'You're discrediting yourself!'...

'You're discrediting yourself!'...

'You're discrediting yourself!' Expert SLAMS FDA's approval of COVID-19 vaccines for children under 5 saying there is little evidence that they are needed as some parents of America's youngest kids line up to get them the shot

Americans children under the age of five have begun to receive the COVID-19 vaccine – with President Joe Biden exclaiming Tuesday that the nation is the only one in the world to jab children as young as six months old. Some experts are slamming the decision, and the subsequent discussion around the shots as dishonest and discrediting.

The Pfizer-BioNTech and Moderna vaccines were approved by both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) for children between six months and four years old last week, and their administration into children began this week.

Dr Vinay Prasad, an associate professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco, said that their was little evidence that the shots were needed in a YouTube video he uploaded Wednesday morning, and slammed officials and other media figures for not being ‘honest’ about the shots.

‘We’re the only country in the world doing this right now,’ Biden said at a vaccination clinic in Washington D.C. on Tuesday, while taking pictures with some in attendance. 
This is a great day for you all. Thanks for the example you are setting.’ 
Biden and other officials have some strong critics, though, with Prasad being among the most scathing, saying that the discussion around the virus was not convincing anyone, and instead was just pushing some people away.

‘All your lying and exaggerating, its gonna be the same thing. The 20 percent [of parents] that wants to [vaccinate their children] will do it, and you’re not flipping any votes,’ he said.
‘You’re not persuading anybody. You’re laying it on a little thick and in the process you’re discrediting yourself’. 
He also had strong criticism for the data being used by mainstream media outlets like the New York Times in order to promote the vaccine. 
Prasad points to a claim that the Moderna vaccine is 38 percent effective against the virus. He says that when data was adjusted by the firm to account for at-home testing – in which some cases do not get recorded properly – the effectiveness drops all the way to 27 percent.

He also said that there is little data available backing the claim that Pfizer’s vaccine is 80 percent effective at preventing infection.  
‘We need to be honest about these,’ he said.

Dr Marty Makary, a public health expert at Johns Hopkins University wrote on Twitter, in response to the CDC’s approval of the shots:
‘A more honest announcement would have been: “We approved the vax for babies & toddlers based on very little data. While we believe its safe in this population, the study sample size was too low to make a [conclusion] about safety. Note that studies were done in kids w/o natural immunity”‘

Florida is the only state in America that has not pre-ordered shots of COVID-19 vaccines for children in the newly approved age groups, saying this week: 
‘Our department of health has been very clear, the risks outweigh the benefits.
‘That’s not the same as banning it, people can still access it if they want to, and patents can to, but if you look at when they were doing the hearing, we had one physician say parents are really really frightened and we know that the risk is low, we’re not sure how this is gonna work, but parents are frightened about Covid for their kids.’
He said that fear, not science, is not a reason to approve the shots for kids, and pointed at the mainstream media as the reason for budding fear among parents.
‘Why would they be frightened about it? It’s because of media hysteria. It’s because of a lot of misinformation, that’s why they’re scared,’ he added.
Uptake for these shots may be limited, especially during the early stages of their rollout.

Polling for the Kaiser Family Foundation found that only about one in five parents of children under age five (18 percent) are eager to get their child vaccinated right away, while a larger share (38 percent) say they plan to wait a while to see how the vaccine is working for others. 
About four in ten parents of children under five are more reluctant to get their child vaccinated, with 27 percent saying they will ‘definitely not’ get their child vaccinated and 11 percent saying they will only do so if they are required. 
There was also limited demand for the shots last time the FDA made them eligible for a younger age group, children aged five to 11.

According to official CDC data, only 30 percent of Americans in the age group are fully vaccinated, half of the 60 percent between ages 12 to 17. Minors in general have low vaccination rates, with the youngest adults having vaccine uptake of around 80 percent.

Former FDA Chief Scott Gottlieb, who now serves as a board member at Pfizer, said over the weekend that he predicts demand for the jabs to be low at first.

‘I think it’s going to be a little bit more of a slow rollout relative to what we’ve seen in past rollouts with the other age groups,’ he told CBS’ Face the Nation.

‘There are going to be pharmacies that are vaccinating children. CVS is going to move it into their pharmacies, but they’re only moving in to the pharmacies with advanced care providers with their MinuteClinics.

‘Maybe around children’s hospitals, you’ll see some clinics stood up, but most people are probably going to get vaccinated in their pediatricians’ offices, and it’s going to take a little bit more time to get the vaccine into those local settings because it’s more difficult to vaccinate a child who is very young.’

Dr Ashish Jha, the White House’s Covid response coordinator, agrees that it will be slow at first, but hopes that uptake will eventually grow as parents are informed by their doctor.

‘We expect confidence in these vaccines to build over time in these populations,’ he said on CBS mornings on Monday.

‘What we have encouraged parents to do is talk to their family physician talk to their pediatrician, you know the people who take care of their kid and have that conversation. I think over time we are going to see a majority of parents ending up getting their children protected with these vaccines.’

Jha also encouraged parents to get their child vaccinated even if they had natural immunity from a previous Covid infection. 
‘Covid has been quite common in children actually we think almost 70 percent of kids have ended up getting infected with Covid,’ Jha told CBS mornings. 
‘Still worth getting the vaccine, it really offers an extra layer of protection and what vaccines do is they keep kids out of the hospital and that’s why they are so effective.

And everybody deserves that level of protection. Even if your child has been previously infected the strong recommendation is to get your child protected.’ 
There are still some concerns about the shots, though, and the small sample sizes used in their clinical trials. Especially as children make up around 0.1 percent of U.S. Covid deaths despite a vast majority having been infected at this point. 
The Pfizer jab will come in three doses, unlike the two dose standard set for older age groups. It will also be only three micrograms, a tenth of the size of the standard adult dose, and a third of dosage for children five through 12. 
The switch was made towards the end of last year when early data showed that only two doses of the jab provided little protection against the virus. 
‘We know many parents in the U.S. have been eagerly awaiting an authorized vaccine for their children under 5 and we are proud to now offer them a vaccine option with a favorable safety profile,’ Albert Bourla, CEO of New York City-based Pfizer, said in a statement. 
Moderna will use a two-dose jab for young children, with each shot being 25 micrograms – a fourth the size of its adult sized shots.

Pain, redness and swelling at the injection site, fever and swelling of the groin and underarm were the most common reported side-effects of the shots.

‘We are thrilled that the FDA has granted Emergency Use Authorization of Moderna’s COVID-19 vaccine for children and adolescents, particularly for our vulnerable, youngest children,’ Stephane Bancel, CEO of Moderna, said in a statement.

Both of the shot’s were deemed safe and effective by both the FDA and by a panel of outside advisors, known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

‘In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations,’ Dr Peter Marks, the FDA’s top regulator, said in a statement.

The most concerning, and most publicized, side-effects of the COVID-19 vaccines are the heart inflammation conditions myocarditis and pericarditis.

The FDA reports that the risk of these conditions is low in this age group, though, instead striking 12 to 17 year olds the most with the Pfizer shot, and 18 to 24 year olds with the Moderna jab.


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