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U.S. FDA vaccine advisors debate boosters as Biden administration plans rollout

By Manojna Maddipatla and Michael Erman (Reuters) -Debate over whether Americans should receive a booster dose of the Pfizer/BioNTech COVID-19 vaccine as planned by the Biden...
U.S. FDA vaccine advisors debate boosters as Biden administration plans rollout © Reuters. FILE PHOTO: A person receives a dose of the Pfizer-BioNTech vaccine for the coronavirus disease (COVID-19), at a mobile inoculation site in the Bronx borough of New York City, New York, U.S., August 18, 2021. REUTERS/David 'Dee' Delgado

By Manojna Maddipatla and Michael Erman

(Reuters) -Debate over whether Americans should receive a booster dose of the Pfizer/BioNTech COVID-19 vaccine as planned by the Biden administration moved to a panel of independent expert advisers to the U.S. Food and Drug Administration on Friday.

While U.S. health officials, some other countries and vaccine makers have said boosters are needed, many scientists, including some inside the FDA and the U.S. Centers for Disease Control and Prevention (CDC), disagree.

Many of them have said that while there is growing evidence that boosters provide increased protection against severe disease to people aged 65 and older, there is not enough evidence that they are needed broadly.

But U.S. health officials planning the booster shot rollout are also eyeing rising COVID-19 cases. The highly transmissible Delta variant has caused a surge in hospitalizations and deaths, mostly among the unvaccinated, but less serious breakthrough infections among fully vaccinated people have also risen.

Dr. Peter Marks, one of the FDA's top officials, acknowledged on Friday that there are different opinions on the necessity of booster shots and urged panelists to consider the current dynamics of the outbreak in the United States.

"We are committed to focusing on the science," Marks said. "We'll carefully consider those data in the context of the clear and obvious public health need to continue slowing the spread of COVID-19, which at this time is leading to the death of close to 2,000 Americans each day."

Pfizer (NYSE:PFE)'s application to the FDA for a booster was for ages 16 and up, and the panel has been asked to weigh only one question: does the safety and effectiveness data support approval of a booster at least six months after the second dose for people aged 16 and older?

The FDA staff said in documents https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-says-third-covid-19-shot-warranted-fda-document-2021-09-15 prepared for the committee this week that the vaccine Pfizer developed with Germany's BioNTech SE (NASDAQ:BNTX) is still very effective at preventing severe illness and death and that the evidence is mixed on whether its efficacy declines over time.

CDC official Sara Oliver in a presentation to the expert advisers on Friday questioned whether waning vaccine protection is due to the passage of time after the first shots, or the spread of the Delta variant.

'A DIFFICULT POSITION'

Scientists say the strongest evidence for boosters is for older adults and other high risk populations, and that the narrow question may be difficult for committee members to parse.

"They're going to be in a difficult position, because I think most of them would believe that over 60 is justified and then under 60 is going to be a gray area," said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, who has reviewed the presentations.

Pfizer, which is arguing for broad use of a third shot, submitted data from an analysis of over 300 participants in a late stage clinical trial showing that the vaccine's efficacy diminished by around 6% every two months after the second dose, and that an additional shot boosted immunity.

The FDA's Vaccines and Related Biological Products Advisory Committee is also considering data from Israel, which began offering a COVID-19 booster https://www.reuters.com/world/middle-east/israel-offers-covid-19-booster-shots-all-vaccinated-people-2021-08-29 to people as young as age 12 last month after starting with people over 60. A top Israeli health ministry official told panelists on Friday that the wide booster campaign was helping reduce cases.

An analysis by Israeli scientists published on Wednesday found that among 1.1 million people age 60 or older who had been fully vaccinated at least five months earlier, those who received a booster were less likely to be infected or become severely ill than those who did not get the third shot.

The Israeli Health Ministry said in documents on Friday that immunity against infection declined during July among all age groups, but particularly among people aged 60 and over who had been vaccinated in January.

Some 2 million Americans have already gotten a booster shot after the government authorized them for people with compromised immune systems, according to the CDC.

The United States is planning a booster campaign as early as next week, contingent on backing by the FDA and CDC.

Eight top health officials in the Biden administration - including the FDA and CDC heads - said in August they believe booster shots will be needed because emerging data shows that protection against COVID-19 decreases over time.

Pfizer shares were off less than 1% at $44.18, while rival Moderna (NASDAQ:MRNA) Inc, which is also pressing for booster shots of its similar vaccine, was down 4% at $422.75.

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29-03-2024 15:59:35 (UTC+7)

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    EUR/USD 1.0777 ↑ Buy  
    GBP/USD 1.2627 ↑ Buy  
    USD/JPY 151.35 ↑ Sell  
    AUD/USD 0.6513 Neutral  
    USD/CAD 1.3551 ↑ Buy  
    EUR/JPY 163.11 ↑ Buy  
    EUR/CHF 0.9719 Neutral  
    Gold 2,254.80 Buy  
    Silver 25.100 ↑ Buy  
    Copper 4.0115 ↑ Buy  
    Crude Oil WTI 83.11 ↑ Buy  
    Brent Oil 86.99 Neutral  
    Natural Gas 1.752 ↑ Sell  
    US Coffee C 188.53 ↑ Sell  
    Euro Stoxx 50 5,082.85 ↑ Sell  
    S&P 500 5,254.35 ↑ Sell  
    DAX 18,504.51 ↑ Buy  
    FTSE 100 7,952.62 ↑ Sell  
    Hang Seng 16,541.42 Neutral  
    Small Cap 2000 2,120.15 Neutral  
    IBEX 35 11,074.60 ↑ Sell  
    BASF 52.930 ↑ Buy  
    Bayer 28.43 Buy  
    Allianz 277.80 ↑ Buy  
    Adidas 207.00 ↑ Buy  
    Lufthansa 7.281 ↑ Sell  
    Siemens AG 176.96 ↑ Buy  
    Deutsche Bank AG 14.582 ↑ Buy  
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# So hôm qua # Chênh TG
SJC Eximbank7,910/ 8,080
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