Budapest Post

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

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.

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
Japanese Technology Firm Fujitsu Launches Advanced Artificial Intelligence Tool for Corporate Disclosures
South Africa Officially Launches Nationwide Campaign for Highly Contested Local Government Elections
United Kingdom Commits Additional Funding for Unexploded Ordnance Clearance in Laos
Singapore Announces Stringent New Greenhouse Gas Regulations for Commercial Cooling Systems
Cambodia and Thailand Hold High-Level Border Security Talks at United Nations Headquarters
Myanmar Military Government and China Sign Major Agreement to Upgrade Media and Cultural Cooperation
Knife Attack at Swiss Train Station Leaves Three Injured in Suspected Act of Domestic Terrorism
Transnational Extortion Gang Threatens Canadian Police With Army of One Thousand Armed Operatives
Australia Imposes Forty-Two-Day Quarantine on Cruise Ship Passengers Following Deadly Hantavirus Outbreak
International Monetary Fund Unlocks Seven Hundred Million United States Dollars for Sri Lanka Following Economic Reforms
Australia Launches Record One Point Four Billion Dollar Lawsuit Against Chemical Giant 3M Over Contamination
China and Canada Foreign Ministers Meet in Ottawa in Effort to Stabilize Strained Diplomatic Ties
Indonesia Demands Urgent United Nations Security Council Reform Amid Escalating Global Conflicts
Extreme Weather Patterns Trigger Severe Drought in Madagascar and Destructive Flooding in East Africa
Indian State of Karnataka Faces Political Upheaval as Chief Minister Siddaramaiah Abruptly Resigns
Philippines and Japan Reaffirm Defense Ties as Crucial for Indo-Pacific Regional Stability
Norway Joins French Nuclear Deterrence Initiative in Major Shift for European Security Architecture
Global Critical Mineral Alliances Expand as Western Nations Move to Counter Chinese Supply Dominance
United States Imposes Fifty Percent Tariffs on Mexican Steel and Aluminum Ahead of Trade Pact Review
European Union and China Head Toward Major Trade Conflict Over Clean Technology Exports
United States Economic Growth Severely Downgraded to One Point Six Percent as Stagflation Fears Mount
World Health Organization Warns Central African Ebola Epidemic is Outpacing Containment Efforts
United States Treasury Department Conditions Sanctions Relief on Reopening of the Strait of Hormuz
Iranian Air Defenses Intercept and Destroy United States Military Drone Over Bushehr Province
Iranian Armed Forces Launch Ballistic Missiles Toward Unspecified Targets Prompting Regional Condemnation
United Nations Secretary-General Warns Global Order Facing Highest Level of Conflict Since 1945
Israel Issues Sweeping Evacuation Orders in Southern Lebanon Amid Intensified Hezbollah Conflict
Russia Announces Systemic Military Strikes Targeting Ukrainian Defense and Energy Infrastructure
United States and Iranian Negotiators Reach Draft Agreement to Extend Ceasefire and Resume Nuclear Talks
United Nations Security Council Deeply Divided Over United States Capture of Venezuelan President
US and Iran Exchange Direct Military Strikes Amid Fragile Gulf Ceasefire
World Health Organization Warns of Catastrophic Ebola Outbreak in DR Congo
Russia Threatens New Wave of Strikes on Ukrainian Infrastructure and Embassies
Scientists Warn Atlantic Ocean Currents Could Collapse Faster Than Projected
Anthropic Reaches $900 Billion Valuation in Historic AI Funding Round
Washington Imposes Crippling Sanctions on Iranian Maritime Authority
Japan and the Philippines Initiate Strategic Intelligence-Sharing Pact
Microsoft Deploys Autonomous Computer-Using AI Agents to Global Markets
Anthropic Secures $45 Billion Compute Infrastructure Agreement With SpaceX
U.S. Director of National Intelligence Resigns Amid Administration Shakeup
Micron Technology Crosses Trillion-Dollar Valuation Amid Unprecedented Hardware Demand
Canada and Germany Finalize Historic Long-Term LNG Export Agreement
China Expands International Travel Restrictions on Domestic AI Researchers
Japan Approves Sweeping Overhaul of National Intelligence Apparatus
Global Airlines Scramble Logistics as Middle East Airspace Remains Fractured
Japan's Naphtha Imports Plunge 47 Percent Amid Strait of Hormuz Closure
Global Crude Prices Retreat Below $96 as Gulf Tensions Momentarily Ease
Generative AI Outperforms Human Baselines in Landmark Global Creativity Study
NASA Partners With Private Aerospace to Unveil Permanent Lunar Base Architecture
South Korean Equity Markets Surge on Next-Generation Memory Chip Frenzy
×