Pfizer and BioNTech Announce Early Positive Data from Ongiing Phase 1/2 Study of mRNA-based Vaccine Candidate Against SARS-COV-2

  • In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2.
  • At day 28 (7 days after dose 2), all subjects who received 10 or 30 µg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
  • Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
  • Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
  • Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021

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Gilead Announces Pricing for Remdesivir in Open Letter

According to Daniel O’Day, Chairman & CEO, Gilead Sciences,  “In the U.S., the same government price of $390 per vial will apply. Because of the way the U.S. system is set up and the discounts that government healthcare programs expect, the price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access.”

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Governor Ducey Announces Enhanced COVID-19 Action Plan

Governor Ducey, Dr. Christ, Maj. Gen McGuire provided an Arizona COVID-19 briefing on June 17, 2020. Governor Ducey reminded everyone of Three Key Messages for all Arizonans:

  1. You are safest at home.
  2. If you must go out, physically distance.
  3. If you can not, Wear A Mask.

Executive Order 40 includes that  “4.  Notwithstanding directives in Executive Order 2020-36, Stay Healthy, Return Smarter, Return Stronger, regarding A.R.S. § 26-307, a county, city or town may, based on conditions in its jurisdiction, adopt policies regarding the wearing of face coverings in public for the purpose of mitigating the spread of COVID-19. Any enforcement of such a policy shall focus first on educating and working to promote best practices to accomplish the goal of mitigation. An individual shall be notified of the provisions of this order or any policy adopted by a county, city or town and given an opportunity to comply prior to any enforcement action being taken.”

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Mask Up Arizona

Wearing a mask when in a public setting, staying a safe distance away from other people, and following CDC recommendations relative disinfecting and personal hygiene can help slow the spread of COVID-19. This is key to improving health and to our economic recovery. 

Joan Koerber-Walker, president & CEO, AZBio  #MaskUpAZ #MaskUpArizona

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