Thursday, October 28, 2021

FDA advised to authorise Pfizer COVID-19 vaccine for US children aged five to 11

An expert panel has voted overwhelmingly to recommend the US Food and Drug Administration (FDA) authorise the Pfizer COVID-19 vaccine for children aged five to 11, saying the benefits of inoculation outweigh the risks.

The vaccine, could be made available to those younger children in the US as early as next week. The FDA is not obliged to follow the advice of its outside experts, but usually does.

If the FDA authorises the shots for this age group, an advisory panel to the US Centers for Disease Control and Prevention (CDC) will meet next week to make a recommendation on the administration of the vaccine.

Pfizer and BioNTech, the companies behind the vaccine, have said the shot was 90.7 per cent effective against coronavirus in a clinical trial of children aged five to 11.

While children becoming seriously ill or dying from COVID-19 is relatively rare compared with adults, some develop complications, and infections in unvaccinated children have risen due to the highly transmissible Delta variant.

Amanda Cohn, a paediatric vaccine expert at the CDC and a voting member of the panel, said the question was "pretty clear". "We don't want children to be dying of COVID, even if it is far fewer children than adults, and we don't want them in the ICU," she said.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose of the vaccine in children, versus 30 micrograms for those aged 12 and older.

The advisers paid close attention to the rate of a heart inflammation, called myocarditis, that has been linked to both the Pfizer/BioNTech and Moderna vaccines, particularly in young men.

If the number of myocarditis cases in the younger age group was similar to that in 12 to 15-year-olds, the hospitalisations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analysed, FDA staff reviewers said.


Children Shouldn’t Get COVID-19 Vaccines, Harvard Professor Says

Children should not get vaccinated against the virus that causes COVID-19, according to Harvard University professor of medicine Martin Kulldorff.

“I don’t think children should be vaccinated for COVID. I’m a huge fan of vaccinating children for measles, for mumps, for polio, for rotavirus, and many other diseases, that’s critical. But COVID is not a huge threat to children,” he said on EpochTV’s “American Thought Leaders” program. The full episode can be watched on EpochTV.

“They can be infected, just like they can get the common cold, but they’re not a big threat. They don’t die from this, except in very rare circumstances. So if you want to talk about protecting children or keeping children safe, I think we can talk about traffic accidents, for example, which they are really at some risk.

“And there are other things that we should make sure [of] to keep children safe. But COVID is not a big risk factor for children.”

Vaccinating older people and people of all ages with compromised immune systems against the coronavirus has drawn support from most medical experts. But vaccinating healthy young people, particularly children, has triggered more opposition, in part because of how little risk COVID-19 poses to them.

Children are more likely to contract serious disease or die from the annual influenza, or the flu, than COVID-19, according to data and studies that Kulldorff has reviewed. Just 195 children under the age of 4 and 442 between 5 and 18 have died from COVID-19 in the United States as of Oct. 20, according to the Centers for Disease Control and Prevention. Children are 15 times less likely to be hospitalized with the disease than individuals who are 85 or older, and 570 times less likely to die, the agency says.

“One example is from Sweden, during the first wave in the spring of 2020, which affected Sweden quite strongly,” Kulldorff said. “But Sweden decided to keep daycare and schools open for all children ages 1 to 15. And there are 1.8 million such children who got through the first wave without vaccines, of course, without masks, without any sort of distancing in schools.

“If a child was sick, they were told to stay home. But that was basically it. And you know how many of those 1.8 million children died from COVID? Zero. Only a few hospitalizations. So this is not a risky disease for children.”

When weighing whether to vaccinate children, the risk of vaccine side effects must also be taken into account, Kulldorff said. The main risk to young people seen so far is heart inflammation, which has occurred post-vaccination at much higher than expected rates. The Food and Drug Administration (FDA) added a warning label to the Pfizer and Moderna vaccines over the summer about myocarditis and pericarditis, two types of heart inflammation.

“If you’re 78 years old, then it’s the no-brainer, in my view, because the benefits are so great that even if you have a small risk for some adverse reaction, the benefit far outweighs the risk,” Kulldorff said. “On the other hand, if you have already have immunity from having had COVID, then the benefits of the vaccines are much, much smaller. If you’re a child, even if you haven’t had COVID, the risk of serious disease or death is minuscule … So it’s not at all clear that the benefits outweigh the risks for children.”

Kulldorff was speaking ahead of an FDA advisory panel meeting. Members on Oct. 26 decided to advise drug regulators to authorize Pfizer’s COVID-19 vaccine for use in children between 5 and 11. They said the benefits of vaccinating the age group, such as the predicted decrease in hospitalizations, outweighed the risks, including estimated incidence of myocarditis.


Moderna says COVID-19 vaccine is safe and effective in children

Moderna's COVID-19 vaccine is safe and effective for children ages 6 to 12 years, the company announced on Monday (Oct. 25).

The findings are part of a clinical trial on the effectiveness and safety of the vaccine in around 5,700 children between the ages of 6 months and 12 years; More than 4,700 children between the ages of 6 and 12 years participated in the study and were given two doses of the vaccine 28 days apart, but at half the dose (50 µg) given to adults (100 µg).

The researchers found that the vaccine at this dose was "well tolerated," and side effects were similar to what was seen in adolescents and adults, according to a statement. The majority of adverse events were mild or moderate; and the most common side effects were fatigue, headache, fever and injection site pain, the company said.

They also found that the vaccine prompted a "strong immune response" one month after the second dose; children in this age group had 1.5 times higher antibody levels than those observed in young adults, the company said.

Moderna previously submitted data to the Food and Drug Administration (FDA) to get authorization for use of its vaccine in people ages 12 to 17, but the agency hasn't yet responded to the request. The company now plans to also submit this new data to the FDA and other regulatory agencies around the world.

Meanwhile, the researchers will continue to monitor the participants for 12 months after their second dose to assess long-term protection and safety.

Currently, Moderna is approved for those who are 18 years or older, while Pfizer is approved for those 12 years and older. Pfizer has already submitted a request to the FDA to authorize its vaccine for children ages 5 to 11, Live Science previously reported.


Vaccine Mandate Threatens Major Trucking Disruption, Industry Insiders Say

American truckers don’t like taking orders. But the Biden administration has increased pressure on some of them to take the vaccine—willing or unwilling.

All through the pandemic, truckers endured hardships to keep America’s infrastructure running. They waited in line for hours in sight of bathrooms they weren’t allowed to use. On the road, some died alone of COVID-19.

Now, with supply chains disrupted, Americans need them more than ever. But faced with the prospect of mandated vaccination, many drivers are considering quitting.

“I’d fight it,” said veteran trucker Mike Widdins, referring to a vaccine mandate. “I think a lot of us will be quitting. Who likes to be forced to do stuff you don’t want to do?”

Widdins isn’t alone in his willingness to leave trucking if he’s required to vaccinate. Polls by trucking publications Commercial Carrier Journal and OverDrive indicate that up to 30 percent of truckers will seriously consider quitting if required to vaccinate. If they quit, the consequences for America may be massive. US Transport estimates that 70 percent of American freight goes by truck.

“It would hurt shipping big-time,” Widdins said.

President Joe Biden ordered his administration to mandate vaccines for private companies with over 100 employees. The Occupational Safety and Health Administration was charged with developing the rule, and the Office of Budget and Management is currently reviewing it. The review process can take as long as 90 days.

Most of the trucking industry consists of companies with fewer than 100 employees, though a significant portion would fall under the over-100-employee umbrella.

Most truck companies have six trucks or fewer, according to the American Trucking Associations.

Some experts say the selective reach of the mandate makes it ineffective. Barbara Smithers, vice president of the Indiana Motor Truck Association, told The Epoch Times via email that it makes little sense to “cherry-pick” who to vaccinate based on company size.

“Truck drivers spend most of their work hours alone in the cab of a truck—literally one of the safest places possible during a pandemic—so why do they need to be regulated in this way?” she said. “Testing hundreds of thousands of truck drivers moving across the country every day is a virtual impossibility.”

For mandate-affected companies, Biden’s decision may drive away employees at a time when America needs them most. The American Trucking Associations estimates that America needs 80,000 more truckers to meet transportation needs.

Whether America runs short on trucks depends on the Biden administration’s orders and how truckers respond.

In the eyes of drivers, Biden’s mandate is the last step in a long line of restrictions that don’t consider their needs or wants.

For many drivers, a vaccine mandate may prove to be the final straw. Some drivers don’t trust the vaccine because of how new it is. Some distrust it for personal medical reasons. Others distrust it because they don’t trust the government.




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