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Pfizer to apply for FDA approval for first COVID vaccine booster shot for kids aged 16 and 17


Pfizer is seeking FDA approval for COVID-19 booster shots for older teens as the Omicron variant of the virus continues to spread worldwide.

The drug-maker is expected to apply for regulatory approval for the booster shot of their vaccine this week.

If approved, children aged 16 and 17 would be able to receive the jab. It would be the first booster shot available to anyone under 18.

Pfizer’s COVID vaccine – comprised of two doses – is the only one to be approved for children aged five and up in the United States.  

The push comes as President Joe Biden warned the nation Monday about the Omicron variant, saying it was ‘a cause for concern, not a cause for panic’.

Pfizer is seeking FDA approval for COVID-19 booster shots for older teens as the omicron variant of the virus continues to spread worldwide

Pfizer and its vaccine development partner BioNTech are expected to request FDA authorization for the booster for the specific age group in the coming days, the Washington Post confirmed Monday. 

Sources familiar with the matter – speaking anonymously – told the newspaper regulators are expected to sign off on approval as early as in one week.

Pfizer did not immediately respond to DailyMail.com’s request for comment. 

This assertion mirrors claims made by Biden who said he is making an effort to eliminate all roadblocks as officials battle Omicron.

While the president claims health expert don’t expect a new vaccine will be necessary to combat the variant, he will fast track that process if it becomes needed.

‘Dr. Fauci believes that the current vaccines provide at least some protection against the new variant and that boosters strengthen that protection significantly,’ Biden said. 

‘I will also direct the FDA and the CDC to use the fastest process available without cutting any corners for safety to get such vaccines approved and on the market if needed. 

He added: ‘Look, I’m sparing no effort at removing roadblocks to keep the American people safe.’

The drug-maker is expected to apply for regulatory approval for the booster shot of their vaccine this week. If approved, children aged 16 and 17 would be able to receive the jab. It would be the first booster shot available to anyone under 18

The drug-maker is expected to apply for regulatory approval for the booster shot of their vaccine this week. If approved, children aged 16 and 17 would be able to receive the jab. It would be the first booster shot available to anyone under 18

The push comes as President Joe Biden warned the nation Monday about the omicron variant, saying it was 'a cause for concern, not a cause for panic'

The push comes as President Joe Biden warned the nation Monday about the omicron variant, saying it was ‘a cause for concern, not a cause for panic’ 

Biden also encouraged eligible Americans to get vaccinated and receive their booster shots. 

The CDC also called on all Americans aged 18 and up to get their booster Monday, having previously advised that only adults aged 50 and up should receive their booster injection.

‘You have to get your vaccine. You have to get the shot. You have to get the booster,’ Biden added. 

‘Sooner or later we’re going to see new cases of this variant here in the United States.’ 

He continued: ‘The best protection against this new variant or any of the of the various ones out there … is getting fully vaccinated. As additional protection, please wear your masks indoors in public settings around other people.’

Currently, Americans ages 18+ are eligible to get a booster jab six months after having received their second dose of the Pfizer-BioNTech and Moderna vaccines.

Those who received the one-shot Johnson & Johnson shot can also get their booster two months after their initial dose.

The omicron variant of COVID has yet to be detected in the United States. It is also unclear how much of a threat it will pose

The omicron variant of COVID has yet to be detected in the United States. It is also unclear how much of a threat it will pose

The new variant has around 50 mutations and more than 30 of them are on the spike protein. The current crop of vaccines trigger the body to recognize the version of the spike protein from older versions of the virus. But the mutations may make the spike protein look so different that the body's immune system struggles to recognize it and fight it off

The new variant has around 50 mutations and more than 30 of them are on the spike protein. The current crop of vaccines trigger the body to recognize the version of the spike protein from older versions of the virus. But the mutations may make the spike protein look so different that the body’s immune system struggles to recognize it and fight it off

Meanwhile, the omicron variant of COVID has yet to be detected in the United States. It is also unclear how much of a threat it will pose. 

The World Health Organization (WHO) has warned the new variant poses a ‘severe’ risk to the world’s pandemic recovery and the odds of it being infectious enough to spread quickly are ‘very high.’

Omicron, which was first identified in South Africa but is thought to have originated in Botswana, is the most-mutated form of the coronavirus yet found.

The new variant has around 50 mutations and more than 30 of them are on the spike protein. 

The current crop of vaccines trigger the body to recognize the version of the spike protein from older versions of the virus. But, the mutations may make the spike protein look so different that the body’s immune system struggles to recognize it and fight it off.

The new variant was first detected last week and most cases are concentrated in South Africa, where daily infections soared to 6,048 on Saturday, a 20-fold increase on the 306 positive tests registered two weeks earlier. 

Deaths have so far remained flat, with 20 recorded on Saturday.

More than 48 million cases of coronavirus have been detected in the US to date

More than 48 million cases of coronavirus have been detected in the US to date

The current 7-day moving average of daily new cases in the US (88,482) increased 16.1% compared with the previous 7-day moving average (76,223). A total of 47,352,367 COVID-19 cases have been reported as of November 17, 2021

The current 7-day moving average of daily new cases in the US (88,482) increased 16.1% compared with the previous 7-day moving average (76,223). A total of 47,352,367 COVID-19 cases have been reported as of November 17, 2021

Almost 70 percent of the U.S. population has now had one dose of the vaccine or more, but that still leaves millions unprotected across the country

Almost 70 percent of the U.S. population has now had one dose of the vaccine or more, but that still leaves millions unprotected across the country

South Africa province where the Omicron COVID-19 variant was first detected sees 330% surge in hospitalizations in the past two weeks 

The South African province where the Omicron COVID-19 variant was first detected has suffered a more than 300 percent increase in virus related hospitalizations this week.

Gauteng, which includes the city of Johannesburg, recorded 580 hospitalizations because of the virus this week, per official data – a 330 percent jump from 135 two weeks ago.

Just under 40 percent of the provinces 12 million residents have received at least one shot of a COVID-19 vaccine – third-lowest of the nation’s 12 provinces.

Last week, the new Omicron variant was sequenced in 77 cases in the region, and many fear it is the most infectious strain of the virus yet and that it could evade vaccine protection because of its high number of mutations.

While South African health officials have reported that cases of the variant are often mild, the increase in hospitalizations in the province seems to hint otherwise.

Gauteng is the largest province in the country by population, as it is home to more than 12 million people.

After a Covid surge around three months ago, the province has experienced decreasing hospitalizations from the virus for weeks.

During the week that ended on November 7, 120 Covid related hospitalizations were detected.

Last week, that figure doubled to 276, before jumping to 580 last week.

Because genetic sequencing is only performed on a small percentage of positive tests, experts can not say which people have Omicron versus another strain. 

Doctors have said symptoms among patients are mild and include tiredness, muscle aches and a headache.

But they warned the first cases of the variant — scientifically known as B.1.1.529 — in the country have been among younger people, who tend to have higher infection levels due and experience milder illness.  

Vaccine manufacturers are reportedly working to determine the efficacy of their existing products against the variant. 

Experts expect that the vaccines will still offer some protection against the virus, but real world data could reveal the jabs are less effective against omicron compared to previous strains.

However, some scientists have warned the new strain could make COVID vaccines 40 percent less effective. 

But they said emergence of the mutant variant makes it even more important to get a booster jab the minute people become eligible for one. 

The vaccines trigger neutralizing antibodies, which is the best protection available against the new variant. So the more of these antibodies a person has the better, experts said. 

Scientists have also warned the world is weeks away from knowing what impact the new variant will have, due to the delay in people catching the virus and becoming severely unwell.   

Fauci, the US chief medical advisor, said ‘it will take approximately two more weeks’ until experts have more definitive information on transmissibility and severity.

Additionally, WHO noted that how transmissible the variant is; how well vaccines protect against infection, hospitalization and death caused by Omicron; and whether the virus causes more severe illness compared to previous strains are the questions that need to be answered.

It said ‘there is currently no information to suggest that symptoms associated with omicron are different from those from other variants’.

It also warned the variant could change the ‘trajectory of the pandemic’ and the ‘consequences may be severe’. 

Omicron was detected in South Africa last week, where most cases are concentrated, and was quickly spotted in Botswana, Hong Kong, Israel and Belgium.

Cases have since been reported in the Netherlands, Germany, Italy, the Czech Republic, Australia and the UK. 

Most cases have been spotted in Gauteng, a province in north east South Africa where Johannesburg is based. 

The first case was uploaded on November 23 to international variant database GISAID by Hong Kong and was spotted in someone who travelled to the country from South Africa.  



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