On 4/23/2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended lifting the pause on administering the J&J COVID-19 vaccine that was implemented on 4/4/2021. The pause was established to investigate the occurrence of eight cases of thrombosis with thrombocytopenia among seven million patients that received the vaccine in the U.S. On 4/22/2021, ACIP voted 10-4 to resume immunization with the vaccine. The committee also recommended that a warning about the risks of thrombosis with thrombocytopenia syndrome be added to the vaccine information and that clinicians follow the recommendation from the American Society of Hematology guidance for diagnosis and treatment of the condition. The CDC and FDA recommended lifting the pause in immunizations with the J&J vaccine on 4/23/2021. The FDA revised the vaccine EUA, healthcare professional fact sheet and patient fact sheet to include information on thrombosis-thrombocytopenia syndrome (TTS).
Researchers analyzed data from 35,691 pregnant women, who had received either the Pfizer–BioNTech or Moderna COVID-19 vaccines, that were enrolled in the V-safe Surveillance System and Pregnancy Registry and the Vaccine Adverse Event Reporting System (VAERS). Compared to nonpregnant women the incidence of injection-site pain was more frequent, while headache, myalgia, chills, and fever were less frequent. The rate of spontaneous abortion was 12.6%, which falls within the historical range of 10% to 26%. While not directly comparable, the rate of adverse pregnancy and neonatal outcomes after COVID-19 vaccination were similar to the rates reported before the COVID-19 pandemic. Based on data from the study, the CDC now recommends COVID-19 vaccination for pregnant women.
In the 39,321 patient, Phase III, ENSEMBLE trial (NCT04505722), a single immunization with the J&J COVID-19 vaccine resulted in 66.4% efficacy after 28 or more days after vaccination. The vaccine was 85.4% effective in preventing severe disease. Efficacy was similar across age groups after at least 28 days. In South Africa, efficacy was 64% in South Africa for moderate to severe disease and 81.7% for severe disease. There were eleven cases of venous thromboembolic events in the vaccine group compared to three the placebo group. Only one case of transverse sinus thrombosis with cerebral hemorrhage was seen in in the vaccine group.
The Federal Government contracted Emergent Biosolution to manufacturer the active ingredients for COVID-19 vaccines from J&J and AstraZeneca. In March 2021, Emergent had to destroy millions of doses of the J&J vaccine, due to cross-contamination. An FDA inspection has revealed numerous manufacturing, sterility and training issues. Johnson & Johnson has now taken over responsibility for manufacturing their vaccine at the Emergent plant. Production of the AZ vaccine will be moved to a different facility.
The Federal Government will not fund a Phase III trial of Inovio’s COVID-19 vaccine, but will continue to fund a Phase II trial. Depending on the results of the trial, Inovio may run a Phase III trial with China’s Advaccine and the International Vaccine Institute outside the U.S.
Researchers tested antibodies from recovered COVID-19 patients, fully mRNA (Pfizer-BioNTech and Moderna) vaccinated subjects and who received the Regeneron monoclonal antibody combination in neutralizing the B.1.526 (New York) variant. The B.1.526 variant, decreased titers, but was still neutralized by all four types of antibodies.
NIH has determined there is not enough evidence to recommend for or against the use of fluvoxamine to treat COVID-19.
NIH has determined there is not enough evidence to recommend for or against the use of colchicine to treat COVID-19 in non-hospitalized patients and colchicine should not be used in hospitalized patients, except as part of a trial.
In the 90-day, 685 patient, Phase III, TOGETHER trial (NCT04403100), neither hydroxychloroquine nor lopinavir-ritonavir reduced hospitalization or death in high-risk, Brazilian outpatients with early symptomatic COVID-19.