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March 24, 2021

What Just Happened to the AstraZeneca Vaccine?

On Monday I thought I would be reviewing the Covid-19 US data from the Phase 3 Clinical Trial in preparation for the FDA request for an EUA.  It was one of the first vaccines I learned about.  Oxford University developed the platform for the Viral Vector vaccine using a Chimp adenovirus to carry the DNA for the SARS-CoV-2 spike protein into the cells - leading to spike protein production to stimulate the human immune response.  The vaccine was produced in concert with AstraZeneca, and was selected as part of Operation Warp Speed by the US.  For approval here vaccine makers had to conduct a Phase 3 Clinical Trial with at least 30,000 US volunteers - with a full range of ages, races, and ethnicity.  As soon as more than 50% of the volunteers were followed for side effects for more than 2 months, an application could be made to the FDA for EAU. 

Then I woke up Tuesday to several online news alerts: "AstraZeneca's US trial data may have been outdated and incomplete NIH says" (Washington Post). The Data and Safety Monitoring Board, is a group of 11 independent scientists appointed by NIH to oversee the clinical trials with each of the companies.  They suggested that AstraZeneca should include data on all of the volunteers that were beyond 2 months before publishing their efficacy data.  They didn't.  The DSMB has that data and when more volunteers were included, efficacy dropped.  It is highly unusual for the FDA/NIH to make an announcement like this and no further details were given in the first newspaper articles.  Read More Below


Later Tuesday afternoon this was the NYT Breaking News Headline, "In a two-page letter to AstraZeneca and federal authorities, an independent panel of medical experts that was helping to oversee the vaccine's clinical trial in the United States said that the company had essentially cherry-picked data that was most favorable for the study as opposed to the most recent and most complete."  This is a problem with transparency.

The main issue, as written in the news, is that the data up to February 17 was the final data used to determine an efficacy of 79%.  But when the advisory board included data collected after Feb 17, there were more Covid-19 patients diagnosed and they were in the vaccinated group thereby reducing efficacy to 69-74%.  AstraZeneca in their initial Phase 3 Clinical Trial in Europe used two dose regimens in an error, and those volunteers that received half of the planned dose had fewer cases of Covid-19 than the full dose volunteers.  That was difficult to explain and now there are more questions. 

March 20, 2021

Mask Mandates + Slow and Careful Reopening Needed

Covid-19 case numbers were falling in most parts of the world after the Christmas surge, but now 15 states are demonstrating an increase and the total number of cases per day are still at least 50,000.  Dr. Tony Fauci said that we would need to see the case number fall below 10,000 in order to control the spread of the SARS-CoV-2 virus.  Europe saw the case numbers fall when they implemented lockdowns and other public health measures.  But the variant B.1.1.7 is now quickly spreading across Europe. Yesterday Paris was locked down again!  Critics say the new restrictions in Europe have come too late and can be traced back to the speed of reopening.

Scientists predict that unless each state maintains control of the virus, and reinstitutes masks mandates, social distancing, limited group sizes, and more gradual reopenings, we will follow Europe in the next 4-6 weeks.  This estimate is based on the sequence of virus spread from Europe to the US that already occurred earlier in the pandemic.  Dr. Ashish Jha, Dean of Brown School of Public Health, reported yesterday that the B.1.1.7 variant is already 40-50% of virus cases in the US and is now present in every state. This variant has greater transmission and some reported increase in case severity.  Fortunately preliminary studies demonstrated that the current vaccines are still effective against this variant. See Below.


The other variants of concern are also already in the US and the home grown NYC (B.1.526) variant is increasing in frequency in the genomic surveillance tests on New York and each week the percent is higher.  Last week they tested 712 cases in the NY Pandemic Response Lab and the NYC variant accounted for 45.1% of the samples - up from 29.2% 4 weeks earlier. 



March 17, 2021

Nasal Spray to Treat Covid-19- Early Report

Many drugs were tested in randomized, placebo-controlled trials in 2020-21 and most drugs were no better than placebo.  Remdesivir is the exception.  Dexamethasone was already an FDA approved drug for many years.

SaNOtize Research and Development Corp in Vancouver, Canada:  This week there were several online reports of a Nitric Acid Nasal Spray (NONS) that was tested in a Phase 2 trial in the UK (79 NHS patients) and in over 7000 patients in Canada.  The primary outcome measure in the UK trial was the difference in nasal SARS-CoV-2 RNA load from baseline through day 6.  The nasal spray accelerated clearance of the virus by a factor of 16-fold vs placebo.   NONS reduced the virus by more than 95% in infected participants within 24 hours of treatment and by more than 99% in 72 hours, including the B.1.1.7 variant.  No adverse effects were seen in the treated patients and there are decades of experience with nitric acid as an anti-microbial agent. The spray was designed to kill the virus in the upper respiratory tract, preventing the virus from spreading to the lungs.  The news articles say that they are applying for emergency approval in the UK and Canada, and will begin clinical trials to see if the nasal spray can also prevent disease after a Covid-19 contact.  See Below.   


NOTE:  The collage nasal sprays were magnified for effect.  I also verified the reports of the safe antimicrobial activity of nitric acid against bacteria, viruses, and fungi using multiple methods to deliver the nitric acid.  And searched for data from a Phase 3 trial, but couldn't find any.  Maybe the UK and Canada can use Phase 2 Randomized Placebo Controlled Trial (RCT) data for an EUA application, I'm not familiar with their drug approval process. This is an exciting report that would be a much needed drug therapy for Covid-19!

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.

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.