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The show must go on…

As many of you already know, last Thursday there was a highly coordinated attack on my personal and professional social media accounts, which resulted in a successful hack (yes, I had two-step authorization and yes, my passwords were complex). 

Helplessly watching a group take away 11 months of my hard earned blood, sweat, and tears has been one of the most heartbreaking experiences of my life. That is/was a page I started from scratch, which I grew into a following of more than 160,000 people in 11 months with over 500 posts of evidence-based, data driven information. These posts were shared by Republicans and Democrats, conservatives and liberals, scientists and layman, families and neighbors. They infiltrated echo chambers. They became a place of scientific debate and transparency. All of which are greatly missing from social media and something I’m incredibly proud of building. Also, many of those followers became my friends and highly respected colleagues. But, now, all I can do is watch it slowly burn. 

If I’ve learned one thing from this experience, it’s the fact that we all rent space from social media without any tenant rights or control. I still don’t have any access to my social media accounts. I don’t know if (or when) I’ll ever get access again. I have received zero communication. If it wasn’t for my girlfriend working at FB headquarters, I would be completely blind. 

But it’s time to pull myself together and get back in the game. So, I’m starting this newsletter. If you found my previous posts useful at all, consider signing up here.

Instead of a FB post or IG post, you will receive an email when I post something new. You won’t get advertisements, FB won’t be collecting any of your data, and it will still be easily accessible to you (something science should always be).

NOTE: If you were already receiving emails from me, you need to sign up again. I think (and hope) that this new site will be more user friendly and, like I said before, you won’t have advertisements stuck to my emails anymore.

Time to rebuild this thing. Here we go.

Love, YLE

PS Thank you to my husband for handing me this mug filled with coffee this morning, ultimately refueling my fire.

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Hacked

YLE FACEBOOK and IG has been attacked in a coordinated effort, which resulted in a successful hack. I am working on it with FB. Please do not share or click on anything that’s shared for now.

Love, YLE

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Variant B.1.351

Variant B.1.351 (also known as 501Y.V2; first discovered in South Africa)…

…is, yes, in the United States.

Importantly, it was discovered in two individuals who didn’t know each other AND hadn’t recently travelled. This tells us, epidemiologists, that it’s been spreading within the community (and we just didn’t know about it). We aren’t surprised. This also strongly suggests that others are infected with B.1.351 too. Unfortunately, we don’t know how many people because B.1.351 isn’t easily detectable. PCR tests won’t tell us if someone has this new variant compared to an old variant. PCR tests CAN tell us this with B.1.1.7 (the variant first discovered in the U.K.)

Earlier this week, Moderna and Pfizer confirmed that their vaccines still work against this variant. However, it doesn’t work as well as against the old variants (about a 6-fold difference). Despite this reduction, neutralizing titer levels with B.1.351 remain above levels that are expected to be protective. Moderna is working on a booster that would work much better against this particular variant, just in case we need it down the road.

Today, Novavax also came out with important information about B.1.351…

  1. They released, for the first time, “real world” data about the vaccine effectiveness against B.1.351. This is opposed to the Moderna and Pfizer vaccine petri dish studies (which are done in a controlled environment and sometimes don’t represent what happens in the real world with environmental exposures). The Novavax vaccine also works against B.1.351. Reduced efficacy, but still works.
  2. They are also changing up the vaccine formula just in case we need it down the road.
  3. Unfortunately, Novavax also found that prior “natural” COVID19 infection (with an old variant) does not always protect against B.1.351 (while the vaccine does)

So, what does this mean? Three things…

  1. Get vaccinated. Our best defense against B.1.351 or any other variant right now is a vaccination.
  2. We need to stop transmission (of B.1.351 and all other variants). And we need to stop it now. The more this virus jumps from one person to the next, the more opportunity this virus has to mutate. Our vaccines work for now, but that might not be the case in the next mutation or two or three or ten.
  3. There’s now some serious pressure on Johnson and Johnson to perform.

This is worrisome news, but we knew this was coming. Stay vigilant. And, honestly, I would be much more worried about what mutations we have not detected in the US. We rank 48th in the world on mutation surveillance.

Have I convinced you yet that it’s important to invest in public health before a pandemic hits?

Love, YLE

Data Sources:
Moderna: https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against

Novavax: https://ir.novavax.com/node/15506/pdf

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Novavax!

Our little company from Maryland pulling through! A company that almost lost it all, but making a comeback during the pandemic. This will likely be their first vaccine to make it.

Novavax is a very different “type” of vaccine than Pfizer and Moderna. It uses a coronavirus protein, soapbark tree, and moth cells. Check out my previous post here to orient yourself:
https://yourlocalepidemiologist.com/novavax-vaccine/

In September, Novavax started Phase III trials in Britain among 15,000 people. Interim results were just released yesterday. What did they find?

  • 89.3% efficacy! 56 cases of COVID-19 in the placebo group vs. 6 cases in the vaccine group
  • Participants were 18-84 years old. Over 27% are over the age of 65, with a lot of participants also having underlying medical conditions.
  • Of the 62 cases, 61 were mild or moderate, and 1 was severe (which was in the placebo group).
  • Efficacy was 95% on the old variant and 85% on B.1.1.7
  • Severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

My humble opinion: I cannot overstate how ecstatic we are with the efficacy of these vaccines. We were hoping for something over 50%, and we are outperforming. This will, no doubt, help us fight the pandemic. Also, this is super exciting because it’s a different biotechnology. This will help with raw supply issues (eventually). Finally, who doesn’t love a story about an underdog pulling through.

Also my humble opinion: US trials started in Dec, so we won’t see interim results until April. It’s time for the FDA to seriously consider clinical trial data outside of the US for emergency use authorization. This is a global pandemic. It’s time we start fighting it like one.

Love, YLE

Data Source:
https://ir.novavax.com/node/15506/pdf

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ACIP meeting- Jan 27

The CDC ACIP (Advisory Committee on Immunization Practices) had an emergency meeting today.

The purpose of this meeting is to update everyone on the current affairs related to COVID19 vaccinations. There were a lot of big wigs in attendance: new CDC Director, FDA, NIH, DOD, HHS, CDC, AAP, ACOG, AMA, CSTE, AAP (just to name a few).

Here are your cliff notes…

AstraZeneca updated…
• Enrollment ended in the US. 32,459 people enrolled. As of Jan 21, 26,327 trial participants have received their second dose. 57.8% have a comorbidity and 23.6% are 65+ years old. Trial participants are only getting the standard dose (not the half dose that some in the UK received)

COVID19 epidemiology among kids…
• Kids with the most severe COVID19 are in these groups (and in this order): Obesity; Asthma; Immunocompromised; Chronic lung disease; Cardiovascular disease; sickle cell disease; diabetes; cerebral palsy; down syndrome; hypertension, and renal disease.
• 1,659 cases of MIS-C in 47 states, leading to 26 deaths

Vaccines for children…
• Rationale for pediatric clinical trials: 1) Pediatric burden of disease is significant 2) Disproportionate burden among children in minority communities 3) Indirect effects to the child and society (school, development, etc.) 4) Continued burden if we wait for natural “herd” effects 5) Data suggests that vaccination prevents asymptomatic carriage, thus reversing pandemic more rapidly 6) Safety data are best collected in clinical trials
• Age de-escalation trials will be organized as the following: 6 to <12 years; then 2 to < 6 years; and infants to < 2 years
• True placebos (like saline) are being considered. Another vaccine hasn’t been proposed as a control yet
• Will test multiple dose levels (full, half, and quarter doses)

Vaccine safety…
• Safety of COVID-19 vaccines are reassuring and consistent with clinical trials
• We (the U.S.) are actively collecting safety data from three main sources: V-safe (active surveillance), VAERS (passive surveillance), and Clinical Immunization Safety Assessment Project (CISA) (which investigates individual cases).
• V-safe data has been initially analyzed. 2.08M people have participated in V-safe (out of 21.8M people vaccinated). There are 15,131 pregnancies reported to v-safe (they will follow these women that consent up to 3 months after babies are born)
• See the Figure for the reactions to the vaccines being seen in real-time.
• Anaphylaxis: 50 people reported for Pfizer (out of 9.943M doses) and 21 reported in Moderna (out of 7.581M doses). 90% happened within 30 minutes of vaccination. 80% (Pfizer) and 86% (Moderna) of people had a history of allergies
• VAERS has 196 deaths reported following vaccination. None of them have been causally linked to vaccinations.

Other random notes…
• Prior COVID infection and vaccine side effects: they are designing a study to get a better idea of what’s happening
• Vaccine and transmission: This is a priority. 5,000 healthcare providers and first responders are being assessed for transmission after vaccination. They are getting tested weekly for infection.
• Among 65+ years, 90% of vaccine recipients are White. Speed is compromising health equity
• There is no additional data for delayed doses. The current recommendation remains: don’t delay your second dose more than 6 weeks (42 days) after your first dose
• mRNA vaccines are NOT interchangeable unless in an exceptional situation

Okay, now you’re up to date. Phew.

Love, YLE

Here are all the presentation slides if you want more: https://www.cdc.gov/vaccines/acip/meetings/slides-2021-1-27-21.html

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ADE

Antibody-dependent Enhancement (ADE)…

A major goal of antibodies is to bind to the pathogen and prevent it from infecting, or entering, a cell. Antibodies that prevent entry into cells are called neutralizing antibodies. Many vaccines work by inducing neutralizing antibodies. However, not all antibody responses are created equal. Sometimes antibodies do not prevent cell entry and, on rare occasions, they may actually increase the ability of a virus to enter cells and cause a worsening of disease through something called antibody-dependent enhancement (ADE).” (CHOP has a fantastic layman explanation of ADE, link below).

A classic example of ADE was a vaccine made for dengue fever in 2016. The vaccine was given to 800,000 children in the Philippines. 14 vaccinated children died after encountering dengue virus in the community. Since, this vaccine has not been used for children under 9 years of age. In the 1960’s, we also saw ADE with a RSV vaccine and an early version of the measles vaccine. Trials for the RSV vaccine were immediately stopped and the vaccine was never distributed. The measles vaccine was fixed and now does NOT induce ADE.

Now in terms of COVID19…

Neither COVID-19 disease nor the new COVID-19 vaccines have shown evidence of causing ADE.

There were early concerns that COVID19 could induce ADE given a few conflicting animal studies. 2 animal studies showed the potential for ADE, while 3 animal studies did not show ADE. It’s clear that ADE is highly dependent on the type of vaccine. The 2 animal studies that showed potential were NOT testing mRNA vaccines (which gives you a small piece of an antibody, rather than the whole antibody). Vaccines with a high theoretical risk of inducing ADE are inactivated viral vaccines. However, it’s encouraging that a recent animal study of an inactivated COVID19 vaccine elicited strong neutralizing antibodies.

Nonetheless, this is why Phase II and Phase III are so crucial in clinical trials. We need to test enough people to ensure that things like this don’t come up. The trials are designed to find potential problems like ADE. And, there has been no evidence of ADE in the trials authorized for emergency use. If there was evidence of ADE, these vaccines would have never made it through and would have been quickly yanked from distribution.

Love, YLE

PS There is/was a PubMed nature article circulating stating the contrary. However, the authors did not state their reasons as to WHY they are concerned about it. They just say they are. Which is not helpful. Also, keep in mind that any article can be uploaded to PubMed. If it’s on PubMed, it doesn’t necessarily mean it’s been peer-reviewed… an important distinction.

Here are some great sources:
A science heavy explanation: https://www.nature.com/articles/s41564-020-00789-5
A good layman explanation: https://www.chop.edu/centers-programs/vaccine-education-center/vaccine-safety/antibody-dependent-enhancement-and-vaccines

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Pre-treatment before vaccine

Ibuprofen (e.g. Advil, Motrin) or acetaminophen (e.g. Tylenol) before vaccination…

It’s recommended that you do not take either of these before vaccination. Pre-treating MAY reduce the your immune response to the vaccine (specifically the ability of B cells to mount an immune response).

“May” is the key word here.

In 2016, scientists conducted a systematic review. They basically took all the studies ever done on this topic (there were 20 total) to try and see whether pre-treatment of Ibuprofen and/or acetaminophen impacted immune response.

Their conclusions?

  • Results are too mixed to come to a conclusion. In other words, 4 studies showed that the medications decreased immune response. Some studies showed pre-treatment increased immune response. And the rest of the studies showed no impact. The authors stated “Thus, at this time, there is no clear answer as to whether [ibuprofen or acetaminophen] blunts the immune response to a degree that could result in vaccine failure.”
  • You CAN take ibuprofen or acetaminophen after vaccination. In all studies that reported a negative effect on antibody response, the medications were given as pre-treatment. Interestingly, this effect was not seen when given only 4 hours after immunization.
  • All reported decreases in antibody response occurred only with the first shot, with little to no impact observed following booster shot.

Bottom line: We don’t really know whether ibuprofen/acetaminophen impacts immune response. But, the shot just doesn’t hurt that bad. So, if you do decide to take ibuprofen or acetaminophen, take it a few hours after instead of pre-treatment, just to be careful.

As always, this page is for educational purposes only. It’s always best to talk to your healthcare provider before taking any medication (or stopping any medications) and if you’re having adverse reactions to the vaccination.

Love, YLE

Systematic review:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5027726/pdf/khvi-12-09-1183077.pdf?fbclid=IwAR3-Vm268QPY789y_-KXsAKQHz1b3NgKe3CsrL6qafK94-i33BtMgBuEDsw

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Resources

Many resources and tools came forward this week from sources I trust. These may be helpful for you to make data driven, evidence-based decisions…

Pregnant and breastfeeding…
A group of experts in the fields of OB/GYN, Maternal-Fetal Medicine, Shared Decision-Making and risk communication, Emergency Medicine, and current COVID-19 research at the University of Massachusetts Medical School – Baystate made a decision aid to help individuals who are pregnant, lactating, or planning on becoming pregnant decide whether or not to receive an mRNA COVID-19 vaccine (in conjunction with their healthcare providers). At this site you can get the decision aid in 10 languages.
https://foamcast.org/covidvacpregnancy/?fbclid=IwAR1OmwmtFllDljpomnK_0R7yl33xkmkRkvdGCz-n3QLcaA15vW80AAC6XcM

Differences in mRNA vaccines…
My students made these fliers, which are currently being used for healthcare providers/patients in Texas. But thought I would share for anyone else who would find it useful. It’s been translated in Spanish, Mandarin, and Vietnamese. If you want the PDF, message me your email address and I can send it to you.

Vaccine, Infection, and Herd immunity tracker…
This site was created by Dr. Gu, an MIT data scientist whose expertise is in machine learning to understand data and make practical, accurate predictions. He created some fantastic real-time graphs for the US as a whole and by states. For example, his data found that yesterday Vermont was the first US state to have more people vaccinated against COVID-19 (6%) than infected with COVID-19 (4%). Whoo hoo! (Yes, I know it’s a small state; but take the small wins).
https://covid19-projections.com/

Hope these are helpful!

Love, YLE

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“But 99% of people don’t die”.

First off, this is NOT true for specific populations. If you’re going to spread this stat, please at least get the number right. The most accurate way to measure death is IFR and this is the distribution of IFR across ages in the United States:
0-19 years: 0.003%
20-49 years: 0.02%
50-69 years: 0.5%
70+ years: 5%

Second, death isn’t the only outcome. Period. There isn’t one body system that COVID19 hasn’t left a mark.

Why? Because organs have doors called ACE2 receptors. The little spikes on the COVID19 virus are keys to these doors. It takes about 10 minutes for COVID19 to open the door and make a cell its home. Once in, the virus starts multiplying eventually killing the cell (and sometimes even killing all the cells in the organ). On top of this, our immune system then “overreacts” to these cells dying causing even more problems. We have these COVID19 doors on almost all of our organ systems. This leads to short- and long-term health problems (yes, among young and healthy individuals too).

We have so much science on this it’s insane. I’ve posted on this before (August), but thought it was worth resharing with updated science and statistics.

Lungs: Lose the ability to pass oxygen to the blood and remove carbon dioxide. This leads to distress (and sometimes requires ventilation). The type of pneumonia often associated with COVID-19 can cause long-standing damage to the tiny air sacs (alveoli) in the lungs. The resulting scar tissue can lead to long-term breathing problems. We’ve also seen long-term lung function abnormalities.

Heart: Chest pain, heart racing, and heart attacks. 20-30% of patients have heart damage. Imaging tests taken months after recovery from COVID-19 have shown lasting damage to the heart muscle, even in people who experienced only mild COVID-19 symptoms. This may increase the risk of heart failure or other heart complications in the future.

Nervous System/Brain: 33% patients experience neurological or psychological “COVID19 fog”. Even in young people, COVID-19 can cause strokes, seizures and Guillain-Barre syndrome. Break in communication between the nerves and muscles, causing MS like symptoms (tingling, numbness, weakness). Smell and taste problems (10% people aren’t getting their smell back long term), sleep issues, difficulty with concentration, memory problems

Kidney: 78% of patients in ICU develop kidney injury.

Skin: rash, hair loss

Digestive system (stomach, pancreas, gallbladder): 33% report diarrhea, nausea, abdominal pain. 17% have severe pancreatic damage leading to chronic disease

Blood: COVID-19 can make blood cells more likely to clump up and form clots. While large clots can cause heart attacks and strokes, much of the heart damage caused by COVID-19 is believed to stem from very small clots that block tiny blood vessels (capillaries) in the heart muscle. Extensive clotting in the veins and other small blood vessels have also been seen in patients’ kidneys, liver, brain, and lungs. Lymphopenia- the mass destruction of WBCs our immune fighting cells

Psychological: Mental health issues lead to struggling for words, simple math, or just trying to think. Simply surviving mechanical ventilation can make a person more likely to later develop post-traumatic stress syndrome, depression and anxiety.

Bottom line: Get your vaccine. If you don’t want the vaccine, that’s okay. If you want to wait, that’s okay too. But do NOT spread misinformation to people that are genuinely interested in the truth and making data-informed decisions. Especially, on my page.

Love, YLE

Lungs:
https://www.bmj.com/content/370/bmj.m2426
https://www.medscape.com/viewarticle/938683_4
https://www.ersnet.org/the-society/news/covid-19-patients-suffer-long-term-lung-and-heart-damage-but-it-can-improve-with-time
https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-020-01286-5
https://www.ajronline.org/doi/pdf/10.2214/AJR.20.23034
https://www.nature.com/articles/d41586-020-02598-6#ref-CR1
https://radiologyassistant.nl/chest/covid-19/covid19-imaging-findings

Heart: https://jamanetwork.com/journals/jamacardiology/fullarticle/2769182; https://jamanetwork.com/journals/jamacardiology/fullarticle/2768916; https://www.heartrhythmjournal.com/article/S1547-5271(20)30625-1/fulltext

Nervous system: https://academic.oup.com/brain/advance-article/doi/10.1093/brain/awaa240/5868408https://www.acpjournals.org/doi/10.7326/L20-0845; https://jamanetwork.com/journals/jama/fullarticle/2768351https://els-jbs-prod-cdn.jbs.elsevierhealth.com/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_ft95_5_18.pdf; https://www.acpjournals.org/doi/10.7326/L20-0845 ; https://cp.neurology.org/content/early/2020/06/30/CPJ.0000000000000897 ; https://cp.neurology.org/content/early/2020/06/30/CPJ.0000000000000897

Kidney: https://www.bmj.com/content/369/bmj.m1996 ; www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/coronavirus-kidney-damage-caused-by-covid19%3famp=true

Digestive System: https://www.cghjournal.org/article/S1542-3565(20)30646-7/pdf; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7194639/https://www.biorxiv.org/content/10.1101/2020.04.14.040204v1.abstract

Skin: https://www.aad.org/public/diseases/hair-loss/causes/covid-19

Blood: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30178-4/fulltext

CDC IFR list: https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html
Also liked this source: https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-long-term-effects/art-20490351

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Viral-Vector Vaccines

AstraZeneca (and Sputnik and J&J) vaccine’s biotechnology.

The Oxford-AstraZeneca vaccine hasn’t been authorized for emergency use in the United States yet (still waiting for trials to end) but has been authorized in the UK, Mexico, Argentina, and India.

This vaccine is considered a “viral-vector” vaccine. There are essentially three components to this biotechnology:

1. The instructions: The vaccine needs to tell what the body to do. This vaccine tells cells to make the COVID19 spike protein by using DNA. The spike proteins then resemble a natural infection, which jumpstarts the immune system for protection.

2. The carrier: Scientists insert the instructions into a carrier. The carrier is another weakened virus called an “adenovirus”. Adenoviruses are common viruses that typically cause colds or flu-like symptoms. The AstraZeneca vaccine uses a chimpanzee adenovirus.

3. The pathway: Finally, scientists need to choose one of two potential pathways: 1. vaccine enters your cells and instructs them to make spike proteins 2. vaccine already has the spike protein on its surface and the vaccine cells slowly replicate. The AstraZeneca vaccine uses approach #1. It can enter cells, but it can’t replicate inside them.

This type of biotechnology has been in development for decades. However, until this past year, it’s never been approved before. (In July 2020, the FDA approved Johnson & Johnson’s Ebola viral-vector vaccine).

The fantastic thing about this biotechnology is that it uses DNA instead of mRNA. DNA is much more stable so it doesn’t have to be stored in expensive freezers and can be transferred very easily. It’s also very easy (and cheap) to make. Because of this, it’s going to be an absolute game changer in stopping the global pandemic. It will save billions of lives, especially those that are hard to reach and most vulnerable. AstraZeneca expects to produce up to two billion doses in 2021.

Love, YLE

For more than you ever wanted to know on this vaccine, I appreciated this article: https://www.nytimes.com/…/oxford-astrazeneca-covid-19…

Nature figure and article: https://www.nature.com/articles/d41586-020-01221-y