Vincerx Pharma Reports Third Quarter 2021 Financial Results and Provides a Corporate Update

Vincerx Pharma Reports Third Quarter 2021 Financial Results and Provides a Corporate Update

Study shows dramatic decline in effectiveness of all 3 COVID-19 vaccines over time – Honolulu Star-Advertiser

Study shows dramatic decline in effectiveness of all 3 COVID-19 vaccines over time – Honolulu Star-Advertiser

November 10, 2021

As the Delta variant became the dominant strain of coronavirus across the United States, all three COVID-19 vaccines available to Americans lost some of their protective power, with vaccine efficacy among a large group of veterans dropping between 35% and 85%, according to a new study.

Researchers who scoured the records of nearly 800,000 U.S. veterans found that in early March, just as the Delta variant was gaining a toehold across American communities, the three vaccines were roughly equal in their ability to prevent infections.

But over the next six months, that changed dramatically.

By the end of September, Modernas two-dose COVID-19 vaccine, measured as 89% effective in March, was only 58% effective.

The effectiveness of shots made by Pfizer and BioNTech vaccine, which also employed two doses, fell from 87% to 45% in the same period.

And most strikingly, the protective power of Johnson & Johnsons single-dose vaccine plunged from 86% to just 13% over those six months.

The findings were published Thursday in the journal Science.

The three vaccines held up better in their ability to prevent COVID-19 deaths, but by July as the Delta variant began to drive a three-month surge of infections and deaths the shots effectiveness on that score also revealed wide gaps.

Among veterans 65 and older who were inoculated with the Moderna vaccine, those who developed a breakthrough infection were 76% less likely to die of COVID-19 compared with unvaccinated veterans of the same age.

Older veterans who got the Pfizer-BioNTech vaccine and subsequently experienced a breakthrough infection were 70% less likely to die than were their unvaccinated peers.

And when older vets who got a single jab of the J&J vaccine suffered a breakthrough infection, they were 52% less likely to die than their peers who didnt get any shots.

For veterans under 65, the Pfizer-BioNTech and Moderna vaccines provided the best protection against a fatal case of COVID-19, at 84% and 82%, respectively. When younger veterans inoculated with J&J vaccine suffered a breakthrough infection, they were 73% less likely to die of COVID-19 than were their unvaccinated peers.

Johnson & Johnson representatives did not immediately respond to requests to discuss the studys findings.

The Centers for Disease Control and Prevention has recommended booster shots for everyone who got the Johnson & Johnson vaccine at least two months earlier.

Boosters are also recommended six months after a second dose of the Moderna or Pfizer vaccines for everyone 65 and older; those with medical conditions that make them more vulnerable to a serious case of COVID-19; those who live in nursing homes or other group settings; and those who live or work in high-risk settings like hospitals or prisons.

In addition, all people with compromised immune systems are advised to get a booster shot if its been at least 28 days since their vaccine took full effect.

With millions of vaccinated Americans pondering whether they need a boost, the new study offers the most comprehensive comparison yet of how the three vaccines have performed across the nation this year.

It tracked 780,225 veterans of the U.S. armed forces from Feb. 1 to Oct. 1. Close to 500,000 of them had been vaccinated, while just under 300,000 had not.

Hailing from across the country, all were cared for by the Veterans Affairs unified system, which provides health care to 2.7% of the U.S. population. While the group under study was ethnically and racially diverse, the record-keeping that researchers relied upon was uniform.

Because these were veterans, the study population comprised six times as many men as women. And they skewed older: about 48% were 65 or older, 29% were between 50 and 64, and 24% were under 50.

While older veterans were more likely to die than younger vets throughout the study period, the decline of the vaccines protection against illness and death was seen in both young and old.

The study was conducted by a team from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center.

Dr. Barbara Cohn, the studys lead author, said in addition to its comparison of COVID-19 vaccines, the groups analysis provides a lens for making informed decisions around primary vaccination, booster shots, and other multiple layers of protection. That includes mask mandates, coronavirus testing and other public health measures aimed at countering viral spread.

Strong evidence of the vaccines declining power should prompt even states and locales with highly vaccinated populations to consider retaining mask mandates, the authors said. And the findings strongly support the CDCs recent recommendation that all recipients of the J&J vaccine get a booster.

The study concluded that the Delta variant, which drove a wave of infections and deaths across the country this spring and summer, was likely the factor that most eroded the protection of vaccines.

Other researchers have found similar evidence of declining vaccine effectiveness. But they have suggested that the immune systems defenses against SARS-CoV-2 simply fade with time, and that waning vaccine effectiveness would likely have been seen with or without the arrival of a new, more transmissible strain.

Distributed by Tribune Content Agency LLC.


See more here: Study shows dramatic decline in effectiveness of all 3 COVID-19 vaccines over time - Honolulu Star-Advertiser
What is the Valneva COVID-19 vaccine? Is it better? – Deseret News

What is the Valneva COVID-19 vaccine? Is it better? – Deseret News

November 10, 2021

A new COVID-19 vaccine aims to stop the entire novel coronavirus not just provide antibodies to stop the spike protein of the virus.

Per Al Jazeera, French pharmaceutical company Valneva has created a COVID-19 vaccine that stimulates an immune response to the entire virus, and that might just give it an edge over its competitors.

The vaccine has been making headlines for successful trials. The vaccine reportedly provided more protection against COVID-19 compared to the AstraZeneca vaccine in a clinical trial, which led the company to prepare for approval from European regulators, according to Bloomberg.

Scientists are working hard to find new ways to stop the coronavirus. As I wrote for the Deseret News, researchers from Duke Human Vaccine Institute and the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill discovered an antibody that could stop COVID-19 and other coronavirus variants.


Read the rest here: What is the Valneva COVID-19 vaccine? Is it better? - Deseret News
3 LAPD employees face firing after refusing COVID-19 vaccines or testing, while thousands of others agree to plan – The Mercury News

3 LAPD employees face firing after refusing COVID-19 vaccines or testing, while thousands of others agree to plan – The Mercury News

November 10, 2021

The Los Angeles Police Department has placed on leave at least three employees who refused to either get vaccinated against COVID-19 or follow the citys requirement to get tested weekly.

LAPD Chief Michel Moore told police commissioners Tuesday that the three a pair of sworn officers and a civilian employee were a tiny fraction of the thousands of department employees who were asked last week to sign agreements to follow the citys vaccination mandate.

LAPD supervisors are personally approaching the employees who have not agreed yet to the citys mandate and asking their intentions.

Our desire would be to have all of (the remaining) notices served forthwith, Moore said.

L.A. city employees have until December to get fully vaccinated. Under plans hashed out with the citys unions, those employees with legitimate medical or religious reasons for not getting vaccinated are still required to get tested weekly. And they have to pay for the tests.

Moore said 2,239 LAPD employees had sought such exemptions, which are still subject to review and approval by city administrators. Some might have since chosen to get vaccinated.

On Tuesday, Moore and police commissioners indicated they were confident the mandate was working. The departments vaccination rate now stands at 78%, with that percentage of employees having received at least one shot.

LAPD has about 9,500 sworn officers and 2,500 civilian employees.

The surge in vaccinations among LAPD employees comes after the department appeared to lag for months behind other city agencies. In September, Police Commission President William Briggs harshly criticized officers who still hadnt been vaccinated, saying as employees in public-facing roles they endangered L.A. residents.

On Tuesday, he was far more upbeat.

We are taking strides not steps strides in the right direction, Briggs said.

Moore said the departments mobile vaccine clinic had gotten shots to thousands of employees so far at least 1,500 since the program was started over the summer in response to LAPDs lagging vaccination rate.

He said in just the last week, 429 employees have used the mobile clinics. That number included more than 170 officers and civilians getting vaccinated for the first time, and others who got their booster shots.

At least 10 LAPD employees have died from COVID-19 since March 2020.

We want to make sure we dont lose anyone (else to the virus), Moore said, and that they dont lose their career over something emotionally charged.

Of the three employees who refused, all have been assigned to home, Moore said. They will face administrative hearings to determine whether theyll keep their jobs.

LAPD didnt identify the employees. But one, Mike McMahon, a 14-year veteran of the department, said in an Instagram video on Saturday, Nov. 6, that he had his gun and badge taken away last week after he refused to sign the agreement.

I did just leave the captains office not too long ago, he said. I did refuse everything. I was subsequently relieved of duty, returned my gun, my badge, my police ID. All of my police powers have been suspended and I have been assigned to home, pending a Board of Rights, for which is essentially going to be an insubordination charge, which will ultimately result in termination from the department.

McMahon said he is part of a group of officers called Roll Call 4 Freedom, which opposes the mandates for L.A. city employees. McMahon appeared at a protest on Monday, Nov. 8, at Grand Park in downtown Los Angeles, speaking to a large group of vaccine opponents.

Union leaders said last week that officers who refuse to get vaccinated would not face insubordination charges. Rather, theyll be judged on whether theyre fit for duty, a less serious charge than insubordination. If theyre found unfit and fired, they could still return to LAPD if they later get vaccinated.


Read more: 3 LAPD employees face firing after refusing COVID-19 vaccines or testing, while thousands of others agree to plan - The Mercury News
UW-Madison testing COVID-19 vaccine in children 6 months to 4 years old – Wisconsin Public Radio News

UW-Madison testing COVID-19 vaccine in children 6 months to 4 years old – Wisconsin Public Radio News

November 10, 2021

As children ages 5 to 11 begin to get vaccinated against COVID-19, even younger kids are participating in clinical trials that will determine if they will be able to get similar protection against the disease in the near future.

This week, the University of Wisconsin School of Medicine and Public Healthannounced a phase 3 clinical trial of the Moderna vaccine in kids ages 6 months to 4 years old had filled up. The trial has been underway for two weeks.

"Weve had an overwhelming response from the Madison community," said Dr. Bill Hartman. "So, we had way more people interested in the study than we had spots."

Hartman is co-principal investigator of the KidCOVE clinical trial at UW-Madison, which also tested the Moderna vaccine on children ages 5 to 11.

So far, the Pfizer vaccine is the only brand approved for that age group. Moderna could seek emergency use authorization for children ages 5 to 11 next month, Hartman said.

The parents of 4-year-old twins Sam and Theo Rodriguez were eager to participate in the study for the sake of science and to protect their family. The children started school this fall and their grandmother, who has diabetes and COPD, lives with them at their home in eastern Dane County.

No one in the family has ever participated in clinical trial before, said their mother, Anne Rodriguez. But she said they were watching for this opportunity in hopes of potentially getting early access to a vaccine for their young children.

Hartman expects the Moderna clinical trial in these younger children to be finished in mid-December. Pfizer is further along in testing its vaccine on children under age 5, but federal approval isnt expected until 2022.


Read more here: UW-Madison testing COVID-19 vaccine in children 6 months to 4 years old - Wisconsin Public Radio News
Can your child get the flu and COVID-19 vaccines at the same time? Here’s what health officials say. – News 12 Bronx

Can your child get the flu and COVID-19 vaccines at the same time? Here’s what health officials say. – News 12 Bronx

November 10, 2021

News 12 Staff

Nov 10, 2021, 1:04pm

Updated on: Nov 10, 2021, 1:10pm

Can your child get the flu and COVID-19 vaccines at the same time?

Dr. Sharon Nachman, a pediatric infectious disease specialist and the director of the Office of Clinical Trials at Stony Brook Children's Hospital, suggests that your child receive the shots in different arms.

"We have a history of vaccinating our kids with multiple vaccines," says flu specialist Richard Webby of St. Jude Children's Research Hospital.

Staying up to date on all vaccinations will be especially important this year, experts say.

Since people were masked and staying home, last year's flu season barely registered. This year, it's unclear how intense the flu season will be with more places reopening.

"The worry is that if they both circulate at the same time, we're going to have this sort of 'twin-demic,'" Webby says. "The concern with that is that it's going to put extra strain on an already strained health care system."

The CDC recommends an annual flu vaccine for everyone 6 months and older, and says ideally everyone should be vaccinated by the end of October. It takes 10 to 14 days for the flu vaccine to take full effect so if you wait until the flu begins circulating, your body may not have time to build up protection. Vaccine options vary by age but include several types of shots or a nasal spray version.

One caution: COVID-19, colds and flu all share similar symptoms so if you feel ill, the CDC says to postpone a vaccination appointment until you're better to avoid getting others sick.

AP wire services contributed to this report.


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Can your child get the flu and COVID-19 vaccines at the same time? Here's what health officials say. - News 12 Bronx
Answering kids’ (and parents’) questions about the Covid-19 vaccine for ages 5 to 11 – CNN

Answering kids’ (and parents’) questions about the Covid-19 vaccine for ages 5 to 11 – CNN

November 10, 2021

"My mommy and my papi said that it will help keep me, my friends, my neighbors, my abuela all healthy," Rosita tells CNN Chief Medical Correspondent Dr. Sanjay Gupta on the sixth town hall co-hosted by CNN and Sesame Street's Big Bird and friends.

"Your parents are absolutely right," Gupta tells Rosita. "Covid vaccines are now available for children 5 years and older and the more people who get them, the better we're going to be able to help stop the spread of Covid and keep everyone healthy."

Will it hurt?

"I never lie to kids. I never tell them it's not going to hurt at all or you're not going to feel it, because it's just not true," said Hill, who is a co-host on the American Academy of Pediatrics' flagship podcast, "Pediatrics on Call."

Parents are bound to hear this question before they get into the car to go get the vaccine, and Hill has some ready advice:

"You want to be honest. You want to say, 'You know what, it's going to hurt just a little bit, but it's not going to hurt as bad as some other things that happen to you all the time -- like falling down when you're running or stubbing your toe.'"

Can you keep it from hurting?

Being told it will hurt -- even just a bit -- might still be alarming for some kids, especially those who are hesitant about needles. There are things parents (and health care practitioners) can do just before and during the shot that can help, Hill said.

Give the child a sense of control. Talk with the child about what they can do, such as deciding where they would like to receive the shot.

"You like to play baseball and you're right-handed, right? Maybe you want to have the shot in your left arm instead of your right," Hill said.

Use distraction and calming techniques. Hill suggests talking to children in advance about how they can use breathing and distraction techniques to reduce their focus on the shot.

He suggests asking your child: "'Do you know that if you take a breath and blow out really slowly things hurt less? They also hurt less if you're singing or if you're holding my hand.'

"If you can reassure children that yes, you're going to have control, and yes, it's going to hurt a little, but we're going to help you keep it from hurting as much as you think, those things can be very helpful," Hill said.

A child could also hold some ice to their arm to numb it just before the shot, Foy and McLarney suggested. (Buy an instant cold-pack to use or check with your pediatrician in advance to see if they can refrigerate one.)

Pop-it toys, fidget spinners, bubble wrap, squeeze balls, even vibrating toys can also be great distractions, they said. Older children may benefit from creating a playlist of songs to listen to, playing a video game, or cuing up a distracting video to watch.

Play a fun activity to do after. Kids get excited about family outings, visits to their favorite places and play dates, experts say. So plan something fun they can look forward to.

Positive attitudes are key

Getting vaccinated is a positive thing, and parents should emphasize the benefits, experts stress, such as more play dates with friends and seeing relatives or family friends who have been off limits due to age or immune status.

"The data has been really compelling. We knew how good the vaccines were from the initial data: They reduce the likelihood of infection 11.5 times and reduce the likelihood of getting severely ill 20 times. They're not perfect. They're really, really good," Gupta said.

As far as kids are concerned, this is just one more shot just like all the others they get, Hill stressed.

"How they react is going to be very largely -- if not completely -- dependent on how the adults in their lives frame the experience," he said.

"If we are expressing concern, skepticism or worry, they're absolutely going to pick up on that. If we're expressing confidence and relief, they're going to pick up on that as well. And children are always listening, even when we think they aren't," he added.

Mixing Covid-19 and flu vaccine

Many parents want to know if they can get their child immunized from the flu at the same time they are receiving the Covid-19 vaccine.

"The answer is yes," Gupta told Berman. In fact, he said, pediatricians often encourage getting multiple vaccines on the same day.

"It's easier that way -- you don't have to keep bringing the child back," Gupta said. "They'll have a sore arm for a couple of days, but get both shots. It may be a worst flu season this year."

Wen stressed that even healthy children need to get the Covid-19 vaccine as soon as possible.

"About one-third of the children who have been hospitalized from Covid-19 are those with no underlying health conditions. Healthy children can become very sick from coronavirus," she said.

Side effects

Speaking of sore arms, what other side effects should parents look for from the Covid-19 vaccine?

The authorized dosage for ages 5 to 11 is 10 micrograms, or one-third the 30 microgram dose given to adults and kids age 12 and older.

"Some parents may be worried about long-term side effects," Wen added. "There is no scientific reason to think that this would happen. Side effects from other immunizations occur within the first two or three weeks following the shots, not months afterward."

One safety concern has been the risk of myocarditis, an inflammation of the heart muscle, and pericarditis, the inflammation around the heart, which has appeared occasionally in younger adults who received the vaccine.

The clinical trials on ages 5 to 11 were careful to track any responses that might be warning signs and saw no cases of myocarditis in the children's trial, said Dr. Emanuel "Chip" Walter Jr., chief medical officer of the Duke Human Vaccine Institute and professor of pediatrics at the Duke School of Medicine in Durham, North Carolina, who led one of the trials.

Can children with food allergies get vaccinated?

There's no reason to avoid the Covid-19 vaccine if your child has a common food allergy, Wen stressed.

"The Covid-19 vaccines do not contain egg products, as some other vaccines do. If your child has a food allergy or had a reaction to another vaccine in the past, that is not a reason to refrain from the Covid-19 vaccine," she said.

"Your doctor will help you decide if it is safe for you to get vaccinated," the CDC wrote.

Overall, the only reason not to get this vaccine, according to the CDC, is if the child has a severe allergic reaction to one of its components -- PEG or polysorbate.

"PEG is an ingredient in the mRNA vaccines (Pfizer-BioNTech and Moderna), and polysorbate is an ingredient in the J&J/Janssen vaccine," the CDC states.

When is my child fully vaccinated?

Just like with adults, a child is considered fully vaccinated two weeks after the second injection. At this point, there is no way for children to be fully vaccinated by Thanksgiving or Hanukkah, experts say. Therefore all precautions, including masking and social distancing from high-risk family members, should be followed.

As long as the first shot is administered by November 19, a child will have full protection for Christmas, Kwanzaa and end-of-year gatherings.

CNN's Madeline Holcombe, Katie Hurley and Faye Chiu contributed to this story.


Read this article: Answering kids' (and parents') questions about the Covid-19 vaccine for ages 5 to 11 - CNN
IDOH: Less than 6,500 kids age 5-11 received first COVID-19 vaccine shot last week – WANE

IDOH: Less than 6,500 kids age 5-11 received first COVID-19 vaccine shot last week – WANE

November 10, 2021

INDIANAPOLIS, Ind. (WANE) Since expanding vaccine eligibility to kids 5-11, a number of younger children in Indiana have received their first dose of the COVID-19 vaccine.

According to the Indiana Department of Health (IDOH), 6,445 children age 5-11 received their first shot since it was approved last week. That is barely more than one percent of Hoosiers in that age category.

Despite the low number of younger children receiving a COVID-19 vaccine, vaccine rollout is at its busiest levels since this past spring. The state is administering more than 18,000 shots per day, with most being boosters. The 7-day average of shots administered peaked at just over 22,000 per day in late October.

Across the state, just under 3.3 million Hoosiers are fully vaccinated against COVID-19. That is more than half of the eligible population, but still below national averages.


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IDOH: Less than 6,500 kids age 5-11 received first COVID-19 vaccine shot last week - WANE
NYS COVID-19 vaccine incentive program gives 5- to 11-year-olds chance to win SUNY or CUNY scholarship – WKBW-TV

NYS COVID-19 vaccine incentive program gives 5- to 11-year-olds chance to win SUNY or CUNY scholarship – WKBW-TV

November 10, 2021

NEW YORK (WKBW) New York Governor Kathy Hochul announced a new COVID-19 vaccine incentive program for 5- to 11-year-olds Tuesday.

"Vaccinate, Educate, Graduate" gives the parents and guardians of 5- to 11-year-olds who receive their first COVID-19 vaccine dose by December 19 the ability to enter for a chance for their child to win a full scholarship to any two- or four-year SUNY or CUNY college or university. There will be 50 scholarships awarded over a five-week period with 10 announced each week beginning November 24.

- Gov. Hochul

The winners will receive the following:

Parents and guardians can enter their eligible children here or call 1-833-697-4829 to submit an entry over the phone. You can find the official rules here.

"New Yorkers looking to schedule vaccine appointments for 5- to 11-year-old children are encouraged to contact their child's pediatrician, family physician, county health departments, Federally Qualified Health Centers (FQHCs), rural health centers, or pharmacies that may be administering the vaccine for this age group," a release says.


Read more: NYS COVID-19 vaccine incentive program gives 5- to 11-year-olds chance to win SUNY or CUNY scholarship - WKBW-TV
Mandatory vaccinations for most Florida health workers remain in place  for now – The News-Press
Navy’s shipyards, already struggling to maintain fleet, will lose workers over COVID-19 vaccine – Kitsap Sun