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August 29, 2021

NY and Vaccination, Delta, Infections, and Booster?

This is an interesting compilation of data from NY between May 3 and July 25, 2021.  It illustrates the type of information that would be helpful in all of the states in order to determine whether and when we might need booster shots.  This full paper was published in MMWR by the CDC this week and I wanted to briefly review the results.  People >60 years were eligible for vaccination by Mar 10 and to all residents >18 years by April 6. 

Breakthrough infections and hospitalizations were counted in fully vaccinated (10,135,322) and unvaccinated (3,472,197) people and results were stratified in 3 ages groups (18-49), (50-64), and (>65).   Vaccines received were Pfizer 51.3%, Moderna 39.8% and J and J 8.9%.  During this period the vaccination rate increased to 65% as the delta variant increased from <2% to >80%.   See Below 

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Results: 

Cases:  9,675 in vaccinated and 38,505 in unvaccinated (1.31 vs 10.69/100,000 person days). Case rates were generally similar across all age groups in both vaccinated and unvaccinated subjects.  Cases decreased from March through the end of June and then increased with the delta surge through July for both vaccinated and unvaccinated. Vaccine efficacy for all age groups generally declined from 91.7% to 79.8%.

Hospitalizations:  1,271 hospitalizations among vaccinated and 7308 among unvaccinated.  They declined from March to June, and then increased in July as the delta variant became predominant.  There were more hospitalizations in the 65+ group than in the other two younger cohorts, but no information about comorbidities was available.  Vaccine efficacy against hospitalizations remained above 90% in all age groups.    And finally the ratio of hospitalizations was moderately lower in the vaccinated group (13.1 per 100 cases vs 19.0).

These types of real world studies are difficult to analyze fully but they may be equally or more important in defining objectives, i.e. prevention of disease and hospitalizations by vaccinations.    

August 25, 2021

Will Full FDA Approval Lead to More Vaccinations?

As my son Jason wrote on Instagram on Monday "I've said here many times that these vaccines are the most studied medical interventions in human history, building on over 20 years of brilliant research to deliver a miracle in one of humanity's greatest moments of need.  The FDA's full approval now validates the safety and effectiveness of Pfizer's shot, and a Moderna approval is likely only a few weeks away."  Now we can only hope that those who didn't take the vaccine because they wanted full FDA approval will get vaccinated so our country can control this pandemic.  As the virologists say, the virus will not stop spreading until there are no more susceptible people.  The vaccine was fully approved for two doses 3 weeks apart for people aged 16 and older.

Almost 100 million people in the US, ages 12-95+, have received the Pfizer vaccine and efficacy and safety was proven over and over.  But the FDA's new full approval for people age 16 and older was based on tens of thousands of data pages on the 44,000 volunteers in the Phase 3 Clinical Trial.  These trial subjects will still all be followed for a full 24 months from enrollment, so we should continue to see more scientific data until the trial ends.   Vaccine efficacy which was 95% when the EUA was granted has dropped slightly to 91% and there were no new safety concerns. Were any of the new cases due to the delta variant?  I couldn't find that info.  Children age 12-15 are now being vaccinated under the emergency approval until the FDA-CDC complete their review of the data in these adolescents. 

See Below 

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The Pfizer vaccine was approved for an EUA (Emergency Use Authorization) in December 2020 and has been granted a BLA (Biologic License Application) this week.  There are some new changes, for example the vaccine now has a name that no one will remember, it can be advertised and sold, and physicians may be able to use it "off-label" which means some variation from the current schedule of 2 doses 3 weeks apart.  Importantly it is still free for all of us in the US. It is important to remember that this dosing was determined in a carefully monitored study.  Consumers should beware of use in a new regimen without equally good scientific information proving vaccine efficacy and safety.  Children <12 years old should not receive the current dose, off-label, because the trial to establish the correct, SAFE dose has not yet been determined.

Now that the vaccine has full approval by the FDA  many institutions, companies and organizations have mandated vaccination for employment - including the active-duty Military, and many schools, universities, and hospitals.  85 million Americans are still unvaccinated and mandates like these will make it safer for all of us.  New cases are up to 150,000 per day in this surge and it is nearly impossible to calculate your risk of infection, especially in states without mandates for vaccinations and masks.  Come on people - it will take everyone to be vaccinated to change the course of this pandemic and get us back to our previous lives.

 

 


 

 


August 21, 2021

Booster Shots for the Vaccinated

Yesterday 2 of my unvaccinated grandsons asked if they could come over to watch me make 3 layer cloth masks for them before school starts.  One of them likes the elastic to go around his neck and head like N95 masks so I am his provider!  For this blog post I am reposting a Covid collage that appeared on July 11, 2020.  In that blog post I described the 3 phases of the clinical trials for the mRNA vaccines that were beginning http://www.paperandthreads.com/2020/07/roll_up_your_sleeve.php.  I now have created 122 Blog Posts about Covid and I feel as if we are back at the beginning. 

It is possible to collect plasma from patients infected with the delta variant to measure "neutralizing antibodies" to determine vaccine efficacy.  But following breakthrough cases in the real world gives scientists information about the full immune response in vaccinated patients.  The CDC follows these very carefully and the increase in the number of breakthrough cases in vaccinated people made them decide that it would be better to stay ahead of the virus.    High rates of infection in the unvaccinated leads to more mutations!Continue below. 

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Dr. Fauci, in the CDC announcement last Wed, presented 4 reasons for considering booster shots 8 months after our second doses:

1.  Antibody levels decrease over time.  2.  Higher antibody levels are more protective.  3. Higher antibody levels may be required against the delta variant.  4.  There is a 10-fold increase in antibody levels against delta variants after a 3rd dose of the same vaccine.  There are many vaccines that require several doses and/or annual boosters, so this is not an indication of vaccine failure.  It is still enormously effective against hospitalizations and deaths due to delta variant, less so against mild to moderate disease, thus the new recommendation.  Schedule your booster shot at one 0f 80,000 centers 8 months after you received your 2nd dose of mRNA vaccine.  Please don't rush out before that!  Two of our closest friends (same age as us) both developed Covid recently and they were so thankful for the vaccine, because the infection was just like a cold.     

August 18, 2021

Get Your Arm Ready Again.

This week the CDC will recommend that fully vaccinated people should get a routine booster shot, 8 months after their second mRNA dose.  It should be the same mRNA vaccine they received previously.  The FDA needs to approve this recommendation - which was always a possibility, but now will be a reality.  The mRNA vaccine efficacy was still high 6 months after vaccination, but that was before the current surge in the delta variant in the observed population.  Scientists have been examining both the power of the antibodies against the delta variant in the lab and also watching breakthrough cases that have occurred since the delta virus became the dominant virus spreading rapidly in the US.  It is hard to determine exactly when a booster might be needed for any vaccine and there has only been several months of data to analyze, but this week the CDC/NIH thinks it is best to start planning for it. 

During the last 4-6 weeks the scientific community experts were starting to discuss the real possibility of a booster shot before or at a year, but said they didn't have enough data yet to make a decision.  But then they observed the surge across the country, the recent breakthrough cases, and the increased number of severe breakthrough cases in the elderly who were vaccinated in Israel in Jan and Feb. Israel's vaccination rate is high, they used an mRNA vaccine for most of the vaccinations, and they have a robust government health system for following the cases. But we still need to see peer reviewed data from them. Current  vaccine efficacy had fallen to 55% against severe disease in fully vaccinated people in their series.  The articles say that the same trend was "being seen in several other countries."  This waning protection can occur because of the slow decline in antibody titers or a virus variant that spreads more aggressively or a combination of both.   Read Below

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The articles I read said the Israel data was reviewed by two independent vaccinologists, Dr. Peter Hotez from Baylor and Dr. Jesse L. Goodman, at Georgetown (formerly from the FDA), who agree with the recommendations  - i.e. start planning for a booster shot 8 months after the second vaccine dose (beginning in Mid-September). Israel is currently giving booster shots to people over 50, and Germany and France plan to begin next month.  The UK hasn't decided on a starting date.  The Boosters will start with Health Care Workers, Nursing Home Patients, Emergency Workers and then the elderly.  Pfizer submitted an addendum to their vaccination protocol to the FDA for approval, and Moderna will follow.

This recommendation is NOT for the immune deficient patients, they are all eligible for their 3rd dose now - hoping that they will get a good antibody response this time. 

August 14, 2021

CDC Strongly Recommends Vaccinations for Pregnant Women

Last week groups including the American College of OB-Gyn and the American Academy of Pediatrics said data shows that the mRNA vaccines are safe and effective when administered during pregnancy and have no impact on fertility. In spite of this data, only 23% of pregnant women have been vaccinated with at least one dose.  This is understandable, when pregnant we are all extremely careful about what we put in our bodies. But there have been many vaccinated patients followed since the vaccines became available and there are no safety concerns for mothers or babies.

The CDC is now strongly recommending that women who are pregnant should be vaccinated since the data shows that Covid-19 is more severe in pregnant patients (with hospitalizations and ventilator support) and  pre-term births are increased.  There have been no safety issues noted - Among 2500 patients miscarriages were no more common than in women who did not get vaccinated.

Another benefit to consider, when the mother gets vaccinated, antibodies to Covid can be measured in the umbilical cord blood and in breast milk, providing some level of passive immunity to the babies.  

 

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