Covid News Watch
Next up for COVID Vaccines: Kids Under 12 + More
Next up for COVID Vaccines: Kids Under 12
The U.S. Food and Drug Administration has given full approval to Pfizer’s coronavirus vaccine for people age 16 and older. Approval for youths ages 12-15 is expected to follow soon.
“I don’t think it’ll be long before they extend it to 12 to 15 — maybe within a few weeks to a month or so,” said Dr. Bob Frenck, director of the Vaccine Research Center at Cincinnati Children’s Hospital.
Parents are already clamoring to hear more about approval or authorization for children under 12, however. Studies looking at that are underway.
NIH Director: Vaccine Approval for Kids Unlikely Before Late 2021
One of the federal government’s top public health experts on Tuesday predicted it is unlikely children under the age of 12 will be eligible to receive the coronavirus vaccine before late 2021, contradicting the speedier timelines offered by other Biden administration officials.
Vaccine makers Pfizer and Moderna are currently studying the shot’s safety and efficacy in younger children and infants, with Pfizer expected to deliver the results of its trials for 5-11-year-olds to the Food and Drug Administration sometime in September.
New CDC Studies Point to Waning Immunity From Vaccines
Two new studies from the Centers for Disease Control and Prevention show fully vaccinated Americans’ immunity to COVID-19 is waning as the more-transmissible Delta variant continues to spread across the country.
One study, which focused on frontline health care workers, found that vaccine effectiveness declined by nearly thirty percentage points since the Delta variant became the dominant strain in the U.S. The analysis also concluded that the COVID-19 vaccines were 80% effective in preventing infection among the frontline health care workers.
Caught in the Crossfire Over COVID’s Origin
In the early days of the pandemic, scientists reported a reassuring trait in the new coronavirus: It appeared to be very stable. The virus was not mutating very rapidly, making it an easier target for treatments and vaccines.
At the time, the slow mutation rate struck one young scientist as odd. “That really made my ears perk up,” said Alina Chan, a postdoctoral fellow at the Broad Institute in Cambridge, Mass. Dr. Chan wondered whether the new virus was somehow “pre-adapted” to thrive in humans, before the outbreak even started.
“By the time the SARS-CoV-2 virus was detected in Wuhan in late 2019, it looked like it had already picked up the mutations it needed to be very good at spreading among humans,” Dr. Chan said. “It was already good to go.”
New Evidence Points to Antibodies as Reliable Indicator of Vaccine Protection
When Dr. Anthony Fauci spoke recently at a White House briefing about the need for COVID-19 booster shots, buried in his slideshow of charts and data points was a little-noticed scientific paper that offers evidence for a reliable way to predict how much protection a COVID-19 vaccine offers.
The study appeared on a preprint server earlier this month without much fanfare, but many interested in the future of COVID-19 vaccines had been eagerly awaiting the results.
The researchers were looking for markers in vaccinated patients’ blood that would indicate protection against COVID-19, what’s known as “correlates of immunity.” What the team of scientists found were neutralizing antibodies — proteins made by the immune system that are known to disarm the coronavirus.
Where Do Moderna and Johnson & Johnson Stand on Full FDA Approval?
While the FDA approval of the Pfizer COVID-19 vaccine is welcome news for public health officials hoping it boosts vaccine uptake, it’s just one of the three COVID-19 vaccines in the U.S. So far, Moderna and Johnson & Johnson are still under Emergency Use Authorization.
Back in June, Moderna announced it would start “rolling submission” of data to the FDA for approval over the coming weeks. Moderna said it would request a Priority Review. This designation would call for the FDA to make a decision within six months rather than the typical 10-month waiting period.
Pfizer started that process in May and the FDA made a decision four months later. It means Moderna’s full FDA approval could come as early as next month.
Biden to Receive a Classified Report on The Origins of COVID-19
Leila Fadel, host:
Today marks 90 days since President Biden ordered a systematic review into the origins of the coronavirus. Many scientists believe that the virus likely came from nature. But an alternative view is that it leaked from a laboratory in China, a theory that had been dismissed by many as a conspiracy theory until recent months. Joining us to discuss what this report might say is NPR’s science and security correspondent Geoff Brumfiel.
The NFL’s COVID Reality: Unvaccinated Players Are a Liability
For months, the NFL’s vaccine stragglers have clung to the nebulous need for more. More data, more research, more approval.
Now they’ll need more excuses.
That’s what Monday’s biotech news brought, by way of the FDA’s approval of the Pfizer vaccine. It’s a development that is sure to be followed in the coming months by other approvals in the space, just as it’s sure to be blown off by some NFL players who refuse to get vaccinated. But this time around, players won’t be able to lean on the lack of an FDA approval, leaving some to continue grasping at their own nebulous concoction for why they refuse an added layer of protection from COVID-19.
Carnival Calls Circumstances of Passenger’s COVID-Related Death ‘Disinformation’
Carnival Cruise Line is calling the circumstances of a COVID-related death that occurred to a cruise passenger last month “disinformation” after suggestions were made that the passenger contracted the virus on board.
“Regrettably, there is a fair amount of disinformation about the circumstances of this matter,” Carnival said in a statement. “The guest almost certainly did not contract COVID on our ship, and she was assisted with expert medical care on board and was ultimately evacuated from Belize after we provided a resource to her family.”
FDA Renames Newly Approved Pfizer Vaccine: ‘Comirnaty’ + More
The FDA Reveals the New Name for the Pfizer COVID Vaccine
According to the FDA, the Pfizer-BioNTech COVID-19 vaccine will be marketed as Comirnaty — pronounced “koe-mir’-na-tee.”
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- The vaccine will be marketed as a vaccine to protect against COVID-19 disease for those 16 years old and up.
- Anyone from 12 to 15 years old can get the vaccine under emergency use approval, but it has not been fully approved for those age groups.
FDA Grants Full Approval to Pfizer/Biontech COVID-19 Vaccine
The U.S. Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” the FDA said in its announcement on Monday.
Maryland Gov. Hogan Calls for Expedited Approval of COVID-19 Vaccine in Children Under 12
Maryland Governor Larry Hogan called for an expedited approval for the COVID-19 vaccine in children younger than 12 years old on Monday.
In a statement following the approval of the Pfizer COVID-19 vaccine by the U.S. Food and Drug Administration (FDA), Hogan wrote, “We want to thank federal officials for authorizing full approval of the Pfizer vaccine, which is something we have been pushing for over the last several weeks. For people who are still hesitant about getting the vaccine, this is an assurance that it has met the most rigorous standards for safety and effectiveness.”
“We also continue to call on the federal government the expedite approval so that our 5- to 11-year-olds can begin receiving COVID-19 vaccines,” the statement continued. “Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away.”
Pfizer and BioNTech Surge After the FDA Officially Approves Its COVID-19 Vaccine
Shares of Pfizer and BioNTech surged on Monday after the FDA officially approved their COVID-19 vaccine.
Pfizer jumped as much as 5% to near record highs, while BioNTech was up as much as 11% in Monday trades …
Pfizer’s first-mover advantage in the COVID-19 space helped the company gain more than $30 billion in revenue from its vaccine in 2021. That revenue figure could move even higher going forward as the company evaluates a third booster shot, which is expected to be administered next month.
Monoclonal Antibodies Are Free and Effective Against COVID-19, but Few People Are Getting Them
When Mike Burton came down with a breakthrough case of COVID-19 earlier this month, the infection posed a double threat to his family. At 73, the retired surgeon faced elevated risk of serious illness. His wife, Linda, has a suppressed immune system, the result of drugs she takes after two liver transplants that put her in greater danger of life-threatening illness.
The Burtons, both vaccinated, moved to separate parts of their Mount Sterling, Ky., home, masked up and hoped for the best.
Then a friend called and insisted they ask their doctors about monoclonal antibodies — an effective, widely available COVID-19 therapy that few people are receiving.
WHO Chief Calling for Two-Month Halt on Vaccine Boosters
World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus on Monday called for a two-month moratorium on COVID-19 booster shots as many low- and middle-income countries still struggle to provide enough vaccine doses for their citizens.
The Associated Press reported Ghebreyesus made these remarks while speaking to reporters in Budapest. The WHO head argued that “vaccine injustice and vaccine nationalism” fuels the risk of more infectious COVID-19 variants emerging.
He had made a similar call for a moratorium on booster shots in richer nations earlier this month, arguing that it has yet to be proven whether a booster shot is any more effective at preventing COVID-19 transmission than the two shots that are normally administered.
Burial Costs Covered for Canadians Killed by Approved Vaccines
Burial costs will now be covered by Ottawa for individuals killed by federally approved vaccines.
According to Blacklock’s Reporter, the department of health will pick up the tab and says the new program “addresses a longstanding gap in Canada’s national immunization programming by providing a timely, no-fault financial support mechanism for all people in Canada, in rare instances where they are seriously and permanently injured performing a public good, being immunized.”
The Vaccinated Are Worried and Scientists Don’t Have Answers
Anecdotes tell us what the data can’t: Vaccinated people appear to be getting the coronavirus at a surprisingly high rate. But exactly how often isn’t clear, nor is it certain how likely they are to spread the virus to others.
Though it is evident vaccination still provides powerful protection against the virus, there’s growing concern that vaccinated people may be more vulnerable to serious illness than previously thought.
There’s a dearth of scientific studies with concrete answers, leaving public policy makers and corporate executives to formulate plans based on fragmented information. While some are renewing mask mandates or delaying office reopenings, others cite the lack of clarity to justify staying the course. It can all feel like a mess.
Nascar Star Says Asking About Vaccinations Like Asking About Vasectomies
Joey Logano was taking every possible precaution to keep COVID-19 from eliminating him from NASCAR’s impending playoffs.
He said he watches where he goes and who he’s with and this week canceled three public appearances. He also went a step further and got vaccinated.
Corey LaJoie became an example of what can happen to unvaccinated NASCAR drivers: He missed Sunday’s race at Michigan because the rules state that competitors who haven’t gotten jabbed but are exposed to someone who tested positive for COVID-19 must quarantine for seven days.
New Evidence Points to Antibodies as a Reliable Indicator of Vaccine Protection
When Dr. Anthony Fauci spoke recently at a White House briefing about the need for COVID-19 booster shots, buried in his slideshow of charts and data points was a little-noticed scientific paper that offers evidence for a reliable way to predict how much protection a COVID-19 vaccine offers.
The study appeared on a preprint server earlier this month without much fanfare, but many interested in the future of COVID-19 vaccines had been eagerly awaiting the results.
The researchers were looking for markers in vaccinated patients’ blood that would indicate protection against COVID-19, what’s known as “correlates of immunity.” What the team of scientists found were neutralizing antibodies — proteins made by the immune system that are known to disarm the coronavirus.
FDA Warns Against Ivermectin as COVID Treatment
The Food and Drug Administration (FDA) reiterated a warning against the use of ivermectin as a COVID-19 treatment amid growing reports of individuals taking the drug often used to treat parasitic worms in animals.
Mississippi state health officials issued a recent alert prompted by increasing calls of people with potential ivermectin exposure taken to prevent or treat COVID-19 infection. While the drug has FDA-approval for certain uses in animals and humans, over 70% of the recent calls involved livestock formulations, officials said.
The FDA previously issued concerns over self-medication with ivermectin intended for animals, noting some people might mistakenly believe the drug can substitute for ivermectin intended for humans.
China Hits Zero COVID Cases With a Month of Draconian Curbs
It’s been just over a month, and China has once again squelched COVID-19, bringing its local cases down to zero.
It was more difficult this time, even though the leaders of the world’s most populous nation used the same playbook they followed to quell more than 30 previous flare-ups. The arrival of the more infectious delta variant has raised the stakes, as the pathogen refines its ability to escape curbs and flout vaccination. It’s unclear how long the victory will last.
The China model shows what it takes to get COVID under control, and raises questions about whether other nations would be willing – or able – to follow the same draconian steps.
U.S. Reviewing if Moderna Shot Tied to Higher Heart Inflammation Risk + More
U.S. Reviewing if Moderna Shot Tied to Higher Heart Inflammation Risk
U.S. health officials are reviewing reports that Moderna Inc’s (MRNA.O) COVID-19 vaccine may be linked to a higher risk of a rare heart condition in younger adults than previously thought, the Washington Post reported late on Thursday, citing people familiar with the review.
The review was focused on Canadian data that suggests a higher risk from the shot than the Pfizer-BioNTech vaccine, especially in men below the age of 30, according to the paper.
Vaccination Status May Be Considered to Get ICU Beds at Dallas-Area Hospitals if COVID Spread Worsens
If North Texas starts running out of ICU beds, doctors may have to consider coronavirus vaccination status as a factor in who gets priority care — a situation health officials hope to avoid but worry is becoming increasingly likely — with the vaccinated potentially being prioritized for treatment on the assumption that they’re more likely to survive.
WHO Issues Call for Experts to Help With COVID Origins Probe
U.S. News & World Report reported:
The World Health Organization has issued a call for experts to join a new advisory group it’s forming, in part to address the agency’s fraught attempts to investigate how the coronavirus pandemic started.
In a statement on Friday, the U.N. health agency said the new scientific group would provide the WHO with an independent analysis of the work done to date to pinpoint the origins of COVID-19 and to advise the agency on necessary next steps. The experts will also provide guidance on critical issues regarding the potential emergence of other viruses capable of triggering outbreaks, such as MERS and Ebola.
Fauci Says U.S. Expanding COVID Vaccine Manufacturing to Donate More Doses to the World
The United States is expanding manufacturing of COVID-19 vaccines to donate more doses to countries that don’t have as much access to the lifesaving shots.
“We are now working on greatly expanding the capacity to allow us to donate hundreds and hundreds of millions of doses to the low- and middle-income countries,” Dr. Anthony Fauci, medical advisor to President Joe Biden, said in an interview Thursday on CNBC’s “Closing Bell.”
After Pandemic Ravaged Nursing Homes, New State Laws Protect Residents
When the coronavirus hit Martha Leland’s Connecticut nursing home last year, she and dozens of other residents contracted the disease while the facility was on lockdown. Twenty-eight residents died, including her roommate.
But under a law Connecticut enacted in June, nursing home residents will be able to designate an “essential support person” who can help take care of a loved one even during a public health emergency. Connecticut legislators also approved laws this year giving nursing home residents free internet access and digital devices for virtual visits and allowing video cameras in their rooms so family or friends can monitor their care.
Similar benefits are not required by the Centers for Medicare & Medicaid Services, the federal agency that oversees nursing homes and pays for most of the care they provide. But states can impose additional requirements when federal rules are insufficient or don’t exist.
Sens. Wicker, King, Hickenlooper Test Positive for COVID-19 After Vaccination
Sens. Roger Wicker, Angus King and John Hickenlooper all have COVID-19 breakthrough infections, their respective offices announced Thursday.
Wicker, a Republican from Mississippi, and King, an independent from Maine who caucuses with Democrats, both tested positive for the virus following mild symptoms, according to their statements, released earlier in the day. Later on Thursday, Hickenlooper, a Democrat from Colorado, announced that he, too, tested positive following mild symptoms.
4 in 10 Parents Have No Plans to Get Child Vaccinated for School: Poll + More
4 Out of 10 Parents Have No Plans to Get Child Vaccinated for School: Poll
Almost 90% of U.S. parents plan to send their kids back to the classroom this fall, but fewer than 60% plan to get a COVID-19 vaccine for those who are old enough, a new poll reveals.
Anxiety is also high among many parents, who wonder just how safe in-person learning will be as the highly contagious Delta variant spreads nationwide and the pandemic grinds on.
“To feel safe sending their children to school in-person, most parents — especially those still unsure about in-person schooling — want classroom ventilation, teachers to be vaccinated, and social distancing in schools, in that order,” said Heather Schwartz, director of Pre-K to 12 educational systems at RAND, a nonprofit research organization.
UW Medicine Pulls Heart Transplant Patient From List After Refusing COVID Vaccine
The University of Washington Medical Center denied organ transplants to patients who refuse a COVID vaccine as early as June 2021. And hospital officials refuse to answer basic questions about their policy.
In fact, they won’t even directly acknowledge they have a policy.
The Jason Rantz Show on KTTH has learned that UW Medicine removed a 64-year-old patient from the transplant waitlist. He says he was on the list for two and a half years. The hospital made the decision after they learned the patient refused to be vaccinated against COVID. They said they would consider adding him back to the waitlist should he satisfy their “compliance concerns.”
Fully Vaccinated People With ‘Breakthrough’ COVID Delta Infections Carry as Much Virus as the Unvaccinated
A study by University of Oxford scientists has found that people who contract the Delta variant of COVID-19 after being fully vaccinated carry a similar amount of the coronavirus as those who catch the disease and have not been inoculated. The researchers stressed that vaccination still offers good protection against catching the disease in the first place, and protects against getting seriously ill with it.
The survey of real-world U.K. data indicates, however, that vaccinated people with “breakthrough” infections could still pose a significant infection risk to those who have not been vaccinated.
“With Delta, infections occurring following two vaccinations had similar peak viral burden to those in unvaccinated individuals,” the study, which has not yet been peer reviewed, concludes. Viral “burden” or viral load refers to how much coronavirus-infected people carry and thus “shed,” or release into the environment around them, where it can potentially infect others.
Where’s the Data on Delta? Lack of Testing, Info Makes It Hard to See Virus’s Full Scope
In the earliest and darkest days of the pandemic last year, health experts were plagued by a lack of coronavirus testing, long wait times for results and an incomplete picture of what was driving outbreaks.
Now, more than a year and a half later, many public health professionals are confronting the same issues.
The delta variant is fueling a devastating new surge of infections, but experts say declines in testing and a lack of granular data about hospitalizations make it difficult to know just how much the virus is circulating in communities — and who remains most vulnerable.
Why Push for Boosters Could Make Pandemic Even Worse
Officials at the World Health Organization said Wednesday that it strongly opposes booster shots for all adults in rich countries because the boosters will not help slow down the pandemic. By diverting doses away from unvaccinated people, booster shots will help drive the emergence of more dangerous mutants, the WHO doctors said.
“I’m afraid that this [booster recommendation] will only lead to more variants … And perhaps we’re heading into an even more dire situation,” WHO chief scientist Dr. Soumya Swaminathan said.
Will Johnson & Johnson COVID-19 Vaccine Recipients Need Booster, Too?
The plan for booster shots laid out by health officials on Wednesday applies to Americans who received both doses of an mRNA COVID-19 vaccine, but for the nearly 14 million who received Johnson & Johnson’s one-dose jab, the details are not yet clear.
According to the Centers for Disease Control and Prevention (CDC), the data behind the booster plan includes studies that demonstrated waning vaccine effectiveness against COVID-19 infection in people who received either the Pfizer-BioNTech or Moderna two-dose shots. The rollout for those shots began months before the Johnson & Johnson vaccine received FDA authorization, however, so the data on long-term effectiveness is forthcoming.
