F.D.A. Will Attach Warning of Rare Nerve Syndrome to Johnson & Johnson Vaccine

The Food and Drug Administration is planning to warn that Johnson & Johnson’s coronavirus vaccine can lead to an increased risk of a rare neurological condition known as Guillain–Barré syndrome, another setback for a vaccine that has largely been sidelined in the United States….No link has been found between Guillain-Barré syndrome and the coronavirus vaccines developed by Pfizer-BioNTech or Moderna, the other two federally authorized manufacturers. Those rely on a different technology….Several thousand people — or roughly 10 out of every one million residents — develop the condition every year in the United States. Most fully recover from even the most severe symptoms, but in rare cases patients can suffer near-total paralysis….Guillain-Barré syndrome has also been linked to other vaccines. The Centers for Disease Control and Prevention has said that flu vaccines, including the 1976 swine flu vaccine, led to a small increased risk of contracting the syndrome, although some studies suggested that people are more likely to develop Guillain-Barré from the flu itself than from flu vaccines. 

(J. Harris: Rare as this complication it is, I’d rather take Moderna or Pfizer vaccines right now. The JNJ is said to have prolonged Delta coverage, however — see below). Fortunately, Buillain-Barre Syndrome is usually not fatal.)


J&J-Janssen recently announced preliminary data demonstrating its single-shot SARS-CoV-2 vaccine generates a strong immune response against all highly prevalent variants for at least 8 months, including Delta. 


MIX & MATCH VACCINES This week, Germany became one of the first countries to strongly recommend that anyone who received the AstraZeneca-Oxford vaccine for their first dose should receive a dose of either the Pfizer-BioNTech or Moderna vaccines for their second dose.


1. Turkmenistan Makes COVID-19 Vaccination Mandatory (Reuters) Turkmenistan’s healthcare ministry said on Wednesday it was making COVID-19 vaccination mandatory for all residents aged 18 and over as the former Soviet region of Central Asia reported a fresh spike in new cases. Turkmenistan has reported no COVID-19 cases but introduced a number of restrictions such as setting out requirements for wearing facemasks. Turkmenistan’s healthcare ministry said in an announcement published by state media that exceptions would only be made for those with medical contraindications to inoculation. 

2. Gene Hunters Turn Up New Clues to Help Explain Why Covid-19 Hits Some People So Hard (Stat News) Over the last 15 months, more than 3,300 researchers from 25 countries have poured data from millions of people, including more than 125,000 Covid-19 patients, into the initiative, making it one of the largest gene-hunting missions in history. The international effort has revealed that an individual’s genetic inheritance can indeed influence their risk of infection and the severity of disease. On Thursday, it was reported in Nature that more than a dozen parts of the human genome were linked with either enhanced susceptibility to infection with SARS-CoV-2 or severe Covid-19. The research won’t change current treatment decisions for patients, but these genetic clues may point to existing drugs that could be repurposed to help the worst-off among them.

 (J. Harris: This will be valuable and exciting information, but it will take a few years to be of much real use.)

3. CDC Data Shows Highly Transmissible Delta Variant is Now the Dominant Covid Strain in the U.S. (CNBC) The highly transmissible delta variant is now the dominant coronavirus strain in the United States, surpassing the alpha variant, according to Covid-19 modeling data released by the Centers for Disease Control and Prevention. Delta, the variant that was first found in India and is now in at least 104 countries, represented 51.7% of new Covid cases in the U.S. over the two weeks ended July 3, according to recently updated estimates by the CDC.

(J. Harris: And remember, in Israel, Pfizer Vaccine Dwas less responsive against the Delta Virus in preventing illness while at the same time it did generally prevent severe illness. If Delta hits your community, get your masks out and be careful. I don’t know what this might mean for school children in the fall — probably masks?)****


Pfizer-BioNTech on July 8 announced it plans to seek authorization in the US and Europe for a third booster dose of its vaccine based on “encouraging data.”

90-year-old woman infected with UK and South African COVID-19 variants at the same time (BECKER CITED)

Autoimmunity to Annexin A2 Predicts Mortality Among Hospitalised COVID-19 Patients (European Respiratory Journal) This study investigated the possibility that COVID-19 patients have autoimmune antibodies to Annexin A2, a protective protein expressed in the lung and other organs. Since this phospholipid-binding protein is critical for fibrinolysis, lung elasticity, cell membrane repair, and integrity of the pulmonary vasculature, antagonism of Annexin A2 may explain many of the hallmark clinical features of severe COVID-19 cases. In our primary analysis of mortality among the 86 hospitalised COVID-19 patients, we found that anti-Annexin A2 antibody levels strongly predicted death after adjustment for age, sex, race, and comorbidities with an odds ratio of 9.3 per RU (CI: 1.9–44.6, p=0.005).

(J. Harris: This elegant article is readable and may explain many of the deleterious effects of Covid. People have a lung-protective protein called ANNEXIN A2. Covid can somehow produce or cause the production of a deleterious antibody(ANTI-ANNEXINA2 ANTIBODY) as a reaction or response to the Covid infection. Patients with a higher level of the antibody do less well, and when coupled with obesity, diabetes, age and other factors predictably die more often. Later on, genetics will likely be implicated in the equations as well as variants viruses and quantity of initial infections load.)


1. Milton may allow photographs but, at least for now, he prefers not to give autographs nor to make endorsements of this, that, or the other. He is considering a Facebook page. 


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