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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 


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. 


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



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."


May 15, 2021

Part 3: Pfizer BioNTech Vaccinations in Israel

The pier-reviewed paper for Israel's Vaccination program just appeared in Lancet and the "real-world" effectiveness >7 days after the second dose was almost identical to the Pfizer Phase 3 study results done for the EUA.  When the vaccine was obtained in Israel their goal was to vaccinate 6.5 million residents age 16 to >65 yrs.  In order to determine effectiveness, assessments were made >7 days after the second dose was given and then vaccinated and unvaccinated individuals were followed with a median follow-up of 7 weeks.  The study period was Jan 29 - Apr 3rd during which they vaccinated 72% of the population of Israel age 16 or older. This surveillance study was done when the UK variant B.1.1.7 was the dominant circulating strain in Israel. See Results Below


There were 109,876 infections in the unvaccinated group and 6,266 cases in the vaccinated group with a calculated effectiveness of 95%.  Asymptomatic, symptomatic, hospitalized, severe or critical hospitalized, and deaths were all assessed and effectiveness in all groups was above 90%.  I was especially interested in the group that was age 65+ (N=1,015,620) and the effectiveness was 94.8% (>65yrs),  95.1% (>75 years), and 94.1% (>85 years).  Immunosenescence, the reduced immune response in elderly patients, is always a concern, but apparently not with this vaccine, or with the UK variant, which makes me very happy.   There are many statistics in the paper, but I thought I would include only the effectiveness of preventing severe disease and deaths:

Severe Disease:  Unvaccinated (3,201)  Vaccinated (206)  Vaccine Effectiveness 98.6%

Deaths:              Unvaccinated (715)     Vaccinated (71)    Vaccine Effectiveness 98.5% 

Please get vaccinated!!!  Two more of our 8 grandchildren got vaccinated yesterday and today as part of the new 12-15 year old group.  One more will be vaccinated now and the other 3 are still too young.  Today's Vaccination for Callum was done under the Whale at the Museum of Natural History - no appointment needed.

May 12, 2021

Part 2: Pfizer-BioNTech Vaccine Trial in Qatar

The best way to determine the efficacy of vaccines against the SARS-CoV-2 variants is to see how protected vaccinated people are in a real world setting.  Qatar has a National Federal Covid-19 data collection system and on Dec 21st they launched a mass vaccination program.  Data was collected from Feb 1-Mar 31, at a time when the UK variant (B.1.1.7) and the South African variant (B.1.351 each accounted for almost 50% of the coronavirus samples that were genome sequenced in their population.  There were 265,410 people who received 2 doses of the vaccine during that time period.  They matched PCR positive cases and PCR negative cases by age, sex, and nationality and then calculated the number of cases of Covid-19 in each group more than 2 weeks after their 2nd vaccine dose. 

The effectiveness of the vaccine against documented infections, more than 14 days after the 2nd dose, was 89.5% with the B.1.1.7 variant and 75.0% with the B.1.351 variant.  In addition the vaccine effectiveness against severe, critical, or fatal disease with these variants was 100% with each variant. However effectiveness after only one dose was much, much lower.  Out of the vaccinated group here have been only 1,616 breakthrough cases in patients who received two doses, but 6,689 cases in people who only received one dose.  See Below


 If you did not get your second dose of Pfizer or Moderna vaccine, please get it now.

Both Pfizer and Moderna are developing an updated mRNA vaccine that targets B.1.351 - which is a mutation of concern.  We may not need it, but this mutation from South Africa is one of the most worrisome of the current variants.  Next time Part 3: The recent studies of variants in the Israel Vaccine Groups.



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