In her final COVID wrap for the year, public health researcher Alison Barrett provides an update on vaccine developments, reports on a study of “wounded healers”, and brings some seasonal levity to the table.
Update on COVID-19 vaccines
In a year that has seen unprecedented disruptions to science and research, vaccines against the COVID-19 virus have been developed in record time, providing hope to many as results from three vaccine candidates are found to be effective at preventing COVID-19 symptoms.
On Tuesday, 8 December, the first Pfizer/BioNTech vaccine was administered to a grandmother in the United Kingdom (UK) after the British Medicines and Healthcare Products Regulatory Agency provided emergency use authorisation (EUA) for the vaccine to begin rollout.
Regulatory bodies in Bahrain, Canada and the United States have also granted EUA for the Pfizer/BioNTech vaccine. On 17 December, another vaccine by biotechnology company, Moderna, was given EUA by the US Food and Drug Authority (FDA).
This comes after the three leading vaccine candidates by Pfizer/BioNTech, Moderna and AstraZeneca, released preliminary results from Phase 3 of their clinical trials.
Below is an overview of the three vaccines.
Pfizer/BioNTech vaccine
The peer-reviewed results of the Pfizer/BioNTech clinical trials were published on 10th December in the New England Journal of Medicine.
Researchers found the vaccine produced the desired outcome of preventing COVID-19 symptoms in 95 percent of study participants who acquired a confirmed case of COVID-19, when compared to those who received the placebo. Some side effects, which were generally gone within two days of immunisation, included fever, fatigue, headache, muscle and joint pain and diarrhoea.
The trial included 43,548 participants 16 years or older in the US, Argentina, Brazil, South Africa, Germany and Turkey who were in either the trial group that received the vaccine or a placebo group that received a saline solution. Two doses of the vaccine or placebo were injected into the upper arm muscle 21 days apart.
While the vaccine was found to be highly effective in study participants, it is unclear if the vaccine will work in pregnant women, children or younger teenagers – groups that were not included in the initial trial. With only two to three months of follow-up, the long-term impact and immunity is also unknown. Researchers intend to assess the long-term safety and efficacy of the vaccine, and include other groups in future trials.
Moderna mRNA vaccine
Not yet peer-reviewed, Moderna announced results of their phase three trial by press release on 16 November 2020. Similar to the Pfizer/BioNTech vaccine, the Moderna vaccine was found to have 94.5 percent vaccine efficacy in preventing COVID-19 symptoms, compared to those who were received the placebo.
Their trial included 30,000 participants, aged 18 years or older, in the US who were given two doses 28 days apart of the vaccine or placebo. Side effects included local pain at the injection site, fatigue, muscle pain and headache.
Thirty-seven percent of the participants are from racial and ethnic minority groups in the US after researchers actively recruited for participants from groups who are disproportionately affected by COVID-19.
The trial is ongoing and aims to collect long-term impact and immunity information about the vaccine.
Oxford/AstraZeneca vaccine
Peer-reviewed results of the Oxford/AstraZeneca vaccine trial were published in The Lancet on 8th December.
An interim analysis of 11,636 trial participants aged 18 years or older from UK and Brazil found that when all dosing regimens were combined, the Oxford/AstraZeneca vaccine had 70 percent efficacy in preventing COVID-19 symptoms, when compared to those who received the placebo.
While most participants in the trial received two standard doses 28 days apart, of either the vaccine or control solution, due to a measurement error, a subgroup of participants received a lower dose in their first dose, followed by a standard dose in their second injection.
For participants who received the two standard doses, the vaccine was found to have 62.1 percent efficacy; and for those in the subgroup who received the lower first dose, the vaccine was found to have 90 percent efficacy. The researchers are unsure why a lower first dose resulted in higher efficacy; further analyses is required.
Similarly to the Pfizer/BioNTech vaccine trial, as median follow-up of participants was three months, they were unable to determine the long-term protection of the vaccine; however, the trial is ongoing. Other questions about the trial, including its effectiveness on those over 55 years and capability to fight asymptomatic infections, were discussed by Heidi Ledford in Nature on 8 December.
Promising results; public health interventions and further research still required
The results of the Pfizer/BioNTech, Moderna and Oxford/AstraZeneca vaccine trials suggest they are effective in preventing COVID-19 symptoms. However, they have not been found to prevent infection or reduce the spread of the virus and information about long-term immunity is unknown at this stage.
Caution is required in comparing the efficacy of the three vaccines because each trial was conducted differently. However, it is highly beneficial for world-wide distribution and availability to have three efficacious and safe vaccines.
The vaccine developments are exciting, providing hope for many, and highlight how quickly research can be undertaken when funding isn’t an issue and worldwide collaborations occur. However, articles at Croakey have discussed multiple issues over the past few months concerning the development and roll-out of COVID-19 vaccines:
‘A massive assault on trust’: vaccine hesitancy and COVID-19 – misinformation and distrust may challenge the public’s uptake of a vaccination.
Will a vaccine really solve our COVID-19 woes? – benefits from a vaccine will likely include a reduced number of cases, hospitalisations and deaths, but public health measures (masks, physical distancing, travel restrictions) are still likely needed to prevent infections.
COVID vaccine announcement makes global news. But many questions remain – concerns raised over the announcement of vaccine trial results by press release, as opposed to publishing the full results by preprint or after peer-review.
More than vaccine needed to ensure continued COVID-19 success – a suite of measures, including public health interventions, treatments and vaccines, required to keep Australians safe in 2021.
Associate Professor Lesley Russell has also discussed concerns about the roll-out of COVID-19 vaccines in her December Health Wraps (on 1 Dec and 15 Dec).
Helen Branswell, global health reporter at STAT News, has raised similar concerns: The COVID-19 vaccines are a marvel of science. Here’s how we can make the best use of them, (on 2 December).
Rapid vaccine roll-outs require clinics and trained staff available to book appointments and administer the vaccines, which are both at limited capacity due to the overwhelming number of cases in many countries. Mistrust in science may result in many being cautious to accept the vaccine.
It is important for health professionals and politicians to work with community leaders to determine how to communicate vaccine messages. As it is unknown how long immunity will last, it is necessary to continue maintaining public health interventions, such as mask wearing and physical distancing.
Also see this article by Branswell at STAT News: A side-by-side comparison of the Pfizer/BioNTech and Moderna vaccines (19 December).
Developing services for long COVID: lessons from a study of wounded healers
Ladds, E et al., Medrxiv Preprint Server, 16 November 2020
Approximately ten to twenty percent of COVID-19 patients experience persistent symptoms lasting more than three weeks. Most common symptoms that long COVID patients report experiencing include fatigue, breathlessness, joint and chest pain.
With limited support and services available for long COVID patients (or ‘long haulers’), grassroots groups have been active in providing support to tens of thousands of long haulers, and advocating for awareness of the long-term impacts of COVID-19 and future research.
Healthcare workers have a greater risk of acquiring COVID-19 and therefore, can provide valuable insight into services to support long COVID sufferers.
Between May and September 2020, researchers in the United Kingdom undertook focus groups and interviews with 43 healthcare workers with long COVID to gain a better understanding of their experiences and recommendations for support services.
The research identified six main themes:
- Uncertainty about the persistent symptoms and that they did not fit with their prior knowledge of the virus.
- Use of professional mindlines – which are guidelines of knowledge and experience shared between colleagues (rather than accessing information from research articles) – was reported to be beneficial.
- Support groups and communities of practice have provided practical support and a “sense of shared identity and belonging”.
- Therapeutic relationships and roles included those that enabled the patient to share their experience and be acknowledged.
- Professional identity and practice, where participants reported professional tensions around accessing care and perceived fear that colleagues would think they were shirking their work responsibilities.
- Suggestions for service improvement.
From this research, a potential structure for a ‘one-stop-shop’ service for long haulers was co-designed as well as clinical quality standards. The Long COVID Clinical Quality Standards are:
- Long haulers should have access to diagnostic tests and referrals to specialists
- Burden of illness minimised
- Clinical responsibility and continuity of care is vital
- Multi-disciplinary rehabilitation services to support patients through a variety of symptoms
- Evidence-based standards to guide management of symptoms
- Further development of the knowledge base and clinical services.
The authors acknowledge that one of the limitations of this research is that the study participants were all from the UK and lacked ethnic diversity; therefore, the results may not be generalisable to other populations.
However, the results provided an in-depth analysis of healthcare workers with long COVID, making the most of their knowledge as healthcare professionals and patients.
The authors wrote, “as well as minimizing patient suffering, it is hoped implementation [of clinical quality standards] would reduce mortality, improve patient outcomes, and optimize return to employment” for long COVID sufferers.
Quirky stories
“Quirky stories, wacky research, amazing images and other eclectica suitable for the festive season” have been published in the Medical Journal of Australia’s December edition. Submissions included:
David G Chapman and Cindy Thamrin conducted a prospective cohort study of staff at five medical research institutes in Sydney between 30 April and 18 May 2020 via an online survey:
To characterise the working arrangements of medical research scientists and support staff in Australia during the COVID‐19 pandemic, and to evaluate factors (in particular: wearing pyjamas) that influence the self‐assessed productivity and mental health of medical institute staff working from home.”
Of 163 people who responded to the survey, a similar proportion of non-scientists (for example, administration, information technology, finance) and scientists wore pyjamas during the work from home day.
Wearing pyjamas whilst working from home was not related to self-reported productivity, but it was related to more frequent reporting of poorer mental health than those who did not wear pyjamas whilst working from home.
Perhaps not surprisingly, having children at home was associated with reduced productivity and reduced generation of “new ideas”.
Early career researchers were more frequently reported to have reduced productivity while working from home than established researchers.
In conclusion, the authors wrote: “Our findings are probably applicable to scientists in other countries. They may help improve work‐from‐home policies by removing the stigma associated with pyjama wearing during work and by providing support for working parents and early career researchers.”
Researchers at the Royal Brisbane and Women’s Hospital investigated the circulation of forks and teaspoons in the work tearoom, and found, in conclusion, that:
Teaspoon disappearance is a more substantial problem than fork migration in a multidisciplinary staff tearoom, and may reflect different kleptomaniacal or individual appropriation tendencies.
If giving cutlery this Christmas, give teaspoons, not forks.
The symbolism of fork rebirth or resurrection is appropriate for both Christmas and Easter, and forks are also mighty useful implements for eating cake!”
Read the third placed submission, on MJA: The year of the ‘rona: an uncontrolled trial in verse, a poem by Rob D Mitchell
In brief
The story of mRNA: how a once-dismissed idea became a leading technology in the COVID vaccine race
Garde, D, Stat News, 10 November 2020
Read this article about how persistent scientist, Katalin Kariko, and colleague Drew Weissman, discovered a key breakthrough that lead to use of mRNA (messenger-RNA) in the Moderna and Pfizer/BioNTech vaccines.
How mRNA vaccines work
Read this thread, shared by Dr Amy Coopes on Twitter, that describes how mRNA vaccines work.
Other science news
In a year that was dominated by COVID-19 news, science and events, it is important to reflect on some of the other scientific and political news and breakthroughs in 2020.
Nature has published their (non-COVID) scientific reflections of the year.
Spotlight on inequality – after the killing of George Floyd in Minnesota in May, millions of protestors around the world gathered to condemn racism and police brutality. Researchers shared their experiences with racism in science and called for action to address systemic inequalities.
Environmental extremes – the year began with devastating bushfires in Australia; wildfires also occurred in Siberia, South America and California. Hurricane season in the US broke records and the Arctic Sea ice disappeared to its second-lowest amount on record.
While the United Nation’s climate summit was postponed due to COVID-19 restrictions, in good news, China vowed to become carbon neutral by 2060 and Japan set a goal of net zero greenhouse-gas emissions by 2050.
Political change – in the US, President Biden’s election is good news for science as he aims to implement more climate-friendly policies and has promised an evidence-based response to the COVID-19 pandemic.
Space missions – three missions to Mars launched in July by United Arab Emirates, US and China; a Chinese spacecraft landed on the moon on 1 December to collect dust to bring back to Earth; and a Japanese spacecraft safely landed in Australia after collecting material from an asteroid’s surface.
Wishing all of the COVID-19 Wrap readers a safe and peaceful Christmas and New Year. The wrap will be back in 2021!
Alison Barrett is a Masters by Research candidate and research assistant at University of South Australia, with interests in public health, rural health and health inequities. Follow on Twitter: @AlisonSBarrett. Croakey thanks her for providing this column as a probono service to our readers.
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