Pfizer Vaccine for Kids 90% Effective and Is Pending FDA and CDC Approval
In a report presented last week to the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), Pfizer’s Comirnaty vaccine showed a vaccine effectiveness of 90.7% against laboratory-confirmed symptomatic COVID-19 occurring at least 7 days after the second dose. The dose of Comirnaty vaccine for kids age 5-11 is 10 micrograms, one-third of the dose given to those age 12 and up.
According to the data shared during the VRBAC meeting, pediatric side effects seen during the study were mild. The most common side effect reported was injection site pain. Kids in the vaccine group also presented with fatigue, headaches, fever, and chills at higher rates than were seen in the placebo group. These were most common after the second dose. Some skin reactions were seen in the study, like itching and rashes, but these were mostly mild and went away within a few days. Interestingly, fatigue, joint pain, and headache were reported in lower percentages in children compared to adolescents and adults. Kids also could have swollen lymph nodes after their vaccinations, as adults sometimes do, but these reactions were temporary.
On Tuesday, members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend the Pfizer 10-microgram shot for children age 5-11, pending an updated EUA and CDC nod (ACIP meets on November 2), COVID-19 vaccinations to this new eligible population could begin within a week to 10 days. According to the American Pharmacist Association (APhA), the PREP Act covers authorized pharmacy providers in administering FDA-authorized or FDA-licensed COVID-19 vaccines according to ACIP COVID-19 vaccine recommendations to patients 3 years or older.
If your pharmacies are giving Comirnaty shots and intend to administer to pediatric patients, upon FDA and CDC approval, let MarkeTouch assist you in the scheduling of patient appointments and engaging booster eligible patients. The MarkeTouch Health and Wellness Scheduler is a time- and high-volume-proven system capable of managing millions of daily appointment inquiries, digital consent forms, and automated patient notifications.
Monoclonal Antibody Treatments
In September, the Department of Health and Human Services extended the PREP Act permitting pharmacists to order and administer FDA-approved intramuscular, subcutaneous, and oral medications to treat COVID-19, including subcutaneous monoclonal antibody therapy for patients who are COVID-19-positive and unvaccinated people who have had a confirmed exposure to the virus.
Research shows that monoclonal antibody therapy reduces COVID-19 hospital admissions, Emergency Room visits, and SARS-COV2 viral levels in the blood of infected people. Generally, monoclonal antibody treatments work by reducing the ability of the SARS-COV2 virus to enter human cells. And, in return, it gives your natural immune system the ability to catch up and fend off the virus.
FDA Authorizes Boosters for Moderna, J&J, Allows Vaccine Mix-and-Match
The FDA and CDC announced last week that people may mix and match their COVID-19 vaccines and booster shots for individuals who received a Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccine.
“As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.“
Acting FDA Commissioner Janet Woodcock, MD
According to the CDC, as of 10/26/2021, 504 million doses of COVID-19 vaccine have been delivered. 415 million doses of vaccine have been administered. This accounts for the following percentages of fully vaccinated people in the U.S.:
Total pop = 57.5%
12+ years = 67.2%
18+ years = 69.0%
65+ years = 84.7%
As a side note, 7.2% of fully vaccinated people have received a booster dose.
Scruples and Drams – News And Notes From Across Pharmacy
New PBM Launched by Nonprofit Coalition
A nonprofit coalition of nearly 40 companies has launched EmsanaRx, a new pharmacy benefit management service. EmsanaRx touts to provide employers a fixed price per prescription as well as guidance from a clinical pharmacist account manager. Initial coalition members include: AAA, Albertsons, Activision, Boeing, CalPERS, Caltech, Chevron, Cisco, Costco, First Republic Bank. Hewlett Packard, Intel, McKesson, Microsoft, PG&E, Pitney Bowes, Qualcomm, Robert Half, Salesforce, Tesla, and Walmart.