Budapest Post

Cum Deo pro Patria et Libertate
Budapest, Europe and world news

FDA advisor explains why she voted against recommending Pfizer's Covid vaccine for emergency use

FDA advisor explains why she voted against recommending Pfizer's Covid vaccine for emergency use

Dr. Archana Chatterjee told CNBC on Friday she's "fully supportive" of emergency use authorization for people who are 18 years and older.


Dr. Archana Chatterjee, a member of the FDA advisory panel who voted against recommending Pfizer’s Covid-19 vaccine for emergency use, told CNBC on Friday that her opposition was because she did not believe 16- and 17-year-olds should be included right now.

In a “Squawk Box” interview, Chatterjee said she would have voted “yes” had the question before her been different. “I want to be very clear that I am fully supportive of the emergency use authorization for the use of this vaccine from Pfizer and BioNTech for adults 18 years and older,” said Chatterjee, a pediatric infectious disease specialist who serves as dean of the Chicago Medical School.

The FDA committee recommended emergency authorization of the vaccine for people who are 16 years old and older.

In addition to Chatterjee, three other members of a Food and Drug Administration advisory panel on Thursday voted against recommending U.S.-based Pfizer and German partner BioNTech’s vaccine for emergency use. One member abstained from voting, while 17 voted in favor of a recommendation.

The decision from the group of outside experts is nonbinding, but on Friday, FDA Commissioner Stephen Hahn said in a statement that the agency was working “rapidly” toward finalizing emergency use authorization.

The vaccine from Pfizer and BioNTech would be the first to receive regulatory clearance in the United States. It has already been granted approvals by health officials in the United Kingdom and Canada.

Chatterjee noted that the vaccine was 95% effective in preventing Covid-19 in clinical trials while also demonstrating a “really good safety profile overall.” She added, “I think that we were pleasantly surprised to see that this vaccine has such good efficacy in tens of thousands of participants that were included in the trial.”

While commending Pfizer and BioNTech for including people under age 18 in the trials, she stressed that she would like to have seen additional data before recommending more individuals in the group receive it.


Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, was among the 17 outside experts who voted in favor of recommending the vaccine for emergency use. He told CNBC a “rigorous” safety review process took place, including for 16- and 17-year-olds.

“There was no particularly different safety signal for them as the older individuals so the majority of the committee members felt comfortable voting ‘yes,’” Levy said Friday on “Worldwide Exchange.”

“Yesterday was a milestone but there is a long road ahead” in the effort to end the coronavirus pandemic, Levy added. He pointed to the need for a large supply of Covid-19 vaccines so more people have the opportunity to be vaccinated, both in the U.S. and abroad.

Because doses of the Pfizer-BioNTech vaccine will be limited at first, concerns raised about younger individuals receiving it at this moment are “moot,” contended Dr. Scott Gottlieb, a Pfizer board member and former FDA chief. Health-care workers and residents of long-term care facilities are set to be first in line to get the shots.

“This vaccine isn’t going to be eligible for 16- and-17 year-olds for quite some time ... and probably until it gets fully licensed at some point, hopefully if everything goes well, in the spring and summertime,” Gottlieb said on “Squawk Box.”

The FDA’s advisory panel is set to meet next week on whether to recommend emergency use of Moderna’s Covid’s vaccine, which like Pfizer’s requires two shots and employs a new approach to inoculations that uses genetic material to provoke an immune response.


AI Disclaimer: An advanced artificial intelligence (AI) system generated the content of this page on its own. This innovative technology conducts extensive research from a variety of reliable sources, performs rigorous fact-checking and verification, cleans up and balances biased or manipulated content, and presents a minimal factual summary that is just enough yet essential for you to function as an informed and educated citizen. Please keep in mind, however, that this system is an evolving technology, and as a result, the article may contain accidental inaccuracies or errors. We urge you to help us improve our site by reporting any inaccuracies you find using the "Contact Us" link at the bottom of this page. Your helpful feedback helps us improve our system and deliver more precise content. When you find an article of interest here, please look for the full and extensive coverage of this topic in traditional news sources, as they are written by professional journalists that we try to support, not replace. We appreciate your understanding and assistance.
Newsletter

Related Articles

0:00
0:00
Close
U.S. and Hungarian Officials Talk About Economic Collaboration and Sanctions Strategy
Technology Giants Activate Lobbying Campaigns Against Strict EU Regulations
Pope Francis Admitted to Hospital in Rome Amid Increasing Speculation on Succession
Zelensky Calls on World Leaders to Back Peace as Tensions Rise with Trump
UK Leader Keir Starmer Calls for US Security Guarantee in Ukraine Peace Deal
NATO Chief Urges Higher Defense Expenditure in Europe
The negotiation teams of Trump and Putin meet directly, establishing the groundwork for a significant advancement.
Rubio Touches Down in Riyadh Before Key U.S.-Russia Discussions
Students in Serbian universities Unite to Hold Coordinated Protests for Accountability.
US State Department Removes Taiwan Independence Statement from Website
Abolishing opposition won't protect Germany from Nazism—this is precisely what led Germany to become Nazi!
Transatlantic Gold Rush: Traders Shift Bullion in Response to Tariff Anxieties and Market Instability
Bill Ackman Backs Uber as the Company Shifts Towards Profitability
AI Titans Challenge Nvidia's Supremacy in Light of New Chip Innovations
US and Russian Officials to Meet in Saudi Arabia Over Ending Ukraine Conflict. Ukraine and European leaders – who profit from this war – excluded from the negotiations.
Macron Calls for Urgent Summit as Ukraine Conflict Business Model is Threatened
Trump’s Defense Secretary: Ukraine Won’t Join NATO or Regain Lost Territories
Zelensky Urges Europe to Bolster Its Military in Light of Uncertain US Backing
Chinese Zoo Confesses to Dyeing Donkeys to Look Like Zebras
Elon Musk is Sherlock Holmes - Movie Trailer Parody featuring Donald Trump's Detective
Trump's Greenland Suggestion Sparks Sovereignty Discussions Amid Historical Grievances
OpenAI Board Dismisses Elon Musk's Offer to Acquire the Company.
USAID Uncovered: American Taxpayer Funds Leveraged to Erode Democracy in Europe Until Trump Put a Stop to It.
JD Vance and Scholz Did Not Come Together at the Munich Security Conference.
EU Official Participates in Discussions in Washington Amid Trade Strains
Qatar Contemplates Reducing French Investments Due to PSG Chief Investigation
Germany's Green Agenda Encounters Ambiguity Before Elections
Trump Did Not Notify Germany's Scholz About His Ukraine Peace Proposal.
Munich Car Attack Escalates Migration Discourse Before German Elections
NATO Allies Split on Trump's Proposal for 5% Defense Spending Increase
European Parliament Advocates for Encrypted Messaging to Ensure Secure Communications
Trump's Defense Spending Goal Creates Division Among NATO Partners
French Prime Minister Bayrou Navigates a Challenging Path Amid Budget Preservation and Immigration Discourse
Steering Through the Updated Hierarchy at the European Commission
Parliamentarian Calls for Preservation of AI Liability Directive
Mark Rutte Calls on NATO Allies to Increase Defence Expenditures
Dresden Marks the 80th Anniversary of the World War II Bombing.
Global Community Pledges to Aid Syria's Political Transition
EU Allocates €200 Billion for AI Investments, Introduces €20 Billion Fund for Gigafactories
EU Recognizes Its Inability to Close the USAID Funding Shortfall Due to Stalled US Aid
Commission President von der Leyen Missing from Notre Dame Reopening Due to Last-Minute Cancellation
EU Officializes Disinformation Code for Online Platforms, Omitting X
EU Fails to Fully Implement Key Cybersecurity Directives
EU Under Fire for Simplification Discussions Regarding Corporate Sustainability Reporting
Shein Encountering Further Information Request from the EU During Ongoing Investigation
European Commission Initiates Investigation into Shein as It Aims at Chinese E-Commerce Regulations
German Officials Respond to U.S. Proposal for Peace Talks with Russia
Senate Approves Robert F. Kennedy Jr. as Secretary of Health and Human Services.
Trump and Putin Engage in Discussions on Ukraine Peace Negotiations Amid Worldwide Responses
Honda and Nissan End Merger Talks
×