TIMES.KY

Cayman Islands, Caribbeanand International News
Monday, May 20, 2024

US Health Regulator Authorizes Pfizer's Covid Pill

US Health Regulator Authorizes Pfizer's Covid Pill

Pfizer's treatment, called Paxlovid, is a combination of two pills taken over five days that was shown in a clinical trial of 2,200 people to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent.

The United States on Wednesday authorized Pfizer's anti-Covid pill for high-risk people aged 12 and up, as a surge of cases driven by the highly infectious Omicron variant threatened holiday plans and Americans struggled to find tests.

Paxlovid, which comprises two types of tablet, was granted an emergency use authorization by the Food and Drug Administration (FDA) after it was shown in a clinical trial to reduce the risk of hospitalizations and deaths among at-risk people by 88 percent.

"Today's action is a testament to the power of science and the result of American innovation and ingenuity," President Joe Biden said in a statement, promising to invoke a law that would help Pfizer ramp up production quickly.

The US has spent $5.3 billion procuring 10 million courses of the treatment, with the first 265,000 to be delivered in January, and the rest by late summer, White House Covid coordinator Jeff Zients told reporters on a call.

The FDA stressed the treatment should complement rather than replace vaccines, which remain the frontline tool against the coronavirus.

But pills that are available at pharmacies should be much easier to access than synthetic antibody treatments, which require infusions administered by drip at hospitals or specialized centers.

The European Union's drug regulator last week allowed member states to use Pfizer's Covid treatment ahead of formal approval, as an emergency measure to curb an Omicron-fueled wave.

The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date -- and testing remains a challenge, with long lines reminiscent of the early part of the pandemic seen across US cities.

Companies including Amazon, Walgreens and CVS have capped how many home tests customers can buy. The Biden administration has promised to ship half a billion of the tests starting from next month, but experts have said that figure is too little and too late.

Not a 'failure'


Biden defended his administration's efforts during an interview with ABC.

"No, I don't think it's a failure" that there aren't enough tests on shelves, the president told the news channel.

He has previously repeated that the country is "ready" to handle a potential rise in hospitalizations and that those who are vaccinated need not "panic."

Health authorities have said Americans should avoid large holiday gatherings and only get together in small numbers with people who are vaccinated.

Biden sought to reassure Americans, saying on ABC: "If you are tested, if you know where you are in terms of having gotten the shots, there's no reason why you can't get together with your family and your friends."

But two of his steps to combat the pandemic -- a nationwide vaccine requirement for large employers and a vaccine mandate for health care workers -- will be put to the test, as the US Supreme Court announced Wednesday it will hold a special hearing on January 7 to consider challenges to those policies.

Every day, about 150,000 Americans are getting infected, 7,800 are being hospitalized and 1,200 are dying, according to the latest Centers for Disease Control and Prevention (CDC) data.

The highly mutated Omicron variant accounts for 90 percent of all cases in some US regions, CDC director Rochelle Walensky told reporters.

Omicron is better able to bypass prior immunity, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.

Unlike vaccines, the Pfizer Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should therefore in theory be more variant-proof, and the company has said preliminary lab studies have backed up that hypothesis.

Paxlovid is a combination of a new molecule, nirmatrelvir, and HIV antiviral ritonavir, that are taken as separate tablets.

Nirmatrelvir blocks the action of an enzyme the virus needs to replicate, while ritonavir slows down nirmatrelvir's breakdown so it remains in the body for longer and at higher levels.

Synthetic antibody treatments developed by Eli Lilly and Regeneron are not effective against Omicron, top scientist Anthony Fauci told reporters, but an antibody treatment by GlaxoSmithKline (GSK) and a prophylactic antibody drug by AstraZeneca remain protective.

The US has bought a million courses of the GSK treatment, with 300,000 expected ready by January, and half a million doses of the AstraZeneca drug, which can be given preventatively to immune-compromised people who don't respond as well to vaccines.

Newsletter

Related Articles

TIMES.KY
0:00
0:00
Close
Paper straws found to contain long-lasting and potentially toxic chemicals - study
FTX's Bankman-Fried headed for jail after judge revokes bail
Blackrock gets half a trillion dollar deal to rebuild Ukraine
Israel: Unprecedented Civil Disobedience Looms as IDF Reservists Protest Judiciary Reform
America's First New Nuclear Reactor in Nearly Seven Years Begins Operations
Southeast Asia moves closer to economic unity with new regional payments system
Today Hunter Biden’s best friend and business associate, Devon Archer, testified that Joe Biden met in Georgetown with Russian Moscow Mayor's Wife Yelena Baturina who later paid Hunter Biden $3.5 million in so called “consulting fees”
Singapore Carries Out First Execution of a Woman in Two Decades Amid Capital Punishment Debate
Google testing journalism AI. We are doing it already 2 years, and without Google biased propoganda and manipulated censorship
Unlike illegal imigrants coming by boats - US Citizens Will Need Visa To Travel To Europe in 2024
Musk announces Twitter name and logo change to X.com
The politician and the journalist lost control and started fighting on live broadcast.
The future of sports
Unveiling the Black Hole: The Mysterious Fate of EU's Aid to Ukraine
Farewell to a Music Titan: Tony Bennett, Renowned Jazz and Pop Vocalist, Passes Away at 96
Alarming Behavior Among Florida's Sharks Raises Concerns Over Possible Cocaine Exposure
Transgender Exclusion in Miss Italy Stirs Controversy Amidst Changing Global Beauty Pageant Landscape
Joe Biden admitted, in his own words, that he delivered what he promised in exchange for the $10 million bribe he received from the Ukraine Oil Company.
TikTok Takes On Spotify And Apple, Launches Own Music Service
Global Trend: Using Anti-Fake News Laws as Censorship Tools - A Deep Dive into Tunisia's Scenario
Arresting Putin During South African Visit Would Equate to War Declaration, Asserts President Ramaphosa
Hacktivist Collective Anonymous Launches 'Project Disclosure' to Unearth Information on UFOs and ETIs
Typo sends millions of US military emails to Russian ally Mali
Server Arrested For Theft After Refusing To Pay A Table's $100 Restaurant Bill When They Dined & Dashed
The Changing Face of Europe: How Mass Migration is Reshaping the Political Landscape
China Urges EU to Clarify Strategic Partnership Amid Trade Tensions
Europe is boiling: Extreme Weather Conditions Prevail Across the Continent
The Last Pour: Anchor Brewing, America's Pioneer Craft Brewer, Closes After 127 Years
Democracy not: EU's Digital Commissioner Considers Shutting Down Social Media Platforms Amid Social Unrest
Sarah Silverman and Renowned Authors Lodge Copyright Infringement Case Against OpenAI and Meta
Italian Court's Controversial Ruling on Sexual Harassment Ignites Uproar
Why Do Tech Executives Support Kennedy Jr.?
The New York Times Announces Closure of its Sports Section in Favor of The Athletic
BBC Anchor Huw Edwards Hospitalized Amid Child Sex Abuse Allegations, Family Confirms
Florida Attorney General requests Meta CEO's testimony on company's platforms' alleged facilitation of illicit activities
The Distorted Mirror of actual approval ratings: Examining the True Threat to Democracy Beyond the Persona of Putin
40,000 child slaves in Congo are forced to work in cobalt mines so we can drive electric cars.
BBC Personalities Rebuke Accusations Amidst Scandal Involving Teen Exploitation
A Swift Disappointment: Why Is Taylor Swift Bypassing Canada on Her Global Tour?
Historic Moment: Edgars Rinkevics, EU's First Openly Gay Head of State, Takes Office as Latvia's President
Bye bye democracy, human rights, freedom: French Cops Can Now Secretly Activate Phone Cameras, Microphones And GPS To Spy On Citizens
The Poor Man With Money, Mark Zuckerberg, Unveils Twitter Replica with Heavy-Handed Censorship: A New Low in Innovation?
Unilever Plummets in a $2.5 Billion Free Fall, to begin with: A Reckoning for Misuse of Corporate Power Against National Interest
Beyond the Blame Game: The Need for Nuanced Perspectives on America's Complex Reality
Twitter Targets Meta: A Tangle of Trade Secrets and Copycat Culture
The Double-Edged Sword of AI: AI is linked to layoffs in industry that created it
US Sanctions on China's Chip Industry Backfire, Prompting Self-Inflicted Blowback
Meta Copy Twitter with New App, Threads
The New French Revolution
BlackRock Bitcoin ETF Application Refiled, Naming Coinbase as ‘Surveillance-Sharing’ Partner
×