Paper and Threads

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. 

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.     

Posted by Shirley at 8:44 AM | Permalink | Comments (1)

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

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. 

Posted by Shirley at 6:19 AM | Permalink | Comments (0)

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.  

Posted by Shirley at 6:04 AM | Permalink | Comments (0)

There are 73 million children in our country and although they have a low risk of developing Covid-19, it is not a 0 risk.  Delta variant is now spreading widely in unvaccinated adults and children.  The number of new infections in children in the US from the last 3 weeks were: 39,000/wk, 72,000/wk, and now 94,000/wk.   Hospitals are reporting a significant increase in hospitalizations and more severe cases.  It is so sad to hear reports of young children having great difficulty breathing without having any understanding.  I saw two very sick babies on TV this week breaking my heart.  The number of deaths during the pandemic is quoted at or near 400 - significantly higher than flu deaths in children each winter.

In addition, there are a significant number of children who develop "Long Covid," including fatigue, brain fog, and numerous other symptoms like adults.  A small, but significant number of children can also develop MIS-C, an overactive immune response that develops weeks after the active Covid infection and can severely affect any organ in their body.  

Children 12 and over are eligible for the Pfizer vaccine, and unless there is a contraindication this group should all be vaccinated prior to returning to school.  They are at great risk of developing Covid-19 if living in a household with unvaccinated people who are at high risk and can transmit the virus to them. 

On Sunday Dr. Fauci said that vaccine mandates for adults are necessary to give children who are currently not eligible  a "shield of vaccinated people."  A study in North Carolina reported only a 1% transmission rate for children in schools if "universal masking is in place in the school (children and adults).  The lower dose vaccination for children 5 - 11 years old is in clinical trials by Pfizer and Moderna and hopefully these vaccines will be as safe and effective, and also available before the end of the year.  We have 8 grandchildren and 5 are vaccinated with #6 turning 12 and getting vaccinated later this month.  The adults in our family are all vaccinated and we will continue to worry about our two youngest grandsons- ages 9 and 10 for the next few months.

Posted by Shirley at 6:56 AM | Permalink | Comments (0)

...And vaccinated Americans were looking forward to it.  Then the Delta Variant spread very quickly in every state and case numbers and hospitalizations increased. Samples collected in NYC on 7/24, and then sequenced, demonstrate that 92% of the circulating virus here is the delta variant, and it is much more transmissible.  No vaccine is 100% effective and breakthrough cases are also increasing in number. 

The CDC reviewed the rapid increase of infected cases and revised their guidelines for masks:  (1.)  Vaccinated people in high transmission areas should wear masks again indoors - especially if the transmission rate is >100 weekly cases per 100 thousand people, or unknown.  NYC is classified as high, right now, today.  (2.)  In K-12 schools universal mask wearing should be required for everyone over the age of 2.  (3) Vaccinated people should even consider wearing a mask in crowded outdoor venues. 

More Below

The CDC recommends masks with two or more layers of washable breathable fabric and a nose wire.  There should be no gaps.   You can test the mask by demonstrating that you can't blow out a birthday candle when wearing it.  When wearing 2 masks, place the cloth mask over the surgical mask.  In high risk areas, you should upgrade to an N95 or KN95 mask. 

There is no "0 risk" and each of us need to establish what level of risk we are comfortable with.  The elderly may have a diminished immune response and others may have immune deficiency after transplants, when on steroids, or receiving chemotherapy.  There is now evidence that vaccinated people who may be asymptomatic or have mild Covid-19 can transmit the virus to household members, family, and friends. Breakthrough infections in vaccinated people are very rare and most don't require hospitalizations or die.  The most important advice to protect yourself and your family is - Please Get Vaccinated! 

Posted by Shirley at 6:30 AM | Permalink | Comments (0)