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Covid News Watch

Sep 16, 2021

Pfizer to Seek FDA EUA for COVID Vaccine for 5- to 11-Year-Olds in Coming Weeks + More

Pfizer to Seek FDA EUA for COVID-19 Vaccine for 5- to 11-Year-Olds in Coming Weeks

ABC 10 News:

Children as young as five years old may soon get the COVID-19 vaccine. Friday, Pfizer announced that it would submit its clinical trials for their 5 to 11-year-olds to the Food and Drug Administration (FDA) in the coming weeks.

This March, Pfizer began testing 4,500 children in a three-age group trial for their COVID-19 vaccine. The groups include school-age children from five to eleven, preschool age children from two to five, and infants from six months to two years old.

Parents Seek COVID-19 Vaccine Trials for Their Children Ahead of Official Authorization

Fox News reported:

Many parents across the U.S. are racing to put their children in COVID-19 vaccine trials to try to protect them from the virus sooner rather than later.

The shots haven’t been proven to work safely for youngsters, and child volunteers in later-stage trials may get a placebo, rather than the vaccine. Yet parents said they were willing to take the chance and submit their children to the trials’ blood draws, COVID-19 tests and appointments to safeguard them, as well as their family and classmates.

Babies Could Be Given Pfizer’s COVID Vaccine in the U.S. This Winter

Daily Mail reported:

Pfizer’s COVID vaccine could be rolled out to babies as young as six months in the U.S. this winter, under plans being drawn up by the pharmaceutical giant.

In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.

America Has Its Own Virus Secrets

The Boston Globe via MSN reported:

Questions about the origin of the COVID-19 pandemic are being asked more insistently in Washington. President Biden has directed US intelligence agencies to tell him by the end of August whether the cause was an infected animal or a laboratory leak. He said he had “specific questions for China” and urged Chinese leaders “to participate in a full, transparent, evidence-based international investigation.” Secretary of State Antony Blinken accused China of “failure to meet its basic responsibilities in terms of sharing information and providing access.”

For more than a year, China resolutely ignored the pressure to allow neutral inspectors into its biological laboratory in the provincial capital of Wuhan, where the virus was first detected. Now it is adopting a different public posture. The new Chinese gambit might be called “I’ll show you mine if you show me yours.”

Myocarditis VAERS Analysis Sparks Social Media Uproar

Medpage Today reported:

Researchers are getting pushback over a medRxiv preprint that relied heavily on Vaccine Adverse Event Reporting System (VAERS) data to characterize myocarditis risk with the COVID-19 vaccine in adolescents, particularly young boys.

The report by Tracy Høeg, MD, PhD, of the University of California Davis, and colleagues found that rates of “cardiac adverse events” after the second dose were higher than previous CDC estimates, at 162 per million among boys ages 12 to 15 and 94 per million among boys ages 16 to 17. (Rates were much lower for girls, at about 13 per million for each age group.)

Mu Variant, Which May Be Vaccine-Resistant, in All 50 States After Nebraska Case

Newsweek reported:

The COVID-19 Mu variant was confirmed to be in all 50 U.S. states after the mutation was detected in Nebraska.

According to Outbreak.Info, which uses data from the GISAID virus reporting network, 5,659 Mu variant sequences have been detected worldwide, as of September 4. Of those, 2,436 were detected in the U.S.

Louisiana Nurses Refusing to Get the COVID Vaccine

The Guardian reported:

Louisiana’s largest hospital systems are requiring their employees to be fully vaccinated, but a minority of nursing staff say they are still considering leaving their jobs instead of getting the jab, citing concerns over personal liberty, lack of long-term studies, and discredited conspiracy theories …

“I will not take it and if I get fired, so be it,” said Pam, an LPN employed at an Oschner family medicine clinic in Hammond, Louisiana. “I’m completely against it. If they can take this freedom away from us, what else can they take away from us?

Doctor Argues for More Research Into Effects of COVID-19 Vaccines on Menstruation

CNN reported:

Clinical trials for coronavirus vaccines should include examination of any possible effects on women’s menstrual cycles — if only because so many women are worried about possible problems, a British expert argued Wednesday.

But there’s also evidence the immune response prompted by both vaccines and viral infections can temporarily affect menstrual cycles, so studying these effects is important, Dr. Victoria Male, a reproductive specialist at Imperial College London, wrote in the BMJ.

FDA Authorizes Additional Batch of Johnson & Johnson Vaccine From Troubled Baltimore Plant

Baltimore Sun reported:

The U.S. Food and Drug Administration has authorized an additional batch of COVID-19 vaccine produced by Johnson & Johnson at an East Baltimore plant where regulators previously determined several million doses of vaccine were unusable.

It is not clear how many doses the new batch contains, but regulators said in a Wednesday letter that they meet the agency’s standards for safety and effectiveness.

FDA Strikes Cautious, Neutral Tone Ahead of Friday Vaccine Booster Meeting

CBS 8 News reported:

Influential government advisers will debate Friday if there’s enough proof that a booster dose of Pfizer’s COVID-19 vaccine is safe and effective — the first step toward deciding which Americans need one and when.

The Food and Drug Administration on Wednesday posted much of the evidence its advisory panel will consider. The agency struck a decidedly neutral tone on the rationale for boosters — an unusual and careful approach that’s all the more striking after President Joe Biden and his top health advisers trumpeted a booster campaign they hoped to begin next week.

Sep 15, 2021

Champion Show Jumper, 22, Who Suffered Reaction to Moderna Vaccine May Never Ride Again + More

Champion Show Jumper, 22, Who Suffered ‘Extremely Rare’ Reaction to Moderna Vaccine May Never Ride Again

The Daily Mail reported:

A champion show jumper may never ride a horse again after two massive clots formed on her lungs in an incredibly rare reaction to the Moderna COVID-19 vaccine.

Imogen Allen, 22, was told by doctors that the clots, which formed two weeks after she was jabbed, could have been triggered by the vaccine alongside five years on the combined contraceptive pill.

Ms. Allen, from Woodcote, Berkshire, may never be able to ride a horse again and has had her dreams of becoming a police detective dashed after she was left bedbound.

FDA Staff Declines to Take Stance on Pfizer’s COVID Vaccine Booster Shots, Citing Lack of Verified Data

CNBC reported:

The staff of the Food and Drug Administration on Wednesday declined to take a stance on whether to back booster shots of Pfizer’s COVID-19 vaccine, saying U.S. regulators haven’t verified all the available data.

“There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” they wrote in a 23-page document published on the agency’s website. “Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.”

COVID Teams Can Vaccinate Pupils Against Parents’ Wishes, Schools Told

The Guardian reported:

Healthcare staff can decide whether children get a COVID vaccine against the wishes of their parents, according to government guidelines published on Wednesday that left some headteachers fearing protests at the school gates.

The guidelines say vaccinations for children aged 12 to 15 will be administered by School Age Immunisation Service (SAIS) teams that already carry out flu and human papillomavirus (HPV) vaccinations in England. The role of schools will be limited to providing a site and distributing information and consent forms to pupils and parents.

When It Comes to the Delta Variant, the Kids Are All Right

Washington Monthly reported:

Here’s the cost-benefit calculus parents need to consider — and it’s not a close call.

There’s little evidence that the Delta variant is more dangerous for kids than earlier versions of the virus. It spreads more easily, yes, but the minuscule death rate among infected children continues to drop compared with versions of the virus circulating last year.

By the end of July 2021, more than 80 percent of COVID-19 cases (adults and children) were caused by the Delta variant, according to data from the Centers for Disease Control and Prevention. That sounds like an alarming statistic, and in some ways, it is. But when it comes to children, the facts don’t merit panic. In July, eight children under age 15 died, compared with 17 in July 2020. Some of the decrease may be due to improved treatment and vaccination of children 12 years and older, but the case fatality rate for children too young for the vaccine is lower than last year.

Teens Turn to COVID-19 Vaccine Advocacy as Most State Laws Prohibit Minors From Being Vaccinated Without Consent

ABC News reported:

There is a high school sophomore from Texas who wakes up at 6 a.m. on the weekends when she knows her parents are asleep, so she can secretly and quietly make calls as an ambassador for a teen pro-vaccine group, fighting off vaccine misinformation.

The reason for all the cloak and dagger secrecy? The 15-year-old, who asked to be called Rain (not her real name), is the daughter of QAnon followers who hold strident views against mask wearing, social distancing and the coronavirus vaccine.

A Pfizer Analysis Makes the Case for a COVID Vaccine Booster

NPR reported:

The Food and Drug Administration released an analysis by Pfizer on the need for a booster shot of the Pfizer-BioNTech COVID-19 vaccine.

Pfizer’s analysis says data from Israel and the United States in the context of the Delta variant suggests “that vaccine protection against COVID-19 infection wanes approximately 6 to 8 months following the second dose.”

The company said the available data supports its request for FDA approval of a third dose of the COVID-19 vaccine to be given about six months after the second dose in people 16 years and older.

GOP Lawmakers Call for Pelosi to Subpoena Fauci on COVID-19 Origin

New York Post reported:

A group of House Republicans led by Rep. Chip Roy of Texas are calling on Speaker Nancy Pelosi to direct the committees of jurisdiction to subpoena multiple public health officials — including Dr. Anthony Fauci — to gain answers on the origin of the coronavirus.

In a letter sent to Pelosi on Tuesday, the lawmakers said that they have unsuccessfully attempted to seek information from multiple officials about the National Institute for Allergy and Infectious Diseases’ (NIAID) funding they believe may have been used for gain-of-function research, which can make viruses more infectious.

COVID-19 Hospitalizations Dropping in Florida

Fox News reported:

The number of people ending up in Florida’s hospitals with COVID-19 continues to drop this week, and that’s good news not just for strained staff but also patients who had elective procedures put on hold.

Florida looks to be in better shape now than a month ago when it comes to people hospitalized with the coronavirus.

“We’re looking at about a 40% improvement in the overall census over three weeks and about a 30% improvement in the ICU census,” said Justin Senior, the chief executive officer of Safety Net Hospital Alliance of Florida.

Sep 14, 2021

Cuba Will Begin Giving Shots to Children as Young as 2 + More

Cuba Will Begin Giving Shots to Children as Young as 2

The New York Times reported:

Cuba will begin vaccinating children as young as 2 against the coronavirus this week, making it the only country so far to immunize children that young.

The United States and many European countries currently allow COVID-19 vaccinations for children 12 and older. U.S. regulators could authorize a vaccine for children 5 to 12 later this year.

Chile has begun vaccinating children 6 and older. China and the United Arab Emirates are now vaccinating children as young as 3.

Over 14K Vaccinated People With Breakthrough COVID Cases Have Been Hospitalized or Died

Newsweek reported:

More than 14,000 vaccinated people in the U.S. have suffered severe illness from a breakthrough coronavirus infection.

As of September 7, at least 11,440 people who had a breakthrough case have been hospitalized and another 2,674 people who had a breakthrough infection have died, according to data from the U.S. Centers for Disease Control and Prevention (CDC).

Of these figures, 25% of breakthrough hospitalizations and 21% of breakthrough deaths were among asymptomatic individuals, or their hospital admission or death was not related to COVID-19, although they tested positive for the coronavirus.

Moderna COVID-19 Immunity Lasts 6 Months, No Need for Booster

UPI reported:

Immunity from the Moderna COVID-19 vaccine lasts at least six months, and there is no indication that fully vaccinated people will need a booster shot, a small study published Tuesday by Science found.

The vaccine also appears to produce long-lasting protection against the coronavirus in people of all ages, including those 70 and older who are at higher risk for serious illness, the data showed.

What Happens if You Get Your Flu Shot and COVID Booster at the Same Time?

Huffington Post reported:

Last year, public health experts were deeply concerned about the prospect of a flu and a COVID-19 “twindemic.” But as it turned out, seasonal flu activity was unusually low. This was likely due to the combination of masking, stay-at-home orders, reduced travel and people paying close attention to things like indoor ventilation.

No one yet knows what the upcoming flu season will hold, especially with states’ differing approaches to masking and social distancing.

But one thing is clear: Health guidelines continue to state that anyone ages 6 months and older should get their annual flu vaccine. And that means millions of people will get their flu shot at or around the same time they get a COVID booster dose (or, for some, their very first shot of the coronavirus vaccine).

Is that safe?

57% of Vaccinated COVID-19 Patients Hospitalized in First Half of 2021 Had Mild or Asymptomatic Infections, Study Finds

Yahoo!News reported:

A recent nationwide study may lead health officials to rethink how to analyze COVID-19 hospitalizations as a pandemic metric, The Atlantic reports.

After examining the electronic records for nearly 50,000 patients who had tested positive for COVID-19 at 100 Veterans Affairs hospitals across the United States between March 2020 and June 2021, researchers found that a significant number of the patients actually had mild or asymptomatic infections. Patients who required supplemental oxygen or registered a blood oxygen level below 94 were considered moderate to severe.

Biden’s Clashes With Own Experts Over COVID Booster Shots Undermine Promise to ‘Follow the Science’

Fox News reported:

Clashes between President Biden’s White House and the administration’s own experts over COVID-19 booster shots are threatening to undermine a key Biden campaign promise: that he would always “follow the science.”

The president promised in July 2020 that he would “[l]isten to the experts and follow the science.”

“Let’s set the partisanship aside. Let’s end the politics. Let’s follow the science,” he wrote in a November 2020 tweet.

But internal administration battles call into question whether the president is following the science or leading it.

Experimental Vaccine Lasts 1 Month at Room Temperature

Medical News Today reported:

While nearly 42% of the global population have received at least one dose of a COVID-19 vaccine, only 1.9% of individuals in low income countries have received at least one vaccine dose.

This inequitable distribution is, at least partly, due to the limited supply of vaccines and the stockpiling of vaccines by rich nations.

With the successful vaccination of a substantial proportion of the population in wealthier countries, the supply and distribution of vaccines to middle and low income nations are improving.

UK Plans COVID Boosters for Over-50s to Cope With ‘Bumpy’ Winter

Reuters reported:

Britain will begin a COVID-19 vaccine booster program for older and more vulnerable people soon as Prime Minister Boris Johnson’s government relies on vaccines rather than further lockdowns to navigate a “bumpy” winter.

Officials said COVID-19 vaccines had saved more than 112,000 lives and averted 24 million infections as they proposed a third shot for frontline health workers and those aged over 50 or clinically vulnerable, starting with people most at risk.

Johnson hopes the booster program, which is being undertaken without firm evidence about its likely impact, will mean that hospitals can bear the burden of all winter infections without the need for another lockdown.

Sep 13, 2021

Pfizer Vaccine Could Be Authorized for Kids Ages 5 to 11 in October + More

Pfizer Vaccine Could Be Authorized for Kids Ages 5 to 11 in October, Says Former FDA Head

Fox News reported:

The former head of the Food and Drug Administration said Sunday that Pfizer’s COVID-19 vaccine could be approved for children ages 5 to 11 by the end of October.

Dr. Scott Gottlieb, who helmed the FDA under President Trump and serves on Pfizer’s board of directors, said the company should get information on its vaccines on young kids before the end of September — paving the way for approval for the next age group to get the jab.

“In a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged 5 to 11 by Halloween,” Gottlieb said on CBS News’ “Face the Nation.”

The FDA Again Warns Parents Not to Get Children Under 12 Vaccinated Yet

The New York Times reported:

The U.S. Food and Drug Administration is “working around the clock” to make COVID vaccines available to young children, it said in a statement on Friday. In the meantime, however, the agency urged parents not to seek out the shots for children who are under 12, and therefore not yet eligible for vaccination.

The agency said that it hoped vaccines would be available for young children “in the coming months,” but that it could not offer a more specific timeline. However, once it has applications from the vaccine manufacturers in hand, it will “be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” Dr. Janet Woodcock, the acting FDA commissioner, and Dr. Peter Marks, of the agency’s Center for Biologics Research and Evaluation, said in the statement.

Poor Nutrition Plays Heavy Role in COVID-19 Death Toll, Studies Find

KTAR reported:

Even before COVID-19, America faced a crisis of poor nutrition aggravated by widespread food insecurity. Those underlying factors, researchers say, allowed the disease to decimate poor communities.

More than 42% of Americans are obese, according to the Centers for Disease Control and Prevention. Nearly half of adults have hypertension, and heart disease contributes to 1 in every 4 deaths in the U.S.

When the pandemic was declared in March 2020, a population riddled with underlying conditions found itself unable to fend off the coronavirus that causes COVID-19. The U.S. has recorded the most COVID-19 deaths in the world, with more than 652,000 and rising by more than 1,000 a day, the CDC says.

Single Jab Recommended for 12- to 15-Year-Olds by UK’s Top Doctors

BBC News reported:

Healthy children aged 12 to 15 should be offered one dose of a COVID vaccine, the UK’s chief medical officers say.

The CMOs said it would help reduce disruption to education.

It comes after the government’s vaccine committee said there was not enough benefit to warrant it on health grounds alone — but they said ministers could take into account other factors.

The CMOs concluded this tipped the balance given the virus was going to keep spreading over winter.

Boys More at Risk from Pfizer Jab Side-Effect Than COVID, Suggests Study

The Guardian reported:

Healthy boys may be more likely to be admitted to hospital with a rare side-effect of the Pfizer/BioNTech COVID vaccine that causes inflammation of the heart than with COVID itself, U.S. researchers claim.

Their analysis of medical data suggests that boys aged 12 to 15, with no underlying medical conditions, are four to six times more likely to be diagnosed with vaccine-related myocarditis than ending up in hospital with COVID over a four-month period.

Alabama Holds TikTok Contest to Encourage COVID Vaccines Among Young Adults

Newsweek via MSN reported:

To encourage young people to get COVID-19 vaccinations amid the U.S. surge, Alabama health officials looked to one of the most popular social media platforms as a way to reach the audience, the Associated Press reported. The state held a contest through TikTok that promised a $250 award to the creators of the best video promoting vaccinations.

Rotimi Kuyoki, 17, one of the four winners, shared his video with his 18,000 followers, which he accumulated over a two-year period by making jokes on his account, AP reported.

“I showed the CDC explaining how the vaccine is safe, and how it’s effective, and then I linked resources for people to sign up to get the vaccine,” Rotimi said.

Australia Starts Vaccinating Children as Young as 12

The New York Times reported:

Australia has opened up COVID-19 vaccinations to children as young as 12 as it races to inoculate the population amid an outbreak of the Delta variant.

Children ages 12 to 15 started receiving Pfizer-BioNTech vaccines on Monday. Appointments for the Moderna vaccine can be booked now for sessions starting next week.

Australia’s vaccine campaign is gaining speed after a sluggish first few months. Millions of doses that were ordered earlier this year are arriving, and the country will have enough supply by mid-October to vaccinate every eligible person, Prime Minister Scott Morrison said last week.

Mu Variant, Which May Be Vaccine-Resistant, in All 50 States After Nebraska Case

Newsweek via MSN reported:

According to Outbreak.Info, which uses data from the GISAID virus reporting network, 5,659 Mu variant sequences have been detected worldwide, as of September 4. Of those, 2,436 were detected in the U.S.

The variant, which first emerged in Columbia in January, remains relatively rare in the U.S. despite the presence of at least one case in each state and the District of Columbia. The strain is most common in Alaska, where it accounts for between 3 and 4 percent of COVID-19 cases, according to Outbreak.Info.

26 Out of the 27 Lancet Scientists Who Trashed Theory That COVID Leaked From a Chinese Lab Have Links to Wuhan Researchers

The Daily Mail reported:

Of the 27 scientists who wrote a letter in The Lancet medical journal dismissing the possibility that COVID-19 originated from a Wuhan lab, 26 have links to its Chinese researchers, their colleagues or its benefactors, a new investigation has revealed.

On March 7 last year, the influential journal published the letter in which the 27 scientists said they ‘strongly condemned conspiracy theories’ surrounding the origins of the coronavirus pandemic that has impacted all corners of the world.

All debate into whether COVID-19 had man-made origins or leaked from the lab in Wuhan — the Chinese city that was ground-zero for the virus — was effectively shut down by the letter.