COVID-19 updates
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The Department of Health and Human Services (HHS) has created a summary table of outpatient treatments of mild-to-moderate COVID-19. The table includes Paxlovid, Molnupiravir, Sotrovimab, Bamlanivimab/Etesevimab and Casirivimab/Imdevimab.
COVID-19 Antivirals Ensovibep – a DARPin (Designed Ankyrin Repeat Protein) antiviral is being developed by Novartis and Molecular Partners as a treatment for COVID-19. DARPins are mono or multi-specific protein-based therapies. Ensovibep has three individual DARPin domains that block receptor-binding in the SARS-CoV-2 virus causing strong neutralization of the virus.
Plitidepsin is an eEF1A2 Inhibitor being developed by PharmaMar to treat multiple myeloma. Plitidepsin demonstrated in-vitro antiviral activityagainst a coronavirus similar to SARS-CoV-2.
The FDA expanded the EUA for remdesivir to include a three-day outpatient course in non-hospitalized patients with mild-to-moderate COVID-19 at high risk to progress to severe disease. To make administration easier, Gilead is developing GS-5245, an oral prodrug for remdesivir. COVID-19 Vaccines A retrospective CDC study found that patients who received a booster dose of an mRNA vaccine were less likely to develop symptomatic COVID-19 with the Delta or Omicron variants compared to patients that received two vaccine doses or were unvaccinated. Vaccination was slightly less protective against infection for the Omicron variant. A second CDC study found mRNA vaccine effectiveness after a third mRNA vaccine was 94% for Delta variant cases and 82% for Omicron variant in preventing COVID-19–associated emergency department and urgent care encounters and 94% for Delta variant cases and 90% for Omicron variant cases in preventing COVID-19–associated hospitalization. A third CDC study found the largest impact of receiving a booster dose to decrease the risk of COVID-19 infection and death were seen in 50 years and older. COVID-19 Antibodies The FDA limited the EUA for monoclonal antibody combinations from Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) to only be used when the patients are likely to have been infected with or exposed to a variant that is susceptible to these treatments. This excludes use for Omicron, which is the current dominant COVID-19 variant. The FDA did not discontinue either EUA, because of the potential for use in the future. As a follow-up to the FDA’s update and last week’s restriction of the two combinations in the NIH guidelines, HHS will stop distributing bamlanivimab plus etesevimab and casirivimab plus imdevimab. COVID-19 Anti-Inflammatories In an 11-day, 200 patient, open-label, Phase III trial ( NCT04726098), 31.4% of patients treated with dexamethasone 6 mg once daily for 10 days had clinical worsening compared to 16.3% with dexamethasone 20 mg once daily for 5 days, followed by 10 mg once daily for additional 5 days in hospitalized Spanish patients with confirmed COVID-19 pneumonia requiring oxygen therapy. COVID-19 Vaccines
The CDC conducted a retrospective review of data from 40,627 pregnant women and found that COVID-19 vaccination during pregnancy did not increase the risk of preterm birth or small-for-gestational-age at birth overall, stratified by trimester of vaccination, or number of vaccine doses received during pregnancy, compared with unvaccinated pregnant women. A CDC retrospective analysis of 1,228,664 patients who completed the two-dose primary vaccination from December 2020–October 2021, found the incidence of developing severe COVID-19 was 0.015%. All patients who developed severe COVID-19 had at least one risk factor for developing a severe infection. A week after restating the six-month interval for a booster with the Moderna COVID-19 vaccine, the FDA shortened time period to five-months to match the recommendation for the Pfizer-BioNTech vaccine. In a French case series of 92 kidney-transplant patients, a fourth dose of an mRNA vaccine produced a satisfactory antibody response in about half of the patients who had not responded to three doses. Antibody levels were measured a median of 29-days after the dose. In October the CDC recommended an additional booster dose, given six-months after the first booster dose, in moderately and severely immunocompromised patients. COVID-19 Antibodies NIH recommends AstraZeneca’s monoclonal antibody combination of tixagevimab and cilgavimab for COVID-19 prophylaxis in patients who are moderately to severely immunocompromised with an inadequate immune response to COVID-19 vaccination or not fully vaccinated due to a documented history of severe adverse reactions to a COVID-19 vaccine NIH recommend that nonhospitalized patients with mild to moderate COVID-19 who are at high risk of disease progression, be treated with (in order of preference):
The FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a single booster dose for patients 12 through 15 years of age. Boosters for all patients 12 years and older can now be given as soon as five months after completion of primary series. Patients who are 5 through 11 years, who have undergone solid organ transplantation or are immunocompromised to an equivalent level are also now eligible for a booster dose. The interval between the primary series and a booster dose remains unchanged at six months for the Moderna COVID-19 vaccine and two months for the J&J vaccine. South African researchers examined the results of 133,437 COVID-19 PCR tests and found the effectiveness of the Pfizer-BioNTech COVID-19 vaccine to be 70% after two doses in preventing hospitalizations for COVID-19 during a period when Omicron variant was the dominant strain compared to 93% when the Delta variant was the dominant strain. In a second study, South African researchers compared the COVID-19 neutralization ability for the Beta, Delta, and Omicron variants with serum from 20 patents that had received two vaccinations with the Pfizer-BioNTech COVID-19 vaccine to a group of 20 patients that had received three injections. The researchers found that a third dose of the vaccine increased neutralization efficiency by a factor of 100 against the Omicron variant, but neutralization was lower by a factor of four against the omicron variant compared to the delta variant. Rockefeller University researchers tested plasma from a variety of patients and found that recovered COVID-19 patients and patients that had received a third (booster) vaccination had enhanced protection against the Omicron variant. CDC researchers reviewed data from VAERS and V-Safe voluntarily surveillance systems for children ages 5 to 11 years from 11/3/2021 to 12/19/2021. The researchers found the most common adverse reactions were injection site pain, fatigue and headache. ADR were mostly mild, and few cases of myocarditis were reported. It was estimated that 8.7 million doses were given during this time period to children 5 to 11 years. A retrospective analysis of maternal and umbilical cord blood samples from 1,359 vaccinated pregnant women found that COVID-19 immunization before and throughout pregnancy resulted in detectable antibodies at delivery. The highest maternal and umbilical cord antibody levels were found in mothers who had received a complete vaccination course, had a prior history of COVID-19, or received a third-trimester booster dose. COVID-19 Antibodies The FDA issued an emergency use authorization (EUA) for convalescent plasma, on 8/23/2020, for the treatment of hospitalized patients with COVID-19. The original EUA was granted for any convalescent plasma product collected at FDA registered blood establishments. In February 2021, the FDA narrowed the EUA to high-antibody-titer convalescent plasma. The FDA no longer authorizes the use of plasma with low SARS-CoV-2 antibody titers. In December 2021, the FDA narrowed the EUA to treatment of COVID-19 in inpatients or outpatients who have an immunosuppressive disease or who are receiving immunosuppressive treatment. Fact sheets have been created for health care providers and patients. The Fact Sheet for HCPs has been revised to reflect the changes in the EUA. The documents include dosing instructions and potential adverse effects, such as allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections. COVID-19 Anti-Inflammatories Kiniksa Pharmaceuticals announced that in a 29-day, 582 patient, Phase II/III trial (NCT0444746), treatment with mavrilimumab did not decrease the percentage of patients that required mechanical ventilation or died compared to placebo in patients with severe COVID-19 pneumonia and systemic hyperinflammation. |
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