Connect with us

INTERNATIONAL NEWS

Next On FDA’s Agenda: Booster Shots Of Moderna, J&J Vaccines

Published

on

Vaccines

With many Americans who got Pfizer vaccinations already rolling up their sleeves for a booster shot, millions of others who received the Moderna or Johnson & Johnson vaccine wait anxiously to learn when it’s their turn.

 

 

Federal regulators begin tackling that question this week.

 

 

 

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week.

 

 

 

After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director.

 

 

 

The process is meant to bolster public confidence in the vaccines. But it has already led to conflicts and disagreements among experts and agencies.

 

 

For example, last month the CDC advisory panel backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems.

 

 

But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

Some health experts fear the back-and-forth deliberations are muddling the public effort to persuade the unvaccinated to get their first shots. They worry that the talk of boosters will lead people to wrongly doubt the effectiveness of the vaccines in the first place.

See also  BREAKING: AIB releases Lagos helicopter crash report

 

 

 

As the FDA’s panel meets to review the Moderna and J&J vaccines, its decisions this time are likely to be even more complicated, with experts discussing whether a third Moderna shot should contain just half the original dose and what’s the best timing for a second shot of the single-dose J&J vaccine.

 

 

 

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have not endorsed so far.

 

 

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

 

The two initial Moderna shots contain 100 micrograms of vaccine each. But the drugmaker says 50 micrograms ought to be enough for a booster for healthy people.

 

 

A company study of 344 people gave them a 50-microgram shot six months after their second dose, and levels of virus-fighting antibodies jumped. Moderna said the booster even triggered a 42-fold rise in antibodies able to target the extra-contagious delta variant.

 

 

Side effects were similar to the fevers and aches that Moderna recipients commonly experience after their second regular shot, the company said.

 

 

 

 

J&J released data in September showing that a booster given at two months provided 94% protection against moderate-to-severe COVID-19 infection. The company has not yet disclosed patient data on a six-month booster, but early measures of virus-fighting antibodies suggest it provides even higher protection.

 

 

Even without a booster, J&J says, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the U.S.

 

 

Scientists emphasize that all three vaccines used in the U.S. still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection may wane.

 

 

In one recent study, researchers compared about 14,000 people who had gotten their first Moderna dose a year ago with 11,000 vaccinated eight months ago. As the delta variant surged in July and August, the more recently vaccinated group had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

 

 

Still, medical experts continue to debate the science and rationale for giving extra shots to those who already have significant protection.

 

 

The White House and its top medical advisers announced sweeping plans in August to offer boosters to nearly all adults, citing signs of waning protection and the then-surging delta variant. But they were rebuffed by many experts who said there is little data showing whether such broad use would stop breakthrough infections or curb the overall trajectory of cases.

 

 

While the FDA and CDC ultimately scaled back use of Pfizer boosters, Biden administration officials, including Dr. Anthony Fauci, have suggested that extra shots will eventually be recommended for most Americans.

See also  Record 1.7 Million Migrants Arrested At U.S.-Mexico Border

 

 

They point to data from Israel showing lower rates of infections and severe disease among people who received a third Pfizer shot.

 

 

The FDA meetings come as U.S. vaccinations have climbed back above 1 million per day on average, an increase of more than 50% over the past two weeks. The rise has been driven mainly by Pfizer boosters and employer vaccine mandates.

 

 

By LAURAN NEERGAARD

     MATTHEW PERRONE

 

AP

INTERNATIONAL NEWS

Record 1.7 Million Migrants Arrested At U.S.-Mexico Border

Published

on

migrants

U.S. authorities arrested 1.7 million migrants at the U.S.-Mexico border this fiscal year, the most ever recorded, according to a U.S. government source, underscoring the stark political and humanitarian challenges the Biden administration faces on immigration.

 

 

The Washington Post reported that current numbers for the 2021 fiscal year, which began last October, topped a previous high in 2000.

 

 

 

Adding to concerns was an influx of thousands of mostly Haitian migrants last month who crossed the Rio Grande River from Mexico and set up a makeshift camp under an international bridge in Del Rio, Texas.

 

 

 

President Joe Biden, who took office in January, reversed many of the hard-line immigration policies of his Republican predecessor, President Donald Trump, promising a more “humane” approach to immigration policy.

 

 

 

Democrats and immigration advocates have slammed Biden for his swift expulsions of many of those migrants back to Haiti, a country that has been devastated by violence, political crises and natural disasters.

 

 

The administration also launched an investigation into the tactics of border patrol agents on horseback photographed and filmed in Del Rio trying to push back Haitian migrants along the river bank.

 

 

 

Many of the Haitians were returned under one sweeping Trump policy that Biden has kept in place. Known as Title 42, it was implemented in March 2020 at the beginning of the COVID-19 pandemic in an effort to curb infections and allows most migrants to be quickly expelled without a chance to seek asylum.

See also  We’re Ready For Battle’, Militant Group Confronts Taliban In Afghanistan

 

 

 

Many of the arrests this fiscal year were repeat crossings, with some people expelled to Mexico turning around and trying again.

 

 

 

A federal court has also ordered the Biden administration to reinstate another Trump-era policy known as the Migrant Protection Protocols, which forced thousands of asylum seekers to wait in Mexico for U.S. immigration court hearings. The administration said it is taking steps to restart the program in November, pending agreement from Mexico.

 

REUTERS

 

Continue Reading

INTERNATIONAL NEWS

White House Details Plans to Vaccinate 28M Children Age 5-11

Published

on

Vaccinate

Children ages 5 to 11 will soon be able to get a COVID-19 shot at their pediatrician’s office, local pharmacy and potentially even their school, the White House said Wednesday as it detailed plans Vaccinate for the expected authorization of the  Pfizer shot for elementary school youngsters in a matter of weeks.

 

 

 

Federal regulators will meet over the next two weeks to weigh the safety and effectiveness of giving low-dose shots to the roughly 28 million children in that age group.

 

 

 

Within hours of formal approval, which is expected after the Food and Drug Administration signs off and a Centers for Disease Control and Prevention advisory panel meets on Nov. 2-3, millions of doses will begin going out to providers across the country, along with the smaller needles needed for injecting young children.

 

 

Within days of that, the vaccine will be ready to go into arms on a wide scale.

 

 

“We’re completing the operational planning to ensure vaccinations for kids ages 5 to 11 are available, easy and convenient,” White House COVID-19 coordinator Jeff Zients said. “We’re going to be ready, pending the FDA and CDC decision.”

 

 

The Pfizer vaccine requires two doses three weeks apart and a two-week wait for full protection to kick in, meaning the first youngsters in line will be fully covered by Christmas.

 

 

 

Some parents can hardly wait.

 

Dr. Sterling Ransone said his rural Deltaville, Virginia, office is already getting calls from people asking for appointments for their children and saying, “I want my shot now.”

 

 

“Judging by the number of calls, I think we’re going to be slammed for the first several weeks,” said Ransone, president of the American Academy of Family Physicians.

See also  Ogun Businesswoman Disappears On Way To Vigil In Lagos

 

 

 

Justin Shady, a film and TV writer in Chicago, said his 6-year-old daughter, Grey, got nervous when he told her she would be getting the shots soon. But he is bribing her with a trip to Disney World, and “she’s all in.”

 

 

 

The family likes to travel, “we really just want to get back in the swing of seeing the world,” Shady said.

 

 

 

As for youngsters under 5, Pfizer and Moderna are studying their vaccines in children down to 6 months old, with results expected later in the year.

 

 

 

The Biden administration noted that the expansion of shots to children under 12 will not look like the start of the country’s vaccine rollout 10 months ago, when limited doses and inadequate capacity meant a painstaking wait for many Americans.

 

 

 

The country now has ample supplies of the Pfizer shot to vaccinate the children who will soon be eligible, officials said, and they have been working for months to ensure widespread availability of shots. About 15 million doses will be shipped to providers across the U.S. in the first week after approval, the White House said.

 

 

 

More than 25,000 pediatricians and primary care providers have already signed on to dispense the vaccine to elementary school children, the White House said, in addition to the tens of thousands of drugstores that are already administering shots to adults.

 

 

 

Hundreds of school- and community-based clinics will also be funded and supported by the Federal Emergency Management Agency to help speed the process.

 

 

 

In addition to doctors’ offices, schools are likely be popular spots for the shots.

 

 

See also  July 4th grocery and drugstore chains: Albertsons, Trader Joe's, Kroger, Aldi, CVS are open; Costco is closed

 

In Maryland, state officials have offered to help schools set up vaccination clinics. Denver’s public schools plan to hold mass vaccination events for young children, along with smaller clinics offering shots during the school day and in the evenings. Chicago’s public health department is working closely with schools, which have already been hosting vaccination events for students age 12 and older and their families.

 

 

 

The White House is also preparing a stepped-up campaign to educate parents and children about the safety of the shots and the ease of getting them. As has been the case for adult vaccinations, the administration believes trusted messengers — educators, doctors and community leaders — will be vital to encouraging vaccinations.

 

 

 

Dr. Lisa Reed, medical director for family medicine at MAHEC, a western North Carolina safety net provider that serves patients from rural Appalachia and more urban communities such as the tourist town of Asheville, said it is going to take effort to get some families on board.

 

 

Reed said she lives “in a community that has a lot of vaccine hesitancy, unfortunately.”

 

 

“Some have lower health literacy or belong to ethnic groups that are more hesitant in general” because of a history of mistrust, she said. And Asheville, she said, has a sizeable population of well-educated adults who are longtime vaccine skeptics.

 

 

 

While children run a lower risk than older people of getting seriously ill from COVID-19, at least 637 people age 18 or under have died from the virus in the U.S., according to the CDC. Six million U.S. children been infected, 1 million of them since early September amid the spread of the more contagious delta variant, the American Academy of Pediatrics says.

See also  US Appeals Court Lets Texas Resume Ban On Most Abortions

 

 

 

Health officials believe that expanding the vaccine drive will not only curb the alarming number of infections in children but also reduce the spread of the virus to vulnerable adults. It could also help schools stay open and youngsters get back on track academically, and contribute to the nation’s broader recovery from the pandemic.

 

 

 

“COVID has also disrupted our kids’ lives. It’s made school harder, it’s disrupted their ability to see friends and family, it’s made youth sports more challenging,” U.S. Surgeon General Dr. Vivek Murthy told NBC. “Getting our kids vaccinated, we have the prospect of protecting them, but also getting all of those activities back that are so important to our children.”

 

 

 

Murthy said the administration, which is imposing vaccine mandates for millions of adults, is leaving it up to state and local officials to decide whether to require schoolchildren to get vaccinated. But he said such measures would be “a reasonable thing to consider.”

 

 

 

“It’s also consistent with what we’ve done for other childhood vaccines, like measles, mumps, polio,” he said.

 

 

 

The U.S. has purchased 65 million doses of the Pfizer pediatric shot, which is expected to be one-third the dose given to adults and adolescents, according to officials. They will be shipped in smaller packages of about 100 doses each, so that more providers can deliver them, and they won’t require the super-cold storage that the adult version did at first.

 

 

About 219 million Americans age 12 and up, or 66% of the total population, have received a COVID-19 shot, and nearly 190 million are fully vaccinated.

 

Tanner reported from Three Oaks, Michigan.

__AP

Continue Reading

INTERNATIONAL NEWS

Democrats May Pass Their Agenda After All

Published

on

Democrats

All of a sudden, it appears that the Democrats’ two-bill strategy to pass as much of their agenda as possible is … working as planned? Lots of caveats apply, nothing is agreed to until everything is, and the whole thing could still come apart.

 

 

But Senate Democrats are talking about reaching a deal this week, with Bernie Sanders meeting with Joe Manchin and Kyrsten Sinema and no apparent deal-breakers identified at this point. That’s only the Senate, of course, but all along it’s been hard to believe that House Democrats would reject anything that Sanders and Manchin both supported.

 

Let’s take a step back. What was always hard about this approach was that the party’s agenda was ambitious and the gap between the most and least liberal Democrats was large. That meant that all wings of the party, and especially the most liberal group, were going to have to give up a lot of things they strongly cared about.

 

 

The size of the bill also meant that there were going to be a lot of potential landmines, some of them buried deep in the text. Those could still blow things up; all that Senate Democrats are hoping to get done this week is an overall agreement (a “framework”), with the details to be filled in later — leaving room for someone to object once a final deal is reached. And as always, there’s almost no room for error given the party’s narrow majorities.

 

But two big factors suggest eventual passage is likely.

For one, in contrast with the bipartisan infrastructure deal that passed the Senate in August, everyone negotiating this bill is a Democrat. And given the way elections work these days, with presidential popularity more important to a lawmaker’s re-election than his or her own popularity, all those Democrats have a stake in making President Joe Biden look good.

See also  Victim of Police brutality rendered homeless, losses baby .Sends SoS to Buhari, IGP, Falana, UN, others (see video)

 

 

The other thing? The two bills address issues — such as health care, climate, child care and so on — that Democrats have compromised on numerous times in the past. Seriously: Does anyone think that New York and New Jersey Democrats will ultimately vote against the entire Democratic agenda if relief for state and local taxes isn’t included? Sure, that’s what they’re saying now. And sure, they’ll fight for their districts’ interests. But surely when push comes to shove they’ll accept commitments for the future or some other verbiage from leadership. After all, their districts will benefit from items in both bills, even if they don’t get exactly what they want.

 

 

It’s even possible that the public focus on the total cost of the bill, which everyone seems to agree was a communications nightmare, is playing a helpful role. If there’s one thing that legislators can do, it’s find a compromise between two numbers; that’s a lot easier than haggling over the programs generating the numbers. Meanwhile, since almost no one knows what’s supposed to have been in the bills, Democrats can start talking up whatever they pass, rather than making excuses for what they didn’t.

 

Again: There’s no agreement yet; all they’re working on is a framework, not the full legislative language with all the details; and things could easily still collapse. But I’ve been saying for a while that the eventual outcome to these negotiations is a complete unknown, and I don’t think that’s the case any more.

 

 

Now the most likely outcome is that both bills pass and are signed into law. If that happens, the total size is going to be a lot lower than originally proposed, and a lot of Democratic priorities won’t be included, but it would still cap off an impressive legislative start to Biden’s presidency.

See also  How FirstBank Employees are Making a Difference in their Immediate Environments Through the SPARK Initiative

 

Jonathan Bernstein

 

Continue Reading

Trending

Trending