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August 1, 2020

EUA! PROTESTERS! No Emergency Use Approval!

Three Vaccine developers began their Phase 3 Randomized Controlled Trials in the last several weeks.  Each of them must enroll 30,000 healthy volunteers.  Half of the group will receive vaccine injections and the other half will receive a saline (salt water) injection as placebo.  Each volunteer will then be monitored for adverse events, and Covid-19.  Subgroups will also be tested for efficacy -both development of antibody titers and neutralizing antibodies that block virus proliferation.  In addition cellular immunity will be assessed by T helper cell activity.  No one will know what shot they received until the end of the trial.

Continue Reading Below:

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Evidence of prevention of Covid-19 will be monitored in the treatment and placebo groups and results may depend on the activity of the virus where they are enrolling volunteers.  New York tests 50,000+ individuals each day, but the incidence of positive virus tests is only 1-1.5%.  If volunteers are vaccinated in the states with increasing infectivity, enrollment and protection in the vaccinated vs the placebo group may be faster.  Recently developed FDA guidelines for vaccine approval set the minimum at 50% protection by each vaccine for FDA approval.

BUT there may be political pressure to give "EMERGENCY USE APPROVAL" ("Pre-election Surprise) and then the government would be shortening the observation time for "rare, but significant" adverse effects to be seen.  The FDA commissioner this week said that his decisions will only be based on SCIENCE - and we have to hope that he is a man of his word.

 

July 29, 2020

Masks, Masks, Wear Your Mask

We are going to have to learn how to live with this virus until the population is vaccinated, and natural infection increases herd immunity to more than 70%.  Until we can be vaccinated, we MUST practice social distancing, hand washing, and mask wearing.  There is data to suggest that masks keep us from spreading the virus, AND they also limit the amount of virus that we breathe in.  When populations have protected themselves with masks they tend to have mild symptoms or are asymptomatic! See article link below.

On my morning walk I saw two store windows filled with these head mannequins and they had many different types of masks, in many different colors.  There even was a black mask covered in Swarovski crystals! Why do you think that the masks on the left have a narrow sliver hole over the nose? The store was still closed early in the AM, or I would have asked them.  I made masks for my husband and I, and our kids and grandkids that live in NYC.  As my back continues to improve I will make more.  I think we are destined to be wearing masks until 2021.  I love the pattern I used, and will also include a link at the bottom of this post.  Read more below.

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This week two companies began Phase 3 vaccine trials.  They each need 30,000 healthy volunteers to determine if the vaccinated and placebo groups have a significant difference in Covid-19infection. Research Labs will also be measuring antibody titers and T cell responses in a cohort of the subjects.  In order to have a definitive answer, infectivity in the geographic area must be high enough to make people sick - the FDA approval requires 50% protection in the vaccinated group - at a minimum.  .

The "In Press" paper re: Masks is embedded in this article.  This is not a clinical trial - just a collection of observations from the pandemic by a well trained infectious disease MD and public health expert.
 
I searched lots of mask patterns - and loved this video and pattern.  I insert the elastic so it goes around my neck and head.  Fits each of my family members better than other fabric masks they have - some like ear loops and some prefer the neck-head configuration.  Cut and paste the link into your browser.
https://www.youtube.com/watch?v=1V3SLUHIJ5A 

July 25, 2020

Can Antibodies Be Used to Treat Covid-19?

When you transfuse antibodies into patients, you develop "passive, instead of natural immunity."  During the 1918 flu pandemic, patients who recovered from influenza donated blood so their antibodies could be transfused into other critically ill patients.  More recently, "convalescent plasma" from recovered Ebola patients was given to other patients.  Randomized control trials (RCT) are being done to test "convalescent plasma" for Covid-19 patients, but in addition MONOCLONAL ANTIBODIES are being developed from blood obtained from recovered patients.   Read about them below the collage.

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Patients who have recovered from Covid-19 have naturally occurring immunity against all parts of the SARS-CoV-2 virus.  Their antibodies and immune cells are being studied, and the strongest neutralizing antibodies (which stop viral replication), are used to develop monoclonal antibodies which can be produced in large quantities.  This technology was first developed in the 1970s and is now being used to create many types of therapy, including cancer drugs.  In the classic method, cells which are producing antibodies are fused with a specific clone of antibody producing cells that can be grown in culture.  This clone becomes a protein factory which makes just one potent neutralizing antibody.  There are many monoclonal antibodies being made to SARS-CoV-19 and at least 3 are in early clinical trials.  Passive immunity with monoclonal antibodies is only effective for weeks to a month+, but when administered they can change the course of critically ill patients.  You can usually recognize monoclonal antibodies that are FDA approved because their names end with "ab."

July 22, 2020

Covid-19 Vaccine Development Update

There are 2 front runner vaccines being tested in the US - Moderna is a US Company based in Cambridge Mass and Oxford AstraZeneca is based in the UK, but has US financial support.  Both companies finally published their Phase 1 clinical trial results in the last week in peer-reviewed leading medical journals, and both are ready for Phase 3 "huge trials"  which will continue to test safety and will actually test effectiveness in preventing transmission of SARS-CoV-2 to vaccinated subjects.  These trials are prospective, randomized, placebo-controlled trials in not less than 30,000 volunteers per vaccine.  The trials will be "blinded" so neither the volunteers nor the MDs, Nurses, Trial Coordinators etc. will know what injection the volunteers receive.  The Phase 1 trials for both vaccines demonstrated antibody production, especially neutralizing antibodies which block virus replication.  And side effects were like the usual flu shot - mostly related to the injection site and some flu-like symptoms. 

The collage for my pandemic science series today is to celebrate the beginning of Phase 3 trials.  There are more than 140 vaccines being developed, that have not yet begun clinical trials.  As of today 19 vaccines are in Phase 1 and 13 in Phase 2.  Moderna will begin their Phase 3 trial on July 27th.  If you know the 3 phases of clinical trials, you are now better able to read and listen to the continual "chatter" about vaccines.  We aren't there yet!!  And may not be there until 2021.  But until then we will have to learn to live with the virus - and increasing deaths.  Stay home and stay healthy.

Continue reading below the collage: 

 

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The Moderna-NIH Vaccine Research Center vaccine was made with the newest technology.  Instead of using the viruses themselves (usually dead or made ineffective), they made messenger RNA (mRNA) from the virus binding region of the spike protein of SARS-CoV-2 using the structure reported from China on January 10th. Most vaccines were created by making huge amounts of the antigenic proteins and injected them into us to stimulate the immune response.  Now the mRNA is stabilized and used as the ANTIGEN to stimulate our cells to begin the ANTIBODY immune response. 

The mRNA is transported into cells and acts as a blueprint for the cells to make the important part of the spike protein - the part that attaches to our cells and lets the virus in!  The spike protein then stimulates the immune response in the cells in our body and we make protective antibodies! This method cuts years out of the vaccine development process and has been tested in cell cultures, and various animal models- demonstrating that the immune response is able to then prevent the virus from replication in cells in our body.  Both vaccines completed Phase 2 Clinical Trials in hundreds of volunteers. 

This is complicated but very interesting and hopefully we will all get vaccinated, develop "herd immunity," and stop the pandemic.  The Oxford vaccine is using a similar, but not identical process. 

 

July 18, 2020

Will We Really Have a Vaccine for Covid-19 Soon?

I recently wrote about the 3 phases of Clinical Trials that must be completed to apply for FDA approval.  The mumps vaccine was created in 4 years - and set the record for vaccine development.  The average time is 7-10 years.  There are 150-160 vaccines being developed right now and 30 vaccines are in the pipeline. 

Read more below collage:

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Phase 1 trials are small - to test different doses and assess the safety of the vaccine.  There are 15 vaccines in phase 1 trials.

Phase 2 trials have hundreds of volunteers and safety is still being assessed.  But vaccine effectiveness and antibody production is measured in the vaccinated vs placebo groups.  There are 11 vaccines in Phase 2 trials.   

Phase 3 trials still assess safety, but the effectiveness to prevent Covid-19 in 30,000 or more volunteers will be compared to a placebo group.  There are 4 vaccines in phase 3 trials: including one UK (Oxford), 2 Chinese, and 1 Australian  company (Data taken from NYT vaccine tracker).

The US front runner vaccine is from Moderna-NIAID/NIH and it will begin Phase 3 on July 27th.  The Oxford University/AstraZeneca vaccine is being supported in part by the US Gov't and both will be available in the US after approval. The number of Covid-19 cases and deaths are still in exponential growth in the US and companies are going to develop millions of doses for some of the vaccines, even before FDA approval is complete.   This is a huge financial risk for pharmaceutical companies and we can only hope that distribution will also be discussed and planned before approval is granted.  Until then we need to learn how to live safely with the virus. 

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