COVID-19 Update #100 for 9/20/2021

Our mission at Prescribe Right is to offer budget-friendly products that provide the information you need to proactively plan for budget-busting drugs. To commemorate our 100th COVID-19 update we are offering access to the knowledgebase for 100 hours or 100 days whichever comes first, for only $100. This offer expires at 11:59 pm on Friday, September 24, 2021.

Booster Vaccine Doses

• In a review of data from 1,137,804 patients from the Israeli Ministry of Health database, found that a booster dose of the Pfizer/BioNTech COVID-19 vaccine, given at least five months after the second dose in patients 60 years or older, resulted in a reduction in confirmed and severe cases of COVID-19, during the first 12 days after the third dose.
• In a six-month follow-up of the pivotal trial for the Pfizer/BioNTech COVID-19 vaccine (NCT04368728), vaccine efficacy was 91.3%.  Vaccine efficacy gradually decreased over time, but efficacy for severe disease remained high at 96.7% and 100% for the Beta variant. Overall efficacy was 84% from month four to six.
• A third (booster) dose of the Pfizer/BioNTech COVID-19 vaccine was given to the pivotal trial population (NCT04368728), 7.9 to 8.8 months after the second dose. Antibody titers increased after the third dose for the original SARS-CoV-2 strain and variants.
• A review by the FDA for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) found a third dose of the Pfizer-BioNTech vaccine to be safe and well tolerated. The review questioned whether the available data and quality of the studies support a need for a third (booster) dose of the vaccine, since there is still adequate protection from severe COVID-19 and death.
• The FDA VRBPAC voted 16 to 2 to recommend approval of a booster dose of the Pfizer-BioNtech COVID-19 vaccine, given 6-months after the second dose, in patients 65 years and older. The committee also voted 18 to 0 to recommend a booster dose for younger patients at high risk for severe COVID-19.​

COVID-19 Vaccines
 
ACIP recommended that COVID-19 vaccines can be coadministered with other vaccines, including influenza vaccines in their 2021–22 Influenza Season update.

Pfizer and BioNTech announced that in a 2,268 patient, Phase II/III trial (NCT04816643), two 10 mcg doses of their COVID-19 vaccine given 21 days apart, to children 5 to 11 years, produced antibody titers comparable to the levels seen with two 30 mcg adult doses in adolescents and young adults age 16 to 25 years. Data for children 2 to 5 years of age and children 6 months to 2 years of age is forecast to be available in the fourth quarter.

In a review of data from 1,736,832 patients from an Israeli managed care database, found the Pfizer/BioNTech COVID-19 vaccine increases the risk for lymphadenopathy, herpes zoster infection and appendicitis, while COVID-19 increases the risk for arrhythmia, acute kidney injury, pulmonary embolism, deep-vein thrombosis, myocardial infarction, pericarditis, and intracranial hemorrhage. While the vaccine increased the risk for myocarditis (2.7 events per 100,000 persons) the risk was over four times higher with COVID-19 (11.0 events per 100,000 persons).
 
COVID-19 Antibodies
 
The FDA expanded the Emergency Use Authorization (EUA) for bamlanivimab and etesevimab (Lilly) to include post-exposure prophylaxis in high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination and have been exposed COVID-19.
 
COVID-19 Antivirals
 
In the 15-day, 857 patient, Phase III, DisCoVeRy trial (NCT04315948), adding remdesivir to standard-of care did not improve clinical status (WHO seven-point ordinal scale) compared to standard-of-care alone in European hospitalized patients with COVID-19 for more than 7 days, who were receiving supplemental oxygen.