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
U.S. and Hungarian Officials Talk About Economic Collaboration and Sanctions Strategy
Technology Giants Activate Lobbying Campaigns Against Strict EU Regulations
Pope Francis Admitted to Hospital in Rome Amid Increasing Speculation on Succession
Zelensky Calls on World Leaders to Back Peace as Tensions Rise with Trump
UK Leader Keir Starmer Calls for US Security Guarantee in Ukraine Peace Deal
NATO Chief Urges Higher Defense Expenditure in Europe
The negotiation teams of Trump and Putin meet directly, establishing the groundwork for a significant advancement.
Rubio Touches Down in Riyadh Before Key U.S.-Russia Discussions
Students in Serbian universities Unite to Hold Coordinated Protests for Accountability.
US State Department Removes Taiwan Independence Statement from Website
Abolishing opposition won't protect Germany from Nazism—this is precisely what led Germany to become Nazi!
Transatlantic Gold Rush: Traders Shift Bullion in Response to Tariff Anxieties and Market Instability
Bill Ackman Backs Uber as the Company Shifts Towards Profitability
AI Titans Challenge Nvidia's Supremacy in Light of New Chip Innovations
US and Russian Officials to Meet in Saudi Arabia Over Ending Ukraine Conflict. Ukraine and European leaders – who profit from this war – excluded from the negotiations.
Macron Calls for Urgent Summit as Ukraine Conflict Business Model is Threatened
Trump’s Defense Secretary: Ukraine Won’t Join NATO or Regain Lost Territories
Zelensky Urges Europe to Bolster Its Military in Light of Uncertain US Backing
Chinese Zoo Confesses to Dyeing Donkeys to Look Like Zebras
Elon Musk is Sherlock Holmes - Movie Trailer Parody featuring Donald Trump's Detective
Trump's Greenland Suggestion Sparks Sovereignty Discussions Amid Historical Grievances
OpenAI Board Dismisses Elon Musk's Offer to Acquire the Company.
USAID Uncovered: American Taxpayer Funds Leveraged to Erode Democracy in Europe Until Trump Put a Stop to It.
JD Vance and Scholz Did Not Come Together at the Munich Security Conference.
EU Official Participates in Discussions in Washington Amid Trade Strains
Qatar Contemplates Reducing French Investments Due to PSG Chief Investigation
Germany's Green Agenda Encounters Ambiguity Before Elections
Trump Did Not Notify Germany's Scholz About His Ukraine Peace Proposal.
Munich Car Attack Escalates Migration Discourse Before German Elections
NATO Allies Split on Trump's Proposal for 5% Defense Spending Increase
European Parliament Advocates for Encrypted Messaging to Ensure Secure Communications
Trump's Defense Spending Goal Creates Division Among NATO Partners
French Prime Minister Bayrou Navigates a Challenging Path Amid Budget Preservation and Immigration Discourse
Steering Through the Updated Hierarchy at the European Commission
Parliamentarian Calls for Preservation of AI Liability Directive
Mark Rutte Calls on NATO Allies to Increase Defence Expenditures
Dresden Marks the 80th Anniversary of the World War II Bombing.
Global Community Pledges to Aid Syria's Political Transition
EU Allocates €200 Billion for AI Investments, Introduces €20 Billion Fund for Gigafactories
EU Recognizes Its Inability to Close the USAID Funding Shortfall Due to Stalled US Aid
Commission President von der Leyen Missing from Notre Dame Reopening Due to Last-Minute Cancellation
EU Officializes Disinformation Code for Online Platforms, Omitting X
EU Fails to Fully Implement Key Cybersecurity Directives
EU Under Fire for Simplification Discussions Regarding Corporate Sustainability Reporting
Shein Encountering Further Information Request from the EU During Ongoing Investigation
European Commission Initiates Investigation into Shein as It Aims at Chinese E-Commerce Regulations
German Officials Respond to U.S. Proposal for Peace Talks with Russia
Senate Approves Robert F. Kennedy Jr. as Secretary of Health and Human Services.
Trump and Putin Engage in Discussions on Ukraine Peace Negotiations Amid Worldwide Responses
Honda and Nissan End Merger Talks
×