COVID-19 updates
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COVID-19 Vaccines
On 5/17/2022 the FDA approved a booster dose for children 5 to 11 with the Pfizer-BioNTech COVID-19 vaccine. The CDC updated their COVID-19 vaccine recommendations to include a booster for this age group five months after the primary series. The CDC also recommends a second booster (fourth vaccination) for immunocompromised patients 12 and older and everyone older than 50, at least four months after their first booster (third vaccination). In a review of VAERS data, the CDC found no increase in the occurrence of myocarditis with the Pfizer-BioNTech COVID-19 vaccine in males 5 to 11. Pfizer-BioNTech announced that in a 1,678 patient, Phase II/III trial, vaccine efficacy after three 3mcg doses of their COVID-19 vaccine in children six months to five years was 80.3%. Antibody titers were similar in young children as in patients 16 to 25 years. The third dose was given two months after the second and the trial was done when Omicron was the dominant variant. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on 6/14/2022 to discuss use of the Moderna COVID-19 vaccine in patients 6 years through 17 years of age. On June 15 VRBPAC will discuss use of the Pfizer-BioNTech COVID-19 vaccine in patients 6 months through 4 years of age. COVID-19 Antivirals In the WHO sponsored, open-label 8,275 patient, Phase III SOLIDARITY trial (NCT04315948), treatment with remdesivir did not improve mortality compared to placebo in the hospitalized patients with COVID-19. There was no statistical difference in mortality in patients who already required ventilation but mortality was lower in patients not on a ventilator (11.9% vs. 13.5%). Among patients not requiring mechanical ventilation at treatment initiation, fewer remdesivir patients progressed to a ventilator than those who received placebo (14.1% vs 15.7%). COVID-19 Anti-inflammatories Clazakizumab, is an interleukin-6 (IL-6) inhibitor being evaluated by CSL Behring as a treatment for hospitalized patients with severe or critical COVID-19 disease accompanied by hyperinflammation.
ICER provided a review of drugs for outpatient treatment of COVID-19. ICER found that compared to symptomatic treatment:
All three drugs were found to be cost effective, with a quality-of-life year gained (QALY) < $100,000. The cost of an averted hospitalization was also < $100,000.
In the 4,016 patient, Phase II/III KidCOVE trial (NCT04796896), two 50 mcg doses of Moderna’s COVID-19 vaccine, given 28-days apart, elicited immunogenicity in children 6 to under 12 years of age that was similar to young adults, age18 to 25 years, who received two 10 mcg doses. Vaccine efficacy was estimated to be 88% during a period when the delta variant was dominant. A CDC test-negative, case-control study, using data from December 2021 to February 2022, estimated the Pfizer-BioNTech COVID-19 vaccine effectiveness against symptomatic infection for children 5 to 11 years as 60% one month after the second vaccine dose and 29% after two months. Vaccine effectiveness for adolescents 12 to 15 years of age was 60% one month after the second dose and 17% after two months. Vaccine effectiveness for adolescents who received a booster dose was 71%. The FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include a single booster dose, at least five months after completion of a primary series, for children 5 to 11 years. Only the Pfizer-BioNTech vaccine is approved for use in this age group. COVID-19 Antivirals Based on the review of available scientific evidence the FDA declined to approve an emergency use authorization (EUA) for fluvoxamine for the treatment of COVID-19 because the data was insufficient to support use of the drug in the treatment for COVID-19. NIH has provided a reference page to describe drug interactions and their management for Paxvolid (ritonavir-boosted nirmatrelvir). COVID-19 Vaccines
The FDA limited the authorized use of the J&J COVID-19 Vaccine to when mRNA vaccines are not accessible or clinically appropriate or for patients who choose to receive the vaccine and would otherwise not receive a COVID-19 vaccination. The FDA considers the known and potential benefits of the vaccine to outweigh the known and potential risks of receiving it. The restriction was due to the rare occurrence of thrombosis with thrombocytopenia syndrome (TTS). TTS is estimated to have an incidence of 3.23 cases per million vaccinations and 0.48 deaths per million. Risk factors for TTS associated with the J&J vaccine have not been identified and prompt diagnosis and treatment of TTS may not prevent deterioration of the condition. A pre-print draft of an Israeli analysis examining SARS-CoV-2 antibodies during pregnancy, found antibodies levels were too low to provide protection by delivery in 34.6% of patients who experienced a first trimester infection and 9.1% who experienced a second trimester infection. A single dose of the Pfizer COVID-19 vaccine induced protective antibody titers for both mother and infant with modest adverse effects. COVID-19 Antivirals The FDA has provided additional information about use of Paxlovid in a new posting. The FDA addresses reports of rare infection recurrences after completing a course of the drug combination. A re-analysis of Paxlovid data found that while 1-2% of patients may test positive after treatment, it was unclear whether this was a drug effect, because the same results were seen in placebo patients (tested negative, then tested positive). However, the FDA stated there is no evidence to support use of the drug beyond five days. COVID-19 Convalescent Plasma In a 28-day, 1,181 patient, Phase II trial (NCT04373460), 2.9% of patients treated with high titer convalescent plasma, within nine day of symptom onset, were hospitalized for COVID-19 compared to 6.3% with placebo in outpatients with recent onset of COVID-19. Over 80% of patents were unvaccinated. COVID-19 Vaccines
The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on June 8, 21 and 22 to review use of Moderna and Pfizer/BioNTech COVID-19 vaccines in children under six. COVID-19 Antivirals The FDA expanded approval for remdesivir, on 4/25/2022, for children 28 days and older, who weigh at least 3 kg (7 lbs), if they are hospitalized or outpatients at high risk for progression to severe COVID-19. Pfizer announced that in the 14-day, 2,597 patient, Phase II/III, EPIC-PEP trial (NCT05047601), prophylactic treatment with nirmatrelvir plus ritonavir did not reduce the risk of developing symptomatic COVID-19 compared to placebo in healthy patients exposed to a patient that developed COVID-19. COVID-19 Monoclonal Antibodies NIH does not recommend using bamlanivimab plus etesevimab, casirivimab plus imdevimab, nor sotrovimab for the treatment of COVID-19 due to lack of activity for the Omicron variant. NIH only recommends use of bebtelovimab when ritonavir-boosted nirmatrelvir (Paxlovid) or remdesivir are not available. COVID-19 Convalescent Plasma NIH recommends against the use of convalescent plasma that was collected prior to the emergence of the Omicron (B.1.1.529) variant. Convalescent plasma should not be used for treatment of COVID-19 in hospitalized, immunocompetent patients. NIH did not find sufficient evidence to recommend either for or against the use of high-titer convalescent plasma, collected after the emergence of Omicron for the treatment of immunocompromised patients and nonhospitalized, immunocompetent patients with COVID-19. |
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