Paper and Threads

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

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.

Posted by Shirley at 12:12 PM | Permalink | Comments (1)

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

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 

Posted by Shirley at 6:29 AM | Permalink | Comments (0)

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

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. 

Posted by Shirley at 1:50 PM | Permalink | Comments (0)

At a time when at least 3 variants of the SARS-CoV-2 virus are being recorded in the US, why are the the number of Covid-19 cases, hospitalizations, and deaths in the US decreasing, although they still remain higher than the peaks in the Spring and Summer of 2020?  Is it the time for the seasonal ebb of respiratory viruses?  Or are the mitigation measures working - masking, social distancing, avoiding congregant activities?  It is too soon to stop mandatory masks, yet Wyoming and Iowa have discontinued mandatory masking while CDC recommends double masking.

Vaccination has picked up, but no more than 10% of the population are protected.  It is estimated that as many as 80,000,000 people had Covid-19, based on antibody studies, but case numbers and plus the vaccinations are insufficient to reach herd immunity.  And while numbers are improving, there are a least 3 variant SARS-CoV-2 viruses that have reached the US.  As of Feb. 14 there were 1173 cases of the UK variant (B.1.1.7) reported in 40 states, 17 cases of the S.African variant (B.1.351) in 8 states, and 3 cases of the Brazilian variant (P1) in 2 states.  Some scientists are warning us that the next 4-12 weeks are going to be the darkest days of the pandemic due to the increased transmission of the UK variant which doubles every 10 days (2000 to 4000 to 8000, to 16,000, etc).  Read below. 

In early January the US was doing genomic studies on about 250 virus samples per day.  Since then they have increased to 4000/day, as they continue to ramp up, to follow the spread of the variants and see if new ones arise.  One of the biggest questions will be do our current vaccines protect us against infection with the variants?  Plasma from infected patients can be collected and tested against the variants in the lab to see if the variant viruses are killed by the plasma antibodies.  In addition studies can be done to determine if fully vaccinated patients who develop Covid-19 are infected with one of the variant viruses. 

All RNA viruses mutate and when viral replication increase, due to an out of control surge, so do the mutations. It is time for us to double down and prevent that from happening.  Double mask especially if indoors, socially distance at all times, limit group activities, stay in well-ventilated areas, and get vaccinated.  The best scientific minds are trying to get us to prevent another huge surge of Covid-19 cases.

Posted by Shirley at 6:37 AM | Permalink | Comments (0)

Mask Confusion?  The CDC issued new mask recommendations this week, in part due to the rapid spread of the UK variant in the US.  We know that this variant is very transmissible, and it is already spreading quickly and could be a big surge in the next 4-6 weeks.  Masks are not being worn, or worn properly (not covering nose or pulled down below the chin,) ,or not fitting properly.  Results from a study in which 10 states were surveyed before and after a mask mandate was put into effect, demonstrated a significant decrease in the infection rate.  In order to avoid the spread of the UK variant B.1.1.7, the CDC is now recommending wearing double masks to further decrease exposure. 

N95 masks are still in short supply and should be reserved for health care workers.  Surgical masks rarely fit properly and there are air leaks because of gaps on the sides, or because the metal strip across the bridge of the nose is not shaped to prevent leaks.  Cloth masks that fit tightly, worn over the surgical mask reduce transmission and improve fit.  More below.  

You should not be able to see light through cloth masks.  To test transmission through the mask you can try to blow out a candle.  You should not be able to do this.  To test air leaks around the nose look for steaming of a pair of glasses.  If you see any, your mask doesn't fit properly around your nose.  You can also expire forcefully in front of a mirror and see if you blink.  If you do, you have an air leak. 

Masks that have an elastic that goes around your neck and another around your head (like the N95 masks) fit better than those with ear loops.  I regularly see people who are wearing butterfly masks (far right in the collage above) and they are pulling their mask back up over their nose every few minutes while they are talking.  And unfortunately tightening the ear loops just increases ear pain. 

Posted by Shirley at 7:32 AM | Permalink | Comments (0)