COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

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COVID-19 Vaccines Regulatory Processes :: Announcements/Meeting Dates/Milestones

 

Week of 23 November 2020
CHINA – Leading vaccine maker seeks market approval
2020-11-26
Leading COVID-19 vaccine developer Sinopharm has submitted a market approval application to China’s top market regulator, Xinhua News Agency quoted the company’s Deputy General Manager Shi Shengyi as saying on Nov 25.
The Chinese company has two experimental COVID-19 vaccines – both of which are the inactivated type – undergoing Phase 3 clinical trials overseas.
The Xinhua report did not reveal details about the application.

 

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Week of 30 November 2020
U.K. – UK set to approve Pfizer-BioNTech Covid vaccine within days
Rollout of two-shot jab could begin as soon as December 7
28 November 2020 Sebastian Payne and Donato Paolo Mancini
The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days. Deliveries of the vaccine developed by BioNTech and Pfizer would begin within hours of the authorisation, according to government officials. The first injections could take place from December 7. The UK has ordered 40m doses of the two-shot product, which preliminary data found to be more than 95 per cent effective in preventing disease. Vaccines would normally be authorised by the European Medicines Agency until the end of the Brexit transition on December 31. However the UK’s Medicines and Healthcare Products Regulatory Agency has the power to temporarily authorise products, in cases of urgent public need…

UK MHRA Medicines and Healthcare products Regulatory Agency
:: Pfizer/BioNTech COVID-19 vaccine: MHRA statement 23 November 2020
…Approval process for a potential COVID-19 vaccine
:: Until the end of December, and as part of the transition period, COVID-19 vaccine candidates can be licensed (authorised) via the European Medicines Agency (EMA) and that authorisation will automatically be valid in the UK.
:: However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation allows for temporary authorisation of supply in the UK, based on the public health need.
:: The MHRA will evaluate the data rigorously for quality, safety and effectiveness to reach an independent, scientifically robust opinion. The data must include results from lab and clinical trials in humans; manufacturing and quality controls, product sampling, and testing of the final product.
:: Any COVID-19 vaccine candidate submitted after the transition period ends in January 2021 will not need to go through a European marketing authorisation for use in Great Britain and will instead be assessed directly by the MHRA. The MHRA is globally recognised for requiring the highest standards of safety, quality and effectiveness for any vaccine.

 

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1 December 2020 – Tuesday – 1400-1700/New York
Advisory Committee on Immunization Practices (ACIP)
Webcast: December 1, 2020 meeting is a virtual meeting. No registration is required.
Meeting time, 1400 – 1700 EDT (times subject to change).
Webcast Link
Meeting Agenda
Selected Agenda Elements
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)
:: Clinical considerations for populations included in Phase 1a Dr. Sara Oliver (CDC/NCIRD)
:: Post-authorization safety monitoring update Dr. Tom Shimabukuro (CDC/NCEZID)
:: Public Comment
VOTE
:: Allocation of initial supplies of COVID-19 vaccine: Phase 1a Dr. Kathleen Dooling (CDC/NCIRD)

 

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4 December 2020 – Friday – 1300-1700/New York
U.S. – National Vaccine Advisory Committee NVAC Meeting (Virtual)
Selected Agenda Elements
OPENING REMARKS
Admiral Brett Giroir, Assistant Secretary for Health
APPROACHES TO INCLUDE PREGNANT WOMEN IN COVID-19 CLINICAL TRIALS
Dr. Sascha Ellington, Centers for Disease Control and Prevention
Dr. Ruth Faden, Johns Hopkins University
Dr. Jeff Roberts, Food and Drug Administration
Dr. Linda Eckert, American College of Obstetricians and Gynecologists
Dr. Titi Oduyebo, Centers for Disease Control and Prevention
VACCINE SAFETY SYSTEMS AND COVID-19
Dr. Peter Marks, Food and Drug Administration
Dr. Arnold Monto, Vaccines and Related Biological Products Advisory Committee
Dr. Tom Shimabukuro, Centers for Disease Control and Prevention
Dr. Sonali Kochhar, University of Washington
REGISTER: https://www.hhs.gov/webforms/nvac/index.html

 

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10 December 2020 – Thursday – 0900-1800/New York
FDA – Vaccines and Related Biological Products Advisory Committee
The FDA’s Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in open session to discuss Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Vaccines and Related Biological Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The online web conference meeting will be available at the following:
https://youtu.be/owveMJBTc2IExternal Link Disclaimer
https://twitter.com/US_FDAExternal Link Disclaimer (Supported in Chrome browser)
https://fda.yorkcast.com/webcast/Play/d75d80a3eb6e419986181c1a881fe2671d.

 

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11 December 2020 – Thursday – 1300-1630/CET
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Agenda – EMA public stakeholder meeting on COVID-19 (PDF/310.91 KB) (new)
:: Documents
:: Live broadcast
EMA is organising this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
It will also give the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns, that will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA’s remit and will not be covered at this event.

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
Last updated: 16/11/2020
MA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.)…The rolling review will continue until enough evidence is available to support a formal marketing authorisation application