COVID-19 updates
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COVID-19 Booster Vaccines
Pfizer and BioNTech announced that in a Phase 3 trial (NCT04955626) of over 10,000 patients, a booster dose of their COVID-19 vaccine demonstrated 95.6% effectiveness in preventing COVID-19. In an update to its COVID-19 vaccine guidance, the CDC is recommending that moderately and severely immunocompromised people aged 18 years or older, who completed an mRNA COVID-19 vaccine primary series, may receive a single COVID-19 booster dose (Pfizer-BioNTech, Moderna, or Janssen) at least 6 months after completing their third mRNA vaccine dose for a total of four COVID-19 vaccine doses. COVID-19 Vaccines An FDA review of data for the Pfizer-BioNTech COVID-19 vaccine in children ages 5-11 years, found benefits to outweigh the risks for this age group. In the study, children were given two 10 mcg doses of the vaccine, 21 days apart and found comparative antibody titers to levels seen in ages 16-25 with a 30 mcg dose. Adverse events were also similar. Based on limited follow-up, vaccine effectiveness was estimated to be 90.7% with no cases of severe COVID-19. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0 with one member abstaining to recommend the Pfizer-BioNTech COVID-19 vaccine in children 5-11 years of age. A CDC analysis of data from 464 adolescents, hospitalized for COVID-19, found the Pfizer-BioNTech COVID-19 vaccine to be 93% effective in preventing hospitalizations from 6/1/2021 to 9/30/2021, a period when the predominant variant was the Delta variant. Moderna announced interim data from a cohort of 4,753 children, age 6 to under 12 years of age, enrolled in the Phase II/III KidCOVE trial(NCT04796896), where two 50 mcg doses of Moderna’s COVID-19 vaccine, given 28-days apart, elicited a strong immune response and was well tolerated. A retrospective analysis of 2.5 million patients, in an Israeli HMO database, who received the Pfizer-BioNTech COVID-19 vaccine found the estimated incidence of myocarditis to be 2.13 cases per 100,000 persons with the highest incidence in male patients between the ages of 16 and 29 years (10.69 cases per 100,000). In a similar study from a national database of 5.1 million Israelis that received the Pfizer-BioNTech COVID-19 vaccine, the estimated incidence of myocarditis was 1.76 cases per 100,000 persons with the highest incidence in male patients ages 16 to 19 years (13.73 cases per 100,000). An analysis of the response to vaccination with mRNA vaccines found that pregnant and lactating women develop lower antibody titers after the first vaccine dose. Antibody levels rise to match the immunological response seen in non-pregnant and non-lactating women after the second dose. COVID-19 Antivirals Roche and Atea Pharmaceuticals announced that in the seven-day, 100 patient, Phase II, MOONSONG Trial (NCT04709835), treatment with AT-527 did not reduce viral load compared to placebo in non-hospitalized patients with mild to moderate COVID-19. MOONSONG included vaccinated patients, which could have affected the outcome. The Oregon Poison Center reported an increase in calls for toxic effects of ivermectin. The drug was being taken to treat or prevent COVID-19. Most of the patients were treating themselves using a veterinary formulation. Some of the patients were taking a dose much higher than the 21 mg used in humans. Six of the patients were hospitalized and four admitted to the ICU. In the 28-day, 1,497 patient, Brazilian Phase III, TOGETHER trial (NCT04727424), 11% of patients treated with fluvoxamine required prolonged emergency treatment or were admitted to a hospital for worsening COVID-19 compared to 16% with placebo in outpatients with COVID-19 at high risk to progress to severe disease. COVID-19 Anti-Inflammatories In the 28-day, 982 patient, Phase III, COVID STEROID trial (NCT04509973), treatment with IV dexamethasone 12 mg did not increase days alive without life support compared to a 6 mg dose (22 vs 20.5 days) in patients with COVID-19 and severe hypoxemia. COVID-19 Antibodies Interim data from the 29-day, 583 patient, Phase III, COMET-ICE trial (NCT04545060), found that 1% of patients treated with VIR-7831 were hospitalization or death compared to 7% with placebo in patients with mild to moderate COVID-19 who are at high risk of progression to severe disease.
COVID-19 Booster Vaccines
In September, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. The CDC agreed and also recommended a booster dose for these groups. FDA reviews of booster doses of Moderna’s and Johnson & Johnson’s COVID-19 vaccines, suggested that while some evidence suggest a decrease in efficacy over time for symptomatic and Delta variant infections, the vaccines still provide protection against severe COVID-19 disease and death. The J&J review did note that higher efficacy with the mRNA vaccines. The FDA did not find any safety issues or increased reactogenicity with booster doses for either vaccine.
The FDA is delaying a decision on use of the Moderna COVID-19 vaccine in adolescents to allow more time to examine data on the occurrence of myocarditis. Some European countries have not approved use of the Moderna vaccine in adolescents due to myocarditis, which lead the FDA to more closely examine the data. COVID-19 Antivirals The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) will review molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, including hospitalization or death on 11/30/2021. In the 28-day, 969 patient, Phase III, ACTT-3 trial (NCT04492475), adding subcutaneous interferon beta-1a to intravenous remdesivir did not decrease time to recovery or mortality compared to remdesivir alone in hospitalized patients with COVID-19. COVID-19 Booster Vaccines
In September, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow a booster dose, given at least six months after completion of the second dose to patients 65 years and older or who are at high risk for severe COVID-19, which includes healthcare professionals, frontline workers and people that live in group settings. The CDC agreed and also recommended a booster dose for these groups. Today, Thursday, October 14, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee will discuss a booster dose for the Moderna COVID-19 vaccine. The next day the Advisory Committee will discuss J&J vaccine booster doses. FDA reviews of booster doses of Moderna’s and Johnson & Johnson’s COVID-19 vaccines, suggested that while some evidence suggest a decrease in efficacy over time for symptomatic and Delta variant infections, the vaccines still provide protection against severe COVID-19 disease and death. The J&J review did note that higher efficacy with the mRNA vaccines. The FDA did not find any safety issues or increased reactogenicity with booster doses for either vaccine.
Sanofi announced interim results from a trial where Sanofi’s Fluzone High-Dose Quadrivalent vaccine and Moderna’s COVID-19 mRNA investigational booster were co-administered. Immunogenicity and safety for both vaccines were similar to what is seen with either vaccine administered alone. COVID-19 Antibodies AstraZeneca announced that in the 29-day, 903 patient, Phase III, TACKLE trial (NCT04723394), 4.4% of patients treated with AZD7442, a monoclonal antibody combination of tixagevimab and cilgavimab, progressed to severe COVID-19 or died compared to 8.9% with placebo in COVID-19 patients at high risk of progression to severe disease. COVID-19 Antivirals Azithromycin: In vitro evidence suggested potential activity of azithromycin against SARS-CoV-2, but clinical trials have not found a benefit. NIH recommends against the use of azithromycin with or without chloroquine or hydroxychloroquine in the treatment COVID-19.
COVID-19 Vaccines
A 679 patient, British Phase IV trial found that a COVID-19 vaccine given with an influenza vaccine on the same day in different arms will not affect the immune response of either vaccine. Adverse events were similar in patients that received both vaccines on the same day and patients that received one of the vaccines three-weeks later. The Pfizer-BioNTech and AstraZeneca COVID-19 vaccines were used in the study. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 10/26/2021 to discuss an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccines for children 5 through 11 years old. COVID-19 Vaccine Booster doses The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 10/14/2021 to discuss an emergency use authorization (EUA) for the Moderna COVID-19 vaccines. On 10/15/2021, the committee will discuss an EUA for a booster dose of the Johnson & Johnson vaccine. On 10/15, VRBPAC will also discuss use of a different COVID-19 vaccine than a patient initially received, as a booster dose. COVID-19 Antivirals Merck announced interim results from 775 patients enrolled in the 29-day, 1,550 patient, Phase II/III, MOVe-OUT trial (NCT04575597), where 7.3% of patients treated with molnupiravir were hospitalized or died compared to 14.1% with placebo in outpatients with mild-to-moderate COVID-19 with at least one risk factor to progress to severe disease. Based on interim results from the MOVe-OUT study, Merck plans to file for an EUA and have 10 million doses available by the end of 2021. COVID-19 Antibodies In the 29-day, 1,035 patent, Phase III, BLAZE-1 trial (NCT04427501), 2.1% of patients treated with bamlanivimab 2800 mg plus etesevimab 2800 mg experienced the primary endpoint of COVID-19 related hospitalizations or death compared to 7% that received placebo in patients with mild to moderate COVID-19 who were at high risk for progressing to severe COVID-19 and/or hospitalization. No deaths occurred in the combination treatment group compared to ten deaths in the placebo group. In the 21-day, 2,011 patient, Phase III, REMAP-CAP trial (NCT02735707), treatment with convalescent plasma did not improve organ support–free days or mortality compared to no convalescent plasma in critically ill adults with confirmed COVID-19. AstraZeneca has requested an emergency use authorization (EUA) for, AZD7442 its monoclonal antibody combination of tixagevimab and cilgavimab, as prophylaxis of COVID-19. |
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