1- Monday Infectious Disease News – 15th November 

1 – Pfizer’s novel COVID-19 oral antiviral treatment candidate reduced risk of hospitalization or death by 89% in interim analysis of phase 2/3 Epic-HR study

• PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19
• In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo
• Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible

Source: Pfizer

2 – Covid: Pfizer says antiviral pill 89% effective in high-risk cases

• A pill to treat Covid developed by the US company Pfizer cuts the risk of hospitalisation or death by 89% in vulnerable adults, clinical trial results suggest.
• The drug – Paxlovid – is intended for use soon after symptoms develop in people at high risk of severe disease.
• It comes a day after the UK medicines regulator approved a similar treatment from Merck Sharp and Dohme (MSD).
• Pfizer says it stopped trials early as the initial results were so positive.
• The UK has already ordered 250,000 courses of the new Pfizer treatment, which has not yet been approved, along with another 480,000 courses of MSD’s molnupiravir pill.

Source: BBC

3 – Merck and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the Risk of Hospitalization or Death by Approximately 50 Percent Compared to Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis of Phase 3 Study

• Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission.
• At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-Treated Patients Who were Hospitalized or Died
• Merck Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible and to Submit Applications to Regulatory Agencies Worldwide
• If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-19

Source: Merck

4- Association of Self-reported High-Risk Allergy History With Allergy Symptoms After COVID-19 Vaccination

• Allergic history in individuals with confirmed anaphylaxis to a messenger RNA (mRNA) COVID-19 vaccine is common. However, the risk factors for allergy symptoms after receiving the vaccine are unknown.
• This study aims to assess the association between self-reported history of high-risk allergy and self-reported allergic reactions after mRNA COVID-19 vaccination of health care employees.
• This cohort study found that self-reported history of high-risk allergy was associated with an increased risk of self-reported allergic reactions within 3 days of mRNA COVID-19 vaccination.

Source: JAMA Network

5 – Immune Response of Neonates Born to Mothers Infected With SARS-CoV-2

• Although several studies have provided information on short-term clinical outcomes in children with perinatal exposure to SARS-CoV-2, data on the immune response in the first months of life among newborns exposed to the virus in utero are lacking.
• This study aims to characterize systemic and mucosal antibody production during the first 2 months of life among infants who were born to mothers infected with SARS-CoV-2.
• In this cohort study, SARS-CoV-2 spike–specific IgA antibodies were detected in infant saliva, which may partly explain why newborns are resistant to SARS-CoV-2 infection.
• Mothers infected in the peripartum period appear to not only passively protect the newborn via breastmilk secretory IgA but also actively stimulate and train the neonatal immune system via breastmilk immune complexes.

Source: JAMA Network

6 – Analysis of the Effectiveness of the Ad26.COV2.S Adenoviral Vector Vaccine for Preventing COVID-19

• Continuous assessment of the effectiveness and safety of the US Food and Drug Administration–authorized SARS-CoV-2 vaccines is critical to amplify transparency, build public trust, and ultimately improve overall health outcomes.
• This study aims to evaluate the effectiveness of the Johnson & Johnson Ad26.COV2.S vaccine for preventing SARS-CoV-2 infection.
• This study’s findings are consistent with the clinical trial–reported efficacy of Ad26.COV2.S and the first retrospective analysis, suggesting that the vaccine is effective at reducing SARS-CoV-2 infection, even with the spread of variants such as Alpha or Delta that were not present in the original studies, and reaffirm the urgent need to continue mass vaccination efforts globally.

Source: JAMA Network

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