In a second vote, FDA advisers recommend a booster dose of Pfizer's vaccine for people 65 and older and those at high risk of severe Covid
Vaccine advisers to the US Food and Drug Administration on Friday rejected Pfizer's application to add a booster dose of its coronavirus vaccine to the two-dose regimen, but were preparing to vote on a narrower approval -- perhaps for booster doses for people 60 or 65 or older, or for people at high risk of exposure at work.
Members of the FDA's Vaccines and Related Biological Products Advisory Committee had rejected a broader application to approve the use of booster doses of Pfizer's vaccines in everyone 16 and older six months after they are fully vaccinated.Members of the committee expressed doubts about the safety of a booster dose in younger adults and teens, and complained about the lack of data about the safety and long term efficacy of a booster dose.Expect a bumpy ride this week when FDA advisers consider Covid-19 booster shots Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of September 20, pending signoff from the FDA and US Centers for Disease Control. Some of the advisers -- a group of vaccine experts, immunologists, pediatricians, infectious disease specialists and public health experts -- have said the process was rushed because of that target date.Read MoreOn Friday, several said they wanted to see more data, or they believed boosters were likely necessary, but for a more limited segment of the population."I don't think a booster dose is going to significantly contribute to controlling the pandemic," said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine, said during the meeting."It is very important that the main message that we still transmit is that we have got to get everyone two doses. Everyone has got the get the primary series. This booster dose is not likely to make a big difference in the behavior of this pandemic."During the meeting, Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said several studies indicate that people's immunity can and does wane and that giving booster doses restores that immunity -- sometimes to levels higher than seen at initial vaccination. He said people who got the boosters did not have any more side effects than seen after the first two doses.And Gruber said while the two-dose Pfizer vaccine continues to protect well against severe infection, hospitalizations and deaths, there are hints that could change. The company relied heavily on data from Israel, where vaccinated people started to get breakthrough infections. Israeli researchers earlier told the meeting that adding booster shots in Israel helped keep many people out of the hospital."The Israeli experience could portend the US Covid-19 future," Gruber said."Israel and the United States real world evidence suggests that vaccine efficacy against Covid-19 infection wanes approximately six to eight months following the second dose," he added.Do Americans need boosters yet? Here are the questions the FDA will be asking"In addition, recent US CDC data hint at reduced Covid-19 vaccine effectiveness over time against severe disease and hospitalization in the US," he said."This reduced vaccine effectiveness tracks with longer spans of time between two doses of vaccine and SARS coronavirus exposure."But FDA staff and advisers pushed back on the data available so far. Dr. Phil Krause, deputy director of the FDA's Office of Vaccines Research and Review, noted that Pfizer was using data that had not been reviewed by experts."One of the issues in this is that much of the data that's been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA," Krause told the meeting of the Vaccines and Related Biological Products Advisory Committee.Krause, along with another FDA vaccine official, Marion Gruber, signed a Lancet paper published earlier this week that argued it's too soon to start giving people boosters.Why Fauci and the NIH backed Covid-19 vaccine boosters before the FDA and CDCDr. Michael Kurilla, an infectious disease specialist at the National Center for Advancing Translational Sciences, noted that the studies relied heavily on measurements of antibodies, without looking at other important aspects of immune response."It's a little disappointing that there's been very little reporting of the cellular immune responses and an entire focus on the neutralizing antisera," Kurilla said."Which clearly for that population at high risk is absolutely essential, but for the broad population in terms of their protection, which seems to be holding up well over time -- (that) should be because of adequate cellular immune responses but we have no indication of that."So it's unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease."Local health departments planning for potential Covid-19 booster rollout, but there is still 'some confusion'Pfizer received full approval for its vaccine from the FDA, so the request to add a booster dose is a supplement to that approval. Pfizer -- and other researchers -- say their studies show people develop strong immunity after two doses of vaccine, but that levels of antibodies start to drop after a few months.The FDA noted in its briefing documents that Pfizer's vaccine -- as well as vaccines made by Moderna and Johnson & Johnson -- still provide strong protection against severe disease, hospitalization and death, even if antibodies do wane over time.After the FDA advisory committee makes its recommendation, the FDA makes the decision about whether to approve the booster dose.Get CNN Health's weekly newsletter Sign up here to get The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
The CDC has scheduled a meeting of its vaccine advisers for September 22 and 23 -- and CDC must give its stamp of approval for any booster doses to be officially given. In a letter sent Thursday and obtained by CNN, the CDC urged local and state health officials to wait to administer boosters until both agencies had signed off.Third doses are already approved for certain immunocompromised people, but not for the general public.Read more: CNN Breaking News »
Israeli scuba diver discovers ancient Crusader sword
Israeli archaeologists say a scuba diver has salvaged an ancient sword off the country's Mediterranean coast that experts say dates back to the Crusaders
Agree Reuters nytimes AJEnglish AP ABC FDA DrTomFrieden wapo kaitlancollins JonLemire megtirrell GeoffRBennett CNN AlbertBourla CDCgov WHCOS whca PressSec Surgeon_General 1 Does it mean that the 'booster' shot of pfizer +BioNTech_Group is the same as the 3rd shot? ONLY WOKE TRASH JUDGES . USE TECHNICALITIES . TO MAKE A LAW HAVE THE OPPOSITE MEANING USSupremeCourt USA SCOTUS ILLEGAL RIGHTS RANK 1 TRANSGENDER RANK 2 . CITIZENS RIGHTS RANK 999,993 .BABY W HEART BEAT TEXAS RANK 1 USA NFL BIDEN MLB COVID19
I've got some news for you CNN FaZeClan have a open set party with thousands of faze fans not a single thought of not having face masks at all plus they did some money laundering using SaveTheKidsBSC as they way to take peoples money Strange how Pfizer is still not recommending booster shots. You would think they would, but no.
Give the damn shot to everybody, and stop cherry picking over conditions and age, the worst condition to be in is dead, the virus doesn't pick or choose it just takes, so age and condition shouldn't matter to protection from the virus!!! Millions of people received the J&J 1 shot & the Moderna 2 Shots, so how can boosters be required only for 1? How is it that J&J which had the lowest efficacy rate, that ppl are not asked to go get a 2nd shot. None of this makes sense at all🧐🙄
Pfitzer agent CIA. OMG Also nonsense. Please read these comments There are so many just really stupid people posting negative comments This is science - They need time to decide on the younger groups The level of ignorance is amazing This is how we got TRump Nope
FDA Questions Need For Pfizer Covid-19 Booster Shot Ahead Of Vote FridayScientists at the FDA said Pfizer’s Covid-19 vaccine seems to last long enough that a booster shot may not add much protection
Do those at 'high risk of severe covid' include the 122.2m Americans that the CDC reckons are diabetic or pre-diabetic? Yeah pity some of them haven’t even had the first ones yet… Fauci in 2019: 'You don't need masks.' It took years to develop polio,small pox, measles,and chicken pox vaccines. The current vaccines do not rise to the level of being called a vaccine. Like the influenza shot, it’s like a seasonal inoculation. You need boosters every 6mos to a year! We don’t mandate flu shots!
BREAKING: FDA advisers voted against a Pfizer-BioNTech booster shot, dealing a blow to the president's push to start offering third doses Alerte informations urgent Last minute urgent The président Algérie bouteflika just died at 84 years Last minute Alert informations
FDA Questions Need For Pfizer Covid-19 Booster Shot Ahead Of Vote FridayScientists at the FDA said Pfizer’s Covid-19 vaccine seems to last long enough that a booster shot may not add much protection أرجو منكم الدعم لقناتي بجام و برتاج و أبوني بدعمكم أستمر وينكم يا أحلي أصدقاء في التويتر هذا رابط قناتي على اليوتيوب 😍🙏👍👇👇👇👇👇👇👇👇👇 تونس فلسطين قطر2022 الجزائر I’m buy BabyDoge BabyDogeCoin and I will milliners in Q1 - 2022 BABYDOGEBILLIONAIRE
I’m making over $7k a month working part time. I kept hearing other people tell me how much money they can make online so I decided to look into it. Well, it was all true and has totally changed my life. This is where i started... Www.MoneyApp2.Com LOL You want to no why no one trust you look at our southern boarder. Kids in cages? Really under biden we have thousands of kids under a bridge. Were is your outrage were is your coverage of that. Your shame has no bounds you are politically motivated and we all see it.
The FDA, CDC and WHITE HOUSE need to get their ducks in a row b4 I consider a booster even though I am in the over 65 group! What a fuckiing circus funny, don’t see any fact checkers now….. FDA booster dose of pfizer! Iran where pandemic 2nd most spread after China; khamenei Hitler Quarantined himself since Oct 2019 protests & banned vaccine to kill Iranians, 700 death rate daily For credible IRAN news follow: PahlaviReza LibertyIranian NUFDIran KayhanLife
Complete mismanagement from top to bottom. Man first I missed those military shares at the start of Afghanistan, now wishing I had invested in Big Pharma at the start of this circus. Everyday vaccine everyday vaccine. We are tired of this type of news
What to expect as FDA advisory panel debates Pfizer COVID booster shotsThe FDA's independent advisory committee is convening to review data submitted by Pfizer and discuss whether a booster dose is safe enough for widespread use and whether it's necessary and effective at improving protection levels against COVID-19. Great, we haven't even finished the first wave of hesitancy. They should of let our own DRs handle this booster when they Mandate it. I trust my Doc. Get it?
Members of the FDA's Vaccines and Related Biological Products Advisory Committee rejected a broader application to approve the use of booster doses of Pfizer's vaccines in everyone 16 and older six months after they are fully vaccinated.
FDA advisers vote to oppose Pfizer/BioNTech COVID-19 vaccine boosterA panel of outside advisers to the U.S. Food and Drug Administration on Friday voted against approval of a booster dose of the Pfizer Inc /BioNTech SE COVID-19 vaccine for people aged 16 and older. Wrong headline here. They voted against it for people as young as 16. They have not yet voted on it for adults 60 and older and those with compromised immunity.
FDA panel is first key test for Biden COVID-19 booster planGovernment advisers are debating whether to recommend extra doses of the Pfizer vaccine, a key step toward the Biden administration's plan to dispense COVID-19 booster shots. Scientists have been divided over the need for boosters and who should get them. The Delta variant was from December, 2020. This should be a no-brainer right now. Think more as clinicians and practitioners than researchers. Science is now a debate and not based off evidence or facts. Let that sink in.
FDA Panel Weighs Covid-19 Booster Shots as Health Officials Debate NeedThe Biden administration’s push to introduce widespread vaccine boosters faces a test as a Food and Drug Administration advisory panel meets to weigh evidence on the extra shots, a topic that has divided federal health officials. good luck Clown world What is there to weigh here. Either the science supports it or it doesn’t