Paper and Threads

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.

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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. 

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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."

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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.

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Today I wanted to review what we know about the NYC Variant and other variants found in NYC.  Very little genomic sequencing was done in the US prior to February 2021.  Since then NYC surveys approximately 1100 viruses per week from samples obtained and sequenced in labs here - a very exhaustive process.  I follow the weekly reports to see what variants are circulating, and today outline the variants as of 5.4.21 and review a report from MMWR (the CDC weekly bulletin) on the NYC Variant.  In the first genomic data reported (2.14.21) the NYC variant (B.1.126) accounted for 29% of the variants, the UK variant (B.1.1.7) was 7%, and other variants accounted for 0-1.2%.  Now the NYC variant was 36.7%, the UK variant was 41.5% and only the P.1 Brazilian variant was >1% at 3.6%.  The UK variant definitely increased demonstrating its increased transmissibility.  The NYC variant has increased, but it's trajectory is much slower than the UK variant.

NYC Variant:  There are two subgroups of the NYC Variant, which was originally isolated from an immune deficient patient in Manhattan.  Now the dominating subgroup of the circulating NYC variant is the one which contains the E424K "EEK" mutation - which is present in both the South African and Brazilian variants.  The CDC, after studying patients with either the NYC or UK variant concluded:

1.  The NYC variant does not cause more severe disease.  2.  It is not associated with breakthrough cases after vaccination.  3.  It does not cause more reinfections in patients who had Covid-19.  4.  71% of patients are symptomatic.  Much more testing and analysis is needed, but this is a good start. See  Below

The next Blog Post, Part 2, will review data on variants in other countries:  There is data from Israel on the efficacy of the Pfizer vaccine against the UK and South African variants.  But there are also studies that are reported from Qatar and I will need to look at them before I can pass along the information. 

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