MSN - AP World http://syn2.thecanadianpress.com:8080/mrss/feed/fcf7391a2f354311807f0501c16bde6a MSN - AP World Copyright © 2010-2018 The Canadian Press. All rights reserved. http://www.rssboard.org/rss-specification Mon, 29 Nov 2021 12:38:46 +0000 FDA panel backs boosters for elderly, high-risk http://syn2.thecanadianpress.com:8080/mrss/feed/fcf7391a2f354311807f0501c16bde6a/7d05f11bf5a04be1b678573bcb5c24e2 Dealing the White House a stinging setback, an FDA panel overwhelmingly rejected a plan to give Pfizer COVID-19 booster shots across the board, instead endorsing the extra dose for those who are 65 or older or run a high risk of severe disease. (Sept. 17) 7d05f11bf5a04be1b678573bcb5c24e2 Fri, 17 Sep 2021 21:40:32 +0000 SHOTLIST:RESTRICTION SUMMARY:++QUALITY AS INCOMING++++ONSCREEN GRAPHICS EMBEDDED AT SOURCE++U.S. FOOD AND DRUG ADMINISTRATIONLocation unknown - 17 September 2021++SPLIT SCREEN++1. SOUNDBITE (English) Kathleen Hayes, FDA's designated federal officer:"This vote did not pass since the majority voted no."++WHITE FLASH++2. SOUNDBITE (English) Dr. Michael Kurilla, member, Vaccines and Related Biological Products Advisory Committee:"I can understand where certain populations and Dr. Offit mentioned the elderly, I think also the immunocompromised, there are some very clear populations that have impaired or diminished good cellular responses, and a boost may be very appropriate for them. It's not clear to me that the data we're seeing right now is applicable and necessary to the general population."++WHITE FLASH++3. SOUNDBITE (English) Dr. Hayley Gans, member, Vaccines and Related Biological Products Advisory Committee:"There's several key points, I think, that we're lacking right now. One of them is the very strong safety data that we could have actually with all the third doses that have been given."++WHITE FLASH++4. SOUNDBITE (English) Dr. Doran Fink, FDA deputy director:"In response to these concerns, FDA has formulated a second voting question."++WHITE FLASH++5. SOUNDBITE (English) Dr. Doran Fink, FDA deputy director:"This is the voting question number two that we will ask the committee to consider: based on the totality of scientific evidence available, including the safety and effectiveness data from clinical trial C4591001, do the known and potential benefits outweigh the known and potential risks of the Pfizer-BioNTech COVID-19 vaccine booster dose administered at least six months after completion of the primary series for use in individuals 65 years of age and older and individuals at high risk of severe COVID-19?"++WHITE FLASH++6. SOUNDBITE (English) Kathleen Hayes, FDA's designated federal officer:"We do have a unanimous 18 out of 18 who voted yes for this question."++ENDS ON SOUNDBITE++STORYLINE:Dealing the White House a stinging setback, a government advisory panel overwhelmingly rejected a plan Friday to give Pfizer COVID-19 booster shots across the board.Instead, the committee endorsed the extra dose only for those who are 65 or older or run a high risk of severe disease.The twin votes represented a heavy blow to the Biden administration's sweeping effort, announced a month ago, to shore up nearly all Americans' protection amid the spread of the highly contagious delta variant. The decision was made by an influential committee of outside experts who advise the Food and Drug Administration.In a surprising turn, the panel rejected, by a vote of 16-2, boosters for almost everyone. Members cited a lack of safety data on extra doses. "There's several key points, I think, that we're lacking right now," said panelist Dr. Hayley Gans. "One of them is the very strong safety data that we could have actually with all the third doses that have been given."They also raised doubts about the value of mass boosters, rather than ones targeted to specific groups."There are some very clear populations that have impaired or diminished good cellular responses, and a boost may be very appropriate for them." said committee member Dr. Michael Kurilla. "It's not clear to me that the data we're seeing right now is applicable and necessary to the general population."Then, in an 18-0 vote, it endorsed the extra shot for select portions of the U.S. population — namely, those most at risk from the virus.That would help salvage part of the White House's campaign but would still be a huge step back from the far-reaching plan proposed by the administration a month ago to offer booster shots of both the Pfizer and Moderna vaccines to practically everybody eight months after they get their second dose.Friday's vote was just the first step in the process. The FDA itself is expected to make a decision on boosters in the next few days, but it usually follows the committee's recommendations. The offering of boosters is also subject to approval by the Centers for Disease Control and Prevention. A CDC advisory panel is expected to take up the question on Wednesday. The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.Separate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters.===========================================================Clients are reminded: (i) to check the terms of their licence agreements for use of content outside news programming and that further advice and assistance can be obtained from the AP Archive on: Tel +44 (0) 20 7482 7482 Email: info@aparchive.com(ii) they should check with the applicable collecting society in their Territory regarding the clearance of any sound recording or performance included within the AP Television News service (iii) they have editorial responsibility for the use of all and any content included within the AP Television News service and for libel, privacy, compliance and third party rights applicable to their Territory. Dealing the White House a stinging setback, an FDA panel overwhelmingly rejected a plan to give Pfizer COVID-19 booster shots across the board, instead endorsing the extra dose for those who are 65 or older or run a high risk of severe disease. (Sept. 17) FDA panel backs boosters for elderly, high-risk