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March 13, 2021

Vaccination vs Variants- A Race

President Biden announced a very vigorous vaccination program Thursday night - with televised messages from past Presidents, creation of more vaccination centers, especially in the medically underserved communities, and even mobile vans to go to the people.  He also announced a country wide federal web-based program to link people with their nearest vaccine centers to make vaccination appointments. By May 1st all 18 year old and older people will be eligible for the vaccines and enough vaccine is being planned so supplies won't limit the biggest ever vaccination program in this country. 

As of this week 341 million does in 121 countries have been administered at a rate of  8.51 million doses per day. In the US more than 101 million doses were given with an average of 2.30 million doses per day.  At this rate it could take 5 months to vaccinate 75% of the population with the two-dose vaccines.  If we would like to have an effect on this pandemic we need to make sure we encourage our friends, families, and coworkers to get vaccinated, while wearing masks, socially distancing, and avoiding crowds to try to bring the new case numbers below 10,000 per day.
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These vaccines were tested in over 70,000 volunteers in Phase 3 trials, and since then many millions of us have received the vaccines, and the safety record is great.  Most of the complaints are local reactions at the injection site and/or flu like symptoms for 24 hours, more after the second doses. There are many federal systems set up to collect each and every side effect, and they all are reviewed by scientists and physicians at the CDC. 

This week, when viruses from the current positive cases in New York City were studied to assess the presence of mutations,  12% of them were the UK (B.1.1.7) variant and 39% the NYC  (B.1.526) variant. It appears that they are spreading easily, and we need to decrease their spread wherever possible while we race to vaccinate even more quickly. The more infections we have, the more opportunities there are for more mutations to occur.  Epidemiologists worry that we are at the brink of another surge, as states reopen and variants which are more transmissible spread very quickly.  And children are more susceptible to these variants.  Please continue your mitigation activities!

March 10, 2021

CDC Interim Guidelines for Vaccinated People

The CDC issued Interim Guidelines for Vaccinated people. 

Fully Vaccinated:  At least 2 weeks after the 2nd dose of Moderna or Pfizer vaccines, or at least 2 weeks after receiving the one dose J and J vaccine.

Fully vaccinated people can:

1.  Visit with other fully vaccinated people indoors without wearing masks or physical distancing. 

2.  Visit with unvaccinated people from a single household indoors, who are at low risk for severe Covid-19 disease, without wearing masks.

3.  You do not need to quarantine if exposed to a Covid-19 infected patient - unless you become symptomatic. 

In addition:  Wear masks, socially distance, wash hands when with unvaccinated people who have an increased risk for severe Covid-19.  Avoid medium - and large-sized in-person gatherings.  Delay travel and stay home to protect yourself and others from Covid-19.     Read Below for the excellent link to the CDC. 

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https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html 

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.

 

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