Paper and Threads

Where is influenza this year?  It normally peaks between December and February, and this year the incidence is way down in the US and around the world.  Normally 20-30% of the Influenza tests would be positive.  Most people don't get tested when they have flu symptoms, but this year the positive tests were 0.2% during the 3rd week in January, and hospital cases are also reduced. 

Possible factors include:

Flu was significantly decreased in the Southern Hemisphere this past summer (their winter) - which usually predates our peak flu season - and there was less spread from there. 

The public health measures that are in place for Covid-19 also protect us from other respiratory viruses:  masks, social distancing, and hand washing.  Cleaning surfaces does protect against influenza. 

Children are a major carrier for flu and they are also congregating less.

A "twindemic", of Covid-19 and influenza was feared this winter, and influenza vaccination was strongly recommended.

There was reduced travel.                  See Below 

The reduced incidence of flu this year may affect next year's flu shots.  Each year the flu strains that are circulating here this winter helps scientists make up the multivalent flu shots for next year.  Sometimes they are very well matched, other times not as well.  Next year's vaccine development may be challenging.    

Posted by Shirley at 12:01 PM | Permalink | Comments (0)

I listened to an interview with Dr. Fauci and David Ignatius of the Washington Post yesterday and wanted to share some of the discussion.

1.  Virus mutations will occur unless we stop replication.  The more cases we have the faster the viruses will mutate.  Many of the mutations do not change the virus behavior, others do causing: increased transmission of disease, more serious infection, and/or a change in the response of the virus to vaccines or monoclonal antibody treatments.  Right now the virus, which is out of control, will accumulate more mutations and we need increased genomic testing for surveillance and preparations to upgrade the vaccines.  We have the scientific skills to modify the vaccines and need to stay ahead of the changes.  The current goal is to push ahead with vaccinations as quickly as possible.

2.  The CDC is trying to study masks in order to determine the best way to prevent transmission, but won't have any new recommendations until they have the science to back them up.  Until then Dr. Fauci says if one mask is good, two are probably better (double masking).  It can't hurt and might help.  Read Below

3.  The US gets an A+++ for vaccine development, but now needs to concentrate on distribution.  In order to beat the virus, we need to vaccinate as quickly as we can.  The federal government is working on the supply chain and developing outreach programs in communities to get the available vaccines equitably  "into arms" as quickly as possible.  They are also developing many programs to combat vaccine hesitancy because our control of the virus will depend on having 70-85% of the population vaccinated to reach herd immunity, which is the only way we can return to our prepandemic lives.  Everyone needs to be patient....

Posted by Shirley at 6:25 AM | Permalink | Comments (1)

The randomized controlled Phase 3 trial of their single dose vaccine was done in the US, Central and South America, and South Africa.  There were a total of 43,783 volunteers 18 years and older.  The primary end point was development of symptomatic Covid-19 at 14 and 28 days after the vaccination, with 72% efficacy in the US, 66% in Latin America, and 57% in S. Africa.  In addition it was 85% effective at preventing severe disease - across the sites, ages (13,610 volunteers >60), races/ethnic groups. and variants.  There were no severe cases after day 49 in the trial.  There were very few safety issues: 9% had fever, and none had allergic symptoms or anaphylaxis.   

Johnson and Johnson also has a 2 dose phase 3 clinical trial that began in December and is still enrolling patients in the US.  See Below.

The J and J vaccine is a viral vector vaccine.  The genetic code for the coronavirus spike protein is attached to a harmless common cold adenovirus in order to get the genetic code into our cells.  The cells then manufacture spike proteins which stimulate an immune response as a foreign invader in our bodies - including antibody production and cellular immunity.  The Oxford-Astrazenca vaccine, which was approved in the UK, uses a similar viral vector platform which was approved in the UK.

J and J said that they will apply for an Emergency Use Authorization in the next week and will submit all of the detailed trial results to the FDA.  The FDA will then schedule a meeting of the independent vaccine scientific advisory committee which will make their recommendations to the FDA. 

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

"We need to double down on public health measures.  The less a virus spreads, the less it is going to mutate, "said Anthony Fauci.  The development of the mutations in the UK, South Africa, and Brazil are a concern.  What do we know now?

The Moderna vaccine will work against the UK mutation and the S. Africa mutation, although the efficacy against the South African mutation is less, but probably adequate in lab studies.  The Pfizer vaccine works in lab studies against the UK mutation, but like Moderna, its effectiveness against the S.African mutation is less. Both of these mutations, which occur in the spike region, make it easier for the virus to bind to our cells and may explain their increasing transmission. 

The UK variant is already in the US and will be the dominant variant quite quickly.  It is time for Americans to realize that we all need to follow stringent public health measures, and even to consider double masking.  One patient with the Brazil mutation was reported Monday in Minnesota.  No cases of the S. African virus mutation have been reported here YET!  See More

Paul Offitt, a member of the FDA Vaccine Advisory Board, said that the full immune system may be more effective against the various mutations, and scientists will need to carefully study vaccinated patients if they develop Covid -19, to see which mutations are responsible.    

Moderna is preparing to make another vaccine to deal with the mutations, and is also beginning a clinical trial to study the effects of a booster shot of their current vaccine.

Other vaccine news:  The results of the J and J Phase 3 Clinical Trial are expected in the next few weeks, and then they can apply for an EUA.  Merck discontinued their 2 vaccine trials because the results were disappointing. AstraZeneca said that their vaccine had low efficacy in older people.

Posted by Shirley at 6:34 AM | Permalink | Comments (0)

I have many allergies - some beginning in childhood.  Although I never had anaphylaxis with vaccines or IV drugs, I went to an allergist for clearance.  Readers may remember that I watched full day VRBPAC committee meetings for the Moderna and Pfizer Vaccines and watched the CDC Meeting when Allergies and Anaphylaxis were discussed.   

CDC Recommendations are:

If you had an anaphylactic reaction to either the Pfizer or Moderna vaccine, don't take dose 2.

If you had anaphylaxis with any other vaccine or IV drug, best to consult an allergist.

If you have allergies to food, animal danders, pollens, insect bites, or oral meds, you can be cleared for either of the Covid vaccines.  I fell into this category, but still wanted to discuss my allergies with an allergist, and be injected in a hospital setting.   

It is hard to schedule an appointment, even if you are in Group 1b (75+ or essential worker).  In NYC you have to check the City sites, State sites, and your hospital system, multiple times per day.  Appointment times appear at random and are gone within minutes to hours.  In addition, demand is outstripping supplies. so your appointment may be cancelled. 

A national distribution plan was non-existent, and then the eligible groups were increased suddenly by the Trump administration: 65+ and younger with comorbities were added expanding the pool of people trying to find an appointment.  The supplies are not arriving in the quantities that were promised, and right now scientists are worried about a big surge in cases due to the infectivity of the UK virus mutant.  If one person could pass the virus to 1 person, the ratio now is one infected person passing the virus to 5-7 people.  More on that next week.  New York state now has 25 cases of the UK variant, meaning, greater protection is needed.  Some scientists are recommending double masking and less congregant activity.

Posted by Shirley at 12:18 PM | Permalink | Comments (0)