Paper and Threads

The CDC Morbidity and Mortality Weekly Report just published a study comparing the effectiveness of natural immunity vs vaccination in hospitalized patients (18+ years) from 187 hospitals in 9 states between January and September 2021.  These patients all had documentation of their prior infection or two doses of Moderna or Pfizer vaccines 90-179 days prior to hospitalizations. There were 1,020 hospitalizations among previously infected/unvaccinated patients and 632 among fully vaccinated/but never previously infected patients.  Patients were distributed over all age groups.  Covid-19  infection was confirmed in these hospitalized patients with a Covid-like illness and a positive PCR test.  

There were 89/1020 cases (8.7%) of lab confirmed Covid 19 in previously infected and unvaccinated patients.    

There were 324/6328 cases (5.1%) with lab confirmed Covid 19 in fully vaccinated and previously uninfected patients.                    See Below:   

Conclusion:  In this US epidemiologic study vaccine-induced immunity was 5.49 times more protective than infection-based immunity, including infection during the period of the delta-variant with a Calculated Odds Ratio 5.49 (95% CI = 2.75 - 10.99). . Based on this real-time US study it is currently recommended that unvaccinated people who have a Covid-19 infection should have 2 doses of vaccine as soon as they have recovered from the infection to boost their immunity.   

Posted by Shirley at 5:16 AM | Permalink | Comments (0)

Long Covid, or Long Haulers' disease was seen very early in the Covid-19 pandemic.  Patients, with mild or severe disease had symptoms that lasted more than 4 weeks after their diagnosis and were varied.  Over time it was noted than as many as 1/3 of Covid patients had at least one of the persistent symptoms.  Fatigue or drop-dead exhaustion, is very reminiscent of chronic fatigue syndrome which can occur following a variety of viral illnesses.  Clinicians and investigators are hoping that studies done in the current long covid patients will help to elucidate the mechanisms for these devastating symptoms.  The NIH recently launched a huge initiative to study Long Covid.

Nearly 40% of people who became infected still had at least one symptom 3-6 months after the infection. Persistent symptoms are varied, but can include any of the following:  Fever, change in smell or taste, difficulty breathing, cough, chest pain, stomach pain, diarrhea, fast beating heart/palpitations, joint or muscle pain, fatigue, post-exertional malaise, headache, brain fog, mood changes, pins and needles, sleep problems, dizziness on standing, rash.  The mechanisms for these persistent symptoms are unknown, but there is speculation that there may be a lingering virus reservoir or viral remnants that cause chronic inflammation or autoimmune disease.  Some patients report their symptoms improved after they received the Covid vaccine.    See Below    

There has never been evidence that explains the Chronic Fatigue syndrome.  But patients and clinicians hope that having a viral infection that can be studied in the many patients who develop Long Covid might be able to find answers that will help delineate the cause and provide information for treatment for all post-viral infection disorders.  There are at least 44 centers for these patients in the US, many at medical school hospitals - and patients should be referred to the centers who can assemble a team of doctors based on the symptoms expressed.  Patients with chronic fatigue syndrome rarely have the attention or resources to analyze the symptomatic patients and now they are being included in this much bigger pool of chronically ill patients.  In a recent Washington Post article Survivors Corps, which has 180,000 members was listed as an advocacy group.  Body Politic, also listed, launched a feminist support group.  Patients who suffer from Chronic Fatigue Syndrome hope that this attention will provide greater understanding of the other post-infection diseases.

Posted by Shirley at 5:05 AM | Permalink | Comments (0)

Yesterday Pfizer had a press release about their anti-Covid pill Paxlovid, and the early results are very promising.  Paxlovid is an protease inhibitor that blocks viral replication if given shortly after symptoms occur. The current clinical trial was done in subjects with a high risk of severe disease - older age, obesity, and diabetes.  There are two other clinical trials in progress - one in subjects with standard risks and the other in volunteers living in a household with Covid+ patients in order to test the ability to prevent transmission and infection.  The High Risk Clinical trial was stopped by an Independent Data Monitoring Committee after they examined the data and recommended that Pfizer not enroll more subjects in the placebo group because of the large differences in hospitalization, and death between the treated and placebo groups.

This was a randomized control double blind trial and subjects were treated with 5 days of medication or placebo.  The volunteers were further subdivided into two groups - one that was treated with drug or placebo within 3 days of developing symptoms and the other group treated within 5 days of developing symptoms.  The "within 3 day" treated group had 3 hospitalizations and 0 deaths.  The "within 3 day" placebo group had 27 hospitalizations and 7 deaths for a reduction in hospitalizations and deaths of 89 %.   The "within 5 day" treated group had 5 hospitalizations and 0 deaths and the "within 5 day" placebo group had 41 hospitalizations and 10 deaths (85% reduction).  P values were <0.0001 in both groups.  See Below   

Paxlovid was specifically designed to block the SARS-CoV-2 protease.  It is administered with low dose ritonavir which prolongs the activity of the Paxlovid in the body and it is potent when tested against variants of concern.  The pills of each drug are taken every 12 hours for 5 days.  Safety was assessed in almost 1900 volunteers and mild symptoms were seen in 19% of treated patients and 21% of placebo patients.  Fewer serious adverse events were also seen in the treated patients (1.7 treated vs 6.6% placebo).  Pfizer will submit the data to the FDA for an EUA and the drug should be available by the end of the year. 

Posted by Shirley at 1:40 PM | Permalink | Comments (0)

The CDC ACIP Advisory Committee voted yesterday (14 to 0) to approve the Pfizer Covid Vaccine for 5 to 11 year old children.  Dr. Rochelle Walensky, CDC Director, approved it last evening and now the vaccinations can begin.  On Oct. 27th I reported on the FDA VRBPAC Committee Meeting and summarized the vaccine efficacy (90.7%) and safety data (Paper and Threads: FDA Approves Pfizer Covid Vaccine for 5-11 Year Olds).  At today's full day meeting a Pfizer scientist, CDC scientists, and other investigators reviewed the vaccine again in depth and did a formal benefit vs risk assessment before the committee ended the day with a unanimous vote for approval.

There have been >1.9 million cases of Covid in 5-11 yr. old children, more than 8,300 hospitalizations, 2,316 cases of MIS-C and over 100 deaths during the pandemic.  Many of the children are asymptomatic, but others develop Multisystem Inflammatory Syndrome - Children (MIS-C) which is an inflammatory response to a Covid infection which occurs 2-6 weeks after a case of Covid.  More than 60% of these children are admitted to the ICU and 1-2% of them die.  As many as 8% of children can also have mild or moderate  Covid symptoms lasting more than 12 weeks according to a UK study.  Children will receive only 10ug of vaccine instead of 30ug which the 12-15 and 16+ groups receive.  The caps on the vials for the 10ug dose, parts of the label, and all shipping boxes are bright orange.  The doses for all of the 30ug vaccine vials have purple caps and labels so no errors can be made.     See Below   

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There is a very rare incidence of myocarditis with the mRNA vaccines - mostly in 16-29 year old males. The current incidence of this side effect is 1:10,000 -1:20,000 of vaccine doses.  Myocarditis is an inflammation of heart muscle and in most cases it appears within 7 days after the 2nd dose of vaccine.  Cases have been very mild and recovery is fast - usually with no treatment or non-steroidal anti-inflammatory meds.  There are no deaths.  It is important, however to know that myocarditis also occurs with Covid-19 infection, in greater numbers and severity, so prevention of Covid infection is even more important.  There are other causes of myocarditis and most of the cases occur in males, with fewer occurring below the age of puberty.  So 5-11 year old children may have an even lower incidence than older males.  There were no cases in the clinical trial of over 3000 5-11 year old children.    

Posted by Shirley at 6:30 AM | Permalink | Comments (0)

On Monday Oct 21st Pfizer had a press release about the efficacy of their 3rd dose.  They reported results from a randomized control trial -  on subjects from their Phase 3 Clinical Trial that all received 2 doses of the primary 2 dose series. More than 10, 000 volunteers from age 16 and older received 30 ug of the Pfizer BioNTech vaccine or placebo.  The median time between their second dose and the booster was 11 months.  Symptomatic covid-19 infections were assessed from at least 7 days after the booster or placebo with a median follow-up of 2.5 months.  There were 5 cases of Covid in the boosted subjects and 109 cases in the placebo group for a vaccine efficacy of 95.6%  None of the patients had evidence of a prior Covid infection. 

The age group had 55% subjects between 16 and 55 years and 23% of the subjects were were 65 and older.  They reported that after multiple subgroup analyses the efficacy was consistent across all of the age groups, sex, race, ethnicity and comorbidities.  That is excellent news for the group of 65+ subjects who all received their primary vaccination as part of the original trial and had an excellent immune response to the 3rd dose  now.  Pfizer says that the adverse event profile was the same as the original group and no safety concerns were found.  The Pfizer Press Release says that detailed results from this trial will be submitted to the FDA, European Medicines Agency and for a peer reviewed publication.  See Below  

This very preliminary report is real world data of the efficacy of the 3rd dose at a time when the delta variant was circulating and it makes me happy to see that age didn't affect the immune response or side effects.  In September the FDA and CDC approved the Pfizer 3rd dose going forward for people over the age of 65 and for younger people with a high risk of severe infection or risks of infection because of the groups with whom they are working.  The FDA and CDC recently analyzed a clinical trial of mixing and matching the type of booster with the original vaccine type, now that Moderna and J & J vaccine booster doses were also approved.  However they suggested that it was probably best to continue with the same vaccine type unless their were significant reasons to change.     

Posted by Shirley at 6:48 AM | Permalink | Comments (0)