On 2/27/2021 the FDA granted an emergency use authorization (EUA) to Johnson and Johnson’s COVID-19 vaccine for the prevention of COVID-19 for individuals 18 years of age and older. Vaccine Fact Sheets are available for Healthcare Providers and Vaccine Recipients/Caregivers. The CDC's Advisory Committee on Immunization Practices (ACIP) recommend the Johnson & Johnson Covid-19 vaccine on 2/28/2021. The FDA’s Vaccines and Related Biological Products Advisory Committee voted 22 to 0 to recommend an emergency use authorization (EUA) for J&J COVID-19 vaccineas prophylaxis for COVID-19 infections for patients 18 years and older.
An FDA review of Johnson & Johnson's single dose COVID-19 vaccine, found it to be safe and effective, based on data from the 39,321 patient ENSEMBLE study. FDA reviewers confirmed the 66% overall efficacy. The review found the vaccine to be efficacious for all age groups and ethnicities but noted a decrease in efficacy for patients 60 years and older with risk factors. The vaccine was 77% efficacious at two weeks in preventing severe and critical COVID-19 and 85% efficacious at four weeks. J&J’s vaccine was less effective against the South African variant (B.1.351) with efficacy of 52% at four weeks but maintained protection against severe and critical infection with 82% efficacy. In looking at only U.S. trial participants, efficacy was 72%. The most common adverse effects are injection site pain, headache, fatigue and myalgia. J&J's vaccine can be stored at refrigerator temperatures for at least 3 months.
A published retrospective review by Israeli researchers compared the outcomes of 596,618 patients that received the Pfizer-BioNTech COVID-19 vaccine to an equal number of non-vaccinated patients. Outcomes were assessed seven days and beyond after the second vaccination. The effectiveness of immunization was 92% in preventing documented infection, 94% to prevent symptomatic illness, 87% to prevent hospitalization, and 92% to prevent severe disease. the Pfizer-BioNTech vaccine was also found to be 90% effective in preventing asymptomatic infection.
The FDA approved a change to the storage and transportation requirements for the Pfizer-BioNTech COVID-19 Vaccine. The vaccine can now be transported and stored at conventional freezer temperatures for up to two weeks. There is no change to the requirements for thawed or diluted vials. Thawed vials, before dilution, can still be stored at refrigerator temperatures for up to 5 days. Diluted vials can be held at refrigerator temperature or room temperature for up to 6 hours.
Pfizer and BioNTech are evaluating the effects of a third vaccination (second booster vaccination), 6 to 12 months after the patients received the first of two doses in a Phase I trial. The goal of the study is to determine if boosting antibody titers will be enough to prevent infections from new COVID-19 variants. The companies are also discussing the design of a study to evaluate a variant-specific vaccine with the FDA and EU.
IDSA has updated their COVID-19 guidelines with a conditional recommendation to add tocilizumab to a corticosteroid in patients with severe or critical COVID-19 with elevated systemic inflammation.
In the 21-day, 803 patient, Phase IV, REMAP-COVID trial (NCT02735707), the number of organ support-free days were 10 for tocilizumab, 11 for sarilumab and none for standard of care in patients with critical COVID-19 receiving organ support in intensive care. In-hospital mortality was 27% with the pooled interleukin-6 receptor antagonist groups (tocilizumab and sarilumab), compared to 36% with standard of care. A third of patients received remdesivir and 80% received a corticosteroid. REMAP-COVID is a sub-study of the REMAP-CAP trial.
In the 28-day, 452 patient, Phase III COVACTA trial (NCT04320615), treatment with tocilizumab improved the clinical status (7 point scale ranging from discharge or death) by a non-significant 1 point compared to placebo in hospitalized patients with severe COVID-19-associated pneumonia. There was no difference in mortality between tocilizumab and placebo, but patients treated with tocilizumab were discharged six days sooner, spent 5.8 less days in ICU and needed a ventilator for 5.5 fewer days.
NIH recommends the use of bamlanivimab 700 mg plus etesevimab 1,400 mg in combination for the treatment of outpatients with mild-to-moderate COVID-19 who are at high risk for clinical progression. The risk factors defined in EUA for bamlanivimab plus etesevimab BMI of 35 or more, diabetes, chronic kidney disease, or an immunocompromising condition; all adults 65 and older; adults 55 and older with cardiovascular disease, hypertension or respiratory disease, and those aged 12-17 years with sickle cell disease, neurodevelopmental disorders, respiratory disease, BMI in the 85th or greater percentile or congenital heart disease. The NIH recommends against use of bamlanivimab plus etesevimab in patients hospitalized for COVID-19 unless they are part of a clinical trial.
A meta-analysis of four published and six unpublished convalescent plasma trials involving 11,782 patients with COVID-19 did not find a reduction in mortality or a positive benefit on other clinical measures compared to placebo.