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March 6, 2021

No Masks and Reopening a State?

What is Happening in This Country?

I was physician on a medical school faculty and spent half of my career in Texas and the remaining half in New York City.  Therefore I believe in science like the infectious disease scientists, epidemiologists, and and public health advisors.  Dr. Tony Fauci said "the U.S. shouldn't ease restrictions in place to prevent Covid-19 before the number of new coronavirus cases falls below 10,000 daily, and maybe even considerably less than that.  The US should pull restrictions gradually, after a substantial number of people are vaccinated."  Some states, like Texas are discontinuing their mask mandates and opening their state completely.  I have no idea what they think will happen.  While the country is in the midst of vaccinating people as fast as possible, the country should be trying to lower the number of cases per day to prevent deaths.

Right now the US is vaccinating 2 million people per day, but there are 55,000-70,000 new cases per day.  The number of cases were decreasing since January, but last week the drop stalled, and there is now great concern that there will be another big surge, probably due to the B.1.1.7 UK variant which is present in 46 states, Puerto Rico and Washington DC.  Last summer, as some states reopened much too quickly, there was a big surge in the number of cases and deaths.  Even businesses in Texas aren't willing to end their mask mandates.  And people living in those states can continue to wear their masks!  They should rebel if they ever want to return to our pre-pandemic lives.       Read Below 

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The UK variant has spread widely in this country and is more transmissible and reported to cause even more severe disease.  In addition, the South African and Brazil variants are here, and when the masks and social distancing decrease, and group activities increase, the variant will spread quickly.  Scientists report that increased viral replication increases the rate of mutation and eventually another variant will emerge that will elude our vaccines.  Does anyone understand the rationale of some Governors in the US?  Another surge in the number of cases will only further delay the control of the pandemic  - which they are ignoring. 

Dr. Rochelle Wallensky, our new head of the CDC, said Thursday "state officials must continue to emphasize the wearing of masks and encourage everyone to roll up their sleeve for the vaccine when it's available to them."  That is the way to defeat this virus.  I'm so disappointed in Texas, a place with wonderful scientific institutions and amazing hospitals. I'm having trouble understanding the other states who are following Texas into the darkness.

 

March 3, 2021

CAUTION,,,,

There are recent reports of axillary lymph node swelling on the same side as your Covid vaccine injection, and this occurs in up to 16% of patients (men and women), and with both Pfizer and Moderna vaccines.  After an injection, the adjacent lymph nodes can be  enlarged as the first part of the immune response.  The lymph nodes may also be tender.  There are changes being seen and reported on mammograms, on the same side as the vaccination, when they are done right after Covid vaccination. It is now advised that you delay a routine mammogram until 6 weeks after your 2nd dose of vaccine.

However, if there is concern that a patient may have breast cancer or recurrence of breast cancer, the mammograms and further studies should be done.  The New York Times has a recent article about this vaccine-related axillary lymphadenopathy, and some mammogram centers are now checking to see when the patients' vaccinations occurred, and telling them that a mammogram done that day may lead to further evaluation if they don't want to delay a routine mammogram for 6 weeks. See Below

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I don't ever remember a warning like this with other vaccines, and in my personal experience the 2nd Shingrix vaccine dose against Herpes Zoster ("shingles") caused the worst local reaction I've ever had with any vaccine.  It is probably reasonable to delay a routine screening mammogram for 6 weeks after any vaccine given in the deltoid muscle of the upper arm.

February 27, 2021

Happiness - J and J's Vaccine Will Be #3

Running with Joy!  The FDA independent Scientific Advisory Board met from 9-5 yesterday and unanimously approved the vaccine.  I watched all of it.  It is a "viral vector vaccine" in which DNA from the spike region of the SARS-Cov-2 virus is carried into our cells with a non-replicating adenovirus (Ad26) and the DNA directs the production of the spike protein which stimulates our immune response.  This is the same basic method with which the Astrazenca vaccine was made.  Neither the DNA nor the common cold adenovirus are able to affect our cells in any other way.  The Phase 3 Clinical trial tested a single injection of the vaccine, and its efficacy at preventing moderate to severe Covid-19 was measured at days 14 and 28 after vaccination.   The clinical trial was carried out in the US, S. Africa, and S. America (8 countries total). 

The efficacy of the vaccine in the US trial (approx. 20,000 volunteers) was 74.4% effective at 14 days and 72% effective at 28 days preventing moderate to severe-critical disease, and 85.9% at preventing severe-critical disease. No covid-related deaths occurred in the vaccinated group. Efficacy among age, race, ethnicity, and comorbidities were similar. 

There was one recent case of anaphylaxis in S. Africa, but there were no other major adverse events.  Injection site pain was the most common side effect, followed by headache, fatigue, and myalgia - and most resolved in 1-2 days.  See Below

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There were approximately 5000 volunteers in the South African Phase 3 clinical trial and efficacy was 73% at 14 days and 81.7% at 24 days.  The variant B.1.351 (their mutant virus) was 94.5% of the genetically sequenced viruses which suggests that the vaccine has some effect against their mutant virus.  This is good news.

The FDA will probably approve the J and J vaccine this weekend, and they said they would be ready to deliver 2+ million doses, ASAP  and as much as 20 million doses by the end of March.  Dr. Fauci and other experts are saying "take whichever vaccine you can get."   The clinical trials for the 3 vaccines were very different, and the efficacy data can only be compared if they are part of the same trial.  The side effects for all 3 are similar, as is the fact that no one died of Covid-19 in any of the 3 trials.

 

February 24, 2021

Vaccinations for the Black Communities

This week Governor Cuomo announced the opening of the Medgar Evers College Vaccination Center in Brooklyn.  It is a joint project of the Federal and State governments in order to increase the number of people of color who will be vaccinated.  They have the highest death rates from Covid-19 and a much lower number of people being vaccinated. 

Many zip codes are being targeted for the program and there will be door to door visits to help people understand the importance of vaccination and the efficacy and safety of the vaccines.  Black churches will set up phone banks to announce the program and encourage participation.  People from those zip codes will be allowed to go to the Vaccination Center to register in case they either don't have computer access or skills.  They can make an appointment in person and then return for their vaccinations when scheduled.   In addition special city MTA bus routes will be set up in these zip code areas for transportation to the College.  This is an ambitious program and I hope that it accomplishes its goal.   After several weeks other residents of Brooklyn can schedule vaccinations at the college. 

For more information:  https://www.bkreader.com/2021/02/22/medgar-evers-college-vaccination-center-to-open-wednesday-heres-how-to-get-an-appointment/        And See Below

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Dr. Kizzmekia Corbett, a young black woman scientist at NIH, had a major role in developing the Moderna vaccine.  For several years she was working on coronaviruses in the Vaccine Program, in NIAID, the Institute directed by Dr. Fauci.  When China published the genome for SARS-CoV-2, she already had published work on these viruses.  She then had a major role in developing the mRNA for the spike protein that was used to make the vaccine.  She also played a role in the Phase 1, 2, and 3 clinical trials.  But the current press release I read was about her new "job."  She is now spending lots of time speaking to black communities in order to be able to educate them, answer questions, and develop the trust that is necessary for them to be vaccinated.

https://www.nature.com/articles/d41586-021-00338-y 

February 20, 2021

Vaccine Hesitancy and Vaccine Safety 2

Vaccination of a majority of US citizens will help control the SARS-CoV-2 pandemic.  Dr. Fauci says that herd immunity could occur when 70-85% of people are vaccinated, and that means that we need a large number of people to get vaccinated.  But there are many people who don't want to be vaccinated, and there are many different reasons given.  

1.  "This is a new type of vaccine, an mRNA vaccine," but it is important to know that the mRNA techniques have been studied and used for up to 2 decades. 

2.  "The vaccines were made too quickly" and they want to wait until Spring or Summer to make sure they are safe.  The Clinical Trials for the Pfizer and Moderna vaccines contained 74,000 volunteers -50 per cent of those received the vaccine and there was an excellent safety profile.  Scientists say that significant side effects of almost every vaccine ever made occurred by 6 weeks after vaccination.  Millions of people have since been injected since the vaccines were approved and there is a robust side effect reporting system.  In a paper published this week, 0nly 15-25% of patients reported symptoms after the first month of vaccination with both vaccines (headache, fatigue, dizziness, chills, nausea).       

3.  "They don't trust the government," and people of color have a good reason to be suspicious of past government studies. The development of these Covid-19 vaccines were transparent, reviewed by scientific advisory groups for the manufacturers, and another scientific advisory committee who advised the FDA re: approval.  The data is published for everyone to read and the committee meeting is available live online.   More Below

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The vaccines can cause two types of reactions - one from the injection, and the other an allergic reaction.  Patients can complain of pain, with or without swelling at the injection site.  After the second dose there are more symptoms reported by the patients: fatigue, headache, fever, chills, myalgias, and or joint pain.  These symptoms rarely last longer than 24 hours and can be relieved by Tylenol or Motrin taken if they occur.  These symptoms are a minor price to pay for the assurance that you will almost certainly not be hospitalized or die from Covid-19.  I  had soreness at the vaccination site (as did my husband), but NO other side effects.

The only major side effects reported are allergic reactions: 5 episodes of anaphylaxis/1 million vaccinated with Pfizer and 3 episodes/1 million vaccinations with Moderna since the vaccinations began.  They were treated with epinephrine injections immediately and patients recovered fully.