Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine
On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December.
Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021.
The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours.
FDA Issues EAU for Monoclonal Antibody to Treat COVID-19
On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody therapy, for the treatment of mild to moderate COVID-19 in adult and pediatric patients who:
- Have positive results of direct SARS-CoV-2 viral testing
- Are 12-years-old or older
- Weigh at least 40 kilograms (about 88 pounds)
- Are at high risk for progressing to severe COVID-19 and/or hospitalization.
Bamlanivimab has shown through clinical trials to reduce COVID-19-related hospitalizations or emergency room visits in patients at high risk for disease progression within 28 days after treatment, compared to placebo. As part of the EUA, efficacy of the agent continues to be evaluated and several quality measures have been imposed to protect patients.
Read the FDA announcement.
Update: COVID-19 Emergency Food Assistance Grant Amount Change
Due to increasing demand for the program’s financial assistance, the individual grant award amount has been changed to $300 effective immediately. This adjustment will allow thousands of additional patients to receive meaningful financial support for nutritional needs while maximizing the reach of available funding as the number of people impacting by COVID 19 continues to accelerate.
To date, the COVID-19 Emergency Food Assistance Program has helped more than 13,000 patients, including 1,000 emergency food deliveries made and over 12,000 financial assistance grants being provided to patients in all 50 states.
This innovative program is a collaboration between Team Rubicon (TR) and Patient Advocate Foundation (PAF) and provides emergency food delivery and financial assistance to people living with cancer, multiple sclerosis, and rheumatoid arthritis.
Who is Eligible?
Patients with cancer, multiple sclerosis or rheumatoid arthritis who have trouble accessing or affording food or other nutritional needs due to COVID-19, with eligibility established at the point of application in most cases.
For more information, including application instructions, click here.
Astellas' COVID-19 Pandemic Response
Amidst the unprecedented public health challenge, Astellas and its employees continue to contribute to securing the safety of patients and alleviating strain on healthcare resources during this critical time. This includes financial assistance to support local and global communities; policies focused on the well-being of its employees, healthcare professionals, and partners; employee mobilizations, and company-matched donations to humanitarian organizations. Additionally, Astellas is ensuring that patients have access to its medicines through its Pharma Support Solutions, which offers support to patients needing access and reimbursement assistance.
Read Astellas' full statement on the coronovirus.
Merck's Response to COVID-19
During this unprecedented time, Merck is committed to ensuring its medicines and vaccines reach its patients and customers. This includes supporting patients who might need more help today with their medications, including those who are unemployed or have lost insurance coverage due to the COVID-19 pandemic.
To learn about what support options may be available, visit Merck's Access and Patient Assistance information page.
For more details about Merck’s response to the coronavirus, visit its COVID-19 information page.
Sanofi Genzyme's CareASSIST Patient Assistance Program
In response to COVID-19, Sanofi Genzyme is committed to helping patients. Through its CareASSIST Patient Assistance Program, eligible patients will receive assistance with access and support for their prescribed treatment.
Read the summary on the CareASSIST program.
Merck Broadens Patient Support and Assistance Programs as Part of Overall COVID-19 Relief Efforts
In response to the COVID-19 pandemic, Merck is focused on protecting the safety of its employees and their families, ensuring that its supply of medicines and vaccines reach its patients, contributing its scientific expertise to the development of antiviral approaches, and supporting healthcare providers and their communities.
Read the press release for more information on Merck's response to COVID-19.
How Pfizer Oncology Together Is Addressing Patient Needs
Pfizer recognizes the strain that the COVID-19 pandemic is placing on patients and healthcare providers around the world, and is working with governments, international NGOs, and U.S.-based not-for profit organizations to respond to this pandemic by donating much needed medications and vaccines and working to support front-line health workers.
Read Pfizer's full response to COVID-19.
COVID-19 Healthcare Professional Information Update
As critical and valued partners in the healthcare community in the U.S., Pfizer wanted to share its approach to the COVID-19 pandemic and changes it is making to best address your needs and those of the patients you serve. Pfizer is taking steps to ensure supply of its medicines and help halt the spread of this disease by developing antiviral therapies and, through a partnership, a potential vaccine for the COVID-19 virus.
Pfizer also recently announced a commitment of $40 million in medical and charitable cash grants to help address urgent needs of U.S. and global partners on the front lines of the pandemic.
Read Pfizer's full response to COVID-19.
BMS Patient Support Program Overview
In light of the developing situation around COVID-19, Bristol Myers Squibb would like to share immediate action they are taking to support the health and well-being of patients, customers, and employees during this time.
Bristol Myers Squibb is expanding its longstanding patient support programs to help eligible unemployed patients in the U.S. who have lost their health insurance due to the COVID-19 pandemic. The expanded program offers access to BMS medicine for free.
Read the expanded patient support program overview.