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Pharmacology/Pharmaceutical Industry

COVID-19 vaccines: Keeping pace with SARS-CoV-2 variants.

24 Sep, 2021 | 10:02h | UTC

COVID-19 vaccines: Keeping pace with SARS-CoV-2 variants – Cell

 

Commentary on Twitter

https://twitter.com/Sri_Baqri/status/1438865999281983490

 

RCT confirms antibiotics are not needed for most children with uncomplicated lower respiratory tract infection if pneumonia is not suspected clinically.

24 Sep, 2021 | 09:00h | UTC

Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial – The Lancet

 

Commentary on Twitter

 

Clinical practice guideline on immune checkpoint inhibitor-related adverse events.

24 Sep, 2021 | 08:55h | UTC

Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune checkpoint inhibitor-related adverse events – Journal for ImunoTherapy of Cancer

Related:

NCCN Guidelines Insights: Management of Immunotherapy-Related Toxicities (several resources on the subject)

Immune Checkpoint Inhibitor Myocarditis: Pathophysiological Characteristics, Diagnosis, and Treatment (several resources on the subject)

 

WHO global antimicrobial resistance surveillance for Neisseria gonorrhoeae 2017–18 – In many countries, ciprofloxacin resistance was exceedingly high, and decreased susceptibility or resistance to ceftriaxone and cefixime continued to emerge.

24 Sep, 2021 | 08:53h | UTC

WHO global antimicrobial resistance surveillance for Neisseria gonorrhoeae 2017–18: a retrospective observational study – The Lancet Microbe

 

Large, multinational cohort suggests ondansetron use in pregnancy does not increase the risk for adverse fetal outcomes.

24 Sep, 2021 | 08:57h | UTC

Comparison of Pregnancy Outcomes of Patients Treated With Ondansetron vs Alternative Antiemetic Medications in a Multinational, Population-Based Cohort – JAMA Network Open

Editorial: Providing Data to Empower Pregnant Patients to Make Evidence-Based Choices

Related: Cohort Study: Maternal Ondansetron Use and Risk of Cardiac Malformations and Oral Clefts in Offspring

 

Commentary on Twitter

 

[Preprint] Third dose of Sinopharm inactivated SARS-CoV-2 vaccine induces robust B and T cell responses.

23 Sep, 2021 | 10:18h | UTC

Robust induction of B cell and T cell responses by a third dose of inactivated SARS-CoV-2 vaccine – medRxiv

Commentaries:

Three doses of inactivated BBIBP-CorV SARS-CoV-2 vaccine induce robust B and T cell responses – News Medical

Sinopharm’s COVID booster reverses antibody decline, enhances cell-based responses – study – Reuters

 

[Press release – not published yet] J&J says booster shot at two months provided 75% protection against moderate to severe COVID-19 globally and 94% of such cases in the U.S.

22 Sep, 2021 | 10:26h | UTC

Press release: Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

Commentaries:

Johnson & Johnson says additional dose boosts Covid vaccine efficacy – STAT

J&J booster 94% effective against severe COVID, company says – CIDRAP

Two dose version of Johnson & Johnson shot 94% effective against Covid-19, study finds – CNN

 

Commentaries on Twitter

(thread – click for more)

(thread – click for more)

https://twitter.com/hildabast/status/1440363761299124229

 

The fight to manufacture COVID vaccines in lower-income countries.

22 Sep, 2021 | 10:21h | UTC

The fight to manufacture COVID vaccines in lower-income countries – Nature

 

RCT: Probiotics do not reduce the incidence of ventilator-associated pneumonia in critically ill patients.

22 Sep, 2021 | 10:03h | UTC

Effect of Probiotics on Incident Ventilator-Associated Pneumonia in Critically Ill Patients: A Randomized Clinical Trial – JAMA (free for a limited period)

Commentary: Probiotic Flops for Ventilator-Associated Pneumonia Prevention – MedPage Today (free registration required)

 

[Press release – not published yet] Pfizer announces COVID-19 vaccine in children 5 to 11 years produced strong neutralizing antibody responses.

21 Sep, 2021 | 09:57h | UTC

Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years – Pfizer and BioNTech

Commentaries:

Covid-19 vaccine for 5- to 11-year-olds is safe and shows ‘robust’ antibody response, Pfizer says – CNN

Pfizer says COVID-19 vaccine safe, effective in younger children – CIDRAP

Pfizer Covid-19 vaccine generates robust antibody response in children, without serious safety issues, company says – STAT

Expert reaction to press release giving topline results from Pfizer and BioNTech from their phase 2/3 trial looking at safety and antibody responses from their COVID-19 vaccine in children aged 5 to 11 – Science Media Centre

 

Commentaries on Twitter

(thread – click for more)

(thread – click for more)

https://twitter.com/hildabast/status/1439976038964940803

 

CDC Report: Moderna’s vaccine associated with greater effectiveness (93%) against Covid-19 hospitalization compared to Pfizer (88%) and J&J (71%) vaccines.

19 Sep, 2021 | 23:48h | UTC

Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021 – CDC Morbidity and Mortality Weekly Report

Commentaries:

Moderna’s vaccine is the most effective, but Pfizer and J&J also protect well, CDC-led study says – CNN

CDC: Moderna COVID vaccine most protective against hospital cases – CIDRAP

CDC data: Moderna vaccine has edge in preventing COVID-19 hospitalizations – UPI

 

Commentary on Twitter

 

Does everybody need a booster shot? – “Why some people might need Covid-19 booster shots — and some might not”.

19 Sep, 2021 | 23:43h | UTC

Does everybody need a booster shot? – Vox

 

An FDA panel says only high-risk Americans and those 65+ should get covid boosters.

19 Sep, 2021 | 23:45h | UTC

An FDA Panel Says Only High-Risk Americans And Those 65+ Should Get COVID Boosters – NPR

See also:

FDA advisory panel recommends booster doses of Covid-19 vaccine only for older and high-risk Americans – STAT

5 reasons why FDA advisers did not recommend Covid-19 booster shots for everyone – CNN

Top doctors say not so fast to Biden’s boosters-for-all plan – Associated Press

Related:

An observational study in Israel suggests additional protection from a 3rd dose of the Pfizer vaccine in individuals 60 years of age or older.

Third shot: UK to offer COVID booster jabs to over 50s.

COVID-19 vaccine efficacy does not support boosters for general population, review concludes.

COVID vaccine effects wane over time but still prevent death and severe illness.

What’s the evidence for COVID-19 booster shots?

WHO appeals for countries to postpone COVID-19 vaccine boosters until 2022 to prioritize vaccinating the most at-risk people around the world who are yet to receive their first dose.

AstraZeneca bosses warn against rush for boosters – “giving the most vulnerable, who may not have built up a full immune response from the first two, a third, top-up dose is “sensible”. But any decision to give a third, booster jab “to large swathes of the population”, to extend their protection from the first two, must be based on clinical data”.

 

Side effect patterns in a crossover trial of statin, placebo, and no treatment – This N-of-1 trial, now published in full, suggests the nocebo effect causes most of statins muscle adverse effects.

19 Sep, 2021 | 23:30h | UTC

Side Effect Patterns in a Crossover Trial of Statin, Placebo, and No Treatment – Journal of the American College of Cardiology

See also: #AHA20 – In patients who had discontinued statins because of side effects, a N-of-1 trial of a statin, placebo, or no treatment found that side effects often attributed to statins were the same for those taking a placebo

 

RCT: Rivaroxaban does not have an impact on disease progression and symptoms resolution in high-risk adults with mild COVID-19.

17 Sep, 2021 | 10:19h | UTC

Randomized study of rivaroxaban vs. placebo on disease progression and symptoms resolution in high-risk adults with mild COVID-19 – Clinical Infectious Diseases

 

Case series: Vaccine-induced thrombocytopenia with severe headache may precede cerebral venous sinus thrombosis by several days – patients with severe headache 5 to 20 days after adenovirus vector vaccination against Covid-19 should undergo immediate testing for thrombocytopenia and d-dimer levels and, if available, testing for anti–PF4–heparin IgG antibodies.

16 Sep, 2021 | 10:14h | UTC

Vaccine-Induced Thrombocytopenia with Severe Headache – New England Journal of Medicine

 

Commentary on Twitter

 

Third shot: UK to offer COVID booster jabs to over 50s.

16 Sep, 2021 | 10:11h | UTC

Third shot: UK to offer COVID booster jabs to over 50s – Associated Press

 

COVID vaccine effects wane over time but still prevent death and severe illness.

16 Sep, 2021 | 10:10h | UTC

COVID vaccine effects wane over time but still prevent death and severe illness – The Conversation

Related:

Perspective | What we actually know about waning immunity.

Another study shows Pfizer mRNA vaccine immunity is reduced over time.

[Press release – not published yet] Study shows vaccine protection wanes over time, but vaccines still offer good protection against severe disease.

Studies: COVID vaccine protection waning against infection but not hospitalization.

Pfizer says it’s time for a Covid booster; FDA and CDC say not so fast.

 

An observational study in Israel suggests additional protection from a 3rd dose of the Pfizer vaccine in individuals 60 years of age or older.

16 Sep, 2021 | 10:13h | UTC

Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel – New England Journal of Medicine

 

Editorial | Insulin for all: a hope yet to be realized.

16 Sep, 2021 | 09:59h | UTC

Insulin for all: a hope yet to be realized – The Lancet Diabetes & Endocrinology

Related: One hundred years of insulin therapy.

 

Commentary on Twitter

 

RCT: Remdesivir does not improve outcomes in patients admitted to hospital with COVID-19.

15 Sep, 2021 | 09:59h | UTC

Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a phase 3, randomised, controlled, open-label trial – The Lancet Infectious Diseases

Invited commentary: Remdesivir, on the road to DisCoVeRy – The Lancet Infectious Diseases

Related:

Systematic Review: “Remdesivir probably has little or no effect on all‐cause mortality at up to 28 days in hospitalized adults with SARS‐CoV‐2 infection. We are uncertain about the effects of remdesivir on clinical improvement and worsening”.

WHO Solidarity Trial: Remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19

 

Ivermectin: Cochrane’s most talked about review so far, ever. Why?

15 Sep, 2021 | 09:07h | UTC

Ivermectin: Cochrane’s most talked about review so far, ever. Why? – Cochrane Library

Original review: Systematic review: no evidence to support the use of Ivermectin for treating or preventing COVID-19.

 

Commentary on Twitter

 

CDC report finds unvaccinated people are 11 times more likely to die of COVID-19.

15 Sep, 2021 | 09:09h | UTC

Unvaccinated People Are 11 Times More Likely To Die Of COVID-19, New Research Finds – NPR

Original study: Monitoring Incidence of COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Status — 13 U.S. Jurisdictions, April 4–July 17, 2021 – CDC Morbidity and Mortality Weekly Report

 

Commentary on Twitter

 

The tangled history of mRNA vaccines.

15 Sep, 2021 | 09:06h | UTC

The tangled history of mRNA vaccines – Nature

Related:

mRNA vaccines for infectious diseases: principles, delivery and clinical translation.

After COVID-19 successes, researchers push to develop mRNA vaccines for other infectious diseases and cancer.

 

Commentary on Twitter

 

RCT: Effect of Camrelizumab vs. placebo added to chemotherapy on survival and progression-free survival in patients with advanced or metastatic esophageal squamous cell carcinoma.

15 Sep, 2021 | 08:51h | UTC

Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Immunotherapy for Advanced Esophageal Squamous Cell Carcinoma—Renewed Enthusiasm and a Lingering Challenge – JAMA Oncology (free for a limited period)

 

Commentary on Twitter

 

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