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
‘Looks Like a Wig’: Online Users Express Concern Over Kate Middleton
Florida’s Vaccine Revolution: DeSantis Declares War on Mandates
Trump’s New War – and the ‘Drug Tyrant’ Fearing Invasion: ‘1,200 Missiles Aimed at Us’
"The Situation Has Never Been This Bad": The Fall of PepsiCo
At the Parade in China: Laser Weapons, 'Eagle Strike,' and a Missile Capable of 'Striking Anywhere in the World'
The Fashion Designer Who Became an Italian Symbol: Giorgio Armani Has Died at 91
Putin Celebrates ‘Unprecedentedly High’ Ties with China as Gazprom Seals Power of Siberia-2 Deal
China Unveils New Weapons in Grand Military Parade as Xi Hosts Putin and Kim
Rapper Cardi B Cleared of Liability in Los Angeles Civil Assault Trial
Google Avoids Break-Up in U.S. Antitrust Case as Stocks Rise
Couple celebrates 80th wedding anniversary at assisted living facility in Lancaster
Information Warfare in the Age of AI: How Language Models Become Targets and Tools
The White House on LinkedIn Has Changed Their Profile Picture to Donald Trump
"Insulted the Prophet Muhammad": Woman Burned Alive by Angry Mob in Niger State, Nigeria
Trump Responds to Death Rumors – Announces 'Missile City'
Druzhba Pipeline Incident Sparks Geopolitical Tensions
Cost of Opposition Leader Péter Magyar's Economic Plan Revealed
Germany in Turmoil: Ukrainian Teenage Girl Pushed to Death by Illegal Iraqi Migrant
United Krack down on human rights: Graham Linehan Arrested at Heathrow Over Three X Posts, Hospitalised, Released on Bail with Posting Ban
Asian and Middle Eastern Investors Avoid US Markets
Ray Dalio Warns of US Shift to Autocracy
Eurozone Inflation Rises to 2.1% in August
Russia and China Sign New Gas Pipeline Deal
Von der Leyen's Plane Hit by Suspected Russian GPS Interference in an Incident Believed to Be Caused by Russia or by Pro-Peace or by Anti-Corruption European Activists
China's Robotics Industry Fuels Export Surge
Suntory Chairman Resigns After Police Probe
Gold Price Hits New All-Time Record
UK Fintechs Explore Buying US Banks
Greece Suspends 5% of Schools as Birth Rate Drops
Apollo to Launch $5 Billion Sports Investment Vehicle
Bolsonaro Trial Nears Close Amid US-Brazil Tension
European Banks Push for Lower Cross-Border Barriers
Poland's Offshore Wind Sector Attracts Investors
Budapest Central European Fashion Week Kicks Off
U.S. Celebrates Labor Day
Hungarian National Team Captain Scores Epic Goal
EU is getting aggressive: Four AfD Candidates Die Unexpectedly Ahead of North Rhine-Westphalia Local Elections
Japanese Customer Sways from VW to BYD after “Unbelievable” Test Drive amid Dealership Expansion
Nestlé Removes CEO Laurent Freixe Following Undisclosed Relationship with Subordinate
Pickles are the latest craze among Generation Z in the United States.
Giuliani Seriously Injured in Accident – Trump to Award Him the Presidential Medal of Freedom
Deadline Day Delivers Record £125m Isak Move and Donnarumma to City
Nvidia Reveals: Two Mystery Customers Account for About 40% of Revenue
Woody Allen: "I Would Be Happy to Direct Trump Again in a Film"
Lula and Putin Hold Strategic BRICS Discussions Ahead of Trump–Putin Summit
White House Eyes Budapest for Peace Talks
Cave Diving Beneath the Streets of Budapest
Another American Restaurant Chain Opens in Budapest
Hungarian Opposition Politician Supports Ukrainian Commander
Opposition Leader Threatens Media Outlets
×