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January 30, 2021

Johnson and Johnson Vaccine Information

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.

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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. 

January 27, 2021

Keeping Up With the Coronavirus Mutations

"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

 

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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.

January 23, 2021

JOY!!! Dose 1 of Pfizer Vaccine DONE!

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.   

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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.

 

January 20, 2021

What Are Covid Long Haulers?

Some update on Long Haulers (also called Post-acute Covid-19 Syndrome):  I first wrote about Long Haulers in September, and now there is more information about these patients who had documented Covid-19, but are still symptomatic, and virus negative.  Fatigue is one of the major symptoms, but there is a constellation of symptoms that persist for months and interfere with normal living.  It can occur in patients hospitalized with severe disease or even young people with mild acute infections. If more young people knew about these chronic symptoms, fewer would take risks thinking they would have a mild illness with complete recovery. 

Some recent studies estimate that 10% of Covid-19 patients become long haulers with fatigue, insomnia, shortness of breath, "brain fog,"  lack of smell and taste, depression, myalgias, arthralgias, headache, intermittent fever, and heart palpitations or rapid rate.  There are multiple theories about the cause of these symptoms, but much more data needs to be collected and studies done. Anthony Fauci thinks that some of these patients with symptoms lasting longer than 4 weeks after their virus clears, may develop chronic fatigue syndrome (myalgic encephalomyelitis).  

 

 

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Patients frequently had problems convincing doctors that their lingering symptoms, which prevented them from going back to work or resuming their previous activities, were real.  In recent months Post-Covid Care Centers and support groups are seeing these patients.  Medical School hospitals are among those who are following a large number of patients and collecting longitudinal data to share with other centers.   This is a good general reference for more information: https://www.scientificamerican.com/article/the-problem-of-long-haul-covid/

 

January 16, 2021

Third SARS-CoV-2 Vaccine: Johnson and Johnson

This week J and J published the full results from Phase 1 and 2a Trials on their SARS-CoV-2 vaccine.  These two types of trials are focused on Safety and ability to stimulate an Immune Response.  In these trials they tested multiple variables:  ages 18-55, ages 65+, low dose and high dose, and 1 versus 2 doses.  The vaccine was safe, with mostly low grade local and systemic symptoms (injection site pain, fatigue, headache, myalgia, rare fever).  Immunologic studies demonstrated a 90% immune response, including neutralizing antibodies against the virus.  In addition there was a T cell immune response.  Both age groups included slightly more than 400 volunteers.  Based on these two trials, J and J developed two Phase 3 clinical trials to assess the efficacy of 1 or 2 low doses of the vaccine.  Complete enrollment in the one dose trial was reported on Dec 17th.  An application to the FDA for an EUA requires that at least 50% of the volunteers must be 2 months beyond their vaccination for an adequate safety evaluation (probably Feb).  The 2 dose Phase 3 trial is still ongoing.  Unfortunately J and J says manufacturing is slow.  Read Below

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The virus in the above illustration is a harmless inactivated adenovirus that causes colds. 

The J and J vaccine is similar, but different from the mRNA vaccines by Pfizer and Moderna  The DNA code for synthesizing the SARS-CoV-2 spike protein is introduced into the cells of our body with a harmless adenovirus as the carrier.  There the DNA is a template for synthesis of the spike protein and our immune system responds to the spike proteins by developing antibodies and cellular immunity to SARS-CoV-2  J and J successfully made an ebola vaccine using this technique. Based on the results of the Phase 3 clinical trial it may only require one dose to achieve high levels of immunity and it can be stored in the refrigerator.

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