RxAdvocate August, 2021 — Newsletter

RxAdvocate August, 2021 — Newsletter

What’s New?

  • The CDC Endorses COVID Vaccinations During Pregnancy
  • Pfizer Voluntarily Recalls Chantix, Generic Soon to Market
  • COVID-19 Vaccine Quantity Limit Increased – Allowing 3rd Dose
  • RxConnection Organizational Announcements

The CDC Endorses COVID Vaccinations During Pregnancy

August 11, 2021, the Centers for Disease Control and Prevention (CDC) announced their recommendation urging pregnant people to be vaccinated against COVID-19 citing new safety data that concluded there is no increased risk of miscarriage among those who were immunized during the first 20 weeks of gestation. These new findings support earlier safety data for women vaccinated later in pregnancy. This new CDC guidance for COVID-19 vaccination in pregnancy aligns with the recommendations set by the American College of Obstetricians and Gynecologists and other medical specialty groups, which strongly recommend vaccination. “At this time, the benefits of vaccination, and the known risks of COVID during pregnancy and the high rates of transmission right now, outweigh any theoretical risks of the vaccine,” Sascha R. Ellington, an epidemiologist who leads the emergency preparedness response team in the division of reproductive health at the CDC.

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Pfizer Voluntarily Recalls Chantix, Generic Soon to Market

Pfizer released a statement mid-July regarding their product, Chantix (a smoking cessation product), was being voluntarily recalled by the company due to “the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.” This chemical compound is found in everyday life, however, long term exposure above the ADI level may pose serious health risks over time. Pfizer has reported zero adverse events related to this recall. In the wake of this recall, the FDA has now approved Par Pharmaceutical’s generic version of Chantix, known as varenicline to help keep up with shortages. The FDA has also temporarily approved Apotex’s (a Canadian pharmaceutical corporation) generic called apo-Varenicline, and importation of the product has begun making its way into the U.S. market.

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COVID-19 Vaccine Quantity Limit Increased – Allowing Third Dose

The FDA has expanded the emergency use authorization for both the Moderna and Pfizer/BioNTech COVID-19 vaccines to allow immunocompromised patients to receive a third dose of the vaccine. Patients eligible for the third vaccine dose represent approximately 3% of the population and would be used in the hopes that the additional dose can further boost the immune response if exposed to the COVID-19 virus. Studies support the third dose of vaccine in these select patients, as a decreased immunogenicity has been observed after the two dose series when compared to those that do not have a compromised immune system. The individuals targeted for additional vaccination are still encouraged to follow suggested preventative measures to decrease exposure risk. Eligible patients should wait at least 28 days since their second vaccine to have the additional dose administered. Adverse effects with the third dose are currently the same as with the first and second vaccine. The use of the Johnson & Johnson vaccine is not included in this expanded approval.

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RxConnection Organizational Announcements


Please join us in welcoming Christina Hollis! She is joining RxConnection as an Account Manager.Christina has 5 years’ experience in PBM and 12 years’ experience in account management. Prior to joining RxConnection, she managed accounts for US-Rx Care, Elixir, and Everyday Health, ensuring quick turnarounds for plan design, benefit changes and clinical inquiries, as well as assisting with enhancing marketing performance and online visibility.Christina graduated with a B.A. in Promotional Communications from Cleveland State University.

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Orlando Neal — Principal
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