COVID-19 Vaccine Booster doses
The CDC analyzed surveillance data from 12,591 patients enrolled in V-Safe, who received a booster vaccination of the Pfizer-BioNTech COVID-19, vaccine and found the occurrence of adverse events to be similar to ADR experienced after the second dose.
A study analyzing the antibody levels produced with the Pfizer-BioNTech and Moderna COVID-19 vaccines, in 167 adults, found the Pfizer-BioNTech elicited lower antibody titers in patients 50 years and older compared to patients less than 50 years. Antibody titers were also lower in age-similar peers compared to Moderna vaccine recipients. There were no differences in antibody levels between older and younger patients that received the Moderna vaccine. This study did not measure neutralizing antibodies.
A case-control study involving 105,446 pregnancies, from eight large U.S. healthcare systems and an analysis of outcomes from 2,456 women enrolled in a CDC pregnancy registry found no increase in the risk for spontaneous abortion with COVID-19 vaccinations.
In a 32,449 patient, Phase III, trial (NCT04516746), two doses of AstraZeneca’s COVID-19 vaccine, given 4-weeks apart, had efficacy of 74% overall and 83.5% in patients 65 years and older. Efficacy was defined as prevention of symptomatic COVID-19.
In a 29-day, 4,180 patient, Phase III trial (NCT04425629), 1% of patients treated with 1,200 mg of the combination of casirivimab with imdevimab progressed to hospitalization or death compared to 3.2% with placebo in high-risk COVID-19 outpatients. Treatment with 2,400 mg of the monoclonal combination resulted in 1.3% of patients progressing to hospitalization or death compared to 4.6% with placebo.
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COVID-19 Vaccine Booster doses
On 9/22/2021, 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. On 9/23/2021, ACIP recommended a booster dose of the Pfizer-BioNTech vaccine for patients 65 years and older, residents of long-term care facilities and 50 to 64 years patients at high risk for severe COVID-19. Patients who at 18 to 49 at high risk for severe COVID-19 infection may receive one, if the patient wants one. ACIP did not recommend a booster dose for health care professionals, other front-line workers or people that live in group settings. The CDC agreed with ACIP on recommending a booster dose for patients 65 years and older, residents of long-term care facilities and patients at high risk for severe COVID-19, but also added a recommendation for health care professionals, other front-line workers or people that live in group settings. Neither the FDA nor CDC has recommended booster doses of the Moderna or Johnson & Johnson COVID-19 vaccines. No recommendation was made regarding use of the Pfizer-BioNtech vaccine as a booster dose for patients that originally received the Moderna or Johnson & Johnson COVID-19 vaccines.
J&J announced that in the 31,836 patient, Phase III, ENSEMBLE 2 trial (NCT04614948), a booster dose of the J&J COVID-19 vaccine given 56 days after the initial immunization produced vaccine effectiveness of 100% against severe/critical COVID-19, 75% against symptomatic infections globally and 94% in the U.S.
A study of 36 women, who received an mRNA vaccine during pregnancy, found that antibodies were passed on to infants.
A pre-publication draft of a retrospective review of data from 1,914,670 patients in an insurance claims database estimated the vaccine effectiveness, for the J&J COVID-19 vaccine in states with high Delta variant incidence, at 78% for infections and 85% to prevent hospitalizations.
Gilead Sciences announced that in the 28-day, 562 patient, Phase III, PINETREE trial (NCT04501952), 0.7% of patients treated with three intravenous infusions of remdesivir were hospitalized or died compared to 5.3% with placebo in non-hospitalized COVID-19 patients at high risk for disease progression. Enrollment for this trial was stopped, in April 2021, prior to fulfilling the 1,264 patient enrollment due to a change in epidemiology and adoption of additional treatment options at the time. The Delta variant became the dominant variant in the summer of 2021.
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Booster Vaccine Doses
ACIP recommended that COVID-19 vaccines can be coadministered with other vaccines, including influenza vaccines in their 2021–22 Influenza Season update.
Pfizer and BioNTech announced that in a 2,268 patient, Phase II/III trial (NCT04816643), two 10 mcg doses of their COVID-19 vaccine given 21 days apart, to children 5 to 11 years, produced antibody titers comparable to the levels seen with two 30 mcg adult doses in adolescents and young adults age 16 to 25 years. Data for children 2 to 5 years of age and children 6 months to 2 years of age is forecast to be available in the fourth quarter.
In a review of data from 1,736,832 patients from an Israeli managed care database, found the Pfizer/BioNTech COVID-19 vaccine increases the risk for lymphadenopathy, herpes zoster infection and appendicitis, while COVID-19 increases the risk for arrhythmia, acute kidney injury, pulmonary embolism, deep-vein thrombosis, myocardial infarction, pericarditis, and intracranial hemorrhage. While the vaccine increased the risk for myocarditis (2.7 events per 100,000 persons) the risk was over four times higher with COVID-19 (11.0 events per 100,000 persons).
The FDA expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab (Lilly) to include post-exposure prophylaxis in high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination and have been exposed COVID-19.
In the 15-day, 857 patient, Phase III, DisCoVeRy trial (NCT04315948), adding remdesivir to standard-of care did not improve clinical status (WHO seven-point ordinal scale) compared to standard-of-care alone in European hospitalized patients with COVID-19 for more than 7 days, who were receiving supplemental oxygen.
A CDC analysis of 1,175 U.S. veterans aged 18 years or > from five Veterans Affairs Medical Centers found overall vaccine effectiveness against COVID-19–associated hospitalization to be 86.8% with similar effectiveness before (February 1–June 30) and after (July 1–August 6) Delta variant predominance. Effectiveness was 79.8% for patients 65 years or greater compared to 95.1% for patients 18 to 64 years.
A CDC analysis of data from 32,867 patient visits in nine states from June to August 2021 found overall effectiveness to be 86% at preventing hospitalizations. Effectiveness was 76% for patients 75 years or greater compared to 89% for patients 18 to 74 years. Vaccine effectiveness to prevent hospitalization was highest for the Moderna vaccine at 95% compared to 80% for the Pfizer-BioNTech vaccine and 60% for the J&J vaccine.
A CDC analysis of data from 569,142 viral infections in 13 states found a higher risk for COVID-19 infections, illness, and death in unvaccinated compared to vaccinated individuals.
Booster Vaccine Doses
In a 30-day, 940 patient, Phase III, CONCOR-1 trial (NCT04348656), treatment with convalescent plasma did not decrease intubation or death compared to standard of care (32.4% vs 28%) in patients with COVID-19 receiving oxygen within 12 days of respiratory symptom onset. Patients that received convalescent plasma experienced more adverse events than standard of care (33.4% versus 26.4%).
An analysis of antibody levels in 1,647 Belgium health care workers found higher antibody titers after two doses of the Moderna COVID-19 vaccine compared to the Pfizer-BioNTech vaccine, whether or not the patient had previously been infected with COVID-19. The increase in antibody titers was higher after infection than the difference between the two vaccines. It is unknown if the difference in antibody levels is clinically significant.
Merck initiated a trial to evaluate molnupiravir in the prevention of COVID-19 in the 14-day, 1,332 Phase III, MOVe-AHEAD trial (NCT04939428), in adults who live with a symptomatic patient with a confirmed coronavirus infection.
Pfizer is evaluating PF-07321332 in combination with ritonavir in the treatment of COVID-19. PF-07321332 is a protease inhibitor. It is administered with ritonavir to slow the metabolism of PF-07321332, to increase its half-life.
In the 1,525 patient, Phase III, COV-BARRIER trial (NCT04421027), adding baricitinib to standard of care did not decrease the proportion of patients who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or death by day 28. However, treatment with baricitinib did decrease mortality at 28-days (8% vs 13%) and 60-days (10% vs 15%).
The FDA has requested an additional study to evaluate treatment with remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 in order to be considered for an EUA.
The FDA declined Humanigen’s request for an emergency use authorization for lenzilumab to treat newly hospitalized COVID-19 patients due to inadequate safety and efficacy data.
The FDA reapproved the use of Lilly’s COVID-19 monoclonal antibody combination of bamlanivimab and etesevimab to be used in all U.S. states, territories, and jurisdictions. This expands the use authorized on 8/27/2021 from 20 states to all states. The Assistant Secretary for Preparedness and Response will resume distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use).
If there are logistical constraints to administering COVID-19 monoclonal antibodies, NIH recommends
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