The CDC reported that overall vaccine effectiveness was 91% before the Delta variant became prominent and dropped to 66% since the Delta variant became prominent.
Johnson & Johnson announced interim data from two Phase I/IIa trials (1,085 patient, NCT04436276 trial and 1,210 patient, NCT04535453 trial) that suggested a booster dose of its COVID-19 vaccine, Ad26.COV2.S, would boost antibodies titers nine-fold higher.
British researchers analyzed the national British health database and found a higher incidence and prolonged duration for thrombocytopenia, venous thromboembolism and arterial thromboembolism leading to hospital admission or death in more people infected with COVID-19 than who received at least one vaccination with either the AstraZeneca or Pfizer-BioNTech vaccines.
In its COVID-19 vaccination recommendations, the CDC includes patients that have received the complete vaccination series with the AstraZeneca vaccine or the Novavax vaccine as being fully vaccinated and they do not also need immunization with a vaccine that is approved or available under an EUA.
Brii Biosciences announced interim results from 576 patients enrolled in the 28-day, 837 patient Phase III ACTIV-2 trial (NCT04518410), where treatment with the monoclonal antibody combination BRII-196 and BRII-198 reduced mortality and hospitalizations in non-hospitalized Chinese COVID-19 patients at high risk of progression.
The FDA has modified the EUA for bamlanivimab and etesevimab, to be used in states where recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. Bamlanivimab and etesevimab are effective against the Delta variant, but not the Beta, Gamma, Delta Plus or B.1.621 variant. States where bamlanivimab and etesevimab can be used include Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, New Hampshire, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, Rhode Island, South Dakota, Utah, Vermont, Wisconsin, and Wyoming. Etesevimab is also available alone to be paired with existing supply of bamlanivimab.
The FDA approved Pfizer-BioNTech COVID-19 Vaccine, on 8/23/2021, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee). Comirnaty will continue to be available through an EUA for individuals 12 to 15 years. The EUA also covers a booster dose for immunocompromised patients.
The FDA and AAP are warning physicians and parents not to vaccinate children under 11 years with the adult vaccine. Much smaller dosages are being used in clinical trials and not enough clinical evidence is currently available to predict the correct dose. Pfizer expects to have pediatric data available beginning in September. Trial results will be released for ages 5 to 11, then 2 to 5 and finally 6 months to 2 years in October or November. Once pediatric data is available Pfizer and BioNTech will request an EUA.
Moderna is also working on pediatric and adolescent studies. The Moderna vaccine has approval for adolescents in Europe.
AstraZeneca announced that in the 183-day, 5,172 patient, Phase III, PROVENT trial (NCT04625725), treatment with AZD7442, a long-acting monoclonal antibody combination of tixagevimab and cilgavimab, reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo in patients at high risk of developing COVID-19.
In a retrospective analysis of outcomes from 10,445 COVID-19 patients in Hong Kong, adding dexamethasone after starting remdesivir or giving the drugs simultaneously reduced hospital stay and hospital mortality compared to adding remdesivir two days after dexamethasone or not using remdesivir at all.
Pfizer and BioNTech announced results from a Phase I trial (NCT04955626), where patients received a third Pfizer-BioNTech COVID-19 vaccine dose eight to nine months after the second. Antibody titers elicited after the third dose were 5 to 8 times higher for the original COVID-19 virus, 15 to 21 times higher for the Beta variant, 5 times higher in 18 to 55 year-olds for the Delta variant and 11 times higher for 65 to 86 year-olds for the Delta variant.
An Israeli study of data from an HMO database found a third dose of the Pfizer-BioNTech COVID-19 vaccine to be 86% effective in people aged over 60.
The U.S. Department of Health and Human Services (HHS) announced the government’s plan for a booster (third) dose of the mRNA vaccines(Pfizer-BioNTech and Moderna) to begin in September, if approved by the FDA and recommended by ACIP. If approved, booster vaccinations would begin on September 20, 2021, with health care providers, nursing home residents, and other seniors, who received their second vaccine dose at least eight months ago. Data is still being examined for the Johnson & Johnson vaccine, but it is anticipated a booster will also be needed.
The booster decision was based on data from three studies published by the CDC on 8/18/2021
NIH updated its recommendation for use of monoclonal antibodies and convalescent plasma in the management of COVID-19.
NIH recommends that either casirivimab plus imdevimab (Regeneron) or sotrovimab (Vir) be used for the treatment of outpatients with mild to moderate COVID-19 who are at high risk of clinical progression. NIH recommends against the use of bamlanivimab plus etesevimab (Lilly) due to resistance from the Gamma and Beta variants. NIH now recommends that casirivimab plus imdevimab or sotrovimab be considered for patients with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19 if they otherwise meet the EUA criteria for outpatient treatment. The recommended monoclonal antibodies may also be considered for hospitalized patients with severe COVID-19, who have not developed an antibody response or who are not expected to mount an effective immune response to SARS-CoV-2 infection. The EUAs for casirivimab plus imdevimab or sotrovimab does not cover use in hospitalized patients, but the drugs may be available though an expanded access program.
NIH recommends against the use of low-titer COVID-19 convalescent plasma and the FDA has removed it from the EUA. NIH recommends against the use of high-titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 and normal immunity. For patients with impaired immunity, NIH found insufficient evidence for or against use. NIH also found insufficient evidence for or against use of high-titer COVID-19 convalescent plasma in non-hospitalized patients with COVDI-19.
Novavax will delay requesting an EUA until October 2021 to complete FDA requirements for its manufacturing process. Novavax plans to seek approval in September 2021 in the U.K., Canada and Australia. The company has already sought approval in India, Indonesia and the Philippines.
Novavax announced preliminary data demonstrating that a single booster dose of NVX-CoV2373, given six months after the initial two-dose regimen resulted in a 4.6-fold increase in antibody titers.
ACIP met to review the safety of the three COVID-19 vaccines that have received an EUA. The group recommended that the benefits of vaccination outweigh the risks for Guillain-Barré syndrome and thrombosis with thrombocytopenia syndrome after Janssen COVID-19 vaccination and myocarditis after mRNA (Pfizer-BioNTech and Moderna) COVID-19 vaccination.
In the 3,732 patient, Phase II/III TeenCOVE trial (NCT04649151), no cases of COVID-19 were reported among adolescents ages 12 to 17 years that received two doses of the Moderna COVID-19 vaccine compared to four cases in the placebo group in the adult Phase III COVE study. Efficacy was 93% when measured 14 days after the first dose. The vaccine was well tolerated with no serious adverse events.
In a four-month, 120 patient, Phase IV trial (NCT04885907), 55% of patients that received a third dose of the Moderna COVID-19 vaccine achieved at least 100 U/ml of anti–receptor-binding domain (RBD) compared to 18% that received only two doses in solid organ transplant patients that did not have a previous diagnosis of Covid-19. The percent virus neutralization was 71% in the three-dose group compared to 13% in the two-dose group.
The FDA amended the EUAs for both mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) to allow for the use of a third dose in certain immunocompromised individuals.
The 14-day, 263 patient, Phase III, ACTION trial (NCT04332107) was terminated early after an interim analysis failed to find an improvement in the number of ambulatory COVID-19 patients that were symptom free. There was also no difference in hospitalizations at 21-days.
A CDC investigation of a July 2019 COVID-19 outbreak in Massachusetts found breakthrough infections in fully vaccinated patients. The infections occurred in patients that had attend multiple large public gatherings that included travelers from many areas. This led the CDC to recommend that everyone wear masks, regardless of vaccination status, in indoor settings where there is a high risk of COVID-19 transmission.
In the 29-day, 1,505 patient, Phase III, PREVENTION trial (NCT04452318), symptomatic COVID-19 developed in 1.5% of patients that received a single subcutaneous injection of REGEN-COV (casirivimab and imdevimab) 1,200 mg compared to 7.8% of patients that received placebo in COVID-19 negative patients exposed to a COVID-19 positive patient in the same household. Among patients that became infected, treatment with REGEN-COV resulted in resolution of symptoms two-weeks earlier.
The FDA updated the EUA for Regeneron’s monoclonal antibody REGEN-COV to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination.
Lilly announced that in a sub-study of 101 COVID-19 patients that required mechanical ventilation or ECMO from the 1,525 patient, Phase III, COV-BARRIER trial (NCT04421027), mortality was 39.2% with baricitinib compared to 58% with placebo at 28 days and 45.1% vs 62% at day 60.
The FDA expanded the emergency use authorization for baricitinib to allow the drug to be used alone for the treatment of patients aged 2 years and older who are hospitalized with COVID-19 and require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation. Previously, baricitinib had to be administered with remdesivir when treating COVID-19.
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