TIMES.KY

Cayman Islands, Caribbeanand International News
Thursday, Jan 26, 2023

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.
Newsletter

Related Articles

TIMES.KY
Close
0:00
0:00
Prince Andrew and Virginia Giuffre Photo Is Fake: Ghislaine Maxwell
Opinion | Israel’s Supreme Court Claims a Veto on Democracy
Moonwalker Buzz Aldrin Gets Married On His 93rd Birthday
Who’s Threatening Israeli Democracy?
Federal Reserve Probes Goldman’s Consumer Business
China's first population drop in six decades
Microsoft is finalising plans to become the latest technology giant to reduce its workforce during a global economic slowdown
China's foreign ministry branch in Hong Kong urges British gov't to stop the biased and double standards Hong Kong report
Tesla slashes prices globally by as much as 20 percent
1.4 Million Copies Of Prince Harry's Memoir 'Spare' Sold On 1st Day In UK
After Failing To Pay Office Rent, Twitter May Sell User Names
Lisa Marie Presley, singer and daughter of Elvis, dies aged 54
FIFA president questioned by prosecutors
Britain's Sunak breaks silence and admits using private healthcare
Hype and backlash as Harry's memoir goes on sale. Unnamed royal source says prince 'kidnapped by cult of psychotherapy and Meghan'
Saudi Arabia set to overtake India as fastest-growing major economy this year 
Google and Facebook’s dominance in digital ads challenged by rapid ascent of Amazon and TikTok
FTX fraud investigators are digging deeper into Sam Bankman-Fried's inner circle – and reportedly have ex-engineer Nishad Singh in their sights
TikTok CEO Plans to Meet European Union Regulators
UK chaos: Hong Kong emigrants duped by false prospectus
France has banned the online sale of paracetamol until February, citing ongoing supply issues
Japan reportedly to give families 1 million yen per child to move out of Tokyo
Will Canada ever become a real democracy?
Hong Kong property brokerages slash payrolls in choppy market
U.S. Moves to Seize Robinhood Shares, Silvergate Accounts Tied to FTX
Effect of EU sanctions on Moscow is ‘less than zero’ – Belgian MEP
Coinbase to Pay $100 Million in Settlement With New York Regulator
FTX assets worth $3.5bn held by Bahamas securities regulator
A Republican congressman-elect is under investigation in New York after he admitted he lied about his education and work experience.
Brazilian football legend Pele, arguably the greatest player ever, has died at the age of 82.
Hong Kong to scrap almost all its Covid rules
EU calls screening of travellers from China unjustified
US imposes Covid testing for visitors from China
Ukraine President Volodymyr Zelenskyy Addresses Joint Session of Congress - FULL SPEECH
If a country is denied the right to independence by another, it is not in a union. It is in a dictatorship.
Where is Rishi? Chancellor Jeremy Hunt's excuses about the UK's economic challenges just don't make sense
Former FTX CEO Bankman-Fried finally arrested in Bahamas after U.S. files charges
Corruption works: House Financial Services Chair Waters doesn't plan to subpoena her donor, Sam Bankman-Fried, to testify at hearing on FTX collapse
Ronaldo's new contract...
Prince William's godmother resigns honorary royal role after exposing her/their racism
British PM Rishi Sunak pledges further action on strikes to 'protect lives'
Tax fraud verdict again exposes illusion of Trump the master businessman
Tax fraud verdict again exposes illusion of Trump the master businessman.
Double standards: UK lawmakers attack EU chief over Ireland claims
Yellen hints at ‘national security’ probe into Twitter purchase
Elon Musk reinstates Donald Trump's Twitter account.
George W. Bush and Barack Obama will hold back-to-back disinformation conferences
Mission Improbable: Tom Cruise & Queen Elizabeth
Miss Argentina and Miss Puerto Rico are not single anymore
Matt Hancock is back to the jungle
×