On 4/14/2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that a pause in administering the J&J COVID-19 vaccine be continued, to give the committee more time to analyze a more complete data set. ACIP plans to vote within seven to 10 days on a recommendation for vaccine.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended adding a warning regarding a rare adverse event of thrombosis in combination with thrombocytopenia to the product label for the Johnson & Johnson COVID-19 vaccine. PRAC reviewed eight cases of thrombosis with thrombocytopenia among seven million patients that received the vaccine in the U.S. The committee noted that all cases happened within 3 weeks of receiving the vaccine in patients under 60. Most cases occurred in women and were very similar to those seen with the AstraZeneca vaccine.
A retrospective analysis of 513,284 patients, found the incidence of cerebral venous thrombosis to be eight times more common in patients that developed COVID-19 than in patients that received the AstraZeneca vaccine and ten times more common than in patients that received the Pfizer-BioNTech or Moderna vaccine.
A report describes 22 patients with thrombosis and thrombocytopenia 6 to 24 days after receiving the first dose of the AstraZeneca COVID-19 vaccine. As in previous descriptions the patients were positive for antibodies to platelet factor 4 (PF4), unrelated to the use of heparin. The researchers recommend avoiding heparin and platelet transfusions, using a non-heparin anticoagulant and intravenous immune globulin considered. An algorithm is provided for testing and treating patients.
A preprint article describes the immunity response in 165 patients, 80 or older, that received a single dose of either the Pfizer-BioNTech or Astra Zeneca vaccine. Antibodies were elicited in most patients (93% and 87%). Previous infection caused a higher antibody response.
Both Pfizer-BioNTech and Moderna have said that patients that received both doses of the mRNA COVID-19 vaccines will likely need a booster dose within a year.
Merck announced interim results from the 304 patients enrolled in the 29-day, 1,300 patient, Phase II/III, MOVe-IN trial (NCT04575584), where molnupiravir did not improve the percentage of patients that achieved sustained recovery compared to placebo in hospitalized patients with COVID-19. Merck discontinued the MOVe-IN trial, because the interim results did not demonstrate a clinical benefit with molnupiravir.
Merck announced interim results from 302 patients enrolled in the 29-day, 1,850 patient, Phase II/III, MOVe-OUT trial (NCT04575597), where molnupiravir decreased hospitalizations and mortality compared to placebo in outpatients with COVID-19. Merck expects final trial results in September or October.
NIH discontinued enrollment in the 29-day, Phase III, ACTT-4 trial (NCT04640168) after 1,000 patients when an interim analysis found it was unlikely that baricitinib plus remdesivir would reduce the need for mechanical ventilation or death compared to dexamethasone plus remdesivir in hospitalized COVID-19 patients on supplemental oxygen.
On 4/16/2021, Lilly requested the EUA for bamlanivimab be revoked because of the evolving resistance with variants and availability of a superior regimen that combines bamlanivimab with etesevimab. The FDA revoked the EUA for bamlanivimab given alone on the same day. The EUA remains in place for the combination of bamlanivimab and etesevimab for COVID-19 in outpatients. Lilly will only provide the combination for use and the U.S. government has modified contracts with Lilly to only purchase the two antibodies in combination. Any healthcare site that still has bamlanivimab alone can purchase etesevimab to use in combination.
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