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

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

 

Week of 7 December 2020

09 December 2020
Health Canada authorizes first COVID-19 vaccine
…Health Canada received Pfizer’s submission on October 9, 2020 and after a thorough, independent review of the evidence, Health Canada has determined that the Pfizer-BioNTech vaccine meets the Department’s stringent safety, efficacy and quality requirements for use in Canada….

 

09 December 2020
UAE Ministry of Health and Prevention announces official registration of inactivated COVID-19 vaccine used in #4Humanity Trials
ABU DHABI, 9th December, 2020 (WAM) — The UAE’s Ministry of Health and Prevention, MOHAP, has announced the official registration of Beijing Institute of Biological Product’s inactivated COVID-19 vaccine in a major step towards combating the global pandemic. The registration of this vaccine is a decision in response to the application from Sinopharm CNBG. The announcement is a significant vote of confidence by the UAE’s health authorities in the safety and efficacy of this vaccine.
MOHAP, in collaboration with Department of Health Abu Dhabi, DOH, has reviewed Sinopharm CNBG’s interim analysis of the phase III trials, which shows Beijing Institute of Biological Product’s inactivated vaccine to have 86 percent efficacy against COVID-19 infection. The analysis also shows the vaccine to have 99 percent seroconversion rate of neutralising antibody and 100 percent effectiveness in preventing moderate and severe cases of the disease. Furthermore, the analysis shows no serious safety concerns.
This vaccine was granted Emergency Use Authorisation, EUA, since September by MOHAP to protect frontline workers most at risk of COVID-19. The UAE is conducting Post Authorisation Safety Study, PASS, and Post Authorisation Efficacy Study, PAES, of its EUA programme. These ongoing studies show similar safety and efficacy profiles as the interim analysis.
The #4Humanity phase III trials have included 31,000 volunteers across 125 nationalities in the UAE alone. The EUA vaccination programme has effectively safeguarded the UAE frontline workers. MOHAP’s official registration of Beijing Institute of Biological Product’s inactivated COVID-19 vaccine leads the way to comprehensively protecting the population and responsibly opening the economy.

 

11 December 2020
EMA Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
:: Documents
:: Video recording
Event summary
EMA held 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.
The meeting also gave the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns. This feedback 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 were not covered at this event.

 

12 December 2020
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
Today, the FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

 

11-12 December 2020
Advisory Committee on Immunization Practices (ACIP) – CDC
:: Final Agenda – December 12, 2020 pdf icon[1 page]
:: Presentation Slides – December 11-12, 2020
Editor’s Note:
The ACIP approved recommendations for immunization involving the Pfizer-BioNTech COVID vaccine. No official announcement language was posted as of publication time.