Paper and Threads

There are a growing number of reports of possible myocarditis and pericarditis (inflammation of the heart muscle and sac around the heart) in people following Pfizer and Moderna vaccinations The FDA has at least two extensive ways to detect adverse events from drugs and vaccines so they routinely receive reports to analyze.  To determine if they are caused by vaccines, they try to determine whether the incidence of the adverse effect is higher than in non-vaccinated people.  Myocarditis and pericarditis occur due to many viral/bacterial infections, drugs, and diseases (ex. collagen vascular diseases).  Thursday the FDA had a day long meeting to look at reports from their vaccine safety systems, but more data must still be collected about each report from solicited medical records. Review of the preliminary reports found that the patients were in the younger age groups (12-39), and especially after vaccine dose 2.  Myocarditis has been reported in all age groups that were vaccinated, but it was only in the 16-24 year old patients that the observed number of cases exceeded the expected number of cases in the general population.  There were 2.8 cases/1million first doses and 16.1 cases/1million second doses in these two groups.  See Below   

The most common symptoms are chest pain and shortness of breath.  Additional tests include cardiac enzymes and EKGs.  Most symptoms are mild and recovery is quick with treatment with drugs like Motrin.  81% of patients recovered completely and many of the remaining 19% are of unknown status.  This data is similar to reports from Israel and the US military following Pfizer vaccinations.  Current US patients are young and more likely to be males  - the same as with other causes for myocarditis.  Millions of people have been vaccinated with the Pfizer and Moderna vaccines demonstrating that huge clinical trials like theirs (44,000 and 30,000 respectively) can't pick up these very, very rare adverse effects.  The FDA will continue to verify these reports next week and the independent scientists on the CDC Advisory Committee on Immunization Practices (ACIP) will meet next Friday to discuss the benefit vs risk ratio of the mRNA vaccines going forward.  They will also try to determine the risk of myocarditis/pericarditis from the Covid-19 infections alone.

Posted by Shirley at 5:11 AM | Permalink | Comments (0)

We need to be happy about our vaccines - we wouldn't be at this stage of the pandemic without them.  Moderna is amending their EUA to include 12-15 year olds and both Pfizer and Moderna are testing their vaccines in younger children - maybe down to age 6 by September. We are told that an EUA for the 4th vaccine, from Novavax, will be coming soon.  Now seems like a good time to see where we've been since Mar 2020.

About 33 million of Americans tested + for Covid-19, and we didn't have sufficient testing in Mar-Apr 2020. 

About 595,000 Americans have died from the virus, deadlier than all wars, military conflicts combined in 80 yrs.

Last summer cases were over 65,000/day and by Winter hundreds of thousands had the virus and over 3000 died per day.

As of this week approximately 50% of Americans are fully vaccinated and over 60% have had at least 1 dose.   See Below

The US can't control the virus without vaccines and the risk is as high as ever for unvaccinated Americans.  There will be localized outbreaks in areas where relatively few people are vaccinated.  Highly contagious viruses will continue to spread until most susceptible people are infected. 

New York State still has approximately 800 cases/day (which is <1% of >200,000 Covid tests/day).  Another way to assess the new cases is to count the number of positive cases/100,000 population in each state.   NOW:  US Overall:  4/100,000. The most new cases are in Wyoming and Colorado.  The lowest number of new cases is in Vermont with 1 case/100,000.  NY and New Jersey are 3/100,000population.

In the beginning of April those statistics were: US Overall:  20/100,000 and NY 38/100,000.  But New Yorkers are still being vaccinated and the rates of infection, hospitalizations, and deaths decrease each day.  Latest STATS from CDC:  The 7 day average of new daily cases reported has decreased from 65,053 on Apr1 to 12,780 on June 5.  The 7 day average of new daily cases reported decreased from 681 t0 367.

The virus will continue to circulate in America, but it is now infecting the unvaccinated - and will continue to spread in the "susceptible."  Unfortunately more cases are being seen in children and adolescents who are not vaccinated, and more young people have severe infections and are hospitalized in ICUs.   

Posted by Shirley at 11:23 AM | Permalink | Comments (0)

The CDC caused lots of confusion when new mask recommendations were announced by Dr. Rochelle Walensky at 2:17 PM on May 13th.  The number of vaccinations in the US were dropping everyday, and so were the number of new Covid-19 cases.  But some states still had increasing cases, were opening up, and vaccinated people were told that they could drop there masks outdoors, if they weren't in large groups.  Would this inspire vaccine hesitant people to get vaccinated?      See Below

"Almost immediately the number of visits to vaccine.gov to find vaccination centers spiked - rising even higher that afternoon.  Later that afternoon President Biden encouraged people to get vaccinated so they could remove their masks in many instances.  The increase in traffic to vaccines.gov continued and the number of vaccinations remained stable for the rest of May. This may have been a good example of how hope is better than continued fear.

The closing sentences in this NYTimes article said, "In the case of Covid vaccines, the hype is grounded in reality. Once you are fully vaccinated, you no longer have to organize your life around personal fear of Covid (unless you are immunosuppressed)."  Please get vaccinated, but remember, in some previous studies on "breakthrough cases" in vaccinated people, the efficacy of the vaccines were lower after only one dose.  If you only received 1 dose of the mRNA vaccines, get your second dose now - even if you missed the date for your 2nd dose.  The pandemic will not be over when the virus can still infect susceptible people.  

Posted by Shirley at 5:57 AM | Permalink | Comments (0)

How many patients who had Covid-19 infection during the first wave of the virus in Lombardy, Italy had it again, at least 90 days and 2 negative RT-PCR tests, later?  There is a new study from Lombardy that demonstrates that very few of the original cohort of Covid-19 + patients (Feb-July 2020) redeveloped Covid-19 during the next year. Patients who were negative during those early months were followed for almost a year for comparison, and many developed Covid-19.  The difference in the number of infections in these two groups was statistically significant (P<0.001).

Reinfection was defined as a positive RT-PCR Covid test more than 90 days after recovery plus 2 negative tests.  Only 5 patients of 1579 original Covid + patients had a reinfection - and one was hospitalized. 

There were 528 Covid-19 infections in the original 12,968 Covid-19 negative subjects while being observed for almost a year.

Antibody levels and other markers of immunity were not measured, but the statistical difference in infection rate was a strong indicator that the previously infected patients had enough natural acquired immunity from their first infection to prevent reinfection for almost a year.  (JAMA Internal Medicine May 28, 2021) Recent studies demonstrate that there is a robust antibody response in patients who had Covid-19 after just 1 dose of vaccine.

Posted by Shirley at 6:06 AM | Permalink | Comments (0)