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July 2, 2022

Bivalent Booster Dose for Fall 2022?

The FDA VRBPAC Advisory Committee met on Tuesday for the 2nd time in order to discuss Covid-19 booster shots for Fall.  The influenza vaccine given each Fall is selected late Spring and prepared for administration in October-November.  The influenza virus doesn't mutate as quickly as the coronavirus, and for many years a WHO committee has selected the circulating variants to make a combined flu vaccine for the Fall.  They have lots of experience planning which influenza variants should be used for the vaccine.  

The original SARS-CoV-2 mRNA vaccines (prototype) still have remarkable ability to prevent hospitalization and death, but the coronavirus virus is mutating faster than influenza viruses. Omicron has mutated frequently since its appearance in Dec. 2022, and the current subvariants BA.4 and BA.5 are now the dominant strains in the US.  There is a slight decrease of the prototype vaccine against these variants in lab tests.  After a full day of reviewing the recent efficacy and safety of vaccines made against the variants by Moderna and Pfizer the committee was asked whether the fall booster shot should contain the omicron variants to broaden the efficacy of the vaccine.  See Below 

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The committee voted 19 yes and 2 no, and soon will decide whether it should be a bivalent vaccine combining the original coronavirus mRNA (Wuhan strain) and omicron subvariant mRNA.  Both Moderna and Pfizer have made and tested some bivalent vaccines against the coronavirus SARS-CoV-2 virus and they do have broader efficacy.  Both Moderna and Pfizer said they could manufacture enough of the proposed vaccine by early to mid-October.  For now, vaccinated people should get the 2nd booster.

June 16, 2022

The Youngest Children's Covid Vaccines Were Approved by the FDA

Yesterday the FDA VRBPAC Advisory Committee met to evaluate the Moderna and Pfizer childrens' vaccines for an EUA.  Moderna's vaccine is for children (6 months to <5yrs) and Pfizer's vaccine is for children (6 months to <4 years).  The 21 experts on the FDA Advisory Committee unanimously concluded that the benefits were greater than the risks for both vaccines.  The Moderna vaccine has 2 doses 4 weeks apart.  The Pfizer vaccine has 2 doses 3 weeks apart with a 3rd dose 8 weeks or more later.  

Vaccine development for younger and younger children is based on a method known as "immunobridging".  A small trial is done to determine the dose needed for good antibody production. Once that dose is determined a randomized, controlled clinical trial is done to determine vaccine efficacy and safety with groups receiving vaccine or placebo.  The CDC and its ACIP Advisory Committee will meet Friday and Saturday, and if the vaccines are approved, they may be available next week.  See Below  

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An epidemiologist that I follow online has an evaluation of the two vaccines.  At the end of her article she has information about how she will decide which of the 2 vaccines she will give to her children and why. 

https://yourlocalepidemiologist.substack.com/p/fda-meeting-for-5-covid-vaccine-q?s=r 

May 18, 2022

NYC is Now a High Covid Transmission Area

Today the NYC Health Commissioner raised the Covid-19 transmission rate to HIGH -from MEDIUM risk - which began on May 2nd.  There are 45 out of 62 counties in New York State with high transmission, and this is probably an undercount because results of rapid home tests are rarely reported.  The CDC reported that the average number of daily cases in the US is almost 88,000, four times what it was in March.  Hospitalizations are also rising - but they are divided between "admitted for Covid" and "admitted with Covid and another medical problem."  So far deaths are approximately 300/day and have not increased yet.   

Recommendations Beginning Now:  All New Yorkers should wear high quality masks in all indoor public settings, and those at high risk of severe illness should avoid crowded settings and limit "get-togethers."

The BA.2.12.1 which accounts for all of the circulating variants is 25% more transmissible than was BA.2 which was 30% more transmissible than the original Omicron variant.  The virus will continue to spread to millions of unvaccinated people, and even to vaccinated people who have not received a booster dose.  Breakthrough infections are even occurring in those that were infected by the first Omicron virus.  See Below 

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We are going away with friends for a beach vacation and  I may or may not have breaking news to report before June 4th.  Stay safe and healthy.  Long Covid has affected MANY people who had Covid-19, mild, moderate, or severe.  Reading their stories should make you want to avoid ANY Covid infections.

May 14, 2022

Every Adult Needs to Be Boosted Against Covid-19

Just a few comments today:  The Omicron BA.2.12.1 and BA.2.12 variants, which are more transmissible than Omicron BA.1, now account for all of the Omicron cases in Region 2 which includes NY, NJ, Puerto Rico, and the BVI.  While it doesn't appear to be more severe, US case numbers, breakthrough infections, and hospitalizations are climbing, especially in the  Northeast.  Deaths are also increasing, and not only in the unvaccinated.  Waning immunity and LOW BOOSTER NUMBERS most likely account for this decrease in vaccine effectiveness. 

It is now apparent that booster shots are critically important. One-third of vaccinated people who died from a breakthrough Covid-19infection hadn't had a booster shot (CDC data.). Dr. Peter Marks, Director of the FDA's Center of Biologics Evaluation and Research, said this week that is critically important that people who only had their initial 2 doses should get boosted NOW as the BA.2 subvariants are spreading across the country and cases and deaths are rising.   

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May 7, 2022

Covid-19 Omicron Infections Study by Age

The CDC recently reported results of a "seroprevalence study" of Covid-19 infections, by age group, during the period September 2021 through February 2022.    (MMWR Morb Mortal Wkly Rep 2022;71:606-608)  It is very difficult to get an accurate picture of the number of Covid infections in the country.   But Scientists can measure antibodies that are directed to the NUCLEOCAPSID part of the SARS-CoV-2 virus, and not the spike protein.  These NUCLEOCAPSID antibodies are generated by infection, NOT vaccination.  Samples were collected from people in all 50 states, DC, and Puerto Rico.  Samples were collected every 4 weeks, except February when they were collected every 2 weeks.  The median number of samples was 73,869 except for Feb when it was 45,810.  Seroprevalence (i.e. the number of people who were positive for nucleocapsid antibodies due to covid infection) was assessed every 4 weeks and by age group.  *see definitions below.

RESULTS:  Sept-Dec 2021: overall seroprevalence increased by 0.9-1.9% every 4 weeks.

RESULTS:  Dec-Feb 3022:  overall seroprevalence increased from 33.5% to 57.7%

     Ages 0-11: increased from 42.8 to 75.2%    5-11 years:  Fully Vaccinated 28%

     Ages 12-17: increased from 45.6 to 74.2%                Fully Vaccinated 59%

     Ages 18-49: increased from  36.5 to 63.7%               Fully Vaccinated 69%

     Ages 50-64:  increased from 28.8 to 49.8%               Fully Vaccinated 80%

     Ages >65 years:  increased from 19.1% to 33.2%      Fully Vaccinated  90%     See Below

 

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As of Feb 2022 approximately 75% of children and adolescents had serologic evidence of a previous Covid-19 infection.  One-third of these children became newly positive since Dec 2021 when Omicron was surging.  The greatest increase in seroprevalence during Sept 2021-Feb 2022 occurred in the age groups with the lowest vaccination coverage.

DEFINITIONS: Seroprevalence:  The percent of the nucleocapsid antibody detected in a batch of SERUM samples from patients.  

Serum:  The liquid part of a blood sample after the blood has clotted in a test tube and the cells and clot have been removed.  Serum is pale yellow.