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Health Canada and the European Medicines Agency publish clinical data used to support their authorizations of the Moderna COVID-19 vaccine

Retrieved on:

Tuesday, March 2, 2021

Health sciences, COVID-19 vaccines, Clinical trials, Health, Medicine, Medical research, RNA vaccines, Pharmaceutical industry, COVID-19 vaccine, Ad26.COV2.S, Pfizer–BioNTech COVID-19 vaccine

Today, Health Canada and the European Medicines Agency (EMA) collaboratively published the full clinical data reviewed as part of their authorizations of the Moderna COVID-19 vaccine.

Key Points:

Today, Health Canada and the European Medicines Agency (EMA) collaboratively published the full clinical data reviewed as part of their authorizations of the Moderna COVID-19 vaccine.
Increasing access to clinical data can also have widespread benefits for the health care system and the research community.
The EMA and Health Canada are working together with manufacturers to expedite the publication of clinical information underpinning their authorizations for medicines and vaccines for COVID-19.
The clinical data package for the Moderna COVID-19 vaccine, presenting the interim safety and efficacy data generated in three clinical studies, is available on the EMA'sclinical data website and Health Canada's Public Release of Clinical Information portal .

McKesson Begins Distributing the Johnson & Johnson COVID-19 Vaccine

Retrieved on:

Monday, March 1, 2021

As a centralized distribution partner for the U.S. governments COVID vaccine distribution effort, McKesson today began distributing the COVID-19 vaccine received from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points:

As a centralized distribution partner for the U.S. governments COVID vaccine distribution effort, McKesson today began distributing the COVID-19 vaccine received from Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
In December 2020, McKesson began distributing the ancillary supply kits for Pfizer BioNTechs COVID-19 vaccine.
McKesson has established four dedicated distribution centers which will be specifically used to distribute the Johnson & Johnson COVID-19 vaccine and future refrigerated vaccines.
The U.S. government makes all program administration decisions, including where, when and how many vaccine doses McKesson will distribute.

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use

Retrieved on:

Sunday, February 28, 2021

COVID-19 vaccines, Clinical trials, COVID-19, Medicine, Health sciences, Adenoviridae, Medical research, COVID-19 vaccine, Ad26.COV2.S, Vaccine, Johnson & Johnson, Deployment of COVID-19 vaccines

"We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants.

Key Points:

"We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants.
Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use.
The Johnson & Johnson COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas.
You should not get the Janssen COVID-19 Vaccine if you:
had a severe allergic reaction to any ingredient of this vaccine.

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Retrieved on:

Saturday, February 27, 2021

COVID-19 vaccines, Clinical trials, Medical research, Medicine, Health sciences, Johnson & Johnson, Medical specialties, Adenoviridae, Ad26.COV2.S, COVID-19 vaccine, Vaccine, COVID-19 vaccination in the Philippines

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA.

Key Points:

The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA.
The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19.
The issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an EUA is not approved.
Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 Vaccine.

Johnson & Johnson Single-Shot COVID-19 Vaccine Candidate Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee

Retrieved on:

Friday, February 26, 2021

Medical research, Health sciences, COVID-19 vaccines, Medicine, Health, Clinical trials, Johnson & Johnson, COVID-19 vaccine, Adenoviridae, Vaccine, Janssen Pharmaceuticals, Ad26.COV2.S

The next step in the process is for the FDA to decide whether to grant an EUA for Janssen's COVID-19 vaccine candidate.

Key Points:

The next step in the process is for the FDA to decide whether to grant an EUA for Janssen's COVID-19 vaccine candidate.
The recommendation of the FDA Advisory Committee is non-binding, and the final decision on authorization is made by the FDA.
We are confident that our COVID-19 vaccine candidate will have a significant impact in protecting people around the world," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.
The Johnson & Johnson COVID-19 single-dose vaccine candidate is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas.

Dr. David Berger of Tampa to Address Pregnancy Safety Concerns with FDA COVID-19 Vaccine Advisory Committee

Retrieved on:

Thursday, February 25, 2021

COVID-19 vaccines, Clinical trials, COVID-19, Medicine, Health sciences, Adenoviridae, Medical research, Ad26.COV2.S, Janssen Pharmaceutica, COVID-19 vaccine, Vaccine hesitancy, Vaccine

On February 26, 2021, the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss Emergency Use Authorization (EUA) of the Johnson & Johnson/Jansenn Biotech COVID-19 Vaccine .

Key Points:

On February 26, 2021, the FDA Vaccines and Related Biological Products Advisory Committee will meet to discuss Emergency Use Authorization (EUA) of the Johnson & Johnson/Jansenn Biotech COVID-19 Vaccine .
Dr. David Berger will give a presentation regarding continued vaccine hesitancy and safety concerns related to pregnancy and the COVID-19 vaccines (see submitted slide presentation and submitted written comments ).
Dr. Berger has specific concerns about the Johnson & Johnson COVID-19 vaccine for women of childbearing age.
At this time, we cannot confidently say the same for the Johnson & Johnson COVID-19 vaccine and this may have safety implications for developing fetuses.

Moderna Announces Amendment to Supply Agreement with Switzerland for an Additional 6 Million Doses of COVID-19 Vaccine Moderna

Retrieved on:

Wednesday, February 3, 2021

The initial procurement by the Swiss Federal Government for 4.5 million doses was announced on August 7, 2020, and this was subsequently increased to 7.5 million doses on December 8, 2020.

Key Points:

The initial procurement by the Swiss Federal Government for 4.5 million doses was announced on August 7, 2020, and this was subsequently increased to 7.5 million doses on December 8, 2020.
The additional 6 million doses announced today will be delivered beginning in the summer of 2021, with an option to receive doses in the first half of 2022 as Moderna explores potential vaccine boosters to address emerging variants.
On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.
On November 30, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.