Budapest Post

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

US regulators OK new COVID-19 shot option from Novavax

US regulators OK new COVID-19 shot option from Novavax

The US is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults.
Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the U.S. -- and one that’s already available in Europe and multiple other countries.

Nearly a quarter of American adults still haven’t gotten their primary vaccinations even this late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more conventional option — a protein-based vaccine.

The Maryland company also hopes its shots can become a top booster choice in the U.S. and beyond. Tens of millions of Americans still need boosters that experts call critical for the best possible protection as the coronavirus continues to mutate.

For now, the FDA authorized Novavax’s initial two-dose series for people 18 and older.

“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.

Before shots begin, the Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week.

Novavax CEO Stanley Erck said he expected the U.S. to expand use of the vaccine beyond unvaccinated adults fairly quickly.

Already the FDA is evaluating it for those as young as 12, Erck said. Novavax also has submitted data on booster doses, including “mix-and-match” use in people who’d earlier received Pfizer or Moderna vaccinations.

The Biden administration has bought 3.2 million Novavax doses so far, and Erck said vaccinations should begin later this month.

Sharon Bentley of Argyle, Texas, is one of the holdouts. Bentley was hesitant about the first COVID-19 vaccines but then her husband volunteered for a Novavax trial, getting two doses and later a booster.

Her husband’s positive experience with a more tried-and-true technology, “that convinced me,” Bentley said, adding that she planned to tell some unvaccinated friends about the option, too.

The Novavax vaccine is made of copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases. It’s a very different technology than the dominant Pfizer and Moderna COVID-19 vaccines that deliver genetic instructions for the body to produce its own copies of the spike protein. The lesser-used Johnson & Johnson option uses a harmless cold virus to deliver spike-making instructions.

Like the other vaccines used in the U.S., the Novavax shots have proved highly effective at preventing COVID-19′s most severe outcomes. Typical vaccine reactions were mild, including arm pain and fatigue. But FDA did warn about the possibility of a rare risk, heart inflammation, that also has been seen with the Pfizer and Moderna vaccines.

The Novavax vaccine was tested long before the omicron variant struck. But last month, the company released data showing a booster dose promised a strong immune response even against omicron’s newest relatives — preliminary evidence that several of the FDA’s scientific advisers called compelling.

Still, U.S. regulators are planning for a fall booster campaign using Pfizer and Moderna shots that better target omicron subtypes — and Novavax also has begun testing updated shots. Erck said the company could have updated doses available late in the year.

European regulators recently cleared the Novavax vaccine to be used as young as age 12, and several countries have authorized booster doses of its original vaccine.

Earlier manufacturing difficulties held up the vaccine, although Erck said those have been solved and Novavax can meet global demand. Much of the company’s vaccine, including doses for the U.S., are being produced by the Serum Institute of India, the world’s largest vaccine manufacturer.
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
Thieves Steal Antonello da Messina Renaissance Masterpieces From Sicilian Museum
Google Launches Pixel 11 With Gemini AI at the Center of Its Hardware Strategy
Russia’s A7 Builds a State-Linked Payments Network Beyond Western Sanctions
AI’s Next Bottleneck Is Power, Not Just Nvidia Chips
Meta Raises AI Spending Target to as Much as $145bn Despite Pressure Over Returns
Danube Drought Exposes Nazi Wrecks and Pushes Central Europe’s Power System to the Brink
Joe Biden’s Cancer Has Spread Beyond His Bones, Hunter Biden Says
Why 2027 Could Be a Strong Year for Stocks—and Why the Forecast Is Fragile
Why Markets May Look Quiet in August After Big Tech Earnings
UK Drought Cuts Harvests and Raises Food-Security Fears
UFO: Pentagon Releases Video of Unidentified Object Tracked Over Middle East
Ukraine Tells Senate Republicans Its Drone War Offers a Blueprint for America
Weight-Loss Drug Boom Tests the Limits of Prescription Advertising Rules
Senate Scrutinises AI-Driven Personalised Pricing
Spain Seeks Mainland Transfers for 1,100 Children Stranded in Ceuta
Spain and Morocco Trade Blame After 72,000 Migrants Enter Ceuta
AI Is Remaking the US Economy, From GDP Growth to iPhone Prices
Europe’s Heat and Drought Are Now Disrupting Power, Shipping and Tourism
Europe’s Drying Rivers Trigger Power Cuts, Factory Shutdowns and Wildfire Emergencies
Record-Low Danube Forces Nuclear Cuts and Emergency Power Curbs
Danube Drought Forces Hungary’s Paks Nuclear Plant Into Full Shutdown
Ceuta Death Toll Rises as Spain and Europe Clash Over Border Response
Valued at $109 Million: F-35B Fighter Jet Crashes in Southern California
Record-Low Danube Exposes Probable Mammoth Remains in Bulgaria
US Says It Has Carried Out Heavy Strikes on Iran After Attempted Attacks on Its Forces
The AI User Nightmare: Private Claude Conversations Leaked to the Internet
Over 24 Hours in the Air: Qantas Airbus Completes Record-Breaking Test Flight
Massive Wildfires Ravage Southern Europe: Fatalities in Greece and Evacuations Across France, Spain, and Turkey
Nvidia Reportedly Takes Vast Texas Data-Centre Lease to Underwrite AI Expansion
FIFA’s Private-Investment Plan for World Cup Rights Draws European Revolt
Apple Briefly Crosses Five Trillion Dollar Valuation as Investors Retreat From AI Bets
Fresh Heatwave Threatens to Rekindle France’s Historic Wildfire Crisis
Following OpenAI's Cyberattack: 'Most Companies Still Do Not Understand What Is Coming'
OpenAI Sued After ChatGPT Allegedly Discouraged Emergency Care Before Near-Fatal Embolism
Miliband Sets Climate and International Law at Centre of UK Diplomacy
Czech Central Bank Governor Rejects Early Euro Entry and Rate-Cut Pressure
Trump Readies New Tariffs as Temporary Global Levy Nears Expiry
Vivienne Westwood Casts Cicciolina, 74, in Its New Autumn Campaign
Dejavu: Germany’s Military Expansion Reshapes Europe’s Strategic Balance With France
Morgan Stanley Builds a Wall Street Lead in AI Infrastructure Finance
High Prices Push Coffee Drinkers Toward Whole Beans and Home Brewing
Trump Draws Boos and Podium Scrutiny at Spain’s World Cup Triumph
Brilliant move: Péter Magyar Moves to Nominate Chess Grandmaster Judit Polgár as Hungary’s President
Spain Defeats Argentina in Extra Time to Win Second World Cup
Current AI Seeks to Build an Open Global AI Infrastructure Outside Big Tech Control
Germany’s Economic Malaise Reopens the Sunday Shopping Debate
Proposed U.S.-Saudi Nuclear Pact Could Permit Limited Uranium Enrichment Under International Safeguards
Netherlands Declares Water Shortage Emergency After Drought Pushes Rivers to Historic Lows
Why Kentucky Fried Chicken Became KFC—and Why the False Explanations Persist
Ukrainian Drones Strike Wildberries Warehouses Deep Inside Russia
×