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

Milestones :: Perspectives :: Research

 

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

 

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Week of 30 November 2020

 

European Medicines Agency
News & Press Releases
News: EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
Last updated: 01/12/2020

 

News: EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
Last updated: 01/12/2020

 

News: EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
Last updated: 01/12/2020

 

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UK medicines regulator gives approval for first UK COVID-19 vaccine – MHRA
2 December 2020 — Press release
The first COVID-19 vaccine for the UK, developed by Pfizer/BioNTech, has today been given approval for use following a thorough review carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
The decision by the UK regulatory authority was made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. A dedicated team of MHRA scientists and clinicians carried out a rigorous, scientific and detailed review of all the available data, starting in October 2020.

This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.

The MHRA expert scientists and clinicians reviewed data from the laboratory pre-clinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and also considered the conditions for its safe supply and distribution.

The National Institute for Biological Standards and Control, part of the agency, has been and will continue doing, independent laboratory testing so that every batch of the vaccine meets the expected standards of safety and quality.

MHRA Chief Executive, Dr June Raine said:
“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword.
“I’m really pleased to say that the UK is now one step closer to providing a safe and effective vaccine to help in the fight against COVID-19 – a virus that has affected each and every one of us in some way – and in helping to save lives.
“We are globally recognised for requiring high standards of safety, quality and effectiveness for any vaccine. Our expert scientists and clinicians worked tirelessly, around the clock, carefully, scientifically, robustly and rigorously poring over hundreds of pages and tables of data, methodically reviewing the data.
“Vaccines are the most effective way to prevent infectious diseases. They save millions of lives worldwide.”

 

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Advisory Committee on Immunization Practices (ACIP) – CDC
December 1, 2020 Meeting Recommendation
ACIP approved the following recommendation by majority (13-1) vote at its December 1, 2020 emergency meeting:

 

When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel§ and 2) residents of long-term care facilities¶

This recommendation has been adopted by the CDC Director.
§Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials
¶ Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently

 

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Covid: Russia begins vaccinations in Moscow – BBC
5 December 2020
Russia is starting its Covid-19 vaccination programme, with clinics in the capital Moscow inoculating those most at risk from the virus.
Its own vaccine Sputnik V, which was registered in August, is being used. Developers say it is 95% effective and causes no major side effects, but it is still undergoing mass testing.
Thousands of people have already registered to get the first of two jabs over the weekend, but it is unclear how much Russia can manufacture.
Producers are only expected to make two million doses of the vaccine by the end of the year.
Moscow Mayor Sergei Sobyanin, who announced the programme earlier in the week, said it was being offered to people in the city of 13 million who work in schools and the health service, and social workers.
He said the list would grow as more of the vaccine became available…