributed across the world as equitably as possible. The same can’t be said for politicians in the rich world.
The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4). Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).
Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain [post hoc].
The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
“These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” said Clive Dix, Chair, UK Vaccine Taskforce.
Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom’s regulatory agency, the MHRA, in mid-January.
South Africa Results: Approximately 90% of COVID-19 cases attributed to South Africa escape variant
In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).
This study enrolled over 4,400 patients beginning in August 2020, with COVID-19 cases counted from September through mid-January. During this time, the triple mutant variant, which contains three critical mutations in the receptor binding domain (RBD) and multiple mutations outside the RBD, was widely circulating in South Africa. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of 27 cases) were the South Africa escape variant.
Importantly in this trial, approximately 1/3 of the patients enrolled (but not included in the primary analyses described above) were seropositive, demonstrating prior COVID-19 infection at baseline. Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely variant virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.
“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. “I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”
She recently turned 32 and has had multiple sclerosis for just shy of 4 years. She previously described herself as a moderate drinker having 2 to 3 glasses of wine per day in the week and maybe a bottle of wine per day on weekends. She would have typically her first drink of the day in the early evening when she got home from work. However, with COVID-19 and being forced to work from home she started drinking earlier, typically midafternoon. She has started drinking wine out of a mug to disguise it from her work colleagues on her zoom calls.
Now in the second lockdown, she has her first glass of wine with lunch. Her wine consumption has increased to more than a bottle per day. She admits to being unable to stop drinking and feels hungover on most mornings. She admits that her drinking has become a crutch. She feels lonely as she lives on her own and has not been able to visit family and friends, which is one of the reasons she is now drinking so heavily.
Does this scenario sound familiar? Alcohol consumption data during COVID-19 is worrying; recent studies have shown a large increase in alcohol purchases and consumption.
Alcohol is an anxiolytic and is probably the most used drug on the planet. Its adverse event profile is well described and long-term chronic use is associated with neurological and systemic toxicity. Neuroscientists now say there is no safe level of alcohol consumption when it comes to your brain health.
There is limited data showing that alcohol and drug misuse is higher in people with MS (pwMS) than the general population. The latter is not surprising given anxiety is so common in pwMS. Similarly, social isolation and loneliness, which are strongly associated with alcohol misuse, are endemic in pwMS. A recent survey by the MS Society indicates that 3 out of 5 pwMS describe themselves as lonely.
If you are reading this and feel your alcohol consumption has got out of hand as a result of COVID-19 please contact your HCPs and let them know. There are things that can be done remotely to help you. Don’t be ashamed to admit you have a problem; HCPs are trained to be non-judgemental and understand the issues.
As part of the holistic or marginal gains approach to the management of MS reducing alcohol consumption is one of the lifestyle interventions we promote. I am aware that it is easier said than done, but unless you try you won’t optimise your potential longterm outcome.
If you have any personal experiences you want to share with us about alcohol and how it has affected your MS, we would appreciate hearing about them. Your stories may help your fellow readers.
Objective: To examine the one-month prevalence and impact of substance abuse in a large community sample of persons with multiple sclerosis (MS).
Method: Members of the Multiple Sclerosis Society of King County were surveyed by mail. This multifaceted health survey included questions pertaining to substance abuse. Seven hundred and thirty-nine out of 1374 potential participants (54%) returned the survey, while 708 reported a medically confirmed diagnosis of MS and provided sufficient data.
Results: Fourteen per cent of the sample screened positive for possible alcohol abuse or dependence, and 7.4% reported misusing illicit drugs or prescription medications within the previous month. Possible alcohol abuse and drug misuse were associated with younger age, less severe MS-related disability and being employed, as well as greater self-reported depressive symptomatology. Most persons with alcohol problems indicated an interest in learning more about ways to stop or cut down.
Conclusions: Substance abuse may be present in up to 19% of this sample and contribute to high rates of depression. There may be greater risk of harm due to substance abuse in people with MS because of the potential magnification of motor and cognitive impairments. Comprehensive MS care should include substance abuse screening and advice to cut down or abstain.
A dear and very close friend of my wife and I tragically passed away from inoperable cancer two weeks ago. She sadly died alone in hospice with no family members by her side to comfort her. She is one of the many collateral deaths that have occurred due to COVID-19. From the time she got symptoms to suggest her cancer had returned in late April last year, it took almost four months before she was examined under anaesthesia when it was found her tumour had grown and spread to such an extent that it was then inoperable. Three to four months is a long time in the natural history of highly malignant and invasive cancer. The delays in her management were directly due to the COVID-19 lockdown and reconfiguration of oncology services to cope with the first wave of the pandemic. Pre-COVID-19 she would have been seen and managed within weeks and would almost certainly be still alive today; maybe not cured, but with enough life in her to witness her youngest daughter turn twenty-one.
In cancer the outcome is black and white; survival or death. In MS the outcomes are more subtle and nuanced. How long is too long in the course of a disease that last decades? Saying this I have a collection of patients who I follow when relatively small delays in diagnosis and treatment have major and rarely catastrophic consequences for the individual. Occasionally a spinal cord relapse can leave someone wheelchair-bound or result in loss of bowel, bladder or sexual function.
It is clear that fewer new patients are being referred to our MS service. Where are they? I doubt COVID-19 is preventing MS. A better explanation is that people are sitting on neurological symptoms that in normal times would prompt a referral to a neurologist and a diagnostic work-up. Even if patients are being referred into neurology services they are being seen and assessed virtually and are waiting for MRI scans, evoked potential and other non-urgent diagnostic investigations. These have been suspended until the current COVID-19 surge settles and neurology staff are de-deployed back to neurology. Even if some patients are seeing private neurologists and being diagnosed with MS outside the NHS they still have to wait to access DMTs on the NHS.
This is why a commentary in this week’s BMJ on ‘moral distress’ hit a nerve when I read it. Moral distress is ‘psychological harm’ arising when people are forced to make, or witness, decisions or actions that contradict their core moral values. I can relate to the sense of powerlessness and feelings of guilt, shame and anger that are associated with moral distress. These are some of the feelings we neurologists are having when we can’t diagnose and treat our patients with MS in a timely and appropriate way.
If you are reading this and are one of these people waiting in the COVID-19 induced NHS bottle-neck for either diagnostic or therapeutic decisions about MS, or any other non-urgent problem, you need to understand what your NHS HCPs are actually going through. Unfortunately, there is no alternative but to wait it out and hope that not too much time passes before you get diagnosed and appropriately managed. Writing this is particularly hard for me as I am the chair of the ‘MS Brain Health: Time Matters’ steering committee with the primary objective to ‘maximise your brain health’; to achieve this time really does matter.
If you have 5 minutes I would recommend you read the full BMJ commentary on moral distress; if not, I have pasted a few excerpts that will give the gist of commentary and how HCPs working in the NHS are being affected.
Coming back to our friend; the most we can do for her in death is to attend her socially distanced and very delayed funeral and help support her grieving husband and children. It is going to take a long time for us to digest, understand and accept the full impact COVID-19 will have on our society. I am going to be optimistic and predict that we will come out of this pandemic better for the experience; more in touch with each other’s and the environments’ needs, more tolerant, more willing to share the spoils of our education and careers, and a better understanding of the limits and promises of modern healthcare.
….. Simply working harder cannot resolve the conflicts caused by responsibility without autonomy
…… Doctors are accustomed to difficulty, to long hours, high stress, heavy responsibility. The job involves helping people navigate life’s gravest challenges: death and dying, suffering, loss and grief.
…. But as the profession draws deeply on its resources to respond to covid-19, a new concept is entering the mainstream: moral distress.
…. Moral distress is psychological harm arising when people are forced to make, or witness, decisions or actions that contradict their core moral values. While exposure to the suffering of others can lead to distress, it is not necessarily moral distress. But if serious and sustained resource constraints mean doctors cannot meet patients’ needs, it can open the door to moral distress. If you know that delays to treatment will likely lead to serious harms, consider the effect of repeatedly being forced to place patients on ever-lengthening waiting lists. Moral distress arises in the gap between what professional judgment dictates should be done and what healthcare systems permit. It is also associated with powerlessness—the impossibility of altering the situation so that professional acts can accord with professional values.
…. Understandably, moral distress has been strongly linked to the psychological harms of combat. The term entered health through nursing ethics: lack of professional agency meant that nurses felt unable to challenge behaviour at odds with their core values.
…. Typical emotional responses to moral distress include feelings of guilt, shame, anger, and, in extreme form, disgust. If moral distress is sustained it can lead to moral injury—a deeper or more enduring harm that can lead to burnout and psychological trauma.#
…. Covid has highlighted how essential the NHS is to our collective wellbeing. It is beyond time to fund it effectively—and to make clear the costs of not doing so. Until then, all health professionals need support in managing moral distress—before its effects become too toxic.
