Month: June 2022

U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week.

The Food and Drug Administration's action follows its advisory panel's unanimous recommendation for the shots from Moderna and Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots, about 1 1/2 years after the vaccines first became available in the U.S. for adults, who have been hit the hardest during the pandemic.

There's one step left: The Centers for Disease Control and Prevention recommends how to use vaccines and its vaccine advisers are set to discuss the shots Friday and vote on Saturday. A final signoff would come from CDC Director Dr. Rochelle Walensky.

At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend "because we understand the urgency of this for American parents."

She said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year.

"So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders," she said.

The FDA also authorized Moderna's vaccine for school-aged children and teens. Pfizer's shots had been the only option for those ages.

For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centers and pharmacies allowed to preorder millions of doses. FDA's emergency use authorization allows manufacturers to begin shipping vaccine across the country. Vaccinations could begin early next week.

While young children generally don't get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the omicron wave and FDA's advisers determined that benefits from vaccination outweighed the minimal risks. Studies from Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor.

"As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death," FDA Commissioner Robert Califf said in a statement.

The two vaccine brands use the same technology but there are differences.

Pfizer's vaccine for kids younger than 5 is one-tenth of the adult dose. Three shots are needed: the first two given three weeks apart and the last at least two months later.

Moderna's is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6.

The vaccines are for children as young as 6 months. Moderna next plans to study its shots for babies as young as 3-months-old. Pfizer has not finalized plans for shots in younger infants. A dozen countries, including China, already vaccinate kids under 5.

Dr. Beth Ebel, professor of pediatrics at University of Washington in Seattle, said the tot-sized vaccines would be especially welcomed by U.S. parents with children in daycare where outbreaks can sideline parents from jobs, adding to financial strain.

"A lot of people are going to be happy and a lot of grandparents are going to be happy, too, because we've missed those babies who grew up when you weren't able to see them," Ebel said.

Source: Voice of America

People infected with the earliest version of the omicron variant of the coronavirus, first identified in South Africa in November, may be vulnerable to reinfection with later versions of omicron even if they have been vaccinated and boosted, new findings suggest.

Vaccinated patients with omicron BA.1 breakthrough infections developed antibodies that could neutralize that virus plus the original SARS-CoV-2 virus, but the omicron sublineages circulating now have mutations that allow them to evade those antibodies, researchers from China reported on Friday in Nature.

Omicron BA.2.12.1, which is now causing most of the infections in the United States, and omicron BA.5 and BA.4, which account for more than 21% of new U.S. cases, contain mutations not present in the BA.1 and BA.2 versions of omicron.

Those newer sublineages "notably evade the neutralizing antibodies elicited by SARS-CoV-2 infection and vaccination," the researchers found in test-tube experiments.

The monoclonal antibody drugs bebtelovimab from Eli Lilly and cilgavimab, a component of AstraZeneca's Evusheld, can still effectively neutralize BA.2.12.1 and BA.4/BA.5, the experiments also showed.

But vaccine boosters based on the BA.1 virus, such as those in development by Pfizer/BioNTech and Moderna, "may not achieve broad-spectrum protection against new omicron variants," the researchers warned.

Previous research that has not yet undergone peer review has suggested that unvaccinated people infected with omicron are unlikely to develop immune responses that will protect them against other variants of the coronavirus.

"My personal bias is that while there may be some advantage to having an omicron-specific vaccine, I think it will be of marginal benefit over staying current with the existing vaccines and boosters," said Dr. Onyema Ogbuagu, an infectious diseases researcher at Yale School of Medicine in New Haven, Connecticut, who was not involved in the new study.

"Despite immune evasion, the expectation can be that vaccines will still protect against serious disease," Ogbuagu said. "If you're due for a booster, get a booster. What we've learned clinically is that it's most important to stay up to date with vaccines" to maintain high levels of COVID-19 antibodies circulating in the blood.

Adolfo Garcia-Sastre, a microbiology and infectious diseases researcher at the Icahn School of Medicine at Mount Sinai in New York City, suggested that better protection might be seen with vaccines that target multiple strains of the virus or with intranasal vaccines that would increase protection from infection and transmission by generating immunity in the lining of the nose, where the virus first enters.

Garcia-Sastre, who was not involved in the research, said by the time one variant-specific vaccine becomes available, a new variant may well have taken over.

Source: Voice of America

Fear swept through financial markets Thursday, and Wall Street tumbled as worries roared back to the fore that the world’s fragile economy may buckle under higher interest rates.

The S&P 500 fell 3.3% in a widespread wipeout to more than reverse its blip of a 1.5% rally from a day before. Analysts had warned of more big swings given deep uncertainties about whether the Federal Reserve and other central banks can tiptoe the narrow path of hiking interest rates enough to get inflation under control but not so much that they cause a recession.

The Dow Jones Industrial Average lost 2.4% and was briefly down more than 900 points, while the Nasdaq composite sank 4.1%. It was the sixth loss for the S&P 500 in its last seven tries, and all but 3% of the stocks in the index dropped.

Wall Street fell with stocks across Europe after central banks there followed up on the Federal Reserve’s big interest-rate hike on Wednesday. The Bank of England raised its key rate for the fifth time since December, though it opted for a more modest increase of 0.25 percentage points than the 0.75-point hammer brought by the Fed.

Switzerland’s central bank, meanwhile, raised rates for the first time in years, a half-point hike. Taiwan’s central bank raised its key rate by an eighth of a point. Japan’s central bank began a two-day meeting, though it has held out on raising rates and making other economy-slowing moves that investors call “hawkish.”

Such moves and expectations for plenty more have sent investments tumbling this year, from bonds to bitcoin. Higher interest rates slow the economy by design, in hopes of stamping out inflation. But they’re a blunt tool that can choke off the economy if used too aggressively.

“Another concern is that with the change in policy, there’s been weakening economic data already,” said Bill Northey, senior investment director at U.S. Bank Wealth Management. “That raises the odds of a recession in the latter part of 2022 into 2023.”

The worries dragged the S&P 500 into a bear market earlier this week, meaning it had dropped more than 20% from its peak. It’s now 23.6% below its record set early this year and back to where it was in late 2020. That effectively erases 2021, which was one of the best years for Wall Street since the turn of the millennium.

The S&P 500 fell 123.22 points to 3,666.77. The Dow lost 741.46 to 29,927.07, and the Nasdaq dropped 453.06 to 10,646.10. Thursday’s biggest losses hit the stocks of the smallest companies, a signal of pessimism about the economy’s strength. The Russell 2000 index of smaller stocks sank 81.30, or 4.7%, to 1,649.84.

Not only is the Federal Reserve hiking short-term rates, it also this month began allowing some of the trillions of dollars of bonds it purchased through the pandemic to roll off its balance sheet. That should put upward pressure on longer-term interest rates. It’s another way central banks have been ripping away supports they earlier propped underneath markets to juice the economy.

The U.S. economy is still holding up, driven in particular by a strong jobs market. Fewer workers filed for unemployment benefits last week than a week before, a report showed on Thursday. But more signs of trouble have been emerging.

On Thursday, one report showed homebuilders broke ground on fewer homes last month. Rising mortgage rates resulting directly from the Fed’s moves are digging into the industry. A separate reading on manufacturing in the mid-Atlantic region also unexpectedly fell.

“Corporate earnings estimates have not yet changed to reflect some of the softening economic data and that could lead to the second leg of this repricing,” Northey said.

Treasury yields swung sharply on Thursday, with the 10-year yield down to 3.23% from 3.39% late Wednesday. It had climbed as high as 3.48% in the morning, near its highest level since 2011.

Higher rates have been delivering the hardest hits this year to the investments that soared the most through the easy, ultralow rates of earlier in the pandemic, which now look to be among the most expensive and risky investments. That includes bitcoin and high-growth technology stocks.

Big Tech stocks were among the heaviest weights on the market Thursday, but the sharpest losses hit stocks whose profits depend more on the strength of the economy and whether customers can keep up their purchases amid the highest inflation in decades.

Cruise operators Norwegian Cruise Line Holdings, Royal Caribbean Group and Carnival all lost more than 11%.

It’s all a sharp turnaround from a day earlier, when stocks rallied immediately after the Fed’s biggest hike to rates since 1994. Analysts said investors seemed to latch onto a comment from Fed Chair Jerome Powell, who said mega-hikes of three-quarters of a percentage point would not be common.

Powell said Wednesday the Fed is moving “expeditiously” to get rates closer to normal levels after last week’s stunning report that showed inflation at the consumer level unexpectedly accelerated last month, which dashed hopes that inflation may have already peaked.

The Fed is “not trying to induce a recession now, let’s be clear about that,” Powell said. He called Wednesday’s big increase “front-end loading.”

Source: Voice of America

Florida is the only state that hasn’t preordered COVID-19 vaccines for toddlers in anticipation of their final approval by the federal government, and Governor Ron DeSantis said Thursday that he won’t facilitate their distribution, though he said they’ll be available to those who want them.

White House spokeswoman Karine Jean-Pierre, who confirmed Florida’s outlier status on Thursday, said not preordering the vaccines could mean delaying their availability in children’s hospitals and other facilities that have relied on state distribution of the shots.

Florida officials said the jabs would be available at pharmacies and community health centers, which can preorder them directly from the federal government, and that children’s hospitals and other clinics would be able to order them from the federal government via a state portal and receive them quickly.

“Doctors can get it. Hospitals can get it. But there’s not going to be any state programs that are going to be trying to get COVID jabs to infants and toddlers and newborns,” DeSantis said at a news conference. “That’s not where we’re gonna be utilizing our resources.”

The final OK could come this weekend for vaccines for kids under 5. The Food and Drug Administration’s vaccine advisers gave a thumbs-up Wednesday to kid-size doses from Pfizer and Moderna for children as young as 6 months, deciding the benefits of the shots outweigh any risks.

Florida’s Health Department does not recommend COVID-19 vaccines for healthy children under 17 but says children with underlying health conditions should be considered candidates for them. That advice contradicts the U.S. Centers for Disease Control and Prevention, which so far has recommended the vaccines for everyone 5 years and older, saying the shots provide strong protection against hospitalization and death.

In Florida, pharmacies and several supermarket chains, plus some community health centers, can preorder vaccines directly from the federal government. Other venues such as hospitals have previously benefited from the state’s preordering of shots. However, they also can order them directly from the federal government via a Florida government web portal and receive the doses within days or a week, said health department spokesperson Jeremy Redfern.

Joe DiMaggio’s Children’s Hospital, which has several centers in South Florida, has previously ordered vaccines via the state portal, officials said.

“As a healthcare institution, our goal is to keep our community healthy and safe, and we will follow the process in place to order approved vaccines for children,” said spokesperson Kerting Baldwin.

Preordering shots would mean the Florida health department would stockpile them, ship them to county-level health departments and then out to hospitals, Redfern said. Hospitals that use the portal will be receiving the shots directly from the federal government, he said.

“The timing doesn’t necessarily change” in a significant way, Redfern said. “This just cuts out the middleman.”

Jean-Pierre, at a news conference in Washington, said parents would be able to access children’s vaccines through federal distribution channels at pharmacies and community health centers, “but those are limited options.”

“We encouraged Florida on several occasions to order vaccines,” Jean-Pierre said. By not doing so, the state “will not have immediate, ready access to some,” she said.

Dr. Michelle Kirwan, chief medical officer and a pediatrician at the Center for Family and Child Enrichment in the suburb of Miami Gardens, said the center gets its supply directly through a federal program.

But she said she was concerned that the state not facilitating the program might confuse parents. She also said some children in this age group may be at a higher risk and their families don’t know it yet.

“I think it adds to the anxiety, which leads to indecision and delays,” Kirwan said. “They will say ‘Who do I listen to?’ Is this going to harm my baby?’ They are between a rock and a hard place.”

Source: Voice of America