frequently asked questions u.s. food and drug
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Frequently Asked Questions U.S. Food and Drug Administration Grants EUA of Moderna (mRNA-1273) for Use in the U.S.Prepared by: Toni P. BrownChief Administrative OfficerDelaware River Port AuthorityDecember 21, 2020
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76.8 millionConfirmed COVID-19 Cases Worldwide
2.20%Rate of COVID-19-Related Deaths Worldwide
1.69 millionCOVID-19-Related Deaths Worldwide
3Approximate data as of 12/21/2020
17.9 millionConfirmed COVID-19 Cases in the U.S.
1.77%Rate of COVID-19-Related Deaths in the U.S.
318,000COVID-19-Related Deaths in the U.S.
4 Approximate data as of 12/21/2020
434,000Confirmed COVID-19 Cases in the NJ
4.19%Rate of COVID-19-Related Deaths in the NJ
18,194COVID-19-Related Deaths in the NJ
5 Approximate data as of 12/21/2020
560,000Confirmed COVID-19 Cases in the PA
2.49%Rate of COVID-19-Related Deaths in the PA
13,964COVID-19-Related Deaths in the PA
6 Approximate data as of 12/21/2020
Countries that are Moving forward with the COVID-19 Vaccine (BNT162b2)
Developed by Pfizer-BioNTech and/or Moderna
▸ United Kingdom (EUA granted 12/2/2020)
▸ Canada (EUA granted 12/3/2020)
▸ Bahrain (EUA granted 12/4/2020)
▸ United States of America
▹ EUA granted 12/11/2020: Pfizer-BioNTech
▹ EUA granted 12/17/2020: Moderna (in partnership with NIAID)
▸ Costa Rica (Signed an agreement with Pfizer-BioNTech for the manufacture and delivery of three million vaccines in 2021)
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Centers for Disease Control and Prevention (CDC) RecommendationsIssued Sunday, December 20, 2020
CDC Recommendation: In addition to health care workers and nursing home workers and residents, the following “front-line essential workers” and adults should be next in line to receive limited vaccine doses made by Pfizer-BioNTech and Moderna:
▸ Grocery store workers
▸ Teachers
▸ Day-care staff
▸ Other people on the front lines of America’s workforce (first responders, prison guards)
▸ Adults aged 75 and older
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Vaccine Tracker – New Jersey
New Jersey (~2,149 doses administered as of 12/20/2020)
Expected to receive:
▪ 76,000 doses in the first set of Pfizer vaccines
▪ Total of 400,000 doses before the end of the year
▪ Enough to vaccinate ~4.5% of state population before end of year
▪ State has ~490,000 healthcare workers and 85,000 nursing home residents and workers, and the doses expected in December is not enough to give them a single does by the end of the year.
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Vaccine Tracker - Pennsylvania
Pennsylvania (No information on # of doses administered as of 12/20/2020)
Expected to receive:
▪ 110,000 doses in the first set of Pfizer vaccines
▪ Total of 590,000 doses before the end of the year
▪ Enough to vaccinate ~4.6% of state population before end of year
▪ State has ~820,000 healthcare workers and 86,000 nursing home residents and workers, and the doses expected in December is not enough to give them a single does by the end of the year.
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MODERNA PARTNERED WITH NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
Moderna CEO Stéphane Bancel
Moderna’s Partnership with National Institute of Allergy and Infectious Diseases
Moderna, is a small bio-tech company, based in Cambridge, Massachusetts.
▪ Worked with NIH’s National Institute of Allergy and Infectious Diseases(led by Dr. Fauci) to develop a COVID-19 vaccine;
▪ Received nearly $1billion from the U.S. government to develop the vaccine; and
▪ Its candidate, mRNA-1273, is a new technology based on genetic material called ‘messenger RNA’ or ‘mRNA.’
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SAME EUA REVIEW PROCESS
Information Submitted by Moderna with its EUA Appliction
▸ Regulatory
▸ Chemistry, Manufacturing, and Controls
▸ Safety and Effectiveness Information
EUA for Vaccines to Prevent COVID-19 Guidance for Industry
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Question for the Vaccines and Related Biological Products Advisory Committee (VRBPAC)
What role did the Vaccines and Related Biological Products Advisory
Committee (VRBPAC) play in the FDA’s Decision?
The VRBPAC is made up of external scientific and public health experts from throughout the country.
■ Thursday, December 17, 2020 - Committee met in open session from 9:00 a.m. – 5:00 p.m. (EST)
■ Moderna’s Chief Medical Officer, Tal Zaks, and others presented information concerning mRNA-1273
■ Members of the public made statements and asked questions. ■ The VRBPAC discussed the EUA application submitted by Moderna for a
vaccine to prevent COVID-19 in individuals 18 years of age and older. ■ The VRBPAC’s public meeting was the last step before the FDA made its
decision. The Committee voted 20-0, to support the benefit-risk profile of mRNA-1273 for preventing COVID-19 in persons aged 18 years and older
■ The VRBPAC’s recommendation was not binding on the FDA.16
Check out the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) Open Session –Thursday, December 17, 2020
18This meeting is 8 hours,9 minutes long.
https://www.youtube.com/watch?v=I4psAfbUtC0&featur
e=emb_logo
Additional Information the FDA Considered before Deciding to Grant Emergency Use Authorization of Moderna’s Vaccine (mRNA-1273)
In preparation for the VRBPAC meeting, the FDA published a 54-page evaluation, concluding the Moderna’s vaccine “appears to meet the standards for emergency authorization.”
Standard:The FDA has said a vaccine must be at least 50% effective.
FDA’s own scientists confirmed Moderna’s assessment that the vaccine is 94.1% effective at preventing the COVID-19 virus in a large clinical trial.
FDA's 54-Page Report - Moderna COVID-19 Vaccine
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FDA’s EUA Decision December 18, 2020
Emergency Use Authorization Letter from FDA to ModernaTX, Inc.Issued on December 18, 2020
FDA's Emergency Use Authorization Letter to ModernaTX, Inc.
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“This to me is a triumph of multiyear investment in biomedical research that culminated in
something that was not only done in record time, in the sense of never before has anybody
even imagined you would get vaccines to people in less than a year from the time that
the sequence was made known,” Dr. Fauci said.
“This is an example of government working. It worked really well,” he added.
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“We worked quickly, based on the urgency of this global pandemic, not because of any external pressure,” FDA Commissioner Hahn said in a news briefing shortly after the authorization was announced. “We have not cut corners, but rather have cut through regulatory red tape that can sometimes slow down the process.”
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“The announcement makes the U.S. the first country to authorize two COVID-19 vaccines that demonstrate clear and compelling efficacy, Dr. Peter Marks —director of the Center for Biologics Evaluation and Research at the FDA — said during the press conference. Marks said it is another milestone as we work to end the COVID-19 pandemic.”
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How does the Moderna vaccine compare to Pfizer’s?
Moderna and Pfizer Vaccines: How do they compare?
https://www.sciencenews.org/article/covid-19-coronavirus-moderna-vaccine-fda-approval -
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How long will Moderna’s EUA remain in effect?
▪ The EUA will remain in effect until the declaration that circumstances exist justifying the authorization of the emergency use is terminated by the FDA.
▪ The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
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What’s next for Moderna?
Continue clinical trials to obtain additional safety and effectiveness information. Moderna has said it plans to continue to monitor all clinical trial participants for two (2) years.
Pursue approval (licensure) through the FDA’s Biologics License Application (BLA) process.
Moderna intends to apply for full U.S. license in 2021.
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How many will be inoculated by December 31, 2020?
Between the two vaccines (Moderna and Pfizer-BioNTech), the United States is expecting 40 million doses before year end, enough to eventually vaccinate 20 million people, as both require two shots.
Moderna said it would deliver approximately 20 million doses to the U.S. government this year.
Moderna has deals with the U.S. government to provide a total of 200 million doses by the end of June 2021.
NPR 3-Minute Listen: How will Moderna meet the demand for the vaccine?
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McKesson: Storage, Packing, and Distribution Plan
McKesson - Distributor
The company has a long history of distributing vaccines and is the largest distributor of the seasonal flu vaccine in the United States.
McKesson will be the main distributor of the Moderna vaccine.
▪ McKesson is producing kits that include the supplies needed to administer both doses of the vaccine.
▪ Each kit includes: needles, syringes, alcohol prep pads, face shields and surgical masks, administration sheets for health care providers, and vaccination record and reminder cards for patients.
▪ McKesson will assemble the kits at two of its distribution centers: (1) near Louisville, Ky., a major hub for UPS, and (2) another near Memphis, where FedEx is based.
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McKesson: Storage, Packing & Distribution
▪ McKesson has outfitted at least two of its distribution centers with specially designed, 10,000-square-foot freezers designed to store millions of doses of the Moderna vaccine.
▪ When the time comes to send the Moderna doses out, McKesson will pack the doses into coolers.
▪ Those coolers will be packed with coolant packs, and then sent to administration sites via FedEx and UPS.
▪ The coolers will contain monitoring devices that indicate whether the vaccines ever get too warm.
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Moderna Vaccine Delivery
▪ Unlike Pfizer-BioNTech’s vaccine, Moderna’s vaccine, does not need extreme-cold storage and is delivered in smaller batches.
▪ States are hoping to provide it to less populated areas, reaching rural hospitals, local health departments and community health centers that were not at the top of the distribution list.
▪ Moderna vaccine deliveries will be managed by the federal government under the funding of Operation Warp Speed.
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Other COVID-19 Vaccine Candidates in the Pipeline
▪ Johnson & Johnson
▪ Sanofi of France and GlaxoSmithKline of Britain
▪ British-Swedish drug maker AstraZeneca with University of Oxford
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Credits
▸ https://www.fda.gov/media/144434/download
▸ https://www.fda.gov/media/144636/download
▸ https://www.nytimes.com/2020/12/18/health/covid-vaccine-fda-moderna.html
▸ https://www.google.com/search?q=What+is+next+for+Moderna+and+the+COVID-
19+Vaccine&tbm=nws&source=univ&tbo=u&sa=X&ved=2ahUKEwj8lK-
OsNntAhUu1VkKHSsuDewQt8YBKAB6BAgFEAE&biw=1108&bih=583#spf=1608357946287
▸ https://www.npr.org/sections/health-shots/2020/12/17/947628608/how-will-moderna-meet-the-demand-
for-its-covid-19-vaccine (NPR 3-Minute Listen)
▸ https://www.usatoday.com/story/news/health/2020/12/18/moderna-covid-19-vaccine-authorized-fda-
emergency-use/3941886001/
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Credits
▸ https://www.sciencenews.org/article/covid-19-coronavirus-moderna-vaccine-fda-approval
▸ https://www.wsj.com/articles/modernas-covid-19-vaccine-is-cleared-for-american-use-11608338496
▸ https://www.wsj.com/articles/logistics-set-for-moderna-covid-19-vaccines-rollout-11608289201
▸ https://www.wytv.com/news/coronavirus/differences-between-vaccines-pfizer-vs-moderna/
▸ https://www.law360.com/publicpolicy/articles/1339004?copied=1
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Credits
▸ https://www.sciencenews.org/article/covid-19-coronavirus-moderna-vaccine-fda-approval
▸ https://www.washingtonpost.com/health/2020/12/20/covid-vaccine-front-line-
workers/?wpmk=1&wpisrc=al_news__alert-hse--alert-
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