Featured Journal Content
U.S.: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
HHS
News
Secretary Becerra Announces HHS Purchase of 600,000 Treatment Courses of New Monoclonal Antibody That Works Against Omicron
Thursday, February 10, 2022
BARDA – U.S. Department of HHS [to 12 Feb 2022]
https://aspr.hhs.gov/newsroom/Pages/NewsRoomHome.aspx
News
FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
Friday, February 11, 2022
USG purchases additional Evusheld
Friday, February 11, 2022
FDA
Press Announcements
February 11, 2022 – Coronavirus (COVID-19) Update: FDA Authorizes New Monoclonal Antibody for Treatment of COVID-19 that Retains Activity Against Omicron Variant
February 11, 2022 – Coronavirus (COVID-19) Update: FDA Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
[Editor’s text bolding]
The U.S. Food and Drug Administration has been notified by Pfizer that new data have recently emerged regarding its emergency use authorization request for the use of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15. This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines. We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.
Since the early days of the pandemic, we have always followed the science in this ever-changing situation. Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study. The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group. Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.
The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children. In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caregivers to get vaccinated or receive a booster dose when eligible.
Editor’s Note:
We repeat below the announcement from last week’s edition for reference. See also the Pfizer-Biontech announcement:
Pfizer and BioNTech Provide Update on Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age 02.11.2022
February 1, 2022 – Coronavirus (COVID-19) Update: FDA Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine
Today, the U.S. Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the request for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
“Having a safe and effective vaccine available for children in this age group is a priority for the agency and we’re committed to a timely review of the data, which the agency asked Pfizer to submit in light of the recent Omicron surge. Furthermore, children are not small adults. Because they’re still growing and developing, it’s critical that these vaccines are evaluated in well-designed and well-conducted clinical trials,” said Acting FDA Commissioner Janet Woodcock, M.D. “In the meantime, the best way to protect children, including when they are at school or daycare, is to practice social distancing and masking in accordance with public health recommendations, and for their family members and caretakers to get vaccinated or receive a booster dose when eligible.”…
“The need for a safe and effective vaccine for our youngest children is significant, particularly given the rapid spread of the omicron variant, the notable rise in the number of hospitalizations in young children with severe disease, and the possibility that future variants could cause severe disease in those who are unvaccinated,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “As we have done for other COVID-19 vaccine authorizations, this meeting will help ensure that the public has a clear understanding of the data and information the FDA will evaluate as it considers whether to authorize the vaccine. We are committed to a transparent process, which will include input from our external advisors.”
The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting…
Vaccines and Related Biological Products Advisory Committee– FDA
https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee
Calendar
THIS MEETING IS POSTPONED. Vaccines and Related Biological Products Advisory Committee February 15, 2022 Meeting Announcement – 02/15/2022
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White House [U.S.]
Briefing Room – Selected Major COVID Announcements
Press Briefing by White House COVID-19 Response Team and Public Health Officials
February 09, 2022 Press Briefings
U.S. Department of State
https://www.state.gov/coronavirus/releases/
Media Notes
Press Statement
COVID-19 Global Action Meeting
Antony J. Blinken February 11, 2022
…My counterparts and leaders from regional and international organizations will discuss the leadership roles and actions we will take under the COVID-19 Global Action Plan (GAP), which builds on President Biden’s Global COVID-19 Summit themes of vaccinating the world, saving lives now, and building better health security. Specifically, we are asking countries to step up with us to: (1) Get Shots in Arms; (2) Bolster Supply Chain Resilience; (3) Address Information Gaps; (4) Support Health Care Workers; (5) Ensure Acute Non-Vaccine Interventions; and (6) Strengthen the Global Health Security Architecture. We will coordinate responsibility for sectoral, regional, and global leadership in each line of effort, building on the momentum generated by the COVID-19 Summit and continuing regular engagement among foreign ministers to address health security.
Secretary Blinken’s opening remarks will be streamed on State.gov at 08:30 EST on February 14, 2022.
Editor’s Note:
We paused when reading above that U.S. is asserting that its role might properly be to “…coordinate responsibility for sectoral, regional, and global leadership in each line of effort…” as inventoried.
vaccines and global health :: ethics and policy 