June 19, 2021

Another Beach Break From the City

And a few more black and white drawings from my early AM walks around the Upper Eastside of Manhattan. 

I love the hat store on Lexington Ave and do a drawing when the window display changes. I also missed my individual flower drawings from Battery Park City flower gardens that I painted weekly for years, so I had to draw at least one flower from a plant in my neighborhood.  I have my watercolor paints with me, but these black and white drawings will always be remembered as a "life without color" as part of the pandemic.

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June 16, 2021

WOW! A 4th Covid Vaccine Later This Year

This week Novavax released the Phase 3 clinical trial data on their vaccine, although they probably won't seek an EUA from the FDA until next quarter.  They conducted their phase 3 trial in the US and Mexico.  Almost 30,000 volunteers (N=29,960) were randomized with 2 participants receiving Vaccine for every 1 receiving Placebo.  Vaccinations were given with 2 doses 3 weeks apart.  The vaccine is made with recombinant technology - the spike protein is made using the genetic sequence and then the spike protein is used as the antigen to stimulate an immune response.  There were 77 RT-PCR documented cases of Covid-19 in the volunteers (more than 7 days after the second dose), with 63 cases in the placebo group and 14 in the vaccinated group for an efficacy of 90.4%.  Ten cases were moderate and 4 severe in the placebo group.  There were no moderate or severe infections in the vaccinated group.  The vaccine was equally protective with high risk subjects, including participants 65+,  with comorbidities, or those with frequent covid exposures.  See below.

 

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The method used to make the vaccine has been used for decades and includes influenza, hepatitis B, and HIV vaccines.  It only requires standard refrigeration making it easy to manufacture and administer the vaccine around the world.  The main adverse effects included local injection pain, headache, fatigue,  and myalgia.  There were also smaller, very successful Novavax studies in the UK and South Africa, and I will report on the main findings in those trials after I digest all of that separate data.

 

June 12, 2021

Is Myocarditis a Very Rare Side Effect of the mRNA Vaccines

There are a growing number of reports of possible myocarditis and pericarditis (inflammation of the heart muscle and sac around the heart) in people following Pfizer and Moderna vaccinations The FDA has at least two extensive ways to detect adverse events from drugs and vaccines so they routinely receive reports to analyze.  To determine if they are caused by vaccines, they try to determine whether the incidence of the adverse effect is higher than in non-vaccinated people.  Myocarditis and pericarditis occur due to many viral/bacterial infections, drugs, and diseases (ex. collagen vascular diseases).  Thursday the FDA had a day long meeting to look at reports from their vaccine safety systems, but more data must still be collected about each report from solicited medical records. Review of the preliminary reports found that the patients were in the younger age groups (12-39), and especially after vaccine dose 2.  Myocarditis has been reported in all age groups that were vaccinated, but it was only in the 16-24 year old patients that the observed number of cases exceeded the expected number of cases in the general population.  There were 2.8 cases/1million first doses and 16.1 cases/1million second doses in these two groups.  See Below   

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The most common symptoms are chest pain and shortness of breath.  Additional tests include cardiac enzymes and EKGs.  Most symptoms are mild and recovery is quick with treatment with drugs like Motrin.  81% of patients recovered completely and many of the remaining 19% are of unknown status.  This data is similar to reports from Israel and the US military following Pfizer vaccinations.  Current US patients are young and more likely to be males  - the same as with other causes for myocarditis.  Millions of people have been vaccinated with the Pfizer and Moderna vaccines demonstrating that huge clinical trials like theirs (44,000 and 30,000 respectively) can't pick up these very, very rare adverse effects.  The FDA will continue to verify these reports next week and the independent scientists on the CDC Advisory Committee on Immunization Practices (ACIP) will meet next Friday to discuss the benefit vs risk ratio of the mRNA vaccines going forward.  They will also try to determine the risk of myocarditis/pericarditis from the Covid-19 infections alone.

June 9, 2021

July 4th Goal - 1 dose to 70% of Americans

We need to be happy about our vaccines - we wouldn't be at this stage of the pandemic without them.  Moderna is amending their EUA to include 12-15 year olds and both Pfizer and Moderna are testing their vaccines in younger children - maybe down to age 6 by September. We are told that an EUA for the 4th vaccine, from Novavax, will be coming soon.  Now seems like a good time to see where we've been since Mar 2020.

About 33 million of Americans tested + for Covid-19, and we didn't have sufficient testing in Mar-Apr 2020. 

About 595,000 Americans have died from the virus, deadlier than all wars, military conflicts combined in 80 yrs.

Last summer cases were over 65,000/day and by Winter hundreds of thousands had the virus and over 3000 died per day.

As of this week approximately 50% of Americans are fully vaccinated and over 60% have had at least 1 dose.   See Below

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The US can't control the virus without vaccines and the risk is as high as ever for unvaccinated Americans.  There will be localized outbreaks in areas where relatively few people are vaccinated.  Highly contagious viruses will continue to spread until most susceptible people are infected. 

New York State still has approximately 800 cases/day (which is <1% of >200,000 Covid tests/day).  Another way to assess the new cases is to count the number of positive cases/100,000 population in each state.   NOW:  US Overall:  4/100,000. The most new cases are in Wyoming and Colorado.  The lowest number of new cases is in Vermont with 1 case/100,000.  NY and New Jersey are 3/100,000population.

In the beginning of April those statistics were: US Overall:  20/100,000 and NY 38/100,000.  But New Yorkers are still being vaccinated and the rates of infection, hospitalizations, and deaths decrease each day.  Latest STATS from CDC:  The 7 day average of new daily cases reported has decreased from 65,053 on Apr1 to 12,780 on June 5.  The 7 day average of new daily cases reported decreased from 681 t0 367.

The virus will continue to circulate in America, but it is now infecting the unvaccinated - and will continue to spread in the "susceptible."  Unfortunately more cases are being seen in children and adolescents who are not vaccinated, and more young people have severe infections and are hospitalized in ICUs.   

 

June 5, 2021

Covid Hope Over Fear

The CDC caused lots of confusion when new mask recommendations were announced by Dr. Rochelle Walensky at 2:17 PM on May 13th.  The number of vaccinations in the US were dropping everyday, and so were the number of new Covid-19 cases.  But some states still had increasing cases, were opening up, and vaccinated people were told that they could drop there masks outdoors, if they weren't in large groups.  Would this inspire vaccine hesitant people to get vaccinated?      See Below

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"Almost immediately the number of visits to vaccine.gov to find vaccination centers spiked - rising even higher that afternoon.  Later that afternoon President Biden encouraged people to get vaccinated so they could remove their masks in many instances.  The increase in traffic to vaccines.gov continued and the number of vaccinations remained stable for the rest of May. This may have been a good example of how hope is better than continued fear.

The closing sentences in this NYTimes article said, "In the case of Covid vaccines, the hype is grounded in reality. Once you are fully vaccinated, you no longer have to organize your life around personal fear of Covid (unless you are immunosuppressed)."  Please get vaccinated, but remember, in some previous studies on "breakthrough cases" in vaccinated people, the efficacy of the vaccines were lower after only one dose.  If you only received 1 dose of the mRNA vaccines, get your second dose now - even if you missed the date for your 2nd dose.  The pandemic will not be over when the virus can still infect susceptible people.  

 

June 2, 2021

Protection Against Reinfection in Lombardy, Italy

How many patients who had Covid-19 infection during the first wave of the virus in Lombardy, Italy had it again, at least 90 days and 2 negative RT-PCR tests, later?  There is a new study from Lombardy that demonstrates that very few of the original cohort of Covid-19 + patients (Feb-July 2020) redeveloped Covid-19 during the next year. Patients who were negative during those early months were followed for almost a year for comparison, and many developed Covid-19.  The difference in the number of infections in these two groups was statistically significant (P<0.001).

Reinfection was defined as a positive RT-PCR Covid test more than 90 days after recovery plus 2 negative tests.  Only 5 patients of 1579 original Covid + patients had a reinfection - and one was hospitalized. 

There were 528 Covid-19 infections in the original 12,968 Covid-19 negative subjects while being observed for almost a year.

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Antibody levels and other markers of immunity were not measured, but the statistical difference in infection rate was a strong indicator that the previously infected patients had enough natural acquired immunity from their first infection to prevent reinfection for almost a year.  (JAMA Internal Medicine May 28, 2021) Recent studies demonstrate that there is a robust antibody response in patients who had Covid-19 after just 1 dose of vaccine.

May 29, 2021

Moderna Vaccine Trial in Children 12-18

More Good News: This week Moderna released data on their clinical trial in Adolescents - ages 12 to less than 18.  There were 3,732 volunteers and 2/3rds of the group received the vaccine (in the same dose as adults) and 1/3rd received placebo.  Clinical trials in children are smaller than in adults and the goal is to make sure that it has the same efficacy as seen in the bigger Phase 3 trial in adults.  This is called "immunobridging."  The vaccine was given the same way as in adults, two doses 4 weeks apart.  More than 2 weeks after dose 2 there were 4 cases of Covid-19 in the placebo group and none in the vaccinated group for an efficacy of 100%.  The side effects were similar to that in adults with local pain at the injection site and generalized symptoms of headache, fever, chills, and myalgias - most were mild or moderate.  See Below 

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They also calculated the efficacy rate using the CDC definition:  the presence of one symptom and a positive nasal swab or saliva test by RT-PCR molecular test.  Using this case definition the efficacy was 93%.  All volunteers will be followed for a full 12 months after their second dose.  Moderna will submit a request for approval of the vaccine in adolescents the beginning of June.  All of the data will be reviewed by FDA scientists, and the VRBPAC independent scientific advisory Committee and then presented to the CDC ACIP independent advisory committee for a a one day open discussion and vote.  If approved by the outside committee the CDC will have the final decision re: approval.

May 26, 2021

Part 4: Vaccine Effectiveness and Indian Variants

The more RNA viruses multiply, the more mutations occur.  Therefore uncontrolled infections, like in India or even hot spots in the US, will result in more mutations.  Will our current vaccines protect us?  Mutations can 1. Increase transmission of the virus, 2. Reduce effectiveness of our vaccines, and/or 3. Cause more severe disease.  The Indian mutant has 3 subtypes, and B.1.617.2  has increased transmission and may now be more prevalent than the UK mutant based on Public Health England studies just published.  The total number of cases in England are not increasing, but the Indian variant is replacing the UK variant in new cases.  Two doses of the Pfizer vaccine had an efficacy of 88% against the Indian variant and 93% against the UK variant.  However, the effectiveness after only one dose dropped to 33%.  See below. 

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The NYC Dept of Health is performing genomic sequencing on viruses isolated from random samples of infected patients.  The UK variant has increased from 7% in Feb. to 47% as of May 9.  The NYC Variant remains at approximately 30% (3 subtypes), the Brazil variant is approximately 6%, and the Indian variant has just appeared at the end of April in 4% of New Yorkers.  So far the mRNA vaccines have demonstrated effectiveness against each of the variants, but the recent UK report found that two doses are necessary.  The vaccine was only 33-34% effective after one dose.  The mRNA vaccines are very effective and very safe - everyone who only got one dose should go NOW to get their second dose.  Please get vaccinated - the infection rate, which is published daily by the NY DOH, right now is about 1% or less in NY State, NY City, Manhattan, and in my Zipcode. The virus will now seek out the susceptible people in our midst. 

May 21, 2021

Our First Post-Vaccination Vacation

This week we are taking a beach break, after not being away from our apartment since Jan. 2020.  I'm still surveying Covid-19 science and will resume my "collage/science" blog posts next week.  Here we are taking morning beach walks and trying to re-enter society a little.  My husband and I are both vaccinated and had a delightful dinner with 2 vaccinated friends at their home.  We wear masks in the grocery store and when we have workers indoors with us.  See Below

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During the pandemic, I sometimes did pen drawings as I took early morning walks around my NYC neighborhood.    Most of the time I surveyed store windows - and rapidly sketched a few interesting items.  I like to draw on location, and not in my apt or from photos.  These very rapid drawings were done if I saw something interesting or just felt like drawing as I walked.  I always thought that I may paint them, but my daily Covid-19 news letters, podcasts, publications, and FDA and CDC Advisory Board Meetings kept me busy. These are two drawings done last Fall, and this morning I photographed them and added them to my blog - just as a memory of the "our stay at home life."

 

Shirley Parker Levine
New York City

June 2021

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