What you need to know about the promising Oxford-AstraZeneca COVID-19 vaccine

I would like to share here the positive results from one of the promising SARS-COVID-2 vaccines labelled AZD1222, and explain more about the clinical trial process.

Currently, more than 140 vaccines for COVID-19 are in pre-clinical and clinical development, which means that they are being tested in non-human subjects (cells, mice, rats, ferrets, rhesus macaques, etc). 10 vaccines are being tested in humans for safety and dosages (this means in healthy subjects), 8 vaccines are in phase II, which involves testing the safety in expanded studies. Only 3 vaccines are starting phase III, meaning large scale efficacy tests. In this phase, the vaccine is tested in thousands of people separating the volunteers in 2 groups: one will receive the actual vaccine and the other - the placebo one to determine if the vaccine protects against the coronavirus. The last step can be a phase IV trial with an even bigger and diverse group of volunteers and a review of the results by the local regulatory entity which will evaluate if the vaccine is approved or not for use in that region. Notice that each country has its own regulatory organization and some medicines are approved for use in the USA but not in Europe. Fortunately, there are a lot of different types of vaccines and you CAN NOT put them all in the same bag!

These vaccines use a different type of virus that wouldn’t affect humans in a negative way (called a vector) to deliver coronavirus genes into cells and trigger an immune response.

The British-Swedish company AstraZeneca and the University of Oxford are working on a viral vector vaccine using a chimpanzee adenovirus that will expose the coronavirus’ S protein on its surface in order to trigger an immune system response in the people that will be vaccinated. The vaccine is in Phase II/III trial in the UK and Phase III trials in Brazil and South Africa, and it might be ready by 2021. “AstraZeneca” claimed their total manufacturing capacity stands at two billion doses. This vaccine uses a different type of virus that wouldn’t affect humans in a negative way (called a vector) to deliver coronavirus genes into cells and trigger an immune response.  

They reported last Monday the "encouraging" results from the trial that included 1,077 participants from 18 to 55 years old (who had not previously tested positive for the coronavirus). The participant's gender was fairly well distributed, but they were mostly white. The study was single-blind, meaning patients did not know whether they received the coronavirus vaccine or the control (a meningitis vaccine).

They reported that around 70% of the participants suffered adverse events such as pain, feeling feverish, chills, muscle ache, headache, and malaise, which were reduced by the use of paracetamol, and there were no serious adverse events related to the vaccine. The T-cell immune responses peaked on day 14 and the antibody response rose by day 28. Neutralising antibody responses against SARS-CoV-2 were detected in 91% of participants. After a second vaccine application, called boost, this number rose to 100%. After a booster dose, all participants had neutralising activity. 

Just a friendly reminder: we should be grateful for the existence of vaccines that have helped prevent the spread of terrible diseases, such as tuberculosis and polio. Both brought huge suffering in multiple countries around the world and were controlled thanks to the implementation of vaccines! 

 I encourage you to check on the links below and learn more about the different vaccines and the research behind them. Be aware of your own cognitive bias, for example, stop citing the inexistent connection between autism and vaccines, that research has now been thoroughly debunked, the Lancet journal issued a retraction on Wakefield’s paper, and he lost his medical licence.

Let me leave you with this great advice from the WHO about how to respond to vaccine deniers:

“Vaccine-preventable diseases can be very severe, and still cause millions of deaths per year around the world. Even with the best available care in the world, vaccine-preventable diseases can cause permanent disability and even death. Prevention is by far the best intervention.”

 “There are no equally safe and effective alternatives to vaccinations.”

 “The scientific evidence is clear: vaccination is the most effective health intervention for prevention of many serious diseases.”

 “We as an institution/agency are aiming to sustain the health of every individual member of the public. We are sorry that you have lost trust in our effort, but we hope to regain it.”

 “The scientific evidence is clear; vaccination is a safe way to prevent many serious diseases. Any theoretical risk to the individual and society is far outweighed by the risks to one and all of not doing so.“

 

 

References:

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext

https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker

https://www.youtube.com/watch?v=-dYWZMx-Lfs

https://www.who.int/immunization/sage/meetings/2016/october/8_Best-practice-guidance-respond-vocal-vaccine-deniers-public.pdf

The good news about WFH: your long commute was killing you slowly...

How is your long commute killing you slowly?

 Legend says that Greek messenger Pheidippidies run 42.195 km (26.219 miles) from Marathon to Athens to report the victory over Persia in the Battle of Marathon, and then suddenly died. Since those times, circa 490 BC, the commute to work has changed a lot, it might look as it has improved from that tragic myth, however more and more research is pointing out that the modern long commute is indeed killing us. If you live in a big city, probably you commute around 30 min to 1 hour each way to work every day, if you are lucky you walk or bike, if not you have to suffer horrendous traffic, or crowded and unreliable public transportation, and all this stress affects your health.

Knott and collaborators, from the University of Cambridge, analyzed the “mental wellbeing” of 5.474 British commuters, aged 40-75, with a follow-up of 4,65 years. They reported that depression-asymptomatic commuters who transitioned from inactive to active commuting reported less severe depression symptoms than those who remained inactive, and a similar relationship was evident among commuters with pre-existing symptoms. Moreover, longer commutes were associated with worse depressive symptoms. “Shifting from exclusive car use towards more active commuting may help prevent and attenuate depressive symptoms in working adults”. (1)

 

Another study done in the UK by Flint and collaborators showed that individuals who transitioned from car commuting to active or public transportation had a decrease in body mass index (BMI) of -0.30 kg/m2, contrariwise, individuals who transitioned from active commuting to car had a BMI increase of 0.32 kg/m2. The take-home message is that increased levels of physical activity as part of the commute to work could reduce obesity among middle-aged adults. (2) Already in 2013, Laverty and collaborators reported that, in the UK, using public transport, walking, or cycling to work was associated with a lower likelihood of being overweight. Walking or cycling was associated with a lower likelihood of having diabetes, and walking was associated with a lower likelihood of having hypertension than private transport. (3)

In the USA, one out of every six commuters travels more than 45 min each way every weekday, and this long voyage makes people lonelier (4). Back in 2009, as part of the Gallup-Healthways Well-Being Index study, 173,581 employed adults were interviewed by the phone, and they reported that one in three employees with a commute of more than 90 minutes have had a neck or back condition that has caused recurrent pain; among those with commutes of 10 minutes or less, the figure drops to roughly one in four. Longer commuters are more likely to say they have been diagnosed with high cholesterol and are more likely to have a BMI that classifies them as obese. Their results point to a connection between commuting and emotional well-being. Among employees who take more than 90 minutes getting from home to work, 40% experienced worry for much of the previous day, significantly higher than the 28% among those with negligible commutes of 10 minutes or less. Conversely, workers with extremely long commutes were less likely to have experienced enjoyment for much of the previous day or that they felt well rested that day. (5) Behavioral economists Kahneman and Krueger tracked the emotional states of women in Texas during their daily activities and they found that respondents' ratio of positive to negative emotions was particularly low during the time spent commuting.

In Sweden, using longitudinal individual data from 1985 to 2008, Sandow and collaborators, modeled mortality through propensity score matching and Kaplan–Meyer estimates of survival among long-distance commuters, more than 50 km (31 miles) one way. The results indicate that women who have experienced long-distance commuting face a significantly higher mortality risk compared with women with short commutes to work. This seems to be driven by variations in income and education: for women with long-distance commuting experience, substantially lower survival rates are found among those with low education and low income. Surprisingly, for men mortality risks do not seem to be associated with long-distance commuting. Sandow findings suggest that men and women are subject to different mechanisms regarding the nexus between commuting and mortality. (6) In another study by Dr. Sandow in Sweden they stated the alarming connection of commuting and divorce rates: if one spouse commutes longer than 45 minutes that couple is 40% more likely to get divorced (7).

 

 

One solution is to work from home, as Tim Ferris, the author of the four hours work week, showed working from home can improve your productivity and increase efficiency by, for starters, not wasting time traveling. I used to work at a company where we were allowed to 20% of remote work time and this really improved the work life. More companies are adding this successful work practice because it enhances the employees’ happiness. The WHO set a minimum of 10.000 steps per day to keep your heart healthy, you can reach this goal by walking to work some days. If you can’t change the type and duration of your commute, you can always make it more productive, reading, playing a game or listening to an audio book or music that will make it “me time”.

 

 

 

 

 

References:

 

1- Knott CS, Panter J, Foley L, Ogilvie D. Changes in the mode of travel to work and the severity of depressive symptoms: a longitudinal analysis of UK Biobank. Prev Med. 2018 Mar 28;112:61-69. doi: 10.1016/j.ypmed.2018.03.018.

2- Flint E, Webb E, Cummins S. Change in commute mode and body-mass index: prospective, longitudinal evidence from UK Biobank. Lancet Public Health. 2016 Dec;1(2):e46-e55. doi: 10.1016/S2468-2667(16)30006-8.

3. Laverty AA, Mindell JS, Webb EA, Millett C. Active travel to work and cardiovascular risk factors in the United Kingdom. Am J Prev Med. 2013;45:282–288.

4 -https://www.newyorker.com/magazine/2007/04/16/

5-http://news.gallup.com/poll/142142/wellbeing-lower-among-workers-long-commutes.aspx

6- Sandow, Erika; Westerlund, Olle; Lindgren, Urban

Is your commute killing you?: On the mortality risks of long-distance commuting

Environment and planning A, Pion 2014, Vol. 46, (6) : 1496-1516

7-Erika Sandow. Volume: 51 issue: 3, page(s): 526-543 2014

https://doi.org/10.1177/0042098013498280

How can you boost your immune system? With super vitamin D

Surely you have heard about how important vitamin D is for the correct function of your body is. But do you know why and how much you should get per day or how to improve the intake? And the recently reported connection with Coronavirus infection outcomes?

Vitamin D is important to keep functional healthy muscles and bones (it has a role in the regulation of the calcium and phosphate balance), it also supports the production of antimicrobial peptides in the respiratory tract, reducing negative outcomes from viral or bacterial infections. Additionally, vitamin D helps to reduce the inflammatory response to infection with SARS-CoV-2. Vitamin D interacts with angiotensin-converting enzyme 2 (ACE2), which is the receptor in the human cells that interacts with SARS-CoV-2 and allows its entry into the cell. While SARS-CoV-2 downregulates the expression of ACE2, vitamin D promotes the expression of this gene.

For respiratory tract infections (like the type that coronaviruses cause), it has been reported vitamin D supplementation protected against acute respiratory tract infections and that patients with very low serum 25-hydroxyvitamin D concentrations (a marker of vitamin D status) gained the most benefit. These results were published in a meta-analysis done with data from 25 clinical trials, including 11.321 participants. 

A recent article published in The Lancet analyzed how the relative vitamin D status can influence COVID-19 outcomes. The study emphasizes the importance of Vitamin D supplementation for older people as they are at high risk of poor outcomes from COVID-19 and of vitamin D deficiency. In a cross-sectional analysis across Europe, COVID-19 mortality was associated with vitamin D status in different populations, in addition to very strong circumstantial evidence that highlights this connection. Some countries seem to be exceptions to this “correspondence”: Spain, Italy and the Nordic countries.

Vitamin D deficiency is common worldwide. In the US, more than 42% of the population is vitamin D deficient, and this rate rises to 82% in black people and 70% in Hispanics. One of the concerns is that the main source of Vitamin D is the exposure to the sun, which is reduced in wintertime and even more in some regions and vitamin D intake can be reduced in people with darker skin pigmentation and/or medical conditions. Dr. Holick, an eminence in Vitamin D research, recommends 10 minutes of sun exposure per day without sunscreen follow with sunscreen application because you do not want to increase your risk of getting skin cancer (melanoma). I strongly recommend you to watch the lecture “The D-Lightful Vitamin D for Health” by Michael F. Holick. The best source of Vitamin D is sunlight with 10.000 to 20.000 IU (international units) of Vitamin D being produced in 30 minutes with whole-body exposure to sunlight, and the “excess” is stored in your fat. The good news is that you will never produce too much, the bad news is that you can take too much vitamin D if you take an overdose of supplements and this can cause serious intoxication. Some foods high in vitamin D include salmon, tuna fish, sardines, mackerel, trout, mushrooms, eggs, cod and fortified milk, cereals and juice. The Endocrinology practice guidelines recommend different Vitamin D daily intakes depending on your age group:

0-1 years old 400-1000 IU

1-18 years old 600-1000 IU

Over 18 years old 1500-2000 IU

 Importantly, if you are obese you will need 2 to 3 times more! Now, you had probably run to your vitamin cabinet and checked the label in the supplement bottle, and it might say “Vitamin D 5 ug” (micrograms), meaning only 200 IU… side note, the recommendation in the US is 400-800 IU per day.

 

The professional advice is to measure your vitamin D blood levels and consult a doctor about the best way to get and maintain the optimal level of Vitamin D.

 

References

https://www.thelancet.com/journals/landia/article/PIIS2213-8587(20)30183-2/fulltext

https://tilda.tcd.ie/

https://www.youtube.com/watch?v=-zK8LgVx2G8

https://www.youtube.com/watch?v=EP81YMvs4yI

Why learning about vaccines is important? more than just to make an educated decision… it saves lives!

Understanding the role of vaccines is important, hence this question really resonates with me. First of all, because it can save your life and the life of friends and family. Let me put in my personal hero words: “Vaccines are one of humanity’s most incredible accomplishments and they’ve saved millions of lives,” John Oliver (see the link to his show below).

Secondly, your understanding will allow you to make an educated decision about which type of vaccines you may get, for example, if you are allergic to eggs you should get the flu vaccine that has been produced in mammalian cells (cell culture-based) instead of the one produced in chicken eggs, and you would communicate this to your care provider.

I could continue explaining why having different types of vaccines and knowing more about their modus operandi is a fantastic idea; however here, I would like to explain some thoughts on why some people might think the opposite. Once upon a time (28 February 1998), there was a doctor called Andrew Wakefield, and 12 other medical doctors; they published in a prestigious scientific journal The Lancet, an article entitled “Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children”. In the article, they reported a study of 12 children with gastrointestinal disease and regressive developmental disorder. They claimed to have identified an associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated with possible environmental triggers. Their conclusions drew an association between the MMR (measles, mumps, and rubella) vaccine and autism. The article was retracted on 2 February 2010, in part, thanks to the fantastic work of the journalist Brian Deer, who discovered research fraud, unethical treatment of children, and Wakefield’s conflict of interest through his involvement with a lawsuit against the manufacturers of MMR vaccine. Other concerns about the study came from the parents of children involved in the study: one claimed that part of the data in the paper was not true, another parent claimed that “the data clearly appeared to be distorted”. Some subjects appeared to be “cherry-picked” to participate in the study, for instance, a boy who lived 5000 miles from the hospital had been flown to London and admitted to Wakefield’s project. Furthermore, there were multiple discrepancies (inconsistent data between the article and the actual medical records). For example, only one of the patients had “regressive autism” although the existence of this condition and the gastrointestinal disease was the bedrock of Wakefield’s allegations. Some conditions that were suffered by the children were also suffered by siblings that were not included in the study. There was another key issue: there were no controls (for example unvaccinated children) as this was just a case report, a big red flag in any medical study!

 

The study claimed that all 12 children were previously normal, but five had documented pre-existing developmental concerns. In the article, some children were reported to have experienced first behavioural symptoms within days of MMR, but medical records documented these as starting some months after vaccination. In nine cases, unremarkable histopathology results were changed, after a medical school’s “research review”, to “non-specific colitis”. The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations, all giving time to onset of problems in months, helped to create the appearance of a 14-day temporal link. Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation.

Why would Wakefield commit such terrible fraud and put people's lives at risk? It is thought to be for MONEY. He was recruited to support a now failed lawsuit against vaccine manufacturers and was paid £435,643 for being part of the lawsuit. BTW, after the fraud was uncovered Wakefield’s medical license has revoked.

On the other hand, multiple studies since then have shown that there is NO link between mental illnesses and vaccination. In 2002, a Danish study provided strong evidence against the hypothesis that MMR vaccination causes autism. They studied 537,303 children that had received the MMR vaccine. They reported no association between the age at the time of vaccination, the time since vaccination, nor the date of vaccination and the development of the autistic spectrum disorder (ASD). More recently in 2019, given the risks of a disease outbreak that the anti-vaxxer movements generated in the general population, the research team investigated another 657,461 children born in Denmark, comparing MMR-vaccinated with MMR-unvaccinated children. This study yielded a fully adjusted autism hazard ratio of 0.93, meaning no association between MMR vaccination and autism. In addition, no increased risk for autism after MMR vaccination was consistently observed in subgroups of children defined according to sibling history of autism, autism risk factors, other childhood vaccinations, or during specified periods after vaccination.

Since then there has been a call from researchers around the world to stop “wasting” time and resources trying to find a link between vaccines and autism, because these resources could be used to investigate other diseases and find treatments for them.

Despite claims of many unfounded vaccine damages, vaccines may have a protective effect from unintended diseases. In adults, a study including 4,000 people over age 65 found that people with previous exposure to vaccines for diphtheria, tetanus, polio, and the flu had a decreased risk for Alzheimer's disease. Another study in nearly 12,000 people with chronic kidney disease found that flu-vaccinated people had a 30-40% lower risk of dementia than the unvaccinated control, and showed that people who got their flu shots more regularly had a greater benefit in lowering their risk for dementia. There has been also no evidence that getting the flu shot worsens cognitive decline in people with Alzheimer's disease. However, individuals with dementia who contract the flu are at 1.5-time increased risk for flu-related mortality. These studies suggest that getting an annual flu shot may be one factor in maintaining a healthy lifestyle associated with promoting lifelong brain health.

It is heart-breaking to witness the antivax movement evolve in the last few years and take innocent victims due to misinformation and fraudulent conspiracy theories. Please help to educate everybody about vaccination programs and the important role that each member of the society plays in the wellbeing of the whole community. We are in this together, and only united we can defeat infectious diseases.

For more information about the development of anti COVID-2 vaccines:

https://sciencetechreviews.blogspot.com/2020/06/why-vaccines-are-important-and.html

 

 

 

  

References:

Vaccines: Last Week Tonight with John Oliver: https://www.youtube.com/watch?v=7VG_s2PCH_c

https://www.acpjournals.org/doi/10.7326/M18-2101

https://www.nejm.org/doi/10.1056/NEJMoa021134?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dwww.ncbi.nlm.nih.gov

https://www.bmj.com/content/342/bmj.c7452

https://www.bmj.com/content/342/bmj.c5347

https://www.thetimes.co.uk/article/mmr-doctor-given-legal-aid-thousands-00ftl80msbs